Lineage Cell Therapeutics Completes Patient Enrollment in Phase 1/2a Clinical Study of OpRegen® Cell Therapy for the Treatme...
November 11 2020 - 8:00AM
Business Wire
- OpRegen Data Update to be Featured in Presentation by
Principal Investigator Christopher D. Riemann, M.D., at 2020 AAO
Annual Meeting on November 15, 2020
- Therapeutic Expert Call to Discuss Results Scheduled for
November 17, 2020
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX),
a clinical-stage biotechnology company developing three novel cell
therapies for serious conditions, today announced the successful
completion of enrollment in its 24-patient Phase 1/2a study of its
lead product candidate, OpRegen®. OpRegen is an investigational
cell therapy consisting of retinal pigment epithelium (RPE) cells
administered to the subretinal space for the treatment of dry
age-related macular degeneration (AMD) with geographic atrophy
(GA). Updated interim results from the ongoing Phase 1/2a study
will be presented at the 2020 American Academy of Ophthalmology
Annual Meeting (AAO 2020) during the OP02V Retina, Vitreous
Original Papers Session on November 15, 2020 at 10:40am Eastern
Time / 7:40 am Pacific Time by Christopher D. Riemann, M.D.,
Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye
Institute and University of Cincinnati School of Medicine. Dr.
Riemann also will participate in a call to discuss the interim
results on November 17, 2020 at 4:00 pm Eastern Time / 1:00 pm
Pacific Time. Interested parties can access the event on the Events
and Presentations section of Lineage’s website.
“Completion of patient enrollment in our OpRegen study is a
significant achievement for our team and reflects the focused
commitment we have made to advancing our three cell therapy product
candidates. We believe the potential for transplanted cells to
safely and durably treat serious diseases and conditions,
particularly where traditional molecular approaches have failed,
will usher in a new treatment paradigm for modern medicine.
Demonstrating this potential in clinical trials is a vital step in
that process and we are thankful to have reached this important
milestone,” stated Brian Culley, CEO. “As a result of increased
awareness of our study and promising data we reported recently,
including the first known demonstration of retinal tissue
restoration in a clinical setting, we were able to enroll and treat
the final five patients in cohort 4 in just five weeks. We also
surpassed our original goal by utilizing the Gyroscope Orbit SDS in
7 of the last 9 patients. We extend our gratitude to the
participating patients, their families, and the study investigators
and coordinators in both the US and Israel. With this milestone
reached, our focus turns toward collecting safety and efficacy data
on the most recently treated patients, evaluating options for
later-stage clinical development, including with potential
partners, and approaching the FDA to discuss our next steps. Our
objective is to position the OpRegen program as a front-runner in
the race to address an unmet need in what is widely expected to be
a multi-billion-dollar dry AMD therapeutic market.”
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 patients with vision as high as 20/64.
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.
Additionally, for the patients in Cohort 4 that receive subretinal
delivery of OpRegen utilizing the Gyroscope Orbit Subretinal
Delivery System (Gyroscope Orbit SDS), objectives will include the
evaluation of the safety of delivery of OpRegen using the Gyroscope
Orbit SDS.
Recently, Lineage reported the first known finding of retinal
tissue regeneration in a patient receiving OpRegen for the
treatment of atrophic dry AMD. This unprecedented finding supports
the view that dry AMD is not an irreversible, degenerative
condition and that some portion of diseased retinal tissue may be
recoverable in atrophic end-stage disease patients. These findings
were initially observed by an independent external advisor using
multiple imaging technologies and were subsequently confirmed by
the reading center and additional experts in the field of retinal
imaging. The Company also has observed evidence of benefit in other
patients, including increases in Best Corrected Visual Acuity
(BCVA), reduction in the growth of GA, and increases in reading
speed.
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.
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,” “plan,” “potential,” “predict,” “seek,” “should,” “would,”
“contemplate,” project,” “target,” “tend to,” or the negative
version of these words and similar expressions. Such statements
include, but are not limited to, statements relating to the
potential for cell therapy generally and the expected addressable
market for OpRegen. 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 (the 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 Annual Report on Form 10-K filed with the SEC
on March 12, 2020 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/20201111005229/en/
Lineage Cell Therapeutics, Inc. IR Ioana C. Hone
(ir@lineagecell.com) (442) 287-8963
Solebury Trout IR Gitanjali Jain Ogawa
(Gogawa@troutgroup.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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