Biotime Expands & Advances Ophthalmology Portfolio
June 19 2017 - 7:00AM
Business Wire
- Expanded Exclusive, Global License to
RPE and Photoreceptor Cells for Use in All Eye Disorders
- Data Presented at International Society
for Stem Cell Research (ISSCR) Conference
- Translational Vision Sciences &
Technology (TVST) Journal Publishes OpRegen® Data
BioTime, Inc. (NYSE MKT: BTX), a clinical-stage biotechnology
company developing and commercializing products addressing
degenerative diseases, today reported several developments for its
ophthalmology portfolio including:
- Signing a new and expanded licensing
agreement with Hadassah Medical Organization of Jerusalem,
Israel
- Presentation of data from its Phase
1/2a Dose Escalation Study of OpRegen® at ISSCR
- Presentation of the similarities
between human retinal tissue and 3D retinal tissue derived using
BioTime’s proprietary methodology and pluripotent cells at
ISSCR
- Publication of preclinical data forming
the foundation of the OpRegen® IND submission with the U.S. Food
& Drug Administration in TVST
- Complete control of OpRegen®
development program through consolidation of ownership in Cell Cure
NeuroSciences
“OpRegen is making great progress in the clinic,” said Adi
Mohanty, co-CEO of BioTime. “Data from the Phase 1/IIa trial was
presented this past weekend at the International Society of Stem
Cell Research (ISSCR) conference. As OpRegen® continues to show
encouraging results, we are leveraging our expertise in
ophthalmology to build a leading pipeline of cell therapy products
in ophthalmology. The technology for OpRegen for dry AMD was
originally licensed from Hadassah. The new license increases our
field of use for RPE cells to all eye disorders, and adds
photoreceptor cells, for all eye disorders. As part of this
process, we have consolidated our ownership of Cell Cure
Neurosciences providing BioTime with complete control of the
OpRegen® development program while at the same time building
momentum in developing innovative cell therapies to address
ophthalmic conditions with unmet needs,” concluded Mr. Mohanty.
ISSCR Presentations
A poster demonstrating similarities between normal human retinal
tissue and laboratory grown 3D retinal tissue derived using
BioTime’s proprietary methodology with pluripotent cells (hPSC) was
presented during ISSCR. The study compared normal human retinal
cells with the BioTime’s proprietary hPSC-derived 3D retinal tissue
for the potential use in helping to restore vision for blind people
with advanced stages of retinal degeneration. The results presented
demonstrated high correlation in gene expression profiles, between
the various cellular components of normal human retinal tissue and
the hPSC-derived tissue, including retinal pigment epithelium,
retinal progenitor, photoreceptor, amacrine and ganglion cells.
In addition, the most recent data from the ongoing Phase I/II
clinical trial of the lead product, OpRegen®, for the treatment of
dry age-related macular degeneration was presented during the
conference. The Phase I/IIa dose-escalation study evaluating the
safety and efficacy of three different dose regimens of the
company’s investigational product, OpRegen®. OpRegen® has received
Fast Track designation from the FDA for treatment of the advanced
form of dry-AMD. Details of the trial and about a patient’s
eligibility are available at https://clinicaltrials.gov/ with the
following Identifier: NCT02286089 (dry-AMD).
TVST Journal Publication
The TVST Journal article is titled “Long-Term Efficacy of GMP
Grade Xeno-Free hESC-derived RPE Cells Following Transplantation”
and Trevor J. McGill was the lead author. The article concluded
OpRegen® RPE cells survived, rescued vision function, preserved rod
and cone photoreceptors long term in the Royal College of Surgeons
rat. These data were key elements in support of the potential
clinical utility for the use of OpRegen® RPE cells for the
treatment of human RPE cell disorders including AMD.
“These studies continue to leverage and expand our proprietary
approaches utilizing hPSCs for a broad range of ocular diseases
associated with cellular and tissue degeneration that other
therapeutic approaches can’t address effectively,” said Oscar
Cuzzani, M.D., Ph.D., BioTime’s Vice President of Clinical
Development. “As ophthalmology remains among BioTime’s core areas
of focus, we are uniquely positioned with our broad expertise,
capabilities and IP portfolio in regenerative ophthalmology,
creating a stronger pipeline to address problems of degenerative
diseases of the eye.”
Forward-Looking Statements
Certain statements contained in this release are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Statements pertaining to
future financial and/or operating results, future growth in
research, technology, clinical development, and potential
opportunities for BioTime, Inc. and its subsidiaries, along with
other statements about the future expectations, beliefs, goals,
plans, or prospects expressed by management constitute
forward-looking statements. Any statements that are not historical
fact (including, but not limited to statements that contain words
such as “will,” “believes,” “plans,” “anticipates,” “expects,”
“estimates” should also be considered to be forward-looking
statements. Forward-looking statements involve risks and
uncertainties, including, without limitation, risks inherent in the
development and/or commercialization of potential products,
uncertainty in the results of clinical trials or regulatory
approvals, need and ability to obtain future capital, and
maintenance of intellectual property rights. Actual results may
differ materially from the results anticipated in these
forward-looking statements and as such should be evaluated together
with the many uncertainties that affect the business of BioTime,
Inc. and its subsidiaries, particularly those mentioned in the
cautionary statements found in more detail in the “Risk Factors”
section of its Annual Reports on Form 10-K and Quarterly Reports on
Form 10-Q filed with the SEC (copies of which may be obtained at
www.sec.gov). Subsequent events and developments may cause these
forward-looking statements to change. BioTime specifically
disclaims any obligation or intention to update or revise these
forward-looking statements as a result of changed events or
circumstances that occur after the date of this release, except as
required by applicable law.
To receive ongoing BioTime corporate communications,
please click on the following link to join our email alert
list: http://news.biotimeinc.com.
About BioTime
BioTime, Inc. is a clinical-stage biotechnology company focused
on developing and commercializing novel therapies developed from
what the company believes to be the world’s premier collection of
pluripotent cell assets. The foundation of BioTime’s core
therapeutic technology platform is pluripotent cells that are
capable of becoming any of the cell types in the human body.
Pluripotent cells have potential application in many areas of
medicine with large unmet patient needs, including various
age-related degenerative diseases and degenerative conditions for
which there presently are no cures. Unlike pharmaceuticals that
require a molecular target, therapeutic strategies based on the use
of pluripotent cells are generally aimed at regenerating or
replacing affected cells and tissues, and therefore may have
broader applicability than pharmaceutical products. BioTime also
has significant equity holdings in two publicly traded companies,
Asterias Biotherapeutics, Inc. and OncoCyte Corporation, which
BioTime founded and which, until recently, were majority-owned
consolidated subsidiaries of BioTime.
BioTime common stock is traded on the NYSE MKT and TASE
under the symbol BTX. For more information, please
visit www.biotimeinc.com or connect with the company
on Twitter, LinkedIn, Facebook, YouTube,
and Google+.
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Investor Contact:EVC Group, Inc.Michael Polyviou,
646-445-4800mpolyviou@evcgroup.com;orDoug Sherk,
646-445-4800dsherk@evcgroup.comorMedia Contact:JQA Partners,
Inc.Jules Abraham, 917-885-7378jabraham@jqapartners.com
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