CARLSBAD, Calif.--(BUSINESS WIRE)-- Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today announced that updated results from a Phase I/IIa study of its lead product candidate, OpRegen, a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), were published online via the ARVOLearn platform as part of the 2020 Association for Research in Vision and Ophthalmology (ARVO) Meeting. The presentation entitled, Phase I/IIa Clinical Trial of Human Embryonic Stem Cell (hESC)-Derived Retinal Pigmented Epithelium (RPE, OpRegen) Transplantation in Advanced Dry Form Age-Related Macular Degeneration (AMD): Interim Results (Abstract # 3363764), was presented by Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine. Dr. Riemanns presentation is available on the Media page of the Lineage website. Lineage will also host a live call with Dr. Riemann, on Monday, May 11, 2020 at 5:00 p.m. ET/2:00 p.m. PT to further discuss the results of treatment with OpRegen. Interested parties can access the call on the Events and Presentations section of Lineages website.
This update is significant as it builds on our earlier reports of gains in visual acuity and provides a more comprehensive picture of treatment with OpRegen for dry AMD, with meaningful improvements in the progression of geographic atrophy, visual acuity, and reading speed observed in our first Cohort 4 patient and first Orbit SDS with thaw-and-inject formulation dosed patient, stated Brian M. Culley, Lineage CEO. As dry AMD is a slow and progressive disease, it takes many months to observe changes to retinal anatomy or visual acuity. With the benefit of longer follow-up, we now can report that some OpRegen treated patients are able to see better, have less growth in their area of GA, and are able to read faster, all of which represent significant enhancements to vision and quality of life metrics. In addition to these individual results, the pooled data continues to suggest a treatment effect in both visual acuity and GA progression. Notably, we also are reporting additional evidence that OpRegen cells remain present for at least 4 years and hope that longer follow-up periods will reinforce a growing body of evidence that OpRegen is well-tolerated and can provide sustained and clinically meaningful benefits with a single dose of RPE cells. Our near-term objective is to treat and monitor the final four patients in Cohort 4 of the current study and utilize these data to direct our clinical, regulatory, and partnership discussions. Our goal is to combine the best cell line, the best production process, and the best delivery system, to position OpRegen as the front-runner in the race to address the unmet need in the potential billion-dollar dry AMD market.
As a principal investigator on the OpRegen clinical study, I am excited to present this most recent update, where all Cohort 4 patients treated with OpRegen had improved Best Corrected Visual Acuity up to one year or at their last visit, demonstrating a substantial treatment response, stated Christopher D. Riemann, M.D. The pooled Cohort 4 data demonstrate a significant, greater than 10-letter sustained visual acuity improvement over the entire followup period. Reading center assessments of GA also suggest a reduction in GA progression in the OpRegen treated eye when compared to fellow eye in Cohort 4. I am encouraged by the results observed in patients treated to date with OpRegen and I look forward to dosing patients in this study at CEI.
KOL Call Information and Webcast
Lineage will host a conference call with Dr. Riemann, on Monday, May 11, 2020 at 5:00 p.m. ET/2:00 p.m. PT to further discuss the results following treatment with OpRegen. A live webcast of the conference call will be available online in the Events and Presentations section of Lineages website. Interested parties may also access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the Lineage Cell Therapeutics Call. A replay of the webcast will be available on Lineages website for 30 days and a telephone replay will be available through May 19, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 6597936.
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 robust proprietary cell-based therapy platform and associated in-house 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 to either 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 programs are in markets with billion dollar opportunities and include three allogeneic (off-the-shelf) product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a 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 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, a cancer immunotherapy of antigen-presenting dendritic cells in Phase 1 development for the treatment of non-small cell lung cancer. 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 Lineages objectives with respect to OpRegen. 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 12, 2020 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200506005264/en/
See the original post:
Lineage Cell Therapeutics Reports New Data With OpRegen for the Treatment of Dry AMD With Geographic Atrophy - BioSpace
- Congress Gives Stem Cells Another Shot -ASK THE EXPERT- ... [Last Updated On: August 4th, 2011] [Originally Added On: August 4th, 2011]
- Stem Cell Game 3- Grow with the Flow [Last Updated On: August 5th, 2011] [Originally Added On: August 5th, 2011]
- PROSTATE CANCER and stem cells [Last Updated On: August 13th, 2011] [Originally Added On: August 13th, 2011]
- Preview: 21st Century Snake Oil [Last Updated On: September 2nd, 2011] [Originally Added On: September 2nd, 2011]
- Stem cells: the future of medicine? [Last Updated On: September 5th, 2011] [Originally Added On: September 5th, 2011]
- Stem Cells: Politics vs. Medicine [Last Updated On: September 5th, 2011] [Originally Added On: September 5th, 2011]
- Mesenchymal Stem Cells in Regenerative Medicine: Of Hopes and Challenges [Last Updated On: September 5th, 2011] [Originally Added On: September 5th, 2011]
- An amazing story of stem cells, regenerative medicine and healing power: [Last Updated On: September 6th, 2011] [Originally Added On: September 6th, 2011]
- Preserving Stem Cells: Regenerative Medicine [Last Updated On: September 9th, 2011] [Originally Added On: September 9th, 2011]
- TEDxPhoenix - Jane Maienschein - Stem Cells, Regenerative Medicine and Us [Last Updated On: September 11th, 2011] [Originally Added On: September 11th, 2011]
- Personalized Medicine: Stem Cells 1/2 [Last Updated On: September 14th, 2011] [Originally Added On: September 14th, 2011]
- A Century of Stem Cells - Johns Hopkins Medicine [Last Updated On: September 16th, 2011] [Originally Added On: September 16th, 2011]
- What are stem cells? How can they be used for medical benefit? [Last Updated On: September 17th, 2011] [Originally Added On: September 17th, 2011]
- STEM CELLS TRANSLATIONAL MEDICINE Official Announcement [Last Updated On: September 18th, 2011] [Originally Added On: September 18th, 2011]
- Turning Adult Stem Cells into Medicine - Zannos Grekos, MD [Last Updated On: September 18th, 2011] [Originally Added On: September 18th, 2011]
- A New Era in Regenerative Medicine [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- Bruce Conklin: Drug screening with stem cells [Last Updated On: September 27th, 2011] [Originally Added On: September 27th, 2011]
- Professors Chandran and ffrench-constant - Are stem cells the future of regenerative medicine? [Last Updated On: September 27th, 2011] [Originally Added On: September 27th, 2011]
- Hormone Myths vs. Medical Literature and How to Grow Your Own Stem Cells - Ronald Rothenberg, MD [Last Updated On: September 28th, 2011] [Originally Added On: September 28th, 2011]
- Cardiovascular Derivatives of Embryonic Stem Cells in Cardiac Repair and Drug Discovery [Last Updated On: September 29th, 2011] [Originally Added On: September 29th, 2011]
- Jackson Laboratory symposium: What's vital for effective stem cell therapies? [Last Updated On: September 30th, 2011] [Originally Added On: September 30th, 2011]
- Alzheimer's Disease: Spotlight on Stem Cell Research - Rod Shankle [Last Updated On: October 3rd, 2011] [Originally Added On: October 3rd, 2011]
- "StemEnhance" the Biggest Scientific [Last Updated On: October 4th, 2011] [Originally Added On: October 4th, 2011]
- Stem cell medical breakthrough? [Last Updated On: October 4th, 2011] [Originally Added On: October 4th, 2011]
- The Future of Stem Cells and Regenerative Medicine [Last Updated On: October 4th, 2011] [Originally Added On: October 4th, 2011]
- Stem Cell Clinical Trials : University of Miami Miller School of Medicine [Last Updated On: October 4th, 2011] [Originally Added On: October 4th, 2011]
- Medical tourism in Croatia - Regenerative medicine-Stem cells in reconstructive surgery [Last Updated On: October 4th, 2011] [Originally Added On: October 4th, 2011]
- Bioethics Stem Cells and the New Biology [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- Stem Cells: The Hope The Hype and the Science [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- Skin Stem Cells: Their Biology [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- Spotlight on Cancer Stem Cell Research [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- Lou Gehrig's Disease (ALS): UCSD Team's Stem Cell Therapy Rationale [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- Sickle Cell Anemia: Stem Cell Gene Therapy - Donald Kohn [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- Stem Cells and Parkinson's Disease [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- Stem Cell Research: Macular Degeneration [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- An amazing story of stem cells and regenerative medicine [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- Stem Cell City - Lisa Ray [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- Stem Cell Therapy: Healing Force of the future [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- Adult Stem Cells in Drug Discovery and Therapeutics [Last Updated On: October 7th, 2011] [Originally Added On: October 7th, 2011]
- Medical Breakthrough: First Stem Cell Procedure [Last Updated On: October 7th, 2011] [Originally Added On: October 7th, 2011]
- Dr. Judith Oppenheim, Chicago on Dental Stem Cells on WGN-TV's Medical Watch. [Last Updated On: October 9th, 2011] [Originally Added On: October 9th, 2011]
- Jerome Zack: Creating iPS Cells - Video [Last Updated On: October 14th, 2011] [Originally Added On: October 14th, 2011]
- Sight for sore eyes - Video [Last Updated On: October 15th, 2011] [Originally Added On: October 15th, 2011]
- Regenerative Medicine Update: Stem Cells and Functional Testing - Mitchell J. Ghen, DO, PhD - Video [Last Updated On: October 15th, 2011] [Originally Added On: October 15th, 2011]
- Stem cells as the future of medicine - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- Neural Stem Cells Reverse Alzheimer's-Like Symptoms - Video [Last Updated On: October 19th, 2011] [Originally Added On: October 19th, 2011]
- Deafness: Spotlight on Stem Cell Research - Ebenezer Yamoah - Video [Last Updated On: October 21st, 2011] [Originally Added On: October 21st, 2011]
- Leukemia: Spotlight on Stem Cell Research - Patient Stories - Video [Last Updated On: October 21st, 2011] [Originally Added On: October 21st, 2011]
- Epidermolysis Bullosa: Corrected iPS Stem Cell-Based Therapy - Video [Last Updated On: October 21st, 2011] [Originally Added On: October 21st, 2011]
- iPS Stem Cell-Based Treatment of Epidermolysis Bullosa - Video [Last Updated On: October 21st, 2011] [Originally Added On: October 21st, 2011]
- Parkinson's Disease: Spotlight on Stem Cell Research - Arnold Kriegstein - Video [Last Updated On: October 21st, 2011] [Originally Added On: October 21st, 2011]
- Closing Remarks, Screening Stem Cells 2009: From Reprogramming to Regenerative Medicine - Video [Last Updated On: October 23rd, 2011] [Originally Added On: October 23rd, 2011]
- The Sue and Bill Gross Stem Cell Regenerative Medicine Center at UCI - Video [Last Updated On: October 26th, 2011] [Originally Added On: October 26th, 2011]
- Stem Cell Institute - Video [Last Updated On: October 28th, 2011] [Originally Added On: October 28th, 2011]
- StemCellTV Special Report - Stem Cell Therapy a "Medical Game Changer" - Video [Last Updated On: October 28th, 2011] [Originally Added On: October 28th, 2011]
- Adult Stem Cells and Regeneration - Video [Last Updated On: November 8th, 2011] [Originally Added On: November 8th, 2011]
- Cloned Embryonic Stem Cells, FIRST (Brainstorm Ep26) - Video [Last Updated On: November 12th, 2011] [Originally Added On: November 12th, 2011]
- Beating Heart Stem Cells - Video [Last Updated On: November 13th, 2011] [Originally Added On: November 13th, 2011]
- Stem Cell Research In Toronto - Video [Last Updated On: November 13th, 2011] [Originally Added On: November 13th, 2011]
- Stem Cells and Their Amazing Potential 2011 trailer - Video [Last Updated On: November 15th, 2011] [Originally Added On: November 15th, 2011]
- Stemcell Research and Aging - Panel 1 - Video [Last Updated On: December 13th, 2011] [Originally Added On: December 13th, 2011]
- Austin Forum - Nov 1st (Part 4 of 4) - Video [Last Updated On: December 13th, 2011] [Originally Added On: December 13th, 2011]
- Vet-Stem Medistem Cellmedicine Rheumatoid Arthritis Stem Cell Video - Video [Last Updated On: December 19th, 2011] [Originally Added On: December 19th, 2011]
- Stem Cell Clinical Trial for Heart Failure: Eduardo Marban - CIRM Spotlight on Disease - Video [Last Updated On: December 26th, 2011] [Originally Added On: December 26th, 2011]
- Stem Cell-Derived Heart Cells: Bruce Conklin - CIRM Science Writer's Seminar - Video [Last Updated On: January 5th, 2012] [Originally Added On: January 5th, 2012]
- Pope gives support to adult stem cells and asks for ethics in scientific research - Video [Last Updated On: January 5th, 2012] [Originally Added On: January 5th, 2012]
- Stem Cell Treatment for Rheumatoid Arthritis - Darnell Morris - Video [Last Updated On: January 5th, 2012] [Originally Added On: January 5th, 2012]
- Personalized Medicine: Stem Cells 2/2 - Video [Last Updated On: January 13th, 2012] [Originally Added On: January 13th, 2012]
- Utilizing Stem Cell-derived Cardiomyocytes for Early Safety Screening - Webinar Presentation - Video [Last Updated On: January 22nd, 2012] [Originally Added On: January 22nd, 2012]
- Stem Cell Stage Bypassed in Skin Cell to Brain Cell Transformation [Last Updated On: February 1st, 2012] [Originally Added On: February 1st, 2012]
- Encouraging Results with Stem Cell Transplant for Brain Injury [Last Updated On: February 1st, 2012] [Originally Added On: February 1st, 2012]
- Stem cell injection successfully treats urinary incontinence [Last Updated On: February 13th, 2012] [Originally Added On: February 13th, 2012]
- ImmunoCellular Therapeutics To Present at Targeting Stem Cells Symposium during 19th Annual Molecular Medicine Tri ... [Last Updated On: February 17th, 2012] [Originally Added On: February 17th, 2012]
- Adult Stem Cell Success Stories - Barry Goudy - Video [Last Updated On: February 21st, 2012] [Originally Added On: February 21st, 2012]
- Stem Cell Treatment for T-6 Spinal Cord Injury - Video [Last Updated On: February 21st, 2012] [Originally Added On: February 21st, 2012]
- Stem Cells China-Switzerland.wmv - Video [Last Updated On: February 21st, 2012] [Originally Added On: February 21st, 2012]
- Stem cell find offers hope for infertility [Last Updated On: February 27th, 2012] [Originally Added On: February 27th, 2012]
- Stem cell fertility treatments could be risky for older women [Last Updated On: February 28th, 2012] [Originally Added On: February 28th, 2012]
- A*STAR Scientists Make Groundbreaking Discovery on Stem Cell Regulation [Last Updated On: March 1st, 2012] [Originally Added On: March 1st, 2012]
- UGA study reveals basic molecular 'wiring' of stem cells [Last Updated On: March 1st, 2012] [Originally Added On: March 1st, 2012]