OpRegen® Data Update to Be Featured at 2021 Association for Research in Vision & Ophthalmology (ARVO) Annual Meeting in Pres...
April 12 2021 - 8:00AM
Business Wire
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX),
a clinical-stage biotechnology company developing novel 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 presented at the
2021 Association for Research in Vision and Ophthalmology Annual
Meeting (ARVO 2021), to be held virtually (May 1 – 7, 2021). The
presentation, “Phase I/IIa Clinical Trial of Transplanted
Allogeneic Retinal Pigmented Epithelium (RPE, OpRegen) Cells in
Advanced Dry Age-Related Macular Degeneration (AMD): Interim
Results” will be featured as part of the Stem cells/Gene
Therapy/Transplantation Session, on May 6, 2021 between 5:15 pm and
6:45 pm EDT by Christopher D. Riemann, M.D., Vitreoretinal Surgeon
and Fellowship Director, Cincinnati Eye Institute (CEI) and
University of Cincinnati School of Medicine. (abstract number
3538173).
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 one of the most respected
eye and vision research organizations in the world and its members
include nearly 11,000 researchers from over 75 countries. The
membership is multidisciplinary and consists of both clinical and
basic researchers. 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 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 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 (vision from 20/65 to 20/250 with smaller 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.
Additional objectives include the evaluation of the safety of
delivery of OpRegen using the Orbit Subretinal Delivery System
(Orbit SDS). OpRegen is a registered trademark of Cell Cure
Neurosciences Ltd., a majority-owned subsidiary of Lineage Cell
Therapeutics, Inc.
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, 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) VAC, an allogeneic dendritic cell therapy platform for
immuno-oncology and infectious disease, currently in 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/20210412005113/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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