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RG6501 (OpRegen®) Full Phase 1/2a Results to Be Featured at 2022 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Presentation by Allen C. Ho, M.D., FACS
Lineage Cell Therapeutics (LCTX) reported full results from a Phase 1/2a clinical study of RG6501 (OpRegen®) for dry age-related macular degeneration (AMD). The therapy is developed in collaboration with Roche and Genentech. Results will be presented at the 2022 ARVO Annual Meeting. The study involved 24 patients across four cohorts, assessing safety and efficacy. No new treatment emergent adverse events were reported, indicating OpRegen has been well tolerated. Currently, there are no FDA or EMA approved treatments for dry AMD, highlighting the potential for OpRegen in a significant market.
Positive
OpRegen has been well tolerated with no new adverse events reported.
The study indicates preliminary efficacy for OpRegen in treating dry AMD.
There are no FDA or EMA approved treatments for dry AMD, presenting a strong market opportunity.
Negative
None.
CARLSBAD, Calif.--(BUSINESS WIRE)--
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that full results from a Phase 1/2a clinical study of RG6501 (OpRegen®), a retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), will be presented at the 2022 Association for Research in Vision and Ophthalmology Annual Meeting (ARVO 2022), to be held May 1 – 4, 2022 at the Colorado Convention Center in Denver, CO. The presentation, “Safety and Efficacy of a Phase 1/2a Clinical Trial of Transplanted Allogeneic Retinal Pigmented Epithelium (RPE, OpRegen) Cells in Advanced Dry Age-Related Macular Degeneration (AMD)” will be featured as part of the Retinal Prostheses and Transplantation Session, on May 2, 2022 between 3:00 PM to 5:00 PM MDT, by Allen C. Ho, M.D., FACS, Wills Eye Hospital Attending Surgeon and Director of Retina Research, Professor of Ophthalmology, Thomas Jefferson University, Mid Atlantic Retina and President, The Retina Society (abstract number 3714956). RG6501 (OpRegen) is currently being developed under an exclusive worldwide collaboration between Lineage, Roche and Genentech, a member of the Roche Group.
The Association for Research in Vision and Ophthalmology, Inc. (ARVO) was founded in 1928 in Washington, DC, by a group of 73 ophthalmologists. ARVO is the largest and most respected eye and vision research organization in the world. ARVO members include nearly 11,000 researchers from over 75 countries. ARVO advances research worldwide into understanding the visual system and preventing, treating and curing its disorders. For more information, please visit https://www.arvo.org/ or follow the association on Twitter @ARVOInfo.
About OpRegen
OpRegen® is a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, being developed under a worldwide collaboration between Lineage, Roche and Genentech, a member of the Roche Group. The Phase 1/2a open-label, dose escalation safety and efficacy study evaluated 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 GA and enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study was 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. OpRegen has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events related to OpRegen or study procedures that have not been previously reported.
About Dry AMD
Dry age-related macular degeneration (AMD) is a leading cause of adult blindness in the developed world. There are two forms of AMD: wet AMD and dry AMD. Dry AMD is the more common of the two types, accounting for approximately 85-90% of cases. Wet AMD is the less common of the two types, accounting for approximately 10-15% of cases. Global sales of the two leading wet AMD therapies were in excess of $10 billion in 2019. Nearly all cases of wet AMD begin as dry AMD. Dry AMD typically affects both eyes. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with dry AMD.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s 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. Lineage’s 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; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.
