BioTime Further Expands OpRegen® Clinical Trial in Dry-AMD With the Opening of Two Additional U.S. Sites
May 24 2018 - 7:00AM
Business Wire
- Diana V. Do, MD, Professor of
Ophthalmology at the Byers Eye Institute, Stanford University
School of Medicine
- David Telander, MD, PhD at The
Retinal Consultants Medical Group serving northern
California
BioTime, Inc. (NYSE American: BTX), a clinical-stage
biotechnology company focused on degenerative diseases, today
announced the expansion of its ongoing Phase I/IIa clinical trial
for OpRegen®, with the addition of two new U.S. sites that are
expected to begin treating patients later this quarter.
“The addition of these two leading U.S. clinical trial sites is
in addition to our current two sites in California. We are actively
recruiting patients and are in line with our plans to meet our
patient enrollment projections over the next few months,”
commented Dr. Gary S. Hogge, Senior Vice President of Clinical
and Medical Affairs of BioTime. “We are pleased to be working
with two more leading U.S. clinicians in ophthalmology,
Dr. Diana V. Do and Dr. David Telander, and their
respective institutions. We are excited with the increased interest
in OpRegen from both physicians and patients and remain on track
with our Cohort 4 enrollment and treatment plans.”
Dr. Do is a board-certified ophthalmologist and is an expert in
the management of age related macular degeneration, diabetic
retinopathy, retinal vein occlusion, retinal detachment, macular
hole, retinal infections, and epiretinal membranes. Dr. Do is a
leading clinician-scientist who has authored over 150 publications
in medical literature and has contributed to over 25 book chapters.
She has been the principal investigator and co-investigator on more
than 45 clinical trials investigating novel treatments for retinal
diseases and ocular inflammation.
Dr. Telander is a board-certified ophthalmologist. He received
his BAS at Stanford, and completed his MD and PhD at the University
of Minnesota. Dr. Telander received his surgical retina fellowship
training at the UCLA Jules Stein Eye Institute in Los Angeles. He
joined UC Davis in Sacramento in 2005, where he became an Associate
Professor and taught residents and fellows. Dr. Telander joined
Retinal Consultants of Sacramento in 2012 and continues to serve as
a Clinical Professor at UC Davis and Associate Professor at
California Northstate University College of Medicine. He has served
as principal and sub-investigator for numerous clinical trials
investigating treatments for age-related macular degeneration,
diabetic retinopathy, and inherited retinal dystrophies. Dr.
Telander has authored over 50 papers, many book chapters and has
given national and international talks on retinal disease. He is an
active member of multiple professional societies including the
Retina Society, the American Academy of Ophthalmology, the
Association for Research in Vision and Ophthalmology, and the
American Society of Retina Specialists. Dr. Telander received the
Achievement Award from the American Academy of Ophthalmology for
his service.
About OpRegen®
OpRegen®, which is being studied for the treatment of the dry
form of AMD, consists of a suspension of retinal pigment epithelial
(RPE) cells that are delivered subretinally during a simple
intraocular injection. RPE cells are essential components of the
back lining of the retina, and function to help nourish the retina
including photoreceptors. A proprietary process that drives the
differentiation of human pluripotent stem cells is used to generate
high purity OpRegen® RPE cells. OpRegen® RPE cells are
also “xeno-free,” meaning that no animal products are used at any
point in the derivation and production process. The avoidance of
the use of animal products eliminates some potential safety
concerns. Preclinical studies in rats have shown that following a
single subretinal injection of OpRegen®, the cells can rapidly
organize into its natural monolayer structure in the subretinal
space and survive throughout the lifetime of the animal.
OpRegen® is designed to be an “off-the-shelf” allogeneic
(non-patient specific) product. Unlike treatments that require
multiple, frequent injections into the eye, it is expected that
OpRegen® will be administered in a single procedure.
OpRegen® was granted Fast Track designation
from the FDA, which allows more frequent interactions
with the agency, and eligibility for accelerated approval and
priority review. OpRegen® is a registered trademark
of Cell Cure Neurosciences Ltd., a majority-owned subsidiary
of BioTime, Inc.
About BioTime, Inc.
BioTime is a clinical-stage biotechnology company focused
on degenerative diseases. Its clinical programs are based on two
platform technologies: cell replacement and cell/drug delivery.
With its cell replacement platform, BioTime is producing
new cells and tissues with its proprietary pluripotent cell
technologies. These cells and tissues are developed to replace
those that are either rendered dysfunctional or lost due to
degenerative diseases or injuries. BioTime’s cell/drug delivery
programs are based upon its proprietary HyStem® cell and drug
delivery matrix technology. HyStem® was designed, in part, to
provide for the transfer, retention and/or engraftment of cellular
replacement therapies. BioTime’s lead cell delivery clinical
program is Renevia®, which consists of HyStem® combined with
the patient's own adipose (fat) progenitor cells. Renevia® met
its primary endpoint in an EU pivotal clinical trial for the
treatment of facial lipoatrophy in HIV patients in
2017. BioTime has submitted Renevia® for CE Mark
approval in the EU. There were no device related serious adverse
events reported to date. BioTime’s lead cell replacement product
candidate is OpRegen®, a retinal pigment epithelium transplant
therapy, which is in a Phase I/IIa multicenter clinical trial for
the treatment of dry age-related macular degeneration, the leading
cause of blindness in developing countries. There were no
unexpected serious adverse events reported to
date. BioTime also has significant equity holdings in two
publicly traded companies, Asterias Biotherapeutics,
Inc. (NYSE American: AST) and OncoCyte Corporation (NYSE
American: OCX), and a private company, AgeX Therapeutics,
Inc.
BioTime common stock is traded on the NYSE American and
TASE under the symbol BTX. For more information, please
visit www.biotime.com or connect with the company
on Twitter, LinkedIn, Facebook, YouTube,
and Google+.
To receive ongoing BioTime corporate communications,
please click on the following link to join the Company’s email
alert list: http://news.biotime.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20180524005407/en/
BioTimeDavid Nakasone, 510-871-4188Dnakasone@biotime.com
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