StemCell Therapy

Q3 2020 NeuroMetrix Inc Earnings Call WALTHAM Oct 22, 2020 (Thomson StreetEvents) -- Edited Transcript of NeuroMetrix Inc earnings conference call or presentation Thursday, October 22, 2020 at 12:00:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Shai N. Gozani NeuroMetrix, Inc. - Founder, Chairman, CEO, President & Secretary * Thomas T. Higgins NeuroMetrix, Inc. - Senior VP, CFO & Treasurer ================================================================================ Conference Call Participants ================================================================================ * Jarrod M. Cohen JM Cohen & Company - MD * William Church ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Good morning, and welcome to the NeuroMetrix Third Quarter 2020 Earnings Call. My name is Shannon, and I will be your moderator on the call. On this call, the company may make statements which are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are predictive in nature that depend upon or refer to future events or conditions are forward-looking statements. Any forward-looking statements reflect current views of NeuroMetrix about future results of operations and other forward-looking information. You should not rely on forward-looking statements because actual results may differ materially as a result of a number of important factors, including those set forth in the earnings release issued earlier today. Please refer to the risks and uncertainties, including the factors described under the heading Risk Factors in the company's periodic filings with the SEC available on the company's Investor Relations website at neurometrix.com and on the SEC's website at sec.gov. NeuroMetrix does not intend and undertakes no duty to update the information disclosed on this conference call. I'd now like to introduce the NeuroMetrix Senior Vice President and Chief Financial Officer, Mr. Thomas Higgins. Mr. Higgins? -------------------------------------------------------------------------------- Thomas T. Higgins, NeuroMetrix, Inc. - Senior VP, CFO & Treasurer [2] -------------------------------------------------------------------------------- Thank you, Shannon. I'm joined on the call by Dr. Shai Gozani, our President and Chief Executive Officer. NeuroMetrix develops and commercializes neurostimulation-based medical devices for the diagnosis and treatment of chronic health conditions. Our commercial products are DPNCheck, ADVANCE and Quell. DPNCheck is a point-of-care test for the detection of peripheral neuropathies. ADVANCE is a point-of-care device that provides neuro conduction studies as an aid in diagnosing and evaluating patients suspected of having focal or systemic neuropathies. And Quell is a wearable mobile app-enabled neurostimulation device indicated for symptomatic relief and management of chronic pain. It is available over the counter. Q3 was a good quarter for the company, particularly considering the larger economic environment and the operating constraints imposed by managing the business with employee safety as the top priority. We experienced a rebound in customer orders from the second quarter of 2020. Production was busy throughout Q3 and facility utilization was necessarily high to address customer needs. Our operating activities, that is R&D, sales and marketing and G&A, were all tightly managed. The forward outlook remains unclear. We appreciate the customer demand levels, raw material supply and staffing issues all have a high degree of uncertainty. However, the business performance in Q3 leaves us with a sense of optimism as we enter the last quarter of the year. Turning to our operating results in Q3, which we reported earlier today. Total revenue was about $2 million. DPNCheck orders were strong in the quarter for both devices and biosensors. Demand in the Medicare Advantage sector from new accounts as well as long-standing customers led the way. Our Japanese business with Fukuda Denshi also contributed meaningfully to the quarter results. The ADVANCE diagnostic business rebounded from the depressed levels of Q2, and Quell contributed revenue and product line profitability. Our gross profit on revenue was $1.5 million. This was a gross margin rate of 73.6%. The strong margin level was an encouraging outcome from our efforts at targeting a sustainable margin of 70% plus going forward. Lower indirect production costs and higher throughput contributed to the margin. OpEx spending totaled just under $1.8 million. This level of spending has been consistent over the past 2 quarters, and it's about 1/3 below Q3 of 2019. The current spending level is sustainable going forward. R&D spending of $652,000 was about flat with the prior quarter and 37% higher than Q3 2019. It reflected R&D activity with a primary focus on the next-generation DPNCheck technology for release next year 2021. Sales and marketing spending of $340,000 was down 47% from Q3 of last year. And G&A spending of $762,000 was down 48% from Q3 of last year and reflects reduced professional services. Our net loss for the year was -- for the quarter was $257,000. This was an improvement of $1.1 million or 82% improvement versus Q3 2019 net loss of $1.4 million. On a per share basis, the Q3 2020 loss was $0.07 per share versus a loss of $1.44 per share in Q3 last year. Cash at the end of Q3 was $4.9 million, an amount sufficient to fund the company's operations into and likely through Q4 of 2021. Our capital structure is debt-free. There are about 3.8 million common shares outstanding. With that, let me turn this over to Dr. Gozani, who will now address our overall strategy. -------------------------------------------------------------------------------- Shai N. Gozani, NeuroMetrix, Inc. - Founder, Chairman, CEO, President & Secretary [3] -------------------------------------------------------------------------------- Thank you. As Tom outlined, we are pleased with the company's performance in the third quarter. So I'll take this opportunity to review our business strategy, which is built around 3 principles. The first is that we have prioritized attainment of profitability. This past quarter was encouraging in this respect as we reported an operating loss of about $250,000. We have established an efficient cost structure throughout the business. This covers headcount, manufacturing, marketing and distribution, which has led to lower operating expenses and improving gross margins. I should point out that our ability to realize these efficiencies is a testament to the commitment and talent of our employees. Because of the overall economic uncertainty and the need to get more experience with our business initiatives, we are not currently positioned to state a specific crossover quarter into profitability at this time. The second principle in our strategy is innovation. Our corporate mission is to bring innovative health care products to our customers that improve their health and quality of life. Our products are unquestionably the most advanced in their categories, whether that is neuropathy diagnostics or TENS devices. We have and will continue to maintain our historical focus and investment in R&D. The recent example is our launch of the Quell Watch app, the first smartwatch app to control a wearable pain relief device. Also, as we have previously announced, we are updating all elements of the DPNCheck system, which includes the device itself, the consumable biosensor and the associated reporting software. We recently launched the updated biosensor and expect to release the new software, which includes enterprise and data security features that our large Medicare Advantage customers are requesting. We expect to launch that before the end of the year. And the last principle in our strategy is maintaining a dynamic market strategy. We believe that achieving profitability and leveraging our industry-leading innovation requires a flexible strategy. By that, I mean that we need to be nimble in finding the best opportunities for our products. This is most clearly manifested in Quell, where we have defined 4 core clinical indications. The current application for Quell is lower extremity chronic pain, primarily knee pain, which affects up to 25% of adults in the U.S. Quell is particularly well suited to this application because of its typical placement near the knee and its novel wearable design that enables user activity. We have identified 3 additional indications that we plan to develop: fibromyalgia, chemotherapy-induced peripheral neuropathy or CIPN and restless leg syndrome or RLS. In combination, these conditions represent a market of 10 million to 20 million individuals in the U.S. We have pilot or randomized controlled trial data on all 3 with our fibromyalgia program the furthest along. We hope to announce program updates in the second half of next year. In summary, NeuroMetrix has novel products that are targeting large markets. We are committed and operationally efficient organization that is structured to support growth and move towards profitability. That completes our prepared comments, and we'd be happy to take any questions at this point. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) Our first question comes from Jarrod Cohen with JM Cohen & Company. -------------------------------------------------------------------------------- Jarrod M. Cohen, JM Cohen & Company - MD [2] -------------------------------------------------------------------------------- Yes. Just a quick question. It's been, I guess, what, 5 years since you've launched the Quell. And I'm just curious what your opinion is in terms of why haven't you seen more reoccurring revenue from the gel packs. Since I think you have, what, a little over 200,000 -- you sold a little bit over 200,000 Quell devices in the 5 years since then. -------------------------------------------------------------------------------- Shai N. Gozani, NeuroMetrix, Inc. - Founder, Chairman, CEO, President & Secretary [3] -------------------------------------------------------------------------------- Yes. That's correct, Jarrod. We have -- we've shipped around 200,000 devices over -- it's about 5.5 years now. Yes, I think there's -- we do have a recurring revenue stream from our Quell customers. And as you might expect in a consumer-oriented product, you are going to have churn and trail off of customers over time. Many customers use our product for a period of time. It helps them. They move -- they potentially don't need it anymore or they come back and forth or they go on to alternative therapy. So it's a fairly dynamic situation. I would say, overall, I would agree with you that we're not -- we're a little bit disappointed overall in the consistency of the recurring revenue stream from the consumables and are -- in fact, I think our moving-forward strategy is somewhat reflective of that, where we're focused on more specific indications that I think we can build better connections to the consumers and better serve their needs to get a stronger recurring revenue and more consistent recurring revenue stream. But I think, overall, the answer to your question is there are many reasons, some of which are expected and some of which I think we're somewhat disappointed. But we do have a consistent revenue stream from those customers and continue to see that, but we need to improve on it. -------------------------------------------------------------------------------- Jarrod M. Cohen, JM Cohen & Company - MD [4] -------------------------------------------------------------------------------- Okay. Because you don't give an exact -- but do you see from the existing installed base, about 25% of them coming back to you or even less than that? You don't give an exact number, I know that, but I'm just curious at this point in the life cycle. -------------------------------------------------------------------------------- Shai N. Gozani, NeuroMetrix, Inc. - Founder, Chairman, CEO, President & Secretary [5] -------------------------------------------------------------------------------- Yes. I don't have a good number to give you in that respect, and I think it's kind of a complicated situation. So I don't want to quote a number. Also for competitive reasons, we tend to be fairly subdued on what we describe. But it really depends. I mean, there's a wide variation among customers. I think it needs to be improved, clearly. And again, by being more focused on specific indications that allow us to build more specific services and support setting to the app and to our customer service for those applications, I think we'll strengthen that going forward. -------------------------------------------------------------------------------- Operator [6] -------------------------------------------------------------------------------- (Operator Instructions) Our next question comes from Bill Church with Tgra. -------------------------------------------------------------------------------- William Church, [7] -------------------------------------------------------------------------------- DPNCheck, how much market share growth is in front of us that we see going forward? -------------------------------------------------------------------------------- Shai N. Gozani, NeuroMetrix, Inc. - Founder, Chairman, CEO, President & Secretary [8] -------------------------------------------------------------------------------- Well, we have no -- so that's a good question. I mean the -- there is no competition, so we're the only player in peripheral neuropathy diagnostics at the point of care. So I think there's tremendous opportunity in terms of what the overall market. I mean we're at a fairly early stage, even in terms of our core effort in Medicare Advantage. So I would say that there is significant growth opportunities. We're probably at less than, I would say, what, 5% to 10% of the -- even Medicare Advantage opportunity, which is our core focus in the U.S. and even at lower percentages in international markets, so tremendous growth. Now I want to point out, I mean, this is an emerging concept for many plans and insurers to screen for peripheral neuropathy. So while the opportunity is quite large, there's a lot of education that has to go along with that, but the opportunity is quite impressive. -------------------------------------------------------------------------------- William Church, [9] -------------------------------------------------------------------------------- So how do we realize that? Or I know you've got the new software update coming and that sort of thing. But it's just getting the word out, I guess, or be improved for insurance plans and so forth? -------------------------------------------------------------------------------- Shai N. Gozani, NeuroMetrix, Inc. - Founder, Chairman, CEO, President & Secretary [10] -------------------------------------------------------------------------------- Well, in the U.S., our core focus is on Medicare Advantage accounts. We are in the 2 largest Medicare Advantage insurers in the country. So we've -- over the last 4, 5 years have become sort of standard of care within those insurers. And as they are expanding their footprint, as they are implementing programs, we tend to go along with that. It's not -- it's difficult to push the growth at the rate we'd like to see, because we're dealing with very large organizations, and they tend to develop relatively slowly. So it is getting the word out. It's providing the right kind of software to integrate into their enterprise solutions, and it's growing along with them and growing along with the Medicare Advantage business overall. So to your point, I mean, yes, we try to get the word out. We try to provide the right support. We'd obviously like to see it grow faster, but there is a pace to it that we have to appreciate. -------------------------------------------------------------------------------- Operator [11] -------------------------------------------------------------------------------- (Operator Instructions) I'm currently showing no further questions at this time. I'd like to turn the call back over to Dr. Gozani for closing remarks. -------------------------------------------------------------------------------- Shai N. Gozani, NeuroMetrix, Inc. - Founder, Chairman, CEO, President & Secretary [12] -------------------------------------------------------------------------------- Thank you, and we appreciate you joining us on this call today and look forward to updating you early next year. -------------------------------------------------------------------------------- Operator [13] -------------------------------------------------------------------------------- Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

Continued here:
Edited Transcript of NURO.OQ earnings conference call or presentation 22-Oct-20 12:00pm GMT - Yahoo Finance

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Cardiac Autonomic Neuropathy Treatment Market Is Expected To Experience An Impressive CAGR Growth Of XX% Through 2017 2025 - TechnoWeekly

INDIANAPOLIS and CAMBRIDGE, Mass., Oct. 15, 2020 /PRNewswire/ --Eli Lilly and Company (NYSE: LLY) today announced a definitive agreement to acquire Disarm Therapeutics, a privately-held biotechnology company creating a new class of disease-modifying therapeutics for patients with axonal degeneration. Disarm has discovered novel, potent SARM1 inhibitors and is advancing them in preclinical development, with the goal of delivering breakthrough treatments to patients with peripheral neuropathy and other neurological diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis.

Axonal degeneration is a common, yet unaddressed, pathology in a broad range of neurological diseases and is known to cause severe sensory, motor, and cognitive symptoms. Disarm's scientific founders, Dr. Jeffrey Milbrandt and Dr. Aaron DiAntonio of Washington University School of Medicine in St Louis, discovered that the SARM1 protein is a central driver of axonal degeneration. Disarm's SARM1 inhibitors are designed to directly prevent the loss of axons.

Under the terms of the agreement, Lilly will acquire Disarm for an upfront payment of $135.0 million. Disarm equityholders may be eligible for up to $1.225 billion in additional future payments for potential development, regulatory and commercial milestones should Lilly successfully develop and commercialize new medicines resulting from the acquisition.

"Lilly continues to seek medicines to treat the debilitating pain and loss of function associated with nerve damage," said Mark Mintun, M.D., vice president of pain and neurodegeneration research at Lilly. "The scientific team at Disarm discovered an important and highly promising approach to combat axonal degeneration. We will move quickly to develop their SARM1 inhibitors into potential medicines for peripheral neuropathy and neurological diseases, such as ALS and multiple sclerosis."

"Disarm's innovative approach to treating axonal degeneration holds tremendous promise for addressing a wide spectrum of neurological diseases, and we have made significant strides toward enabling potentially transformative therapies," said Alvin Shih, M.D., Chief Executive Officer of Disarm. "Lilly is ideally suited to advance this exciting new approach to treating axonal degeneration, and we look forward to seeing patients benefit from the work that Disarm initiated." Disarm was founded by Atlas Venture, Drs. Milbrandt and DiAntonio of Washington University School of Medicine in St. Louis, and Atlas Entrepreneurs-in-Residence Dr. Rajesh Devraj and Dr. Raul Krauss. Lightstone Ventures and AbbVie Ventures co-invested with Atlas to support the foundational work at Disarm.

This transaction will be reflected in Lilly's reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly's 2020 non-GAAP earnings per share guidance as a result of this transaction.

Aquilo Partners, L.P. acted as financial advisor and WilmerHale LLP as legal advisor to Disarm on this transaction.

About Disarm TherapeuticsDisarm Therapeutics is a biotechnology company that is creating a new class of disease-modifying therapeutics for patients with axonal degeneration, a central driver of neurological disability and disease progression. By inhibiting the SARM1 protein, identified by the company's scientific founders as the central driver of axonal degeneration, these therapeutics may prevent the loss of axons in chronic and acute diseases of the central, ocular, and peripheral nervous systems. For a broad range of diseases including multiple sclerosis, amyotrophic lateral sclerosis, glaucoma, and peripheral neuropathies, the therapeutic goal is to prevent further degeneration, stabilize disease, and allow for functional recovery.

AboutEli Lilly and CompanyLilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at http://www.lilly.com. C-LLY

Lilly Cautionary Statement Regarding Forward-Looking StatementsThis press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the benefits of Lilly's acquisition of Disarm Therapeutics ("Disarm"), and reflects Lilly's current beliefs. However, as with any such undertaking, there are substantial risks and uncertainties in implementing the transactionand in the process of drug development and commercialization. Among other things, there can be no guarantee that the transaction will be completed in the anticipated timeframe, or at all, or that the conditions required to complete the transaction will be met, that Lilly will realize the expected benefits of the acquisition, or that the acquisition will yield commercially successful products. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

Refer to:Mark Taylor; [emailprotected]; (317) 276-5795 (Lilly Media)Kevin Hern; [emailprotected];(317) 277-1838 (Lilly Investors)Stephanie Simon; [emailprotected]; (617) 581-9333 (Disarm Media)

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Lilly Announces Agreement to Acquire Disarm Therapeutics - PRNewswire

Several late-phase results were shared during the European Society of Medical Oncology (ESMO) Virtual Congress in gynecologic malignancies, but the data presented generated excitement about the number of novel options for patients after initial treatment.

Updated findings in ovarian cancer demonstrated continued benefit for PARP inhibition as maintenance therapies following frontline treatment in advanced ovarian cancer in the phase 3 SOLO-1 trial (NCT01844986) using the PARP inhibitor olaparib (Lynparza) and in the phase 2 PRIMA/ENGOT-OV26/GOG-3012 ([PRIMA], NCT02655016), which utilized the PARP inhibitor niraparib (Zejula).

Enthusiasm also surrounded a potential new approach in cervical cancer from the phase 2 innovaTV 204/GOG-3023/ENGOT-cx6 study ([innovaTV], NCT03438396), which explored treatment with the investigational antibody-drug conjugate tisotumab vedotin.

The longest duration of follow-up for any PARP inhibitor in the previously untreated advanced ovarian cancer setting was performed in the phase 3, randomized, double-blind, placebo-controlled, multicenter SOLO-1 trial, in which olaparib maintenance was given to patients with BRCA mutations. The 5-year follow-up results were presented at ESMO by Susan Banerjee, MD, PhD, FRCP, consultant medical oncologist and research lead for the Gynecology Unit at The Royal Marsden.1

The updated analysis after 5 years of follow-up shows that the benefit of olaparib continues substantially beyond the end of treatment, Banerjee told Targeted Oncology in an interview.

Out of the 391 patients assessed, 260 received olaparib maintenance and 131 received placebo for up to 2 years or until progressive disease (PD). Olaparib maintenance first demonstrated an improvement in progression-free survival (PFS) in the primary analysis with the median PFS not yet reached in the olaparib arm at this timepoint compared with 13.8 months in the placebo arm (HR, 0.30; 95% CI, 0.23-0.41).

The median follow-up for the updated analysis was 4.8 years in the olaparib arm compared with 5.0 years in the placebo arm. The results showed PFS events in 45% of the olaparib-treated population versus 76% of the placebo population. The median PFS observed with olaparib maintenance was 56.0 months compared with 13.8 months in the placebo arm (HR, 0.33; 95% CI, 0.25-0.43).

These are very encouraging results that will help us explain the potential benefits of maintenance olaparib in patients with BRCA mutations, said Banerjee.

A new analysis of the phase 3 randomized, double-blind, placebo-controlled, multicenter PRIMA trial presented during ESMO by GiorgioValabrega, MD, investigated the potential difference in efficacy and safety by age of niraparib maintenance after chemotherapy in patients with advanced ovarian cancer.

The key findings of our trial were that there is no difference in terms of safety and efficacy by adding niraparib to chemotherapy. Also, the [adverse events] that were observed in patients above 65 and 75 [years of age] in comparison to younger patients are not different, Valabrega, associate professor, University of Torino School of Medicine, told Targeted Oncology in an interview.

The subanalysis included 444 patients from the original PRIMA study who were 65 years of age or younger. Of the patients included in this analysis, 297 received niraparib and 147 received placebo.2

A second cohort from the analysis included 289 patients aged 65 or older. Among this group, 76 patients were 75 years or older. One hundred ninety of the patients received niraparib maintenance while 99 received placebo in the younger cohort and of those 75 years or older, 54 patients received niraparib and 22 received placebo.

Demonstrating consistency with the primary analysis which showed a median PFS on 13.8 months with niraparib compared with 8.2 months in the placebo arm, niraparib maintenance prolonged PFS compared with placebo in this subanalysis. In the patients under the age of 65, the median PFS was 13.9 months with niraparib versus 8.2 months with placebo (HR, 0.61; 95% CI, 0.47-0.81). Patients aged 65 or older had a median PFS of 13.7 months with niraparib versus 8.1 months with placebo (HR, 0.53; 95% CI, 0.39-0.74). In the 75 years of age or below group, niraparib led to a median PFS of 13.8 months compared with placebo, which had a median PFS of 8.2 months (HR, 0.62; 95% CI, 0.50-0.77). Finally, in patients aged 75 of older, the median PFS was 13.8 months with niraparib versus 5.6 months with placebo (HR, 0.37; 95% CI, 0.17-0.81).

Both ages groups were similar in terms of the number percentage of treatment-emergent adverse events (TEAEs) observed. The most common treatment-emergent TEAEs were anemia, leukopenia and hypertension. Notably, patients aged 65 years or older experienced a small increase in thrombocytopenia during treatment as did those aged 75 years of age or older. The rates of 3 TEAEs were also similar between the age groups.

Results from the single-arm, multicenter, international phase 2 study innovaTV were presented during ESMO by Robert Coleman, MD, FACOG, FACS, chief scientific officer of The US Oncology Network. The result of the study was that treatment with tisotumab vedotin led to antitumor activity in patients with previously treated recurrent or metastatic cervical cancer.3

We basically confirmed the responses that we saw in the first-in-human phase 1 and 2 study with a 24% response rate, Coleman told Targeted Oncology.

Importantly, 7% of those patients had complete response, which, for those of who have treated this disease, these are not common findings, he added.

As Coleman shared, the objective response rate observed in the trial was 24% (95% CI, 15.9%-33.3%), with complete responses in 7% of the population, partial respondes in 17%, and stable disease in 49%. In terms of PD, 24% of patients progressed on treatment. The median duration of response observed with tisotumab vedotin was 8.3 months (95% CI, 4.2 to not reached). Notably, the treatment also led to a decrease in target lesion size in 79% of the patients who received tisotumab vedotin when compared with their baseline measurements.

Among the confirmed responders, the median time to response was 1.4 months (range, 1.1-5.1). It was also noted during Colemans ESMO presentation that responses were seen across the subgroup populations explored, regardless of tumor histology, lines of prior therapy, or responses to prior treatment.

The median PFS achieved with tisotumab vedotin was 4.2 months (95% CI, 3.0-4.4). At 6 months, the PFS rate was 30% (95% CI, 20.8%-40.1%). The median overall survival with the agent was 12.1 months (95% CI, 9.6-13.9) and the 6-month OS rate was 79% (95% CI, 69.3%-85.6%).

Treatment-related AEs (TRAEs) occurred in greater than 10% of the study population. The majority of the (TRAEs) observed in this study were grade 1 and 2 in severity. The most TRAEs of any grade were alopecia (38%), epistaxis (30%), nausea (27%), conjunctivitis (26%), and fatigue (24%). One patient in the died as a results of treatment-related septic shock.

Ocular, bleeding, and neuropathy TRAEs were also assessed in the study and bleeding TRAES were most prevalent, with grade 1 events having observed in 34% of patients. Ocular TRAEs were the second most prevalent with grade 1 events having occurred in 25% of patients. Finally, grade 1 peripheral neuropathy occurred in 17% of patients.

Data from this study led to the conclusion that tisotumab vedotin is a potential new treatment option for patients with previously treated recurrent of metastatic cervical cancer.

References:

1. Banerjee S, Moore KN, Colombo N, et al. Maintenance olaparib for patients (pts) with newly diagnosed, advanced ovarian cancer (OC) and a BRCA mutation (BRCAm): 5-year (y) follow-up (f/u) from SOLO1. Presented at: 2020 ESMO Virtual Congress; September 19-21, 2020. Virtual. Abstract 811M0.

2. Valabrega G, Pothuri B, Oaknin A, et al. Efficacy and safety of niraparib in older patients (pts) with advanced ovarian cancer (OC): Results from the PRIMA/ENGOT-OV26/GOG-3012 trial. Presented at: 2020 ESMO Virtual Congress; September 19-21, 2020; Virtual. Abstract 819P.

3. Coleman RL, Larusso D, Gennigens C, et al. Tisotumab vedotin in previously treated recurrent or metastatic cervical cancer: results from the phase 2 innovaTV 204/GOG-3023/ENGOT-cx6 study. Presented at: 2020 ESMO Virtual Congress; September 19-21, 2020; Virtual. Abstract LBA32.

Original post:
Updated Findings Show Continued Benefit of PARP in Ovarian Cancer, New Agent on the Scene in Cervical Cancer - Targeted Oncology

If you or a senior you know needs help during this time, please do not hesitate to call the SCV Senior Center at (661) 259-9444. You can also visit their website by clicking here. They remain dedicated to doing everything they can to help while following the latest guidelines from the CDC and LA County Health Officials.

Hosts: Dr. Gene Dorio & Barbara Cochran

Topic:Getting Real Results Treating Neuropathy

Guests:Dr. Thomas Polucki, DC

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Join Barbara Cochran and Dr. Gene Dorio every Wednesday from 11 a.m. to Noon on your Hometown Station KHTS 98.1 FM & AM 1220 for The Senior Hour, your home for Senior Care and Lifestyle.

On this episode of The Senior Hour with Dr. Gene Dorio and Barbara Cochran, Dr. Thomas Polucki, DC, comes in to the studio to talk about getting real results treating neuropathy. To participatein a free telehealth webinar on peripheral neuropathy hosted by Dr. Polucki, you can register by clicking here.If you would like to schedule an appointment with Dr. Thomas Polucki or find out more about the services he offers, you can do so on his website by clicking here.

Listen to the full show by downloading the podcast by clicking on the links above and by listening on Facebook at KHTS Radio or by clicking the Play button in the box below!

The Senior Hour 09/23/20

It's time for this week's episode of The Senior Hour with Dr. Gene Dorio and Barbara Cochran. On this episode, Dr. Thomas Polucki, DC, joins Barbara and Dr. Dorio in the studio.

Posted by KHTS Radio on Wednesday, September 23, 2020

Barbara Cochran has been a resident of the Santa Clarita Valley for over 40 years and has spent much of that time volunteering with and creating a variety of organizations. The 1983 SCV Woman of the Year brings senior news to you every week on your Hometown Station.

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The Senior Hour - Getting Real Results Treating Neuropathy - 09/23/2020 - KHTS Radio

The Diabetic Neuropathy Market report defines and briefs readers about its products, applications, and specifications. The research lists key companies operating in the market and also highlights the key changing course adopted by the companies to maintain their strength. By using SWOT analysis and Porters five force analysis tools, the strengths, weaknesses, opportunities, and commination of key companies are altogether referenced in the report. Every single leading player in this global market are profiled with details such as product types, business overview, sales, manufacturing base, contestant, applications, and specifications.

Diabetic Neuropathy Market has witnessed continuous growth within the past few years and is projected to grow even more throughout the forecast. The analysis presents a whole assessment of the market and contains Future trends, Current Growth Factors, attentive opinions, facts, historical information, and statistically supported and trade valid market information.

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Manufacturer Detail: Eli Lilly and Company, GlaxoSmithKline, Pfizer, Johnson & Johnson and Janssen Pharmaceuticals.

This Diabetic Neuropathy research report includes a close on these trends, share, size which will facilitate the companies in operation within the trade to work out the market and strategize for his or her business development consequently. The analysis report analyses the expansion, market size, key segments, trade share, application, and key drivers.

Regional Analysis ForDiabetic Neuropathy Market

North America(the United States, Canada, and Mexico)Europe(Germany, France, UK, Russia, and Italy)Asia-Pacific(China, Japan, Korea, India, and Southeast Asia)South America(Brazil, Argentina, Colombia, etc.)The Middle East and Africa(Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)

Diabetic Neuropathy Market Research Methodology :

This study estimates it provides a detailed qualitative and quantitative analysis of the Diabetic Neuropathy market. Primary sources, such as experts from related industries and suppliers of Diabetic Neuropathy were interviewed to obtain and verify critical information and assess prospects of the Diabetic Neuropathy market

Key players within the Diabetic Neuropathy market are known through secondary analysis, and their market shares are determined through primary and secondary analysis. All activity shares split, and breakdowns are resolute victimization secondary sources and verified primary sources. The Diabetic Neuropathy Market report begins with a basic summary of the trade lifecycle, definitions, classifications, applications, and trade chain structure and every one these along can facilitate leading players to perceive the scope of the Market, what characteristics it offers and the way itll fulfill customers needs.

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By Company Profile, Product Image and Specification, Product Application Analysis, Production Capability, Price Cost, Production Value, Contact Data is Include in this research report.

What Diabetic Neuropathy Market report offers:

The Report Answers the Following Questions:

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The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. In the end Diabetic Neuropathy Market Report delivers a conclusion which includes Breakdown and Data Triangulation, Consumer Needs/Customer Preference Change, Research Findings, Market Size Estimation, Data Source. These factors will increase the business overall.

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Diabetic Neuropathy Market Expected to accelerate the growth of the industries forecast 2020-2026 - The Daily Chronicle

Nilanjan Ghosh, MD, PhD, a medical oncologist at Levine Cancer Institute, Atrium Health in Charlotte, NC, discussed the case of a 22-year-old patients with advanced Hodgkin lymphoma.

Targeted Oncology: What is your assessment of the patient?

GHOSH: The patients serum albumin is 4.2 g/dL, so thats an issue. The fact that she has stage IV disease, and that the white cell count was high, and the lymphocyte count was low are factors leading to an International Prognostic Score [IPS] of 4. The 5-year overall survival for high IPS, based on historical data, is not as good. I dont know if this would apply as much now, but this is what we have if we use the historical data. That suggests that she is a higher-risk patient. To be honest, the IPS has not affected treatment choice as much, at least in the United States, but well see if some of the newer treatments such as brentuximab vedotin [Adcetris] plus doxorubicin/vinblastine/dacarbazine [A+AVD] have any effect on that subgroup.

What do the National Comprehensive Cancer Network guidelines recommend for stage III or IV disease?

There are 2 treatment pathways that can be followed in patients who have stage III or IV.1 One focuses on a PET-adaptive pathway, which is ABVD [adriamycin, bleomycin, vinblastine, dacarbazine], followed by AVD [adriamycin, vinblastine, dacarbazine] or BEACOPP [bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone]. The non-PET adaptive therapy is the other pathway and uses brentuximab vedotin and AVD or escalated BEACOPP. Escalated BEACOPP is not usually used in North America.

Which regimen was chosen in this patient?

The patient was treated with brentuximab vedotin and AVD. Interim PET scan shows a Deauville score of 3; the patient tolerated this regimen well with G-CSF support. I think most people are certainly familiar with the Deauville scoring system, so just remembering that if the uptake is less than the liver, that is considered as grade 3 response. If its uptake is moderately above or markedly above, then thats considered progressive.

What are the key findings of the ECHELON-1 study (NCT01712490)2?

ECHELON-1 evaluated brentuximab and AVD versus ABVD. The standard of care is ABVD. The most important thing to note is the dose of brentuximab, which is 1.2 mg/kg, not 1.8 mg/kg, because this is given every 2 weeks. Its mirroring when ABVD is administered.

[This was a] large study with [more than] 1200 patients. It examined patients with stage III or IV classical Hodgkin lymphoma who had relatively good performance status. The investigators did allow patients to enroll if they had measurable disease and adequate liver and renal function. There was a PET scan at the end of cycle 2; however, this was not a PET-adaptive therapy. ABVD was given for 6 cycles. There is no decrease to AVD or escalation to BEACOPP

At 3 years, the progression-free survival [PFS] rate was 83% in the treatment arm and 76% in the control arm. This is highly significant, with a P value of .005, a hazard ratio of 0.7.

Overall, subgroup analysis favors brentuximab and AVD. But the confidence intervals do cross over in some categories, especially in the regional subgroup. For some reason, ABVD seems to do better in Asia. The study, though, is not powered to determine if 1 region is better than another. So, you have to take this kind of data with a grain of salt.

Now, remember this patient was young; shes in her early 20s. In a younger age group, the A+AVD did better than ABVD. She lives in North America, so thats a region where ABVD did better. And then looking at the IPS, she had a score of 4, and thats another group in which A+AVD did better.

In general, A+AVD would probably be favored in stage IV disease. Her symptoms are associated with having extranodal sites, and in our case, the patients extranodal site was associated with the bones. Her performance status is good.

Looking at the responses in ECHELON-1, the overall response rate was 86% versus 83%, so there are small differences.

Regarding adverse effects [AEs], remember that when we think about brentuximab, we think of peripheral neuropathy. In the study, peripheral neuropathy was 67% for the treatment arm versus 42% in the ABVD arm. For diarrhea, its 27% versus 18%, and abdominal pain was slightly higher in ABVD, as well. In terms of any AEs, theyre similar; grade 3 events were more for A+AVD versus ABVD.

I will mention that initially in the protocol there was no mandate for growth factor, so most patients were treated without growth factors. There were increasing incidences of neutropenia and neutropenic fevers in the A+AVD arm. Protocol amendments were performed later and G-CSF support was introduced. It was the middle part of the program. The guidelines recommend that A+AVD should be used with G-CSF support. But the protocol for the most part didnt initiate G-CSF support except toward the end. So, we see 83 patients who [received] G-CSF support and 579 who didnt.

In terms of serious AEs, there were more associated with A+AVD. The reason I bring that up is because the majority of that protocol was already carried out without the G-CSF support. The treatment group ended up seeing more AEs and clearly there are more incidences of neuropathy with A+AVD. Drug discontinuation, however, was about the same between the groups. Deaths during treatment [were] very low, and there were more hospitalizations observed with A+AVD.

Did investigators initiate any dose delays?

Most of the dose delays were initiated because of neutropenia and febrile neutropenia. For patients who discontinued more than 1 drug because of AEs, 7% were attributed to peripheral neuropathy, which is an important AE in this treatment.

Regarding pulmonary toxicity, we would expect a bleomycin-containing regimen would have higher pulmonary toxicity. It was seen in 7% of patients with ABVD and 2% with A+AVD,

and grade 3 or more pulmonary toxicity was low in A+AVD but observed in 3% of patients with ABVD.2

How were febrile neutropenia and any neutropenia addressed in the trial?

We see a difference between patients who [received] G-CSF support versus those who didnt, regarding febrile neutropenia versus any neutropenia. In patients who developed febrile neutropenia during treatment, 11% of those who received G-CSF support experienced the AE, and 21% who did not receive G-CSF support experienced the AE.

For neutropenia any grade, 73% of patients who did not receive GCSF versus 35% of patients who did receive G-CSF support developed it. Similarly, for grade 3 or more neutropenia, 70% who did not receive G-CSF versus 29% of patients who did developed it. To me, that is the most striking observation.

In the ABVD arm, there was neutropenia observed with ABVD, and we all have had patients with ABVD where the absolute neutrophil count is low, and we still go ahead and treat. That is done in standard practice.

In terms of serious AEs, there were more serious AEs with A+AVD compared [with] ABVD, 44% versus 28%. And there were no differences in deaths.

The A+AVD regimen can cause peripheral neuropathy. But if you look at complete resolution of peripheral neuropathy, you can see that 78% of patients treated with A+AVD had complete resolution and 83% of those on ABVD had complete resolution. Patients receiving ABVD also get neuropathy primarily because of vinblastine. Improvement in neuropathy also occurred in both groups; 17% of patients had improvement, not resolution, in the A+AVD arm versus 9% in the ABVD arm. The vast majority had resolution, but many had improvement as well.

However, for ongoing neuropathy that [was] grade 1 or 2, 25% of patients in the A+AVD arm and only 11% in the ABVD group experienced this. We have to be vigilant and monitor them throughout treatment so that it doesnt get too bad, so appropriate dose reductions can be made.

The bottom line here is most neuropathy is going to go away, but there will be patients where neuropathy can persist, and that can be an annoying thing, especially for a young person. For many in long-term follow-up, theyll experience improvement in neuropathy over time, which means things are getting better, but that doesnt mean its all resolved.

References:

1. NCCN Clinical Practice Guidelines in Oncology. Hodgkin lymphoma, version 2.2020. Accessed August 26, 2020. http://bit.ly/2YAIYha

2. Connors JM, Jurczak W, Straus DJ, et al. Brentuximab vedotin with chemotherapy for stage III or IV Hodgkins lymphoma. N Engl J Med. 2018;378(4):331-344. doi:10.1056/NEJMoa1708984

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Ghosh Addresses Brentuximab Vedotin Use in Advanced Hodgkin Lymphoma - Targeted Oncology

The Daily Beast

Everyone knows that live television isnt easy. Anything can go wrongfrom a faulty connection, a verbal slip-up, or, as was the case on Tuesday mornings Fox & Friends, Rudy Giuliani bellowing insane conspiracy theories at the nation with no obvious way to stop him.Its always a risk to allow Giuliani to share his wildly unpredictable stream of consciousness live. The man who was named Time magazines Person of the Year for 2001 has long been reduced to sharing the latest Trumpist conspiracy theories on any cable news channel that has the budget to cover any possible subsequent defamation lawsuits.This time, his F&F hosts looked on with visible horror in their eyes as Giuliani shared his completely baseless belief that Joe Biden is suffering from dementia. If you have the time, its worth watching the clip at least three times so you can see each of the hosts panicking in their own unique way as the former New York City mayor rambles on and on.> On Fox & Friends, Rudy Giuliani says Joe Biden "has dementia. There's no doubt about it. I've talked to doctors. ... The president's quite right to say maybe he's taken adderall." The hosts get visibly uncomfortable. pic.twitter.com/2Ma7DKNBpS> > Bobby Lewis (@revrrlewis) September 29, 2020With a mischievous cackle, Giuliani began: The man [Biden] has dementia. Theres no doubt about it. Ive talked to doctors. Ive had them look at a hundred different tapes of his five years ago and today. Trying his very best to shut Giuliani down, host Steve Doocy interjected that Bidens team have said the Democrat has no serious medical problems.Giuliani then made an extraordinary noise at Doocy that can best be typed as Oowughawughawugh, before continuing: He cant recite the Pledge of Allegiance and hes fine? He was in the Senate for 160 years? I mean, he cant do the prologue to the... to the... con... to the... uh... Constitution of the United States or the Declaration of Independence, any of them.Getting louder and increasingly excited about his armchair diagnosis, Giuliani went on: He cant do NUMBERS. Wow, are the numbers screwed up. He actually displays symptoms that two gerontologists told me are classic symptoms of middle level dementia. Doocy and co-host Ainsley Earhardt both responded to that claim by softly saying: Right. The third host, Brian Kilmeade, can just be seen blinking rapidly.Fox News Lobotomizes Its Brain Room, Cuts Fact-Based JournalismNevertheless, Giuliani persisted. Thats when [Biden] does that I pledge allegiance to the United States... uh... uh... um... I think, hes done that twice, said the ex mayor. Thats a classic symptom in the DSM-V, its the fifth symptom, of dementia, hes got eight of the 10.Then, seemingly remembering that he was on the show to talk about tonights presidential debate, he went on: Look, that isnt the debate. He can get through it. I think the president is quite right to say maybe hes taken Adderall or some kind of attention deficit disorder thing.As Giuliani began pulling prescription medicine brands out of the air, Doocy had finally had enough and told him firmly: None of us are doctors, that is your opinion. Giuliani fought back, saying it was actually the opinion of some very professional-sounding doctors that he knows.But the game was up. Kilmeade, in his first verbal interjection of the entire exchange, said with exasperation: We can stay away from that. Earhardt then moved on to pick Giulianis brain on the Supreme Court.This particular line of attack is one that Giulianiwhose work as President Trumps lawyer and top dirt-digger on Hunter and Joe Biden kicked off a chain of events that got his client impeached last yearhas enthusiastically embraced as one of his primary functions now for Team Trump.Shortly before midnight on Monday night, Giuliani started texting The Daily Beast to say that Trump did great in recent White House debate prep (for which the president said on Sunday that Giuliani and former New Jersey governor Chris Christie took part), and to rail against Biden as a senile, broken down old crook whos supposedly suffering from dementia and needs ADD drugs to get through the Tuesday debate. The Trump attorney also claimed that someone had told him how stupid Biden was in law school.Giuliani also mentioned late Monday evening that hed be flying with Trump on Air Force One on Tuesday and would be at the Cleveland debate. Asked about what kinds of questions he peppered the president with during the prep, the former New York City mayor replied, It really doesnt work like that with him. Its much more of a discussion rather than a rehearsal. Plus you are dealing with a very smart, very alert human being not a senile old man.Read more at The Daily Beast.Get our top stories in your inbox every day. Sign up now!Daily Beast Membership: Beast Inside goes deeper on the stories that matter to you. Learn more.

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Ever heard of Small Fiber Neuropathy? Call the Ahn Clinic for a natural treatment - Yahoo News

GlobalDiabetic Neuropathy TreatmentMarket 2020is a fresh specialized intelligence report published byMarkets and Research.Bizwhich comprehensively analyzes the scope of growth of the market that can be expected during the forecast period from the year 2020 to 2025. The report tracks the latest market dynamics, such as driving factors, restraining factors. The report provides market size (value and volume), market share, growth rate by types, applications. The report contains an ability to help the decision-makers in the most important market that has played a significantly important role in making a progressive impact on the globalDiabetic Neuropathy Treatmentindustry. The trends that are expected to be successful during the forecast period due to the growth of the market are covered. It includes a detailed overview of the specific industry, several aspects, product definitions, the prevailing industry landscape, different market segments, as well as market development trends and industrial channels, new expenditure projects.

NOTE: Our final report will be revised to address COVID-19 effects on the specific market.

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The report covers a number of the players in the market, including:Abbott, Roche, Eli Lilly, Johnson & Johnson, GlaxoSmithKline, Lupin, Glenmark, Depomed, Astellas, Pfizer,

Key Players Analysis:

The report focuses on global major leading industry players of the globalDiabetic Neuropathy Treatmentmarket providing information such as company profiles, product picture, and specification, capacity, production, price, cost, revenue, and contact information. The report covers all their information such as historic and future trends, market demand, size, trading, supply, competitors, and prices as well as global predominant vendors information. The report identifies the strengths and weaknesses of different companies along with the opportunities and the threats that they face from different directions. The different advancements in manufacturing technology are also listed.

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Global Diabetic Neuropathy Treatment Market by Business Development, Innovation and Top Companies Forecast 2020-2025 - seaview road

NEWARK, Del., Sept. 24, 2020 /PRNewswire/ --Neurophth Therapeutics, Inc., (hereinafter referred to as "Neurophth") today announced that its leading candidate, NR082 (rAAV2-ND4, NFS-01 project), was granted an orphan drug designation (ODD) by the U.S. FDA for the treatment of Leber's Hereditary Optic Neuropathy associated with ND4 mutation.

Leber's Hereditary Optic Neuropathy (LHON) is a maternally inherited mitochondrial disease, characterized by acute or subacute, painless vision loss or even loss simultaneously or sequentially, accompanied by central visual field defect and color vision impairment with poor prognosis. It was first reported by German scholar Leber in 1871. It affects about 1-9:100,000 people worldwide. LHON is one of the blinding diseases. The disease mainly occurs in young- and middle-aged men. Currently, there is no effective treatment for LHON. About 70% - 90% of LHON is caused by ND4 mutation of harboring a point mutation at nucleotide 11778 associated with a G-to-A transition. With the development of NR082, AAV-based gene therapy of LHON becomes possible.

"Due to the lack of effective treatment, the quality of life of LHON patients associated with ND4 mutation is very poor, and a huge unmet medical needs have not been fulfilled," said Dr. Alvin Luk, Chief Executive Officer at Neurophth. "NR082 is the first candidate drug developed by Neurophth. It uses recombinant adeno-associated virus serotype 2 to deliver the genetically modified ND4 gene (rAAV2-ND4). After a single intravitreal injection, the gene is translated and expressed in cells, which effectively supplements the function loss caused by endogenous mutation. Through this gene therapy, the electron transport function of mitochondrial respiratory chain was maintained, and the increase of ATP synthesis restored the normal function of mitochondria, which in turn improved the sensory function of the retinal ganglion cells and improved the visual acuity of LHON patients."

Luk added, "the significance of orphan drug designation is that regulators recognize the unmet medical needs of rare diseases like LHON. The recognition of NR082 will reduce the R&D investment to a certain extent and accelerate the progress of clinical trials and marketing registration. Furthermore, Neurophth is committed to fundamentally solve the causes and change the quality of life of patients through a single treatment of gene therapy."

Professor Bin Li, Founder, Chairman and Chief Scientific Officer at Neurophth, said: "NR082 has been granted as orphan drug by U.S. FDA, which further strengthens our focus on gene therapy for rare ophthalmic diseases, and develops more drugs for treatment of ocular genetic diseases, bringing hope to patients with ocular genetic diseases in the world".

*FDA grants orphan drug designation to drugs and biological products designed to safely and effectively treat, diagnose, or prevent rare diseases or conditions affecting less than 200,000 people in the US. According to the Orphan Drug Act of FDA, Orphan Drug Designation (ODD) provides opportunities for grant funding, fast approval channel, and some incentives, such as waiver of New Drug Application (NDA) fees, tax credits for clinical trial expenses and exemption for prescription drug users' fees as well as the products are entitled to a seven-year of market exclusivity and will not be affected by patents.

About NR082 (rAAV2-ND4; NFS-01 Project)

LHON disease is caused by mutations in mitochondrial DNA 11778, 14484 or 3460. ND4 gene of 11778 G>A mutation is the main pathological factor, which exists in 55-70% of European and American patients and 90% of Chinese patients. NR082 (NFS-01 project) is an innovative candidate drug for ophthalmic AAV-based gene therapy. It uses AAV2 vector to express human ND4 gene in the retinal ganglion cells to repair optic neuropathy caused by 11778 G>A mutation.

As early as 2011, Professor Bin Li's team started the world's first LHON gene therapy investigator-initiated trial (IIT) with this candidate drug. Nine subjects who participated in the clinical trial have been followed up for up to 8 years with no serious adverse reactions, and 5 of them have significant improvement in their vision. This result is the longest follow-up record of gene therapy in the world, which has already been published in the Scientific Report, EBioMedicine and Ophthalmology journals, and has fully proven the long-term safety, effectiveness, and durability of AAV gene therapy in clinical settings.

After the gratifying results of the first study, Professor Li's team conducted a more comprehensive IIT clinical study from 2017 to 2018, with 159 subjects (including 10 subjects from Argentina), which is the largest clinical trial in the entire gene therapy in the world. Among those, 143 of the patients has completed the 12-month follow-up and 56.6% showed a significant BCVA (best-corrected visual acuity improved by at least 0.3 LogMAR) improvement. No serious adverse reaction was found. In May 2020, at the 23rd online annual meeting of the American Society for Gene and Cell Therapy (ASGCT) and the online annual meeting of the Association for Research in Vision and Ophthalmology (ARVO), Neurophth presented these two clinical research data on the treatment of LHON with NR082 (NFS-01 project of rAAV2-ND4), demonstrating the international advanced level of this research in the field of gene therapy.

Following the positive results of these two IIT trials, Neurophth is actively preparing the China/U.S. IND (Investigational New Drug) applications, and plans to carry out the registration clinical Phase 1/2/3 registration trial to evaluate the safety, efficacy and durability of NR082.

About Neurophth

As a clinical-stage R & D company, Neurophth is committed to exploring and developing new therapies for global patients with ophthalmic diseases. With the help of the mature AAV ophthalmic gene therapy technology platform and the deep understanding of the ophthalmology field by the founding team for decades, Neurophth has established a rich, robust product pipeline, including more than 10 research projects for various ophthalmic diseases, such as dominant hereditary optic atrophy, optic nerve injury diseases, vascular retinopathy, etc., and gradually expanded from rare to common ophthalmic diseases. Additionally, the company is preparing to build a GMP commercial production platform for gene therapy drugs accordance with the international quality standards, and plans to build an ophthalmic gene therapy transformational excellence center, aiming to become a global leader in gene therapy in ophthalmology to benefit patients all over the world.

Prospect of Gene Therapy in Ophthalmology

Inherited retinal diseases (IRDs) have long been regarded as an ideal disease area for gene therapy, because most of the gene mutations leading to the disease have been identified (more than 200 gene defects are associated with the most common IRDS). The eye is, to some extent, an immune privilege. Clinical trials have shown that gene therapy using adeno-associated virus (AAV) or lentivirus (LV) vectors in the eye does not cause systemic side effects and does not cause significant immune responses. The most common IRDs were Retinitis Pigmentosa (RP), Achromatopsia color blindness (ACHM), Leber Hereditary Optic Neuropathy (LHON), Leber Congenital Amaurosis (LCA), Stargardt disease and X-linked Retinoschisis (XLRS).

To date, only one ophthalmic AAV gene therapy product has been approved in the world, namely the first AAV2 gene therapy voretigene neparvovec-rzyl (LUXTURNA; Spark Therapeutics) approved by FDA in December 2017 to treat IRD caused by RPE65 double allele mutation in adult or pediatric patients. The approval of LUXTURNAhas brought confidence and hope to the global ophthalmic gene therapy field. Public information disclosed that at least 20-30 kinds of gene therapy for ophthalmic diseases are in the research and development stage, and the international representative companies include Applied Genetic Technologies Corporation and Meira GTX, and new companies represented by Neurophth have also begun to enter the international stage of ophthalmic gene therapy.

References

Contact:Dr. Alvin LukAlvin.Luk@neurophth.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/neurophth-therapeutics-treatment-of-lebers-hereditary-optic-neuropathy-gene-therapy-nr082-was-granted-orphan-drug-designation-by-us-fda-301138001.html

SOURCE Neurophth Therapeutics, Inc.

Excerpt from:
Neurophth Therapeutics' Treatment of Leber's Hereditary Optic Neuropathy Gene Therapy NR082 was Granted Orphan Drug Designation by US FDA - BioSpace

Diabetic Peripheral Neuropathy Treatment Market research report is the new statistical data source added by A2Z Market Research.

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Top Key Players Profiled in this report are:

Reata Pharmaceuticals Inc, KPI Therapeutics Inc, Achelios Therapeutics Inc, ViroMed Co Ltd, Novaremed Ltd, Commence Bio Inc, Grunenthal GmbH, Immune Pharmaceuticals Inc, Mitsubishi Tanabe Pharma Corp, Medifron DBT Co Ltd, Relief Therapeutics Holding AG, Celgene Corp

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Table of Contents

Global Diabetic Peripheral Neuropathy Treatment Market Research Report 2020 2026

Chapter 1 Diabetic Peripheral Neuropathy Treatment Market Overview

Chapter 2 Global Economic Impact on Industry

Chapter 3 Global Market Competition by Manufacturers

Chapter 4 Global Production, Revenue (Value) by Region

Chapter 5 Global Supply (Production), Consumption, Export, Import by Regions

Chapter 6 Global Production, Revenue (Value), Price Trend by Type

Chapter 7 Global Market Analysis by Application

Chapter 8 Manufacturing Cost Analysis

Chapter 9 Industrial Chain, Sourcing Strategy and Downstream Buyers

Chapter 10 Marketing Strategy Analysis, Distributors/Traders

Chapter 11 Market Effect Factors Analysis

Chapter 12 Global Diabetic Peripheral Neuropathy Treatment Market Forecast

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Impact of COVID-19 on Diabetic Peripheral Neuropathy Treatment Market 2020 | Size, Growth, Demand, Opportunities & Forecast To 2026 | Reata...

Coherent Market Insights has recently updated its massive report catalogue by adding a fresh study titled Global Diabetic Neuropathy Market: Industry Analysis, Size, Share, Growth, Trends, & Forecast 2018-2026. This business intelligence study On current Growth as well as future status during the mentioned forecast period of 2026.

The report also targets important facets such as market drivers, challenges, latest trends, and opportunities associated with the growth of manufacturers in the global market for Diabetic Neuropathy. the report provides the readers with crucial insights on the strategies implemented by leading companies to remain in the lead of this competitive market.

The Well-Established Players In The Diabetic Neuropathy Market are: Eli Lilly and Company, GlaxoSmithKline, Pfizer, Johnson & Johnson and Janssen Pharmaceuticals.

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This research report also provides an overall analysis of the Diabetic Neuropathy Market share, size, segmentation, revenue forecasts, and geographic regions of the market along with industry-leading players are studied with product portfolio, capacity, price, cost and revenue. The research Diabetic Neuropathy report analysis on the market current applications and comparative analysis with more focused on the pros and cons of and competitive analysis of major companies.

The Diabetic Neuropathy Market report identifies the market dynamics and trends within the global and regional market considering numerous aspects including technology, supplies, capacity, production, profit, price and competition. Furthermore, this study highlights the company profiles and competitive landscape of the involved key players within the Diabetic Neuropathy Market.

The research report begins with the introduction of the global Diabetic Neuropathy Market comprising value chain analysis, sourcing strategy and downstream buyers. The report encompasses the statistical analysis of Diabetic Neuropathy Market cost, manufacturers, competition, and impact factors together with market forecast for 2018-2026. This analyzed study offers the buyer of the Diabetic Neuropathy report to gain an integrated picture of the competitive landscape and plan the business strategies accordingly.

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Advancement Trend and Consumer Evaluation A good summary of this Diabetic Neuropathy industry are cited in an in-depth record in addition to the present Market trends and analysis.

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Competitive Evaluation Comprehensive lists of Diabetic Neuropathy supply and demand, gross profit, ingestion ratio, cost analysis, and production capacity are included in the report.

Competitive Landscape of Global Diabetic Neuropathy Industry:

key developments, financial details, product sales and gross margin, Diabetic Neuropathy business short-term and long-term marketing strategies and SWOT analysis of the companies. Diabetic Neuropathy Market players are focused on product innovations and want to expand their geographical footprint in upcoming years.

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Excerpt from:
Diabetic Neuropathy Market :How The Will Perform In Upcoming Years Based On Size, Share And Demand In Major Regions | 2020-2026 - The PRNews Portal

The research and analysis conducted in Peripheral Neuropathy report help clients to predict investment in an emerging market, expansion of market share, or success of a new product with the help of global market research analysis. This report has been designed in such a way that it provides a very evident understanding of the business environment and Peripheral Neuropathy industry. However, this global market research report unravels many business problems very quickly and easily. Due to high demand and the value of market research for the success of different sectors, Peripheral Neuropathy Market report is provided that covers many work areas.

For the basic understanding of strategy in this report, we will focus on the static and dynamic pillars of the industry. Beyond this, identify the business development circle and opportunities. It also focuses on the limitations of analyzing problems in existing business strategies. Focus on various aspects such as application areas, platforms, and key players operating around the world.

Peripheral neuropathy market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market is growing at a healthy CAGR in the above-mentioned research forecast period. Emerging markets and vulnerable diabetic patients worldwideare the factors responsible for the growth of this market.

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Major Key Players Mentioned:

Teikoku Pharma USA, Inc, Sun Pharmaceutical Industries Ltd, Galen Limited, Cipher Pharmaceuticals Inc, Mylan N.V., Aurobindo Pharma,ZydusCadila, Hikma Pharmaceuticals PLC, ACI Limited, Apotex Inc, Johnson & Johnson Services, Inc, Pfizer Inc, Arbor Pharmaceuticals, ALMATICA PHARMA, Alkem Labs, Amneal Pharmaceuticals LLC, Novartis AG, and Lupin, among others.

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COVID-19 Impact Analysis:

The report seeks to track the evolution of the market growth pathways and publish a medical crisis in an exclusive section publishing an analysis of the impact of COVID-19 on the Peripheral Neuropathy market. The new analysis on COVID-19 pandemic provides a clear assessment of the impact on the Peripheral Neuropathy market and the expected volatility of the market during the forecast period. Various factors that can affect the general dynamics of the Peripheral Neuropathy market during the forecast period (2020-2026), including current trends, growth opportunities, limiting factors, etc., are discussed in detail in this market research.

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Our analysis includes market research that considers the impact of the COVID-19 pandemic. Contact us for complete information on the current situation and the impact of the market. Our team of professional analysts will provide you with reports that are tailored to your needs.

Table Of Contents

Part 01: Executive Summary

Part 02: Scope of the Report

Part 03: Research Methodology

Part 04: Market Landscape

Part 05: Pipeline Analysis

Part 06: Market Sizing

Part 07: Five Forces Analysis

Part 08: Market Segmentation

Part 09: Customer Landscape

Part 10: Regional Landscape

Part 11: Decision Framework

Part 12: Drivers and Challenges

Part 13: Market Trends

Part 14: Vendor Landscape

Part 15: Vendor Analysis

Part 16: Appendix

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Peripheral Neuropathy Market Understand The Key Growth Drivers Developments And Innovations - The Daily Chronicle

During a Case Based Peer Perspective event, Alicia K. Morgans, MD, MPH, associate professor of Medicine, Hematology and Oncology, at the Feinberg School of Medicine, Northwestern University in Chicago, IL, discussed the case of a 75-year-old male with metastatic castration-resistant prostate cancer (mCRPC).

Targeted Oncology: What are potential treatment options for the second-line setting in patients with metastatic castration-resistant prostate cancer (mCRPC)?

MORGANS: This patient was started on enzalutamide [Xtandi] and had progression after 8 months; he was started on docetaxel at that time. He received 4 cycles but had neuropathy that resulted in the patient and provider stopping the treatment.

The patient had a rising PSA level and required treatment. We know that we have multiple treatment options in this second-line setting for mCRPC.

We have to consider what these patients were treated with prior to seeing us. This includes assessing the fitness of the patient and the patients goals and preferences. We now know that this patient was treated with enzalutamide. We also know that the options are abiraterone acetate [Zytiga], cabazitaxel [Jevtana], and docetaxel.

After 4 cycles, the patient experienced neuropathy and a rising PSA level after less than 12 months on treatment.

Would you give cabazitaxel to a patient after experiencing neuropathy from docetaxel?

That would be a good treatment option.

We have data from a study in patients with mCRPC called FIRSTANA [NCT01308567].1 Patients were randomized in the first-line setting in mCRPC to receive either cabazitaxel 25 mg/m2, cabazitaxel 20 mg/m2, or docetaxel 75 mg/m2. For cabazitaxel, the 20-mg/m2 dose replaced the 25-mg/m2 dose in the NCCN [National Comprehensive Cancer Network] guidelines in the United States.2

Although none of these agents demonstrated superiority in terms of disease control or efficacy, there was a slightly higher response observed in the cabazitaxel 25-mg/m2 dose versus the 20-mg/m2 dose. Fewer adverse events [AEs] such as neuropathy, neutropenia, and neutropenic fever were observed in patients who received 20 mg/m2 versus docetaxel, which was a little surprising to me.

The study came out just a few years after cabazitaxel was approved.3 In most cases, I start at the 20-mg/m2 dose rather than the 25 mg/m2. We can give this in patients who have had complications with docetaxel. Its on a cycle-by-cycle basis, but it seems reasonable based on these data and on personal experience. I thought this was an interesting postapproval study that was required of the organization to enlighten us about different doses.

There is also the phase 4 CARD study [NCT02485691], which was shared at the ESMO [European Society of Medical Oncology] Congress last year.4 These patients had already progressed on their AR [androgen receptor]targeted agent and docetaxel. This is a European study, so patients had received an AR-targeted agent in the metastatic castration-resistant setting as well as chemotherapy in the metastatic castration-resistant setting. They were not patients who received AR-targeted agents in the hormone-sensitive setting.

Patients were randomized for their next treatment to cabazitaxel at the full 25-mg/m2 dose with Neulasta [pegfilgrastim versus either abiraterone or enzalutamide, depending on which agent that they had not previously received and progressed on in an earlier phase of the disease. Radiographic progression-free survival [rPFS] was the primary end point, overall survival was a secondary end point, as well as quality-of-life concerns including pain and PSA responses.

The baseline characteristics suggested that there were more patients who were older in the cabazitaxel arm. The investigators reported that patients in the AR-targeted arm experienced pain more frequently, but overall, both arms were fairly well matched. This was a small study to begin with, but they matched well overall

Please explain the efficacy of the CARD trial.

We saw that the rPFS was significantly better for patients who received cabazitaxel versus those treated with either abiraterone or enzalutamide. The median rPFS for the cabazitaxel arm was 8.0 months versus the abiraterone or enzalutamide arm at 3.7 months [HR, 0.54; 95% CI, 0.40-0.73; P <.0001]. Subgroup analysis revealed that most subgroups benefited from an rPFS standpoint.

The overall survival data were also presented at ESMO, and this is why I think it was considered one of the presidential symposia. Patients treated with cabazitaxel had a significant improvement in mortality as compared with patients who received either abiraterone or enzalutamide.

There was a 46% reduction in mortality when patients were treated with cabazitaxel compared with the other 2 regimens. Although this is a higher dose than what I normally prescribe, these patients were still able to tolerate it and had an improved survival.

Interestingly, there were significantly more PSA responses reported with treatment with cabazitaxel versus an AR-targeted agent, and significantly more tumor responses [reported] by [the] RECIST [trial]. When investigators measured the tumor size, it seemed to have decreased in size, and a much better pain response was observed. This was determined by using the percentage of the patients who had an improvement in their pain score that was maintained and clinically meaningful over time. Better pain control with cabazitaxel was reported as well. Investigators also observed a longer time to symptomatic skeletal events in the cabazitaxel arm versus the AR-targeted agent.

Whats important to note is when looking at chemotherapy versus AR-targeted agents, there were more AEs that led to treatment discontinuation, with slightly more discontinuations in the cabazitaxel arm. What surprised me and a fair number of people was that there were more AEs leading to death in those patients treated with the AR-targeted agents than with the chemotherapy. This suggests more mortality-related AEs associated with the AR-targeted agents.

Health-related quality of life seemed to be maintained, probably because the disease was better controlled. This was just presented at the 2020 Genitourinary Cancers Symposium. Patients had better pain control and certainly better prostate-specific concerns with cabazitaxel than with the AR-targeted agents, at least through cycle 5 or so.

What other presentations at the 2019 ESMO Congress were noteworthy?

The other study that I think was groundbreaking at ESMO was a phase 3 trial that targeted DNA repair defects.6 PROfound [NCT02987543] evaluated patients with mCRPC who had also progressed on the AR-targeted agents as well as chemotherapy. They were randomized to receive olaparib [Lynparza] or the second AR-targeted agent. All patients had to have DNA repair defects in their tissue to get into this trial. This was an ambitious study to carry out in a population with prostate cancer. The investigators were able to complete it and do a nice phase 3 trial and present it.

When the 2 arms were compared, the rate of AEs was higher in the olaparib arm; those included cytopenias, some nausea, and other complications. Those are some of the common AEs. Importantly, the treatment duration was significantly longer for patients treated with olaparib than AR-targeted agents.

Reviewing the disease response, rPFS as determined by a blinded independent reviewer was significantly longer for patients treated with olaparib compared with patients who received that second AR-targeted agent. Importantly, patients who received that second AR-targeted agent did not have any restrictions on how long they had to have been on that agent in the first place.

This differs from the CARD study, in which patients had to be on treatment for 12 months or less with a response to an AR-targeted agent. These patients, in contrast, could have been on for however long they were responding; they just had to have received treatment in the past. We see at 3.5 months, 50% of patients treated with that second AR-targeted agent are falling off for radiographic progression, which demonstrates that its not an effective treatment. In any event, olapaolaparib seemed to be significantly more effective in terms of rPFS.

Looking at the confirmed overall response rate in cohort A, which included patients with BRCA1/2 and ATM mutations, there was a significant improvement in objective response rate, 33% versus 2.3% [odds ratio, 20.86; 95% CI, 4.18-379.18; P <.0001].

Reviewing the data for cohort B, which included patients with DNA repair-defect mutations and not just BRCA1/2 or ATM mutations, the investigators reported an improvement in rPFS for this selected patient population.

What did the patient end up receiving?

In this particular case, the patient received cabazitaxel. In a pandemic, I think its especially important to try to prevent our patients from being hospitalized for neutropenic fever.

References:

1. Oudard S, Fizazi K, Sengelv L, et al. Cabazitaxel versus docetaxel as first-line therapy for patients with metastatic castration-resistant prostate cancer: a randomized phase III trial-FIRSTANA. J Clin Oncol. 2017;35(28):31893197. doi:10.1200/ JCO.2016.72.1068

2. NCCN. Clinical Practice Guidelines in Oncology. Prostate cancer, version 1.2020. Accessed May 12, 2020. https://www.nccn.org/professionals/physician_gls/pdf/ prostate.pdf

3. FDA approves lower dose of cabazitaxel for prostate cancer. Updated September 14, 2017. Accessed May 12, 2020. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lower-dose-cabazitaxel-prostate-cancer

4. deWit R, Kramer G, Eymard J, et al. CARD: randomized, open-label study of cabazitaxel (cbz) vs abiraterone (abi) or enzalutamide (enz) in metastatic castration-resistant prostate cancer (mcrpc). Ann Oncol. 2019;30(suppl 5):v851-v934. doi:10.1093/annonc/mdz394

5. Fizazi K, Kramer G, Eymard J-C, et al. Pain response and health-related quality of life (HRQL) analysis in patients with metastatic castration-resistant prostate cancer (mCRPC) receiving cabazitaxel (CBZ) versus abiraterone or enzalutamide in the CARD study. J Clin Oncol. 2020;38(suppl 6):16. doi:10.1200/JCO.2020.38.6_suppl.16

6. Hussain M. PROFOUND: phase 3 study of olaparib versus enzalutamide or abiraterone for metastatic castration-resistant prostate cancer (mcrpc) with homologous recombination repair (hrr) gene alterations. Ann Oncol. 2019;30(suppl 5):v851- v934. doi:10.1093/annonc/mdz394

Link:
Morgans Addresses Neuropathic Toxicity in Second-Line Metastatic CRPC - Targeted Oncology

LA JOLLA - MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced positive clinical findings published in Cancer Chemotherapy and Pharmacology regarding MN-166 (ibudilast) as a treatment for prevention of chemotherapy-induced peripheral neuropathy (CIPN).

The publication, entitled 'Ibudilast for prevention of oxaliplatin-induced acute neurotoxicity: a pilot study assessing preliminary efficacy, tolerability, and pharmacokinetic interactions in patients with metastatic gastrointestinal cancer', is the result of a collaborative effort between MediciNova and Dr. Janette Vardy, Professor of Cancer Medicine, University of Sydney Concord Cancer Centre in Australia. The authors report that co-administration of MN-166 (ibudilast) with oxaliplatin resulted in improvement or stabilization of oxaliplatin-induced neurotoxicity in the majority of participants treated with oxaliplatin.

This prospective, open-label, sequential crossover study was conducted to assess whether MN-166 (ibudilast) can reduce acute peripheral neuropathy symptoms in patients with metastatic upper gastrointestinal or colorectal cancer. A total 16 patients consented, and 14 patients completed two cycles of oxaliplatin-containing chemotherapy, one cycle with conventional chemotherapy (Cycle A) and one cycle of chemotherapy with concurrent MN-166 treatment (Cycle B). As a cross-over design, each participant acted as their own control. Participants underwent a number of assessments for neurotoxicity on Day 3 of each cycle, and at the completion of each cycle, including the Oxaliplatin-Specific Neurotoxicity Scale (OSNS), the Total Neuropathy Score Clinical (TNSc), the Functional Assessment of Cancer Therapy/Gynaecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx13), and the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) neuropathy subscale.

About Chemotherapy-induced Peripheral Neuropathy

Peripheral neuropathy is a set of symptoms caused by damage to the nerves that are outside of the brain and spinal cord. These distant nerves are called peripheral nerves. Some of the chemotherapy and other drugs used to treat cancer can damage peripheral nerves that carry sensations to the hands and feet. This damage results in chemotherapy-induced peripheral neuropathy (CIPN) and is a common side effect of cancer chemotherapy. Most commonly, people complain of 'pins and needles' in their toes and fingers. CIPN may affect cancer outcomes due to reductions in chemotherapy dosing and/or premature treatment discontinuation and have a profound impact on quality of life and survivorship. According to a meta-analysis which included more than 4,000 patients, CIPN prevalence was 68% when measured in the first month after chemotherapy, 60% at 3 months, and 30% at 6 months or more (Seretny et al., 2014). Long-term neurotoxicity is an important issue for the growing number of cancer survivors, with the highest number of affected patients having been treated for breast and/or colon cancer.

About MN-166 (ibudilast)

MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule macrophage migration inhibitory factor (MIF) inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. Our earlier human studies demonstrated significant reductions of serum MIF level after treatment with MN-166 (ibudilast). It also attenuates activated glial cells, which play a major role in certain neurological conditions. MN-166 (ibudilast)'s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical studies, which provide the rationale for treatment of amyotrophic lateral sclerosis (ALS), progressive multiple sclerosis (MS) and other neurological diseases such as glioblastoma (GBM), and substance abuse/addiction. MediciNova is developing MN-166 for ALS, progressive MS and other neurological conditions such as degenerative cervical myelopathy (DCM), glioblastoma, substance abuse/addiction, and chemotherapy-induced peripheral neuropathy, as well as prevention of acute respiratory distress syndrome (ARDS) caused by COVID-19. MediciNova has a portfolio of patents which covers the use of MN-166 (ibudilast) to treat various diseases including ALS, progressive MS, and drug addiction.

About MediciNova

MediciNova, Inc. is a publicly-traded biopharmaceutical company founded upon developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs with a primary commercial focus on the U.S. market. MediciNova's current strategy is to focus on BC-PIV SARS-COV-2 vaccine for COVID-19, MN-166 (ibudilast) for neurological disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), degenerative cervical myelopathy (DCM), substance dependence (e.g., alcohol use disorder, methamphetamine dependence, opioid dependence) and glioblastoma (GBM), as well as prevention of acute respiratory distress syndrome (ARDS) caused by COVID-19, and MN-001 (tipelukast) for fibrotic diseases such as nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). MediciNova's pipeline also includes MN-221 (bedoradrine) and MN-029 (denibulin).

Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by or otherwise include the words 'believes,' 'expects,' 'anticipates,' 'intends,' 'estimates,' 'projects,' 'can,' 'could,' 'may,' 'will,' 'would,' 'considering,' 'planning' or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2019 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

Contact:

Geoff O'Brien

Email: info@medicinova.com

Read the original here:
MediciNova : Announces Positive Clinical Results Regarding MN-166 for Prevention of Chemotherapy-induced Peripheral Neuropathy Published in Cancer...

North America will continue to be the Leading Market for Neuropathic Pain over the Forecast Period (20182026)

According to a recent study conducted by TMR, the global market for neuropathic pain is expected to reflect a CAGR of over XX% during the forecast period (20182026). In 2015, the market was valued at over US$XX Billion and is estimated to stand at US$XX Billion by 2026 end.

This Press Release will help you to understand the Volume, growth with Impacting Trends. Click HERE To get SAMPLE PDF (Including Full TOC, Table & Figures) @https://www.trendsmarketresearch.com/report/sample/3726

Factors such as increasing prevalence of chronic disorders including cancer and diabetes, introduction of newer modalities of receiving neuropathic pain treatment, growing number of pain management service providers and higher demand for neuropathic pain treatment drugs are expected to support the growth of neuropathic pain market globally. Further, arrival of various new medications for neuropathic pain treatment in the market, increasing patient awareness on the availability of advanced neuropathic pain therapeutics and rising demand for generic drugs are additional factors expected to drive the market growth. Moreover, pharmaceutical companies are actively focusing on developing enhanced drugs to cater to the requirement of patients with neuropathic disorders. In contrast to all of that, adverse side effects of steroids and opioids coupled with high cost of branded drugs may act as impediments for the global market of neuropathic pain.

Based on drug class, the global market for neuropathic pain has been segmented into anticonvulsants, tricyclic antidepressant, opioids, local anaesthesia, steroids, and others. Anticonvulsants drug is anticipated to be the largest segment of the market, reflecting a CAGR of over XX% during the forecast period. Minimum risk of side effects is a major factor driving the demand for this segment. By the end of 2026, the segment is estimated surpass market valuation of over US$XX Billion. Tricyclic antidepressant drugs are also gaining popularity amongst the physicians and patients and the segment is expected to witness a sound growth during the forecast period.

By indication, the market has been segmented into chemotherapy induced peripheral neuropathy, diabetic neuropathy, and others. Diabetic Neuropathy segment accounts for the largest share of the market. By the end of 2018, the segment is anticipated to account for nearly 47% share of the market in terms of value. On the other hand, chemotherapy induced peripheral neuropathy indication is projected to account for over 42% share of the market in revenue by 2018 end.

By region, the global market for neuropathic pain has been segmented into Asia Pacific North America, Europe, Latin America and the Middle East & Africa. North America is anticipated to be the most lucrative market for neuropathic pain, account highest share of the market in terms of value. The market in the region is expected to expand at a CAGR of over XX% during the forecast period. This is primarily due to a strong distribution network and presence of advanced healthcare infrastructure and major players of the market in the region.

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Key players operating in the global market for neuropathic pain include Bristol Myers Squibb, Depomed, Inc., GlaxoSmithKline PLC, Pfizer, Inc., Sanofi S.A., Eli Lily and Company, Baxter Healthcare Corporation, Biogen Idec, and Johnson & Johnson Services, Inc. Most of these pharmaceutical companies are actively focusing on developing enhanced medication for treat neuropathic pain and other disorders in order to strengthen their presence in the global market for neuropathic pain. Global market for neuropathic pain is expected to surpass market valuation of US$XX Billion by the end of 2026

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Neuropathic Pain Market: Projection of Each Major Segment over the Forecast Period 2026 - The Market Records

Leber's Hereditary Optic Neuropathy (LHON) is a maternally inherited mitochondrial disease, characterized by acute or subacute, painless vision loss or even loss simultaneously or sequentially, accompanied by central visual field defect and color vision impairment with poor prognosis. It was first reported by German scholar Leber in 1871. It affects about 1-9:100,000 people worldwide. LHON is one of the blinding diseases. The disease mainly occurs in young- and middle-aged men. Currently, there is no effective treatment for LHON. About 70% - 90% of LHON is caused by ND4 mutation of harboring a point mutation at nucleotide 11778 associated with a G-to-A transition. With the development of NR082, AAV-based gene therapy of LHON becomes possible.

"Due to the lack of effective treatment, the quality of life of LHON patients associated with ND4 mutation is very poor, and a huge unmet medical needs have not been fulfilled," said Dr. Alvin Luk, Chief Executive Officer at Neurophth. "NR082 is the first candidate drug developed by Neurophth. It uses recombinant adeno-associated virus serotype 2 to deliver the genetically modified ND4 gene (rAAV2-ND4). After a single intravitreal injection, the gene is translated and expressed in cells, which effectively supplements the function loss caused by endogenous mutation. Through this gene therapy, the electron transport function of mitochondrial respiratory chain was maintained, and the increase of ATP synthesis restored the normal function of mitochondria, which in turn improved the sensory function of the retinal ganglion cells and improved the visual acuity of LHON patients."

Luk added, "the significance of orphan drug designation is that regulators recognize the unmet medical needs of rare diseases like LHON. The recognition of NR082 will reduce the R&D investment to a certain extent and accelerate the progress of clinical trials and marketing registration. Furthermore, Neurophth is committed to fundamentally solve the causes and change the quality of life of patients through a single treatment of gene therapy."

Professor Bin Li, Founder, Chairman and Chief Scientific Officer at Neurophth, said: "NR082 has been granted as orphan drug by U.S. FDA, which further strengthens our focus on gene therapy for rare ophthalmic diseases, and develops more drugs for treatment of ocular genetic diseases, bringing hope to patients with ocular genetic diseases in the world".

*FDA grants orphan drug designation to drugs and biological products designed to safely and effectively treat, diagnose, or prevent rare diseases or conditions affecting less than 200,000 people in the US. According to the Orphan Drug Act of FDA, Orphan Drug Designation (ODD) provides opportunities for grant funding, fast approval channel, and some incentives, such as waiver of New Drug Application (NDA) fees, tax credits for clinical trial expenses and exemption for prescription drug users' fees as well as the products are entitled to a seven-year of market exclusivity and will not be affected by patents.

About NR082 (rAAV2-ND4; NFS-01 Project)

LHON disease is caused by mutations in mitochondrial DNA 11778, 14484 or 3460. ND4 gene of 11778 G>A mutation is the main pathological factor, which exists in 55-70% of European and American patients and 90% of Chinese patients. NR082 (NFS-01 project) is an innovative candidate drug for ophthalmic AAV-based gene therapy. It uses AAV2 vector to express human ND4 gene in the retinal ganglion cells to repair optic neuropathy caused by 11778 G>A mutation.

As early as 2011, Professor Bin Li's team started the world's first LHON gene therapy investigator-initiated trial (IIT) with this candidate drug. Nine subjects who participated in the clinical trial have been followed up for up to 8 years with no serious adverse reactions, and 5 of them have significant improvement in their vision. This result is the longest follow-up record of gene therapy in the world, which has already been published in the Scientific Report, EBioMedicine and Ophthalmology journals, and has fully proven the long-term safety, effectiveness, and durability of AAV gene therapy in clinical settings.

After the gratifying results of the first study, Professor Li's team conducted a more comprehensive IIT clinical study from 2017 to 2018, with 159 subjects (including 10 subjects from Argentina), which is the largest clinical trial in the entire gene therapy in the world. Among those, 143 of the patients has completed the 12-month follow-up and 56.6% showed a significant BCVA (best-corrected visual acuity improved by at least 0.3 LogMAR) improvement. No serious adverse reaction was found. In May 2020, at the 23rd online annual meeting of the American Society for Gene and Cell Therapy (ASGCT) and the online annual meeting of the Association for Research in Vision and Ophthalmology (ARVO), Neurophth presented these two clinical research data on the treatment of LHON with NR082 (NFS-01 project of rAAV2-ND4), demonstrating the international advanced level of this research in the field of gene therapy.

Following the positive results of these two IIT trials, Neurophth is actively preparing the China/U.S. IND (Investigational New Drug) applications, and plans to carry out the registration clinical Phase 1/2/3 registration trial to evaluate the safety, efficacy and durability of NR082.

About Neurophth

As a clinical-stage R & D company, Neurophth is committed to exploring and developing new therapies for global patients with ophthalmic diseases. With the help of the mature AAV ophthalmic gene therapy technology platform and the deep understanding of the ophthalmology field by the founding team for decades, Neurophth has established a rich, robust product pipeline, including more than 10 research projects for various ophthalmic diseases, such as dominant hereditary optic atrophy, optic nerve injury diseases, vascular retinopathy, etc., and gradually expanded from rare to common ophthalmic diseases. Additionally, the company is preparing to build a GMP commercial production platform for gene therapy drugs accordance with the international quality standards, and plans to build an ophthalmic gene therapy transformational excellence center, aiming to become a global leader in gene therapy in ophthalmology to benefit patients all over the world.

Prospect of Gene Therapy in Ophthalmology

Inherited retinal diseases (IRDs) have long been regarded as an ideal disease area for gene therapy, because most of the gene mutations leading to the disease have been identified (more than 200 gene defects are associated with the most common IRDS). The eye is, to some extent, an immune privilege. Clinical trials have shown that gene therapy using adeno-associated virus (AAV) or lentivirus (LV) vectors in the eye does not cause systemic side effects and does not cause significant immune responses. The most common IRDs were Retinitis Pigmentosa (RP), Achromatopsia color blindness (ACHM), Leber Hereditary Optic Neuropathy (LHON), Leber Congenital Amaurosis (LCA), Stargardt disease and X-linked Retinoschisis (XLRS).

To date, only one ophthalmic AAV gene therapy product has been approved in the world, namely the first AAV2 gene therapy voretigene neparvovec-rzyl (LUXTURNA; Spark Therapeutics) approved by FDA in December 2017 to treat IRD caused by RPE65 double allele mutation in adult or pediatric patients. The approval of LUXTURNAhas brought confidence and hope to the global ophthalmic gene therapy field. Public information disclosed that at least 20-30 kinds of gene therapy for ophthalmic diseases are in the research and development stage, and the international representative companies include Applied Genetic Technologies Corporation and Meira GTX, and new companies represented by Neurophth have also begun to enter the international stage of ophthalmic gene therapy.

References

Contact:Dr. Alvin Luk[emailprotected]

SOURCE Neurophth Therapeutics, Inc.

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Neurophth Therapeutics' Treatment of Leber's Hereditary Optic Neuropathy Gene Therapy NR082 was Granted Orphan Drug Designation by US FDA - PRNewswire

The Warriors are back in the lab and putting up shots in the Warriors Minicamp, presented by Oracle NetSuite. One of those ready to step back on the hardwood and get their reps in is center Kevon Looney. After a 2019-20 campaign in which he appeared in just 20 of the Dubs 65 games due to a combination of neuropathy and abdominal soreness, Looney says he is doing great and ready to test himself.

See what else the Dubs center had to say following Thursdays practice below:

On his recovery from abdominal surgery in May:I had a lot of time to take my time on the rehab and I didnt have to rush this as though we were playing, so I was able to be really detail-oriented about it and make sure I was feeling 100 percent before stepping on the court and before pushing myself this camp is great for me so I have a chance to play (with) these guys, really test myself and see where Im at.

On what helped him through his injuries during the 2019-20 season:Just being in a good atmosphere like the Warriors. Just having the support of the coaches, the training staff and players made a tough time easier. Kinda got down on myself: signed that contract and wanted to come in and have a big year, but things didnt go as planned. To get injured again, and then get injured again, was kinda frustrating I got a lot of trust in our training staff and that theyre going to put me in a position to succeed. I was able to lean on my family, lean on my teammates, lean on fans. I always have my support.

His feelings on current racial inequality and overcoming the obstacles:Its been a tough time seeing what happened to James Blake. Hes not the first, and probably wont be the last its sad to say. Growing up in Milwaukee, seemed like every couple of months or every couple of years something like this happens Gotta try to persevere, gotta try to stay hopeful, try to encourage people to do the right thing, try to get them to protest peacefully, get them to go out there and vote.

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What They Are Saying in The Dubble - 9/24/20 - Warriors.com

Skyler Simpkins 23

Opinion Editor

When all other options fail, acupuncture is often recommended for those suffering unbearable neuropathy. My father, who was diagnosed with pancreatic cancer last year, developed severe neuropathic symptoms as a side effect of chemotherapy. His doctors recommended that he receive acupuncture after a plethora of other treatments showed no improvement. The appointment was made and my father was optimistic. A short time before the appointment, the therapist called him and cancelled his appointment due to suspicion of coronavirus infection. The only basis the therapist had for cancelling treatment was that my dad had recently traveled to Florida, a coronavirus hotspot. My father was denied life-altering treatment due to mere suspicion. It was at this moment that I saw the effect of coronavirus anxiety on the health of a loved one, and I quickly realized an egregious problem in our modern, pandemic-defined society.

In the age of coronavirus, we have seen the reemergence of infectious disease discrimination. While this discrimination has always existed, it is now more prevalent and apparent than ever. This can be experienced on a daily basis when wefor examplevisit a store or take public transportation. I would believe that most of us would agree with this, as do I, because these are private businesses enforcing their own jurisdiction over their property. Also, many of us would agree that this discrimination is better for the world since it is helping prevent the spread of coronavirus. But what about healthcare institutions like the one mentioned in my example above? Should private healthcare institutions be allowed to discriminate based upon coronavirus suspicion? While legally these institutions have the right to discriminate upon the basis of infectious disease, healthcare professionals have a much higher ethical obligation to the patient that overrides any legal or constitutional argument applicable.

There are two fields of thought to ponder in this argument over the right to discriminate over infectious disease. First, the legal and second, the ethical.

Legally a privately owned American business has the right to discriminate on the basis of infectious disease precaution. As stated above, I wholeheartedly agree with this right as it protects the community (if they choose to disallow those potentially exposed to or with coronavirus) and protects the sanctity of privately-owned business. Its when these private businesses are based around health care that I perceive a startling reality.

The Hippocratic Oath calls upon physicians to swear to uphold ethical standards in regard to their medical practices. This oath holds physicians to do what is good for the patientsand one could assume that this promotes anti-discriminatory practices. While not all medical students and doctors explicitly swear upon the same oath, we could extrapolate the premises of this oath to the plethora of others sworn by medical professionals every year.

When a doctor sees a patient in need, they should treat them as it is their ethical responsibility to do so. Today, many doctorsmostly in private practicesdeny patients out of fear of a coronavirus outbreak. While some may say this is out of caution and for the greater good, the physician denigrates the patient in favor of their own personal safety. Some may argue that the physician is protecting the community as well as themselves; however, if we start to care only for the greater good, we put the most helpless and feeble in danger.

When a healthcare worker enters into their field of work, they accept a formidable taskwhether literally or theoretically. Healthcare workers devote themselves to their patients and those in need. They help without discriminationespecially when its the most helpless. Why, then, do healthcare workers in private institutions neglect these standards when infectious disease is introduced? While I understand physicians are not contractually bonded to these standards, these standards are bound to their work. When physicians deny individualslike my fatherthey lose their perceived higher moral standing in society. These physicians that neglect the individual are no more of an upstanding citizen than the lay people as they care only for themselves when anxiety is high.

If we allow healthcare workers in privatized businesses to neglect their ethical obligations, we permit the societal abandonment of the most needy. We must remind healthcare workers of their obligations and their predecessor Hippocrates who would look down with shame at how these physicians and specialists are conducting their work. We must protect those discriminated against and ensure the care of allunhealthy or wellin these trying times of uncertainty and fear.

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Infectious Disease Discrimination and the Coronavirus - The Trinity Tripod