OpRegen® Data Update to Be Featured at 54th Annual Retina Society Meeting in Podium Presentation by Christopher D. Riemann, ...
July 13 2021 - 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, announced today that updated
interim results from a Phase 1/2a study of its lead product
candidate, OpRegen®, a retinal pigment epithelium cell transplant
therapy currently in development for the treatment of dry
age-related macular degeneration (AMD), will be featured in a
podium presentation at the 54th Annual Scientific Meeting of the
Retina Society, to be held at the Ritz-Carlton Hotel in Chicago, IL
(September 29 – October 2, 2021). The presentation, “Phase 1/2a
Clinical Trial of Transplanted Allogeneic Retinal Pigmented
Epithelium (RPE, OpRegen) Cells in Advanced Dry Age-Related Macular
Degeneration (AMD): Interim Results,” will be presented on
September 30, 2021 at 9:52 am EDT by Christopher D. Riemann, M.D.,
Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye
Institute (CEI) and University of Cincinnati School of
Medicine.
The Retina Society was founded in 1968 exclusively for
educational and scientific purposes concerning the diagnosis, care
and treatment of diseases and injuries to the retina. For more
information on the Retina Society or its annual scientific meeting,
please visit https://www.retinasociety.org/ or follow the
association on Twitter @RetinaSociety.
About OpRegen
OpRegen is currently being evaluated in a Phase 1/2a 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 (GA). The study
enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled
only legally blind patients with 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 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. OpRegen
is a registered trademark of Cell Cure Neurosciences Ltd., a
majority-owned subsidiary of Lineage Cell Therapeutics, Inc.
About Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is an eye disease that
can blur the sharp, central vision in patients and is the leading
cause of vision loss in people over the age of 60. There are two
forms of AMD: dry (atrophic) AMD and wet (neovascular) AMD. Dry
(atrophic) AMD is the more common of the two forms, accounting for
approximately 85-90% of all cases. In atrophic AMD, parts of the
macula get thinner with age and accumulations of extracellular
material between Bruch's membrane and the retinal pigmented
epithelium (RPE), known as drusen, increase in number and volume,
leading to a progressive loss of central vision, typically in both
eyes. Global sales of the two leading wet AMD therapies were in
excess of $10 billion in 2019. Nearly all cases of wet AMD
eventually will develop the underlying atrophic AMD if the newly
formed blood vessels are treated correctly. There are currently no
U.S. Food and Drug Administration, or European Medicines Agency,
approved treatment options available for patients with atrophic
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, 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 subacute 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/20210713005126/en/
Lineage Cell Therapeutics, Inc. IR Ioana C. Hone
(ir@lineagecell.com) (442) 287-8963 Solebury Trout IR
Gitanjali Jain Ogawa (Gogawa@soleburytrout.com) (646) 378-2949
Russo Partners – Media Relations Nic Johnson or David Schull
Nic.johnson@russopartnersllc.com David.schull@russopartnersllc.com
(212) 845-4242
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