BioTime Announces $2 Million Grant for Further Development of OpRegen® for Dry-AMD
August 14 2017 - 7:00AM
Business Wire
BioTime, Inc. (NYSE MKT:BTX), a clinical-stage biotechnology
company focused on developing and commercializing products
addressing degenerative diseases, has been awarded a new grant for
2017 of up to 7.2 million Israeli New Shekels (approximately $2
million) from the Israel Innovation Authority (the “IIA”). The
grant provides funding for the continued development of OpRegen®,
and to date the IIA has provided annual grants totaling
approximately $12 million.
OpRegen® is currently in a Phase I/IIa dose-optimization
clinical study, which in July 2017 received authorization from the
Data Safety Monitoring Board (DSMB) to move forward with enrollment
of cohort 3. In cohort 3, BioTime plans to treat patients at sites
in Israel and the U.S. Data reported to date have shown continued
engraftment through the one year follow-up with encouraging
potential structural improvement. In addition, no serious adverse
events have been reported, indicating a continued favorable safety
profile. BioTime expects to share more data at the American Academy
of Ophthalmology (AAO) later this year.
“This new grant demonstrates the continued high level of support
and confidence that the Israel Innovation Authority has in our
development of cell therapy-based treatments,” said Adi Mohanty,
co-Chief Executive Officer of BioTime.
As noted above, the grant was awarded by the IIA for the
development of OpRegen® to Cell Cure Neurosciences, a
majority-owned subsidiary of BioTime.
About OpRegen®
OpRegen®, which is being studied for the treatment of the dry
form of age-related macular degeneration (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® would be
administered in a single procedure. OpRegen® was granted Fast Track
designation from 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
BioTime is a clinical-stage biotechnology company focused on
developing and commercializing products addressing degenerative
diseases. Its clinical programs are based on two platform
technologies: pluripotent cells and cell/drug delivery. 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. The foundation of the Company’s cell
delivery platform is its HyStem® cell and drug delivery matrix
technology. The Company’s current clinical programs are targeting
three primary sectors, aesthetics, ophthalmology and cell/drug
delivery. BioTime also has significant equity holdings in two
publicly traded companies, Asterias Biotherapeutics, Inc.
(“Asterias”) and OncoCyte Corporation (“OncoCyte”).
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+.
To receive ongoing BioTime corporate communications, please
click on the following link to join our email alert list:
http://news.biotimeinc.com.
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170814005326/en/
Investor Contact:BioTimeDavid Nakasone,
510-871-4188dnakasone@biotimeinc.comorEVC Group, Inc.Michael
Polyviou, 646-445-4800mpolyviou@evcgroup.comorDoug Sherk,
646-445-4800dsherk@evcgroup.comorMedia Contact:Gotham
Communications, LLCBill Douglass,
646-504-0890bill@gothamcomm.com
Brooklyn ImmunoTherapeut... (AMEX:BTX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Brooklyn ImmunoTherapeut... (AMEX:BTX)
Historical Stock Chart
From Sep 2023 to Sep 2024