KOL Call with Principal Investigator
Christopher D. Riemann, M.D., Scheduled for November 17, 2020 at
4:00 pm Eastern Time
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX),
a clinical-stage biotechnology company developing novel cell
therapies for unmet medical needs, will be hosting a call to
discuss updated interim results from the Phase 1/2a study of its
lead product candidate, OpRegen®, with one of the study’s principal
investigators. OpRegen is a retinal pigment epithelium (RPE) cell
transplant therapy currently in development for the treatment of
dry age-related macular degeneration (AMD). Christopher D. Riemann,
M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye
Institute (CEI) and University of Cincinnati School of Medicine,
will present updated interim results from the ongoing Phase 1/2a
study of OpRegen at the 2020 American Academy of Ophthalmology
Annual Meeting (AAO 2020) during the Original Paper Session on
November 15, 2020. Dr. Riemann 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 register for
the event on the Solebury Trout Events Page and access the live
webcast discussion on the Events and Presentations section of
Lineage’s website.
“We are fortunate to have an esteemed surgical expert available
to discuss our updated interim data from the ongoing clinical trial
of OpRegen for the treatment of dry AMD,” stated Brian Culley, CEO.
“Dr. Riemann’s first-hand experience not only with OpRegen RPE
cells, but also with the Orbit SDS delivery device, make him an
ideal person to review data emerging from the ongoing OpRegen
clinical study, which we expect to complete enrollment before
year-end.”
Therapeutic Area Expert: Christopher D. Riemann, M.D.,
Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye
Institute and University of Cincinnati School of Medicine.
In collaboration with the other Retinal Surgeons at CEI, Dr.
Riemann is a principal investigator or co-investigator for many
Phase two and Phase three FDA trials. He specializes in medical and
surgical vitreoretinal diseases including diabetic retinopathy,
macular degeneration, retinal detachment, retinopathy of
prematurity, vascular diseases of the retina, uveitis,
histoplasmosis, complications of anterior segment surgery,
endoscopic posterior segment surgery, and ocular trauma. Dr.
Riemann is a member of the American Society of Retina Specialists,
American Academy of Ophthalmology, Ohio State Medical Association,
Cincinnati Academy of Medicine, Cincinnati Ophthalmology Society,
and the Association for Research in Vision and Ophthalmology. His
original research in the fields of Ophthalmology, Cardiology, and
Endocrinology has been published in international peer reviewed
scientific journals and has been presented at national scientific
meetings. He has several patents for innovative surgical
technologies and enjoys sharing his passion for the blend of
engineering and medicine.
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 will enroll 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, which is currently enrolling, will include patients
with vision as high as 20/64. Cohort 4 also includes 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
expected enrollment timeline for Lineage’s OpRegen trial.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201102005240/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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