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
March 14 2022 - 8:00AM
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220314005160/en/
Lineage Cell Therapeutics, Inc. IR Ioana C. Hone
ir@lineagecell.com (442) 287-8963
Solebury Trout IR Mike Biega Mbiega@soleburytrout.com
(617) 221-9660
Russo Partners – Media Relations Nic Johnson or David
Schull Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com (212) 845-4242
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