StemCell Therapy

The Bucks County commissioners unanimously approved a $2 million state grant that will aid the expansion of the Pennsylvania Biotechnology Center in Buckingham.

With their vote Wednesday, the commissioners accepted the agreement between the biotechnology center and the state, and agreed to act as the facilitator for the Redevelopment Assistance Capital Program (RACP).

"Every entity that applies for the RACP grant has to have a cooperation agreement with one of the governments to move forward," said Lynn Bush, executive director of the Bucks County Planning Commission. "We are basically the go-between for the company and the state agency."

Plans have been in motion for years to add more laboratory and office space to the Biotechnology Center. The state grant and a $4.6 million federal grant will contribute to the overall costs of the project, estimated between $12 million and $13 million. The remainder willbe financed with a conventional loan awarded by Univest Bank.

"We're thrilled to continue our partnership with the biotechnology center and allow them the opportunity to grow and expand in that area," said Bucks County Commissioner Robert Loughery. "The center has become a real success story for the county and the region."

A groundbreaking ceremony for the expansion was held in April, but actual construction has yet to begin. Before work could begin in earnest, Bush said Thursday afternoon the plans need to go before the Buckingham Board of Supervisors for final land development approval.

The Biotechnology Center is credited with contributing approximately $1.8 billion to the local economy and supporting more than 700 jobs since its creation in 2007. A partnership with the Hepatitis B Foundation and Delaware Valley University started the initiative, but disagreements on the center's management ended the relationship.

The Hepatitis B Foundation bought out the university's interests in the center for $2 million in October, ending the disagreement and restarting the stalled expansion plans.

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Bucks commissioners OK state award of $2 million for Pa. Biotechnology Center expansion - The Intelligencer

On May 16, 2017, we issued an updated report on Puma Biotechnology, Inc. (PBYI - Free Report) .

Puma Biotechnology is a development-stage biopharmaceutical company focused on the development and commercialization of innovative treatments that enhance cancer care.

The company posted narrower-than-expected loss in the first quarter of 2017. Reported loss of $1.97 per share was also narrower than year-ago figure of $2.19. With no approved products in its portfolio at the moment, the company does not generate revenues yet. The company reported first-quarter results on May 10, 2017.

So far this year, Pumas shares have outperformed Zacks classified Medical-Biomed/Genetics industry. The companys shares have gained 4.1% while the industry registered an increase of 2.2%.

Puma has made significant progress with its lead candidate, neratinib. The candidate is currently under review in both the U.S. and the EU for HER2+ breast cancer. An approval would be a huge boost for the company given the immense commercial potential in the target market.

We note that several additional studies on neratinib targeting different types of breast cancer patient populations are currently underway. During the quarter, Puma presented encouraging data from several ongoing studies on neratinib at the annual meeting of the American Association for Cancer Research (AACR).

Puma also expects to achieve several milestones in the second quarter of 2017. These include additional data from the phase III study on neratinib in third-line HER2-positive metastatic breast cancer patients and data from a phase II study on neratinib in HER2-positive metastatic breast cancer patients with brain metastases.

However, dependence on the successful development of a single candidate may hurt the companys growth prospects in case of any adverse development or regulatory setback.

Moreover, lack of partnership deals could hamper progress of the candidate as the company has no sales, marketing or distribution capabilities.

Zacks Rank & Key Picks

Puma currently carries a Zacks Rank #2 (Buy). Other stocks in the health care sector that warrant a look include Aeglea BioTherapeutics (AGLE - Free Report) , VIVUS, Inc. (VVUS - Free Report) and MEI Pharma, Inc. (MEIP - Free Report) . While Aeglea carries a Zacks Rank #2, VIVUS and MEI Pharma sport a Zacks Rank #1 (Strong Buy). You can see the complete list of todays Zacks #1 Rank stocks here.

Aegleas loss per share estimates narrowed from $3.64 to $2.48 for 2017, over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 20.75%.

VIVUSs loss per share estimates narrowed from 50 cents to 39 cents for 2017, over the last 30 days. The company posted positive earnings surprises in all of the four trailing quarters with an average beat of 233.69%.

MEI Pharmas posted positive earnings surprises in three of the four trailing quarters with an average beat of 66.56%. The companys shares gained 16% so far this year.

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With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.

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Reasons to Add Puma Biotechnology (PBYI) to Portfolio Now - Zacks.com

GuruFocus.com

Digging Up the Facts on Puma Biotechnology, Inc. (PBYI) StockNewsJournal Puma Biotechnology, Inc. (PBYI) is an interesting player in the Healthcare space, with a focus on Biotechnology. The stock has been active on the tape, currently trading at $36.25, up from yesterday's close by 13.46%. Given the stock's recent action ... Coherus Biosciences Inc (CHRS) Given a $43.00 Price Target by Maxim Group AnalystsBNB Daily (blog) all 78 news articles »

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Digging Up the Facts on Puma Biotechnology, Inc. (PBYI) - StockNewsJournal

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Global Biotechnology Congress 2017 - (5th in the Series) Corporate" conference to their offering.

The 'Global Biotechnology Congress 2017' would provide eminent scientists the opportunity to present their cutting edge researches in the field of biotechnology and its applications in medicine. A number of Nobel Laureates and leading researchers are expected to participate in this important conference.

This unique international conference provides a platform for researchers and decision makers in biotechnology to present their latest findings and learn about all the important developments in biotechnology. Many Nobel Laureates and world's renowned experts will participate in the conference.

The conference will cover the translational nature of biotechnological research, with emphasis on both the basic science as well as its applications in industry and academia. Presentations will include major research advances in biotechnology, business development, strategic alliances, partnering trends, product opportunities, growth business models and strategies, licensing and pharmaceutical biotechnology (e.g. vaccines, CNS, cancer, antibodies), medical biotechnology, industrial biotechnology, bioprocess engineering, protein engineering, plant and environmental technologies, transgenic plant and crops, bioremediation, and microbial diversity research.

Throughout the course of the four day conference, you will have the opportunity to both network and hear leaders from the international academic and corporate biotechnology communities.

Benefits of Attending

- Exchange ideas and network with leading biotechnologists and decision makers.

- Bring together top international biotechnology professionals presenting cutting-edge discoveries, research and opportunities for new biotech business practices and partnerships.

- Participants can gain direct access to a core audience of biotechnology professionals and decision makers, and have increased visibility through branding and networking at the conference.

- Obtain a global roundup of Pharmaceutical research capabilities and opportunities.

- The conference will feature a commercial exhibition and poster sessions.

For more information about this conference visit http://www.researchandmarkets.com/research/k2mmsx/global

Read more:
Global Biotechnology Congress 2017 - Corporate Registration ... - Business Wire (press release)

USA Commerce Daily

Puma Biotechnology, Inc. (PBYI): Some of the key technical areas USA Commerce Daily With all other things going on, Puma Biotechnology, Inc. (NASDAQ:PBYI) has been on a free fall declining -4.23 percent in just three months. It looks like traders are not happy with the stock. On the other side, analysts now consider Puma ... and more »

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Puma Biotechnology, Inc. (PBYI): Some of the key technical areas - USA Commerce Daily

NEW YORK, NY--(Marketwired - May 18, 2017) - Planda Biotechnology (OTCQB: PLPL) announced that it will conduct a human clinical trial to study the effectiveness of using its highly bioavailable green tea extract, Phytofare Catechin Complex, to regulate blood glucose levels in type 2 diabetics. If the positive data that was recently published in the Journal of Human Nutrition and Dietetics is any indicator, Planda should expect to receive its own positive data. The two studies could complement one another, and Planda's study could further strengthen the case for using green tea catechins in improving the health of type 2 diabetics.

According to an industry report, the market for diabetes drugs alone was valued at $30.95 billion in 2016, and it's expected to grow at an exponential rate and become a $44.53 billion market by 2021, at a CAGR of about 7.5%.

Obviously Planda would like to carve out its own space in this industry, and with a recently published study showing success with a green tea supplement that only contained 1 of the tea plant's 8 catechins, Planda has to feel pretty confident it can produce even better data given it can deliver all 8 catechins with its Phytofare extract.

Catechins are known as antioxidants, and antioxidants protect the body from free radicals that are thought to play a role in everything from heart disease to cancer. Catechins are found in the greatest abundance in the leaves of the tea plant.

And we already know that Planda produces a product (Phytofare) that contains all 8 of the catechins found in the tea plant. But, more importantly, Planda's product has proven in human clinical trials that it can deliver 10 times more of the catechins into the bloodstream and keep those antioxidants there at therapeutic levels for more than 24 hours.

Now, let's fast forward to the data from a study that was just published in the Journal of Human Nutrition and Dietetics and how Planda can add to that data with its clinical trial in diabetes. In that clinical trial, over 400 pregnant women, all of whom were in their third trimester and were diagnosed with gestational diabetes mellitus or "GDM," participated in investigating the effects of the catechin "epigallocatechin 3-gallate" (EGCG) on GDM in terms of both maternal and neonatal treatment outcomes.

Data from the study suggests that mothers with GDM, who were given EGCG as a supplement during the third trimester of their pregnancy, had significantly improved maternal diabetic parameters, and fewer cases of neonatal complications, compared to similar women given a placebo supplement.

One of the trial's authors, H. Zhang, said of the study, "Our current clinical trial is the first to report the potential therapeutic value of the natural compound EGCG in GDM, which is able to both alleviate maternal diabetic symptoms and reduce the incidence of neonatal complications."

A point that we can't emphasize enough from the GDM study that could benefit Planda greatly is that participants were given a supplement that contained only 1 of the 8 catechins, and we don't even know how bioavailable the supplement was. During Planda's clinical trial however, participants will be given Phytofare, which we know will deliver all 8 catechins into the bloodstream of each participant in the study. So we expect that Planda's data could be extremely positive and further strengthen the research done in the GDM study.

Given how potent Phytofare is, and how Planda is able to enhance the already highly bioavailable extract even more by entrapping it in liposomes, positive data from Planda's upcoming clinical trial in type 2 diabetes could thrust the company into the conversation, and become a real solution for how we're treating/managing type 2 diabetes worldwide.

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We may from time to time include our own opinions about our featured companies, their businesses, markets and opportunities. Any opinions we may offer are solely our own, and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers and viewers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice, or construed or interpreted as research. Any investment decisions you may make concerning any company are solely your responsibility based on your own due diligence. Our publications are provided only as an informational aid. We encourage you to invest carefully and read the investor information available at the web site of the U.S. Securities and Exchange Commission at: http://www.sec.gov. We also recommend as a general rule, that before investing in any securities you consult with a professional financial planner or advisor, and you should conduct a complete and independent investigation before investing in any security after prudent consideration of all pertinent risks.

We are not a registered broker, dealer, analyst, or adviser. We hold no investment licenses and may not sell, offer to sell or offer to buy any security. Our publications are not a recommendation to buy or sell a security.

Section 17(b) of the 1933 Securities and Exchange Act requires publishers who distribute information about publicly traded securities for compensation, to disclose who paid them, the amount, and the type of payment. In order to be in full compliance with the Securities Act of 1933, Section 17(b), we are disclosing that SMMG is compensated $5,000 per month by Plandai Biotechnology for content development. Neither SMMG nor anyone associated with it owns shares in PLPL.

For more information: http://www.stockmarketmediagroup.com.

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Planda Biotechnology's Upcoming Clinical Trial Could Strengthen Case for Phytofare in Treatment of Diabetes - Markets Insider

Posted on 5/19/2017

When

5/25/2017 8:00 PM

MORGANTOWN, W.Va. Knees, hips, fingers, shoulders arthritis can cause pain in joints all over the body, and it affects millions of people. What can be done about it? Find out on the next Doctors on Call at 8 p.m. on Thursday, May 25, on West Virginia Public Broadcasting.

During live interviews, Mollie Cecil, M.D., WVU Medicine family medicine specialist, will share her experience with Lyme disease. Ghulam Abbas, M.D., director of surgical thoracic oncology at the WVU Cancer Institute, will discuss the importance of screening for lung cancer, and George Sokos, D.O., director of advanced heart failure at the WVU Heart and Vascular Institute, will dispel some myths about being an organ donor. WVU Medicine pharmacist Charles Ponte, Pharm.D., and director of outpatient pain services Richard Vaglienti, M.D., will appear back to back to discuss both medications and alternatives to medicine to relieve chronic pain.

Dont miss the story of Randy Ash, who experienced a severe hunting accident and was rushed to the Jon Michael Moore Trauma Center at J.W. Ruby Memorial Hospital.

DOC Talk, the call-in portion of the show, will provide viewers with the opportunity to ask questions about arthritisof two WVU Medicine experts rheumatologist Bruce Rothschild, M.D., and orthopaedic surgeonMatthew Dietz, M.D.

Its summer! That means cook-outs and picnics, and DOC in the Kitchen will show you how to practice food safety while you enjoy summer treats. Summer can also bring allergies, and the DOC List has the most common allergy triggers. The DOC Demo will show you some warm-water exercises in the pool that can relieve arthritis pain, and Its No Big Deal will show you how easy it is to become an organ donor.

WVU Medicine physicians John Phillips, M.D., and Kathy Moffett, M.D., will host the show. Highlights will be tweeted live on Thursday evening (@DOCWVU). Viewers can also get updates, suggest topics, and provide feedback anytime on Facebook (facebook.com/DoctorsOnCallWVU).

Now in its 25th season, Doctors on Call is an hour-long magazine-style show that airs quarterly.

To see previous episodes, visit wvumedicine.org/DOC.

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'Doctors on Call' show to focus on arthritis - WVU Medicine (press release)

Steroid shots are the go-to treatment for people with painful knee arthritis. Patients typically receive injections of corticosteroid drugs directly into the knee joint every few months at an outpatient clinic.

However, a new study has found that steroid shots do not work any better than salt-water, and they may actually worsen cartilage loss.

The researchers randomly assigned 140 men and women over 45 years old to receive injections of either salt-water or a steroid shot. The patients were injected every 12 weeks for two years.

All of the patients had knee arthritis with inflammation of the synovial membrane, making them ideal patients for treatment with the anti-inflammatory corticosteroid triamcinolone.

At the end of the study, there was no overall difference between the two groups in terms of pain, stiffness, ability to stand from a seated position, or walk. Bone and joint scans also showed no differences.

The only major difference was that patients who got steroid shots had twice the amount of cartilage loss in their knees 0.21 millimeters for the steroid shot group, vs. 0.10 millimeters for the salt-water group.

The results were surprising because the researchers thought steroid shots might reduce inflammation, or at least slow down the progression of cartilage damage. Instead, they found steroid shots had the opposite effect.

Dr. Timothy E. McAlindon, chief of rheumatology at Tufts Medical Center in Boston, Massachusetts, said steroid shots may be useful for treating short-term pain associated with flareups of arthritis, but not as a long-term treatment strategy:

Theres a lot of excitement about treating inflammation to influence this disease, but this study is a test of that notion, and its negative. So we really have to question whether its correct.

Osteoarthritis, also known as degenerative joint disease, affects 30 million adults in the United States. It is caused by the breakdown of cartilage, which is the pad of tissue between the knee bones. It is extremely painful when the bones scrape together.

Steroid shots temporarily relieve pain, but the effects wear off in about two months. The long-term trade-off is faster degeneration of cartilage in the knees and progressive joint damage.

Source: Effect of Intra-articular Triamcinolone vs Saline on Knee Cartilage Volume and Pain in Patients With Knee Osteoarthritis JAMA (May 2017)

Original post:
Steroid Shots For Knee Pain May Worsen Arthritis - Daily Hornet

Austin American-Statesman

Walking to battle arthritis Austin American-Statesman Buckner Villas, a senior living community in North Austin, recently held a community walk where residents and their families hit the track to exercise and raise money for the Arthritis Foundation. Shown here are Holly Jones, left, and Jean Jenkens ...

Continue reading here:
Walking to battle arthritis - Austin American-Statesman

May 18, 2017

Now that we know that egg-making stem cells exist in adult rodents and humans and that these cells can be transplanted into mice with premature ovarian failure to produce offspring, the next question is to assess whether the offspring from the egg-making stem cells of a single adult mouse are biologically normal compared to natural births. On May 18 in the journal Molecular Therapy, researchers in China show that female mice with early menopause that receive egg-making stem cells from another mouse are capable of producing healthy pups 2 months later with no observable genetic malfunctions.

"One of our aims is to cure the disease of premature ovarian failure using female germline stem cells," says senior author Ji Wu, a reproductive biologist at Shanghai Jiao Tong University. "Before this treatment can be applied to humans, we need to know the mechanism of female germline stem cell development and safety after transplantation of single mouse female germline stem cells."

Premature ovarian failure, also called early menopause, is the loss of normal ovarian function, and thereby the release of eggs, before the age of 40. The condition is rare, affecting 200,000 women in the United States per year, and is incurable, although it can be treated with hormone supplements. Multiple groups are now looking at whether stimulating tissue regeneration or using stem cell transplants could help.

In the Molecular Therapy study, Wu and her colleagues isolated and characterized female germline stem cells from a single transgenic mouse with cells that show green fluorescence when activated by a blue laser. This allowed the researchers to observe and analyze the development of the transplanted stem cells, which were introduced to the ovaries of other mice using a fine glass needle.

Wu and colleagues found that the transplanted egg-producing stem cells exhibited a homing ability and began to differentiate into early-stage oocytes when they reached the edge of the ovary. The oocytes spent a few weeks maturing and yielded offspring within 2 months. The researchers then demonstrated that the developmental mechanisms of eggs derived from transplanted germline stem cells were similar to that of normal eggs.

"The results are exciting because it's not easy to get offspring from female germline stem cells derived from a single mouse," Wu says.

Wu's lab is also working to establish female egg-producing stem cell lines from scarce ovarian tissues derived from follicular aspiratesthe leftover cells gathered when a clinician searches a patient for oocytesthat are produced and discarded in in vitro fertilization centers worldwide. These aspirates can yield stem cells that differentiate into eggs in the lab, with the potential to be transplanted. The study not only provides a new approach to obtain human female germline stem cells for medical treatment, but also opens several avenues to investigate human oogenesis in vitro.

Explore further: Making sperm from stem cells in a dish

More information: Molecular Therapy, Wu et al.: "Tracing and characterizing the development of transplanted female germline stem cells in vivo" http://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(17)30180-6 , DOI: 10.1016/j.ymthe.2017.04.019

Journal reference: Molecular Therapy

Provided by: Cell Press

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by: Darrell Greene Updated: May 17, 2017 - 10:40 PM

MEMPHIS, Tenn. - Diabetes is attacking younger Americans more often than ever before.

According to new research released by the New England Journal of Medicine, cases of both type 1 and type 2 diabetes rose dramatically between 2002 and 2012.

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Those new diagnoses crossed all racial boundaries in young people through age 20.

While a cure is still distant on the horizon according to researchers, new treatments are helping diabetics live longer and better lives.

Emily Fonville is your average 15-year-old learning to drive, playing high school sports, and of course dressing up for the prom.

What you can't see in her pictures, is her daily fight against type 1 diabetes.

"It's like the hidden disease," Emily said.

But that fight is becoming more and more winnable.

Just three weeks ago, Emily became the first person in the Mid-South and one of the first in the nation to begin wearing the artificial pancreas.

It's true name, Medtronic is the hybrid closed loop system.

It's comprised of an insulin pump which attaches to the patient's skin, and a sensor which monitors in real time the patient's blood sugar.

The sensor sends those readings to the pump and when the patient's blood sugar is high, the pump gives the patient a precisely measured dose of insulin.

If the patient's blood sugar is too low, it has the ability to suspend delivery of insulin automatically.

"It is a game changer," Emily exclaimed when asked about the new tool.

Dr. Kashif Latif is Emily's doctor. He's one of the leading endocrinologists in the nation.

"There's a lot of technology going on, but this breakthrough has been the best thing ever for people with type 1 diabetes," said Latif who operates the first insulin pump center in nation out of his practice in Bartlett.

And while he admits this is not a cure, he said it's the next best thing to come along to date.

"It kind of matches what our body or our pancreas does for us. It's a more physiologic delivery of insulin for high glucose or low glucose," said Latif.

That means a lot less worry about diabetes for Emily.

"I think it is life changing. Being on this pump I feel like a normal person. I don't have to pull out a shot and give it in the middle of a restaurant.

I can just look down, press a button, and it's done."

FOX13 spoke to representatives of Medtronic who said the company was somewhat taken off guard.

They applied to the FDA for approval of the system in 2015, understanding that the approval process can take years.

But the human trials of the system went so well, the hybrid closed loop system was approved late last year.

Medtronic is making the systems as quickly as they can to fill the need.

2017 Cox Media Group.

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Artificial pancreas helping people with diabetes - FOX13 Memphis

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DAVIS COUNTY, Utah -- The growth rate of Type 1 diabetes among Utah students in grades K-12 is rapid.

The Utah Health Department said the most recent data shows in the 2015 to 2016 school year, there were 2,000 Type 1 diabetic students statewide.

The Davis County School District recognized the rapid increase in newly diagnosed students more than five years ago, and at that time they developed a Diabetes Education Program.

They collaborated with The Juvenile Diabetes Research Foundation, the American Diabetes Association, and the Primary Childrens Hospital diabetes clinic to develop their program.

We've had 56 graduates in this program the past five years, said Adam King, one of the program coordinators. Our number of diabetics has gone up exponentially over the years. There are new ones being diagnosed every day. We had three new ones diagnosed this week."

King said the program provides a valuable service, especially to children who may feel afraid after a diagnosis.

"And being able to have this program helps parents, helps educators, helps students have some confidence because its scary to be diagnosed with diabetes; it's life-threatening," he said. "When they are so young it can cause a lot of fear and apprehension.

Type 1 diabetes is an auto-immune disease and means the pancreas organ has stopped doing its job, which is to produce insulin to break down the food youre eating and turn it into nutrients and energy for your body to use. If the disease is not controlled, it can cause major complications and even become deadly.

When a student is more worried about being able to survive day-to-day, whether they are hungry, whether their blood sugar is going to be up or down, how it's impacting them, they don't have the brain power to think about learning their math or their science or English, King said. A program like this takes all the students as they come, with disabilities, with diabetes, and gives them a safe, appropriate education.

The program is catered to individual diabetics. Some students are older or have a better grasp of their condition early on.

Diabetes can be diagnosed at any age. The program is step-based and starts with the essentials, then progresses to counting carbohydrates and calculating how many insulin units a diabetic would need to inject or dial on their insulin pump.

It starts with basics such as washing hands or starting to recognize how they're feeling, and it develops up through five levels of getting to the point where they are counting their own carbs, doing their own blood sugar checks, and giving their own insulin doses," King said. "At the end they have a one-month trial where they are doing things without having a [Teacher's Assistant] standing there giving that support.

Recently at Knowlton Elementary School, 8-year-old Emerie Gelter, graduated from the program earlier than most diabetic students her age. Emerie is still in second grade.

We are very proud of Emerie, said King as he handed her a certificate of graduation from the program. She has gone through a lot of stuff. She has great family support, but she also does a good job with advocating for herself. She is very precocious. She is very excited and that helps her being a self-advocate.

The program is critical for most diabetic students because they learn to take care of themselves at school as they move on to higher levels of learning.

A lot of times we have students who focus on safety so much that they learn a helplessness to where they expect someone to do everything for them, King said. And while we want them to be safe, we also want them to develop those skills.

The Davis County School District is aware other districts do not use the same diabetes program and have talked with parents who have diabetic children who attend other districts. Those parents have seen what Davis is doing and are encouraged by the results.

Davis County would like to see all Utah schools implement a Diabetes Education Program similar to this one.

I don't know why it's not at other schools; this is something we developed on our own about five years ago because we recognized that while we were trying to achieve our goal with the students self-managing, there wasn't a good way to show their progress," King said."This isn't a one-size fits-all program; this is something that we take standardization and framework and cater to what a student needs and the pace they want to move at.

If you want to explore the program at Davis County School District, click here.

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Young Utahn recognized for early graduation from Diabetes Education Program - fox13now.com

By Robert Preidt

HealthDay Reporter

WEDNESDAY, May 17, 2017 (HealthDay News) -- The type 2 diabetes prescription drug canagliflozin (brand names Invokana, Invokamet, Invokamet XR) appears to increase the risk of leg and foot amputations, the U.S. Food and Drug Administration says.

The FDA is requiring the medications to carry new warnings about the risk. The required warnings on the drug's labeling include the most serious and prominent boxed warning.

The agency's decision is based on data from two large clinical trials showing that leg and foot amputations occurred about twice as often in patients taking canagliflozin as among those taking a placebo.

Amputations of the toe and middle of the foot were the most common, but leg amputations below and above the knee also occurred. Some patients had more than one amputation, some had amputations involving both limbs, according to the FDA.

Type 2 diabetes occurs when the body becomes resistant to insulin. Insulin is a hormone that helps to usher sugar from foods into the body's cells. When this process doesn't work correctly, blood sugar levels rise. Left untreated, high blood sugar levels can cause a number of possible complications, including heart disease, kidney problems and amputations, according to the American Diabetes Association.

Canagliflozin is meant to be used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. These drugs lower blood sugar levels by causing the kidneys to remove sugar from the body through the urine.

It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet.

Patients taking canagliflozin should immediately notify their health care providers if they develop new pain or tenderness, sores or ulcers, or infections in the legs or feet, the FDA said in a news release. Patients should not stop taking their medication without first talking to their health care provider.

Before prescribing canagliflozin to patients, doctors should consider factors that may predispose patients to the need for amputations, including a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers, the FDA said.

In addition, doctors should monitor patients taking canagliflozin for the above signs and symptoms, and discontinue canagliflozin if these complications occur.

In a statement, Janssen Pharmaceuticals, the maker of canagliflozin, said the company had already shared the findings on amputation risk with medical professionals prior to this warning.

"While the incidence was low, the highest incidence of amputations across all treatments was seen in patients with prior amputation," Janssen said. "At Janssen, patient safety is our highest priority. We are working with FDA to include this information in the prescribing information for canagliflozin."

WebMD News from HealthDay

SOURCES: U.S. Food and Drug Administration, news release, May 16, 2017; statement, Janssen Pharmaceuticals

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Diabetes Drug Gets FDA Warning Due to Amputation Risk - WebMD

Science Daily

Improving drugs for type 2 diabetes Science Daily Type 2 diabetes, a prolific killer, is on a steep ascent. According to the World Health Organization, the incidence of the condition has grown dramatically from 108 million cases in 1980 to well over 400 million today. The complex disease occurs when ... and more »

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Improving drugs for type 2 diabetes - Science Daily

The FDA has approved a new drug that could reverse the effects of diabetic macular edema, which is what causes blindness in people with diabetes.

Jeremy Baker, KENS 1:34 PM. CDT May 17, 2017

A new medication could help reverse diabetes vision loss. (Photo: KENS)

Diabetes is reportedly the number one cause of blindness in the United States. Until recently, there was no way to reverse it. However, a fairly new drug recently approved by the FDA is changing that.

"It was one of those things that's hard to believe," said Sonny Groves, a portrait photographer. He found out he had diabetes 20 years ago. "As the disease progressed, I had problems like neuropathy in the hands and feet, that sort of thing," Groves said.

His vision also started to go. That's when he was referred to the Medical Center Ophthalmology Associates.

"Better control of your blood sugar will give us better control of the back of your eye," said Dr. Michael Singer as he examined Groves' vision. Singer is the director of clinical trials at MCOA.

"Dr. Singer was the first one to notice I had any problems because he noticed tiny bleeders in my retina," Groves said.

"When tissues are deprived of oxygen, they scream for help. They send out a signal called VEGF," said Singer.

The VEGF sends new blood vessels to help the tissues, but that's not a good thing.

"Instead of being helpful, they are actually harmful. They cause swelling in the central part of your vision," Singer said.

In comes a drug called Lucentis.

"This is the first time the FDA has approved a drug like this to reverse the disease," Singer said. The usage is for diabetic retinopathy in patients either with or without diabetic macular edema. This latest approval broadens the diabetic retinopathy indication to include patients both with and without diabetic macular edema.

That disease is called diabetic macular edema. Lucentis is a shot given in the white of the eye after it is numbed. The typical Lucentis dose for diabetic retinopathy is 0.3 mg, which is slightly lower than the 0.5 mg dose used for other eye diseases.

"The process takes literally about two seconds and the results can be seen as early as three days," Singer said.

Groves said the results were amazing.

"When I started taking the Lucentis, it got better. The swelling that causes all of that stopped," Groves said.

"They go from a situation where they are not seeing as well to actually improving their vision and increasing activities they are able to do in their daily life," Singer said.

Now, thanks to Lucentis, Groves said he doesn't have to stop being a photographer.

Some of the side effects of Lucentis could be eye irritation, eye pain, dry eyes or some potentially serious side effects.

Uncommon side effects could reportedly include changes in vision and eye infections.

2017 KENS-TV

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'Breakthrough' drug could reverse vision loss caused by diabetes ... - KENS 5 TV

Cancer stem cells are bad actors. They enable cancers to metastasize, or spread, and help revive cancers after the malignancies go dormant. One of the few agents that can effectively attack them is a small molecule called salinomycin. But scientists havent understood how the compound kills the cells.

Now, researchers have discovered salinomycins mechanism (Nat. Chem. 2017, DOI: 10.1038/nchem.2778). The findings reveal a key weakness of cancer stem cells that could lead to the design of other drugs to help fight the cells.

To discover the mechanism, Raphal Rodriguez of Institut Curie and Frances National Center for Scientific Research, Maryam Mehrpour of Institut Necker Enfants Malades and INSERM, and coworkers first tried to create a more potent version of salinomycin by modifying it with groups of varying polarity and charge. The most potent was ironomycin, in which one of salinomycins hydroxyl groups was replaced by a short amine-alkyne chain. Ironomycin has an order of magnitude greater potency than salinomycin at killing breast cancer stem cells, both in culture and in mice.

They then used in vivo click chemistry on ironomycins alkyne group to label the compound with a fluorescent dye, enabling them to track where the compound goes when in cancer stem cells. They had expected it to distribute evenly throughout the cells and were surprised when it instead localized in lysosomes, which are cellular compartments with enzymes that break down certain molecules.

This led them to the mechanism: Salinomycin, or ironomycin, binds cellular iron and sequesters it in lysosomes. The high concentration of lysosomal iron then triggers a process called ferroptosisin which iron catalyzes the so-called Fenton reaction, producing reactive oxygen species that break lysosomal membranes, oxidize cell lipids, and cause cell death. The mechanism is not specific to cancer stem cells, Rodriguez says, but these cells are more susceptible to salinomycins or ironomycins activity because they are more dependent on iron and may be less efficient at scavenging free radicals than conventional cells.

The study is the first to characterize salinomycins mechanism of action at a molecular level, which is in itself a major step forward and an impressive feat, given the structural complexity of this compound, says Piyush Gupta of the Whitehead Institute and MIT, who discovered salinomycins activity against cancer stem cells. It is also the first to convincingly show that iron plays an unusually important role in regulating the malignant properties of cancer stem cells. These are both important contributions that will guide the development of new therapies targeting the most malignant of cancer cells.

Selective mechanisms for killing cancer stem cells have been a long-standing goal of cancer drug discovery, but few mechanisms have been identified, says Brent R. Stockwell of Columbia University, who discovered ferroptosis. This paper suggests that iron sequestration in lysosomes could be one such effective mechanism for targeting cancer stem cells.

One possible drawback to a cancer-stem-cell-targeting compound is that other cells in the tumor might still survive, he adds. So you would likely need a combination of drugs targeting cancer stem cells and non-stem-cell tumor cells. And there might be toxicity to normal stem cells, so this would need to be evaluated as research on stem-cell-targeted agents progresses.

Read more:
Route to cancer stem cell death ironed out - Chemical & Engineering News

May 18, 2017

New research presented at this year's European Congress on Obesity (ECO) in Porto, Portugal (17-20 May) shows the obese people have higher levels of a protein called survivin, which protects fat-containing adipocyte cells in the body from being destroyed. The study was led by Dr Sonia Fernndez-Veledo and Dr Joan Vendrell and is presented at ECO by Dr Miriam Ejarque, all of the Pere Virgili Institute, Rovira i Virgili University, CIBERDEM, Taragona, Spain.

Adipose tissue (AT) has a central role in obesity-related metabolic imbalance through the dysregulated production of inflammatory proteins called cytokines and adipokines. In addition to its known risk for cardiovascular disease and diabetes, obesity is also a major risk for cancer. Human adipocyte-derived stem cells (hASCs), which determine AT expansion, are important players in pathological development of obesity and associated cancer; however, the mechanisms underlying hASCs-induced alterations in cancer remain unknown. The authors aimed to better understand these mechanisms.

hASCs were isolated from subcutaneous AT of lean and obese subjects. Serum and AT from a cross-sectional study of 111 subjects classified by body-mass index were collected. Apoptosis (the process of cell death) was measured by flow cytometry, which uses highly focused beams of light to analyse functioning of individual cells. Gene and protein expression were assessed using the standard methods of quantitative polymerase chain reaction (qPCR) and western blotting.

The authors then investigated the impact of obesity on the expression of survivin, an anti-apoptotic protein (which protects cells from death), already known to be a diagnostic biomarker of tumour onset and recurrence that has been studied in several cancers. In this new cross-sectional study, circulating levels of survivin and gene expression in subcutaneous AT were 2.5 times higher in obese and morbidly obese patients than lean patients. Within AT, survivin was detected in hASCs, and its expression was significantly increased in obesity and by pro-inflammatory interleukin proteins.

Analysis of survivin expression in hASCs revealed a complex regulation within cell mechanisms, including epigenetic modifications and improved protein stability (giving the cell protection). "We discovered that survivin levels determine the susceptibility of hASCs to stimuli that cause the cell to die," explains Dr Ejarque Carb. "hASCs from an obese person were better protected from death than those in normal weight subjects."

She concludes: "Collectively, these data shed new light on the molecular mechanisms controlling AT expansion in obesity through promotion of hASCs that are resistant to cell death, and point to survivin as a new molecular player in the communication between hASCs and tumour cells. Thus, promoting cell death by targeting survivin might represent an effective strategy for both obesity and cancer therapy."

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Study shows protein called 'survivin' which protects fat cells from death is at higher levels in obese people - Medical Xpress

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It will facilitate organ donation as well as increase awareness of organ transplants

The UAE Ministry of Health and Prevention has issued a decree on declaration of death. Abdul Rahman Mohammed Al Owais, Minister of Health and Prevention, issued the ministerial decree (No. 550 of 2017) recently. It covers three main provisions, namely death resulting from cardiac-respiratory arrest; death resulting from complete loss of brain functions; and paediatric brain death guidelines.

Sustainable health solution

HE Dr Amin Hussein Al Amiri, Assistant Undersecretary for the Ministry's Public Health Policy and Licensing sector, said that the decree complements the national programme for organ transplantation as embodied in Federal Law No. 5 of 2016, that excludes stem cells, blood cells and bone marrow transplants,. It is a sustainable health solution, especially for individuals suffering from cancer, heart disease, pulmonary failure, hepatic fibrosis, and kidney failure. He reiterated the UAE's commitment to criminalize illegal organ transplant procedures, saying these violate human dignity.

Clinical death

A national committee composed of all local health authorities prepared the latest resolution in consultation with the General Authority for Islamic Affairs and Endowments.

The decree was made in response to the urgent need to enact legislation on the declaration of death in a bid to protect hospitals and enable doctors to stop the suffering of brain-dead patients. The question of clinical death is a medical and legal problem, while the issue of organ transplants has raised vital ethical issues such as the clear definition of death and the timing and manner of authorizing the transplant procedures.

Patient protection from regional and global non-accredited facilities

Al Amiri said a number of patients diagnosed with kidney and liver failures, among others, will go abroad to seek organ transplants. Out of desperation, however, they fall prey to false promises of non-specialized centers, especially those located in some Asian countries. Worse, they might become infected with AIDS and viral hepatitis as a result of the fraudulent procedure. The ministerial resolution, he said, will protect UAE patients from becoming victims.

Moreover, the resolution aims to help contribute to the enhancement of the country's medical tourism. Significant investments are expected to pour into the country with the opening of new international centers specializing in organ transplants. It also allows the establishment of a national organ bank and a database to record all individuals who signify their wish to donate their organs upon their deaths.

An organ donor can save 5 to 8 lives

Al Amiri explained that organ transplant will take place only in accredited public and private hospitals with Ministry-approved standards and prior approval of competent authorities to ensure patient safety and implementation of correct procedures.

According to him, one donor can save 5 to 8 lives. Organs that have been successful transplanted include the heart, kidneys, liver, lungs, pancreas, and intestines, while tissues include bone, tendons, cornea, skin, heart valves, nerves, and veins. Worldwide, kidney transplantation is the most common, followed by liver then heart. He pointed out the importance of keeping the identity of the donor and his family confidential as well as the name of the beneficiary.

Cardiac arrest and loss of brain functions

Al Amiri also noted that the resolution differentiates between the declaration of death resulting from cardio-respiratory arrest and death resulting from complete loss of brain functions. This serves as a guide to hospitals, especially for those with intensive care units. Brain death is defined as an irreversible cessation of all functions of all parts of the brain.

The decree also explained the conditions and exceptions for the declaration of brain death, including proper diagnosis through clinical preliminary examination, then the brain reflexes test with the visual response to light. It also covers the observation period, or intervals between clinical tests, and protocols. The results of these tests should be duly recorded along with the electrical brain layout. The time interval between the tests varies according to the age groups, from 48 hours for infants to 6 hours for adults.

Paediatric brain death

For paediatric brain death, the decree mandates 48- hour observation period for infants aged 7 days to two months; 24 hours for infants aged two months to 1 year; with 2 electroencephalograms separated by a period of 24 hours and both showing the absolute lack of effectiveness of brain or one ECG showing brain inactivity and lack of blood flow to the brain confirmed through CT scan or radioisotope,; and children aged 1 year and until puberty, the same adult protocol is followed except the observation period which must be at least 12 hours. After puberty, he same protocol for adults is followed.

Sustainable organ transplant programme

Dr Ali Abdul Kareem Al Obaidli, Chair of the National Organ Transplant Committee, praised the completion of procedures allowing the expenditure of the national organ transplant programme, including organ donation upon death. He said that the efforts of the country's wise leadership and the Ministry of Health and Prevention will lead to the establishment of a sustainable programme for organ transplants given that the UAE enjoys modern health infrastructure and the willingness of the citizens and residents to donate their organs as per the results of various surveys and studies in support of the National Organ Transplantation Programme.

The decree aims to ease the burden on patients suffering from organ failure and protect them from undergoing operations in non-specialized centers abroad that may cause numerous complications.

Clear criteria to establish credibility in declaration of death process

Dr Marwan Al Mulla, Director of the Department of Health Regulation of Dubai Health Authority, this decree will lead to the rearrangement of priorities for hospital-based healthcare programmes to prevent patients in critical conditions to be moved to less efficient healthcare centers. It also seeks to increase the hospitals' capacity and capability to receive more emergency cases that require intensive and continuous care. The decree aims to provide financial support to patients, their families, and healthcare providers, in addition to establishing clear criteria that will lend credibility to the process of death declaration. Lastly, it strives to promote organ donations to help critical patients according to relevant legislations.

Enhancing the health system

Dr Amer Sharif, Vice Chancellor of the Mohammed Bin Rashid University of Medicine and Health Sciences (MBRU) and CEO of Dubai Healthcare City Authority's Education Sector, commanded the efforts of the Ministry of Health and Prevention and the national committee for organ transplantation in establishing these standards. He indicated that this development will definitely facilitate organ donation as well as increase awareness of organ transplants in the UAE.

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UAE issues decree on declaration of death - Khaleej Times

A gene therapy that deliberately infects the eye with a virus can safely preserve vision in people affected by one of the leading causes of blindness, research has shown.

In a small preliminary study, scientists used an altered common cold-type virus to carry a repair gene that combats age-related macular degeneration (AMD).

The disease is marked by abnormal blood vessels that leak fluid into the central part of the retina, or macula.

After being injected into patients' eyes, the virus penetrated retinal cells and deposited the gene, which manufactured a therapeutic protein called FLT01.

Lead researcher Professor Peter Campochiaro, from Johns Hopkins University in the US, said: This preliminary study is a small but promising step towards a new approach that will not only reduce doctor visits and the anxiety and discomfort associated with repeated injections in the eye, but may improve long-term outcomes.

The Phase I clinical trial involved 19 men and women aged 50 and older with advanced wet AMD.

With the help of the gene, retinal cells were turned into factories making FLT01.

The scientists hope this will eliminate the need to administer repeated injections of the protein, which suppresses a natural growth-driving molecule called VEGF.

Prolonged suppression of VEGF is needed to preserve vision, and that is difficult to achieve with repeated injections because life often gets in the way, said Prof Campochiaro.

For safety and ethical reasons, the patient group consisted of people for whom standard approved treatments were highly unlikely to restore vision.

Only 11 patients stood any chance of fluid reduction. Of those, four showed dramatic improvements after the gene therapy. The amount of fluid in their eyes dropped from a severe level to almost nothing.

Two other patients experienced a partial reduction in the amount of fluid in their eyes.

The findings are reported in the latest issue of The Lancet medical journal.

Press Association

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Gene therapy infection can prevent blindness, research shows | The ... - The Independent