Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX),
a clinical-stage biotechnology company developing allogeneic cell
therapies for unmet medical needs, reported today that updated
interim results from a Phase 1/2a clinical study of its lead
product candidate, OpRegen®, an investigational retinal pigment
epithelium cell transplant therapy currently in development for the
treatment of dry age-related macular degeneration (AMD), will be
featured in a presentation at the 2021 American Academy of
Ophthalmology (AAO) 125th Annual Meeting, to be held at the Ernest
N. Morial Convention Center, New Orleans, LA (November 12 – 15,
2021). The presentation, “OpRegen Trial: Phase 1/2a Dose Escalation
Study of Human Embryonic Stem-Cell Derived Retinal Pigment
Epithelium Cells Transplanted Subretinally in Patients with
Advanced AMD,” will be presented on November 13, 2021 at 2:38 pm
EDT as part of the Gene and Cell-Based Therapies Session, by
Michael S. Ip, M.D., Professor, Department of Ophthalmology at the
David Geffen School of Medicine at the University of California -
Los Angeles.
In addition to Dr. Ip’s presentation, Lineage also intends to
announce updated interim results from the Phase 1/2a study next
month, which will include a minimum of 12 months of follow-up in
all 24 patients treated with OpRegen, including all 12 patients
treated in Cohort 4, which had better baseline vision and smaller
areas of GA at baseline than earlier cohorts. OpRegen is
well-positioned among product candidates in development for dry AMD
as the only experimental therapy that has demonstrated an ability
to halt or reverse the expansion of geographic atrophy as well as
restore layers of retinal tissue in three patients to date.
Specifically, outer retinal layer restoration was observed via
optical coherence tomography (OCT) and was evidenced by the
presence of new areas of retinal pigment epithelium (RPE) monolayer
with overlying ellipsoid zone, external limiting membrane, and
outer nuclear layer, all of which were not present at the time of
baseline assessment. These findings are suggestive of integration
of the new RPE cells with functional photoreceptors in areas that
previously showed no presence of any of these cells.
The American Academy of Ophthalmology is the world’s largest
association of eye physicians and surgeons. The mission of the
American Academy of Ophthalmology is to protect sight and empower
lives by serving as an advocate for patients and the public,
leading ophthalmic education, and advancing the profession of
ophthalmology. For more information, please visit
https://www.aao.org/ or follow the association on Twitter
@aao_ophth.
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
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, 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 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.
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,” “can,” “plan,” “potential,” “predict,” “seek,” “should,”
“would,” “contemplate,” “project,” “target,” “tend to,” ‘suggest,”
or the negative version of these words and similar expressions.
Such statements include, but are not limited to, statements
relating to the projected timing of future announcements or
presentations of updated or additional data from the Phase 1/2a
clinical study of OpRegen, the potential benefits of treatment with
OpRegen in dry AMD patients with GA, the significance of clinical
data reported to date from the ongoing Phase 1/2a study of OpRegen,
including the findings of retinal tissue restoration, Lineage’s
plans to meet with the FDA to discuss OpRegen’s clinical
development, the potential utilization of OCT imaging to measure
efficacy in a pivotal clinical trial of OpRegen for the treatment
of dry AMD with GA, and the potential for Lineage’s investigational
allogeneic cell therapies to provide safe and effective treatment
for multiple, diverse serious or life threatening conditions.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause Lineage’s 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 Lineage’s business
and other risks in Lineage’s filings with the Securities and
Exchange Commission (SEC). Lineage’s 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 Lineage’s periodic reports with the SEC, including
Lineage’s most recent Annual Report on Form 10-K and Quarterly
Report on Form 10-Q filed with the SEC and its other reports, which
are available from the SEC’s 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20211026005496/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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