CARLSBAD, Calif.--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cellular therapies for unmet medical needs, today announced additional patient data from its ongoing Phase I/IIa clinical study of OpRegen, the Companys retinal pigment epithelium (RPE) transplant therapy, for the treatment of dry age-related macular degeneration (dry AMD), a leading cause of adult blindness in the developed world with no FDA-approved treatment options.
The first Cohort 4 patient treated using both a new subretinal delivery system and the Companys new thaw-and-inject (TAI) formulation of OpRegen has continued to demonstrate notable improvements in vision, having gained 25 readable letters (or 5 lines) 6 months following administration of OpRegen RPE cells, as assessed by the Early Treatment Diabetic Retinopathy Scale (ETDRS). This represents an improvement in visual acuity from a baseline of 20/250 to 20/100 in the treated eye. A second Cohort 4 patient has been similarly dosed, and though early, the patient has shown a small improvement in visual acuity in the treated eye at just 14 days following treatment. To date, improvements have become most evident approximately three to six months after treatment. Both patients had rapid healing at the surgical site with no unexpected complications or any serious adverse events.
We are increasingly optimistic about the data we are collecting in dry AMD, stated Brian M. Culley, CEO of Lineage. We have treated five patients in Cohort 4, those with less advanced disease, which more closely match our intended patient population. At the longest-available assessment point for each patient, all five have shown an increase in the number of letters they can read on an ETDRS eye chart. Importantly, these gains have been maintained for as long as 15 months, which is the longest time point for which we have collected data in the better vision cohort. Notably, the first two patients dosed with the new sub-retinal delivery system by Gyroscope Therapeutics and our innovative TAI formulation of OpRegen had no unexpected complications, so we intend to request the removal of the enrollment treatment stagger from the protocol, which should permit us to significantly accelerate our rate of enrollment. Our objective is to combine the best cells, the best production process and the best delivery system, which we believe will position us as the front-runner in the race to address the unmet opportunity in the potential billion-dollar dry AMD market.
We expect 2020 will be a year of major milestones for Lineage. Based on our existing cash and the current value of our marketable securities, we believe we will be able to achieve these milestones under our reduced 2020 spending plan, continued Mr. Culley.
Having dosed a patient with the combination of Gyroscopes recently 510(k)-cleared Orbit Subretinal Delivery System alongside Lineages new thaw-and-inject formulation of OpRegen RPE cells, I found the procedure to be relatively straightforward, leading to the successful delivery of RPE cells to the subretinal space, stated Judy Ju-Yi Chen, M.D., a retinal surgeon at West Coast Retina, San Francisco, CA. I am hopeful that additional procedures will show that this combination provides superior dose control, safety, and efficacy compared to conventional procedures.
The ETDRS eye chart consists of a set of letters of diminishing size on each line. The more letters a patient can read, the better their vision. The Company also is collecting data on rate of geographic atrophy (GA) growth, best corrected visual acuity (BCVA), low-light visual acuity, reading speed, quality of life questionnaires, microperimetry, and assessing structural changes using optical coherence tomography (OCT), fundus autofluorescence (FAF), and color fundus photography.
About the Phase I/IIa Clinical Study
This is a Phase I/IIa open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with geographic atrophy. The study will enroll approximately 24 patients, divided into 4 cohorts. The first 3 cohorts consisted solely of legally blind patients, with best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort will include approximately 12 patients with vision ranging from 20/250 to as high as 20/64. Cohort 4 also includes patients treated with one of two formulations of OpRegen; the first 3 patients were treated with a formulation which required plating and preparation of cells one day prior to use. The remaining patients on Cohort 4 will be treated with an off-the-shelf or thaw-and-inject formulation of OpRegen which can be shipped directly to sites and used immediately upon thawing, which removes the complications and logistics of having to use a dose preparation facility. Staggered intervals within and between cohorts are applied to ensure patient safety and welfare. The primary objective of the Phase I/IIa study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. Additionally, for the patients in Cohort 4 that receive subretinal delivery of OpRegen utilizing Gyroscope Therapeutics Orbit Subretinal Delivery System (Orbit SDS), objectives will include the evaluation of the safety of delivery of OpRegen using the Orbit SDS.
About OpRegen
OpRegen is a retinal pigment epithelium (RPE) transplant therapy in Phase I/IIa development for the treatment of dry AMD, a leading cause of adult blindness in the developed world. OpRegen consists of a suspension of RPE cells delivered subretinally as an intraocular injection. RPE cells are essential components of the back lining of the retina and function to help nourish the retina including photoreceptors. OpRegen has been granted Fast Track designation from the U.S. Food and Drug Administration. OpRegen is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of Lineage Cell Therapeutics, Inc.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its proprietary cell-based therapy platform and associated development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally-differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed either to replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical assets include (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase I/IIa development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase I/IIa development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic cancer immunotherapy of antigen-presenting dendritic cells currently in Phase I development for the treatment of non-small cell lung cancer. Lineage is also evaluating potential partnership opportunities for Renevia, a facial aesthetics product that was recently granted a Conformit Europenne (CE) Mark. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as believe, may, will, estimate, continue, anticipate, design, intend, expect, could, plan, potential, predict, seek, should, would, contemplate, project, target, tend to, or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the development of Lineages OpRegen program, as well as Lineages spending plans. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineages actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineages business and other risks in Lineages filings with the Securities and Exchange Commission (the SEC). Lineages forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading Risk Factors in Lineages periodic reports with the SEC, including Lineages Annual Report on Form 10-K filed with the SEC on March 14, 2019 and its other reports, which are available from the SECs website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
- AI has perfect detection rate for severe cases of condition that causes blindness in preemies - OHSU News - March 10th, 2024
- PulseSight launches with gene therapy platform targeting age-related blindness - Longevity.Technology - March 10th, 2024
- AIOS and RANZCO Unite to Combat Preventable Blindness - Hindustan Times - March 10th, 2024
- Baby born without eyes defies the odds as she thrives despite blindness - Express - March 10th, 2024
- Penn Medicine Accelerator Program to Boost AI-Powered Projects Targeting Blindness and Cervical Cancer - India Education Diary - March 10th, 2024
- Scientists discover gut bacteria`s role in genetically-linked vision loss - WION - February 27th, 2024
- Prevent Blindness launches new Retinopathy of Prematurity Education and Support Program as part of inaugural ... - Modern Retina - February 27th, 2024
- Revolutionizing Eye Disease Treatment: The Unseen Link Between Gut Bacteria and Blindness - Medriva - February 27th, 2024
- The Virtue of Color-Blindness & The End of Race Politics: Arguments for a Colorblind America Book Review - National Review - February 27th, 2024
- Sight loss could be treated by antibiotics after being linked to gut bacteria - The Independent - February 27th, 2024
- Prevent Blindness Launches New "Retinopathy of Prematurity (ROP) Education and Support Program" as Part of ... - PR Web - February 27th, 2024
- $35 million to fight blindness with manufactured corneas | Health Portfolio Ministers | Australian Government ... - Department of Health - February 10th, 2024
- Eye care, vision impairment and blindness - World Health Organization (WHO) - October 27th, 2023
- CHOROIDEREMIA RESEARCH FOUNDATION EXPANDS RESEARCH SUPPORT INTO NONSENSE MUTATIONS OF A RARE INHERITED RETINAL - EIN News - May 1st, 2023
- Chennai eye hospital ties up with Iceland firm to adopt mathematical algorithm to predict diabetic retinopathy - The Hindu - April 23rd, 2023
- Drug-Resistant Bacteria Tied to Eyedrops Can Spread Person to Person ... - April 7th, 2023
- Prevention of Blindness Week 2023: Mumbai experts explain why you should be concerned about glaucoma and the need for regular eye checkups -... - April 7th, 2023
- Childhood blindness - Wikipedia - February 24th, 2023
- FDA Approves Syfovre (pegcetacoplan injection) for the Treatment of ... - February 24th, 2023
- Human mini brains illuminate path to curing blindness - February 16th, 2023
- Raymond V. Gilmartin: Man with a global vision - February 16th, 2023
- Why Are People So Mad About MrBeast's Blindness Video? - February 16th, 2023
- This heartwarming video of a colorblind boy seeing color for the first time will make you cry - Indiatimes.com - February 16th, 2023
- Blindness (Vision Impairment): Types, Causes and Treatment - February 8th, 2023
- CDC urges people to stop using brand of artificial tears linked to ... - February 8th, 2023
- Health News Roundup: U.S. FDA says India-made eye drop linked to some infections, blindness and one death; China records 3,278 COVID-related deaths... - February 8th, 2023
- I had two strokes at 29 and gone blind -I've been accused of faking my sight loss - Daily Mail - February 8th, 2023
- Blindness and vision impairment - World Health Organization - January 23rd, 2023
- Recovery from blindness - Wikipedia - January 23rd, 2023
- Colour blindness tests, juggling, avoiding glare: A hockey goalkeepeers quest to train his biggest weapon, eyes - The Indian Express - January 23rd, 2023
- But Did You See the Gorilla? The Problem With Inattentional Blindness ... - October 15th, 2022
- Canadians unaware of diseases that lead to blindness, survey says - CTV News Northern Ontario - October 15th, 2022
- A Review of Corneal Blindness: Causes and Management - Cureus - October 15th, 2022
- A cure for blindness may be first product made in space - Freethink - October 15th, 2022
- Is MrBeast trying to cure 1000 people's blindness? - indy100 - October 15th, 2022
- Early detection and management is the key to prevent glaucoma related blindness: Experts - Express Healthcare - October 15th, 2022
- As World Sight Day Nears, River Blindness is Fading - SaportaReport - October 15th, 2022
- Tears of happiness: How curing blindness in Dolakha saved a girls future - City A.M. - October 15th, 2022
- World Sight Day: Orbis, UC Davis team up to train eye care teams from Latin America to fight avoidable blindness - Ophthalmology Times - October 15th, 2022
- Juan Williams: The GOPs epidemic of intentional blindness - The Hill - October 15th, 2022
- Charles pays tribute to Malawi's elimination of disease causing blindness - Express & Star - October 15th, 2022
- Coping with calamity: Former NYT columnist Frank Bruni on blindness and vision, at Morristown book fest keynote - Morristown Green - October 15th, 2022
- Sighting solutions in a world of vision for weavers - The New Indian Express - October 15th, 2022
- Blindfold run raises $40,000 for the MUHC Foundation to support glaucoma care at the MUHC - StreetInsider.com - October 15th, 2022
- MacKenzie Scott Donates $15M to Address the Eyecare Needs of the Impoverished - InvisionMag - October 15th, 2022
- Astellas and MBC BioLabs Announce Astellas Future Innovator Prize to Help Biotech Start-ups Accelerate Early Drug Discovery and Research Efforts -... - September 20th, 2022
- Treating cataracts before 'critical age' imperative FBC News - FBC News - September 20th, 2022
- GenSight Biologics to Present at Upcoming Industry and Investor Conferences - Business Wire - September 20th, 2022
- Ashton Kutcher battled vasculitis causing blindness, loss of hearing. Know all about the rare condition - India TV News - August 11th, 2022
- Prevent Blindness Is Recognized as a Healthy People 2030 Champion for Supporting the Initiative's Vision - Vision Monday - August 11th, 2022
- Researchers make progress toward a stem cellbased therapy for blindness - Ophthalmology Times - August 11th, 2022
- The strategic blindness of Israel's caretaker government - JNS.org - August 11th, 2022
- UND professor carries the torch for UND studies of visual impairment and blindness - Grand Forks Herald - August 11th, 2022
- Karan Nagrani is using social media to raise awareness about the 'spectrum of blindness' - ABC News - August 11th, 2022
- Vision impairment and blindness related to NCDs: Fong - FBC News - August 11th, 2022
- Strategic blindness of caretaker government - The Jewish Star - August 11th, 2022
- Massachusetts woman blinded by attack working to help others regain sight - WCVB Boston - August 11th, 2022
- Persuasion Film Review: Is Heterogeneous Casting Race-Inclusionary Or Escapist? - Feminism In India - August 11th, 2022
- Is It Time To Start Using Race And Gender To Combat Bias In Lending? - Forbes - August 11th, 2022
- The journey of Kali Yugi started with the mistake of objectives! - Youthistaan - August 11th, 2022
- A 50-State Review of Access to State Medicaid Program Information for People with Limited English Proficiency and/or Disabilities Ahead of the PHE... - August 11th, 2022
- iHealthScreen Completed Prospective Trial of AI-Based Tool for Age-Related Macular Degeneration (AMD) Screening and Submitting the Results to FDA for... - August 11th, 2022
- Vitamin B12: Why You Need It & Foods To Increase Your Vitamin B12 Intake - NDTV - August 11th, 2022
- Jack Levine: Remembering a dad who proved that even in blindness, there can be vision - The Florida Times-Union - June 26th, 2022
- Potion of Blindness | Minecraft Ideas Wiki | Fandom - June 26th, 2022
- Tightening a molecular "zipper" could help prevent hereditary blindness - New Atlas - June 26th, 2022
- What's the Link Between Glaucoma and Dry Eyes? - Healthline - June 26th, 2022
- Lisa Durden's upcoming documentary "Blind Divas" follows Krystle Allen and Naquela Wright-Prevoe, two Black women entrepreneurs, determined... - June 26th, 2022
- Trump election lies may fit legal concept of willful blindness - Chicago Tribune - June 26th, 2022
- Sightsavers relaunches its thematic strategy The Sun Nigeria - Daily Sun - June 26th, 2022
- Trachoma elimination: millions more to benefit from donated azithromycin - World Health Organization - June 26th, 2022
- Dangers of super gonorrhoea from infertility to blindness as global warning issued - Daily Star - June 26th, 2022
- Fifty years of Title IX: What is it, what does it cover and do we still need it? - The Athletic - June 26th, 2022
- How The SMH Got That Rebel Wilson Story So Wrong - Junkee - June 26th, 2022
- The Week That Was: All of Lawfare in One Post - Lawfare - Lawfare - June 26th, 2022
- Why Brad Pitt quit smoking and drinking altogether during the pandemic - BusinessGhana - June 26th, 2022
- Watch your eye - The New Indian Express - June 26th, 2022
- Olivia Brouwer's art is for everyone to see and touch - Hamilton Spectator - June 26th, 2022
- Monkeypox may not mutate as fast as coronaviruses, but that doesn't mean it can't adapt to its new hosts - The Conversation - June 26th, 2022
- Former American Express Foundation President Takes Helm of Signature Theatre - The Chronicle of Philanthropy - June 26th, 2022