Full Press Release Details
Inc. Reports Second Quarter 2015 Results and Recent Developments
ALAMEDA, Calif.--(BUSINESS WIRE)--August 10, 2015--BioTime, Inc. (NYSE
MKT:BTX) today reported financial results for the second quarter ended
June 30, 2015 and provided a corporate update.
"BioTime's management team has sharpened its focus on our high priority
programs," said Dr. Michael D. West, BioTime's Chief Executive Officer.
"Our strategy for achieving the leadership role in regenerative medicine
includes: continuing to advance the ongoing clinical trials of our
products that are expected to address large unmet patient needs,
collaborating with high-quality corporate partners and leading academic
medical institutions, financial de-risking by leveraging various sources
of non-dilutive financing, adding experienced biopharma executives to
our teams at both BioTime and our subsidiaries, and progressively
unlocking shareholder value in our subsidiaries. We continue to make
progress with our several clinical programs in cell therapies, cell
delivery matrices, and cancer diagnostics."
Through the second quarter, BioTime and its subsidiaries have reported
the following progress on key products and programs.
Cell Cure Neurosciences Ltd.
Cell Cure Neurosciences, Ltd. (Cell Cure Neurosciences) is currently
enrolling patients at Hadassah University Medical Center in Jerusalem,
Israel, in a clinical Phase I/IIa dose-escalation study evaluating the
safety and efficacy of OpRegen for geographic
atrophy (GA), the severe stage of the dry form of age-related macular
degeneration (dry-AMD). Dry-AMD represents nearly 90% of AMD
prevalence and currently has no FDA-approved therapy. The Phase I/IIa
clinical trial is designed with four cohorts and allows for interim
Cell Cure Neurosciences presented preclinical efficacy data for its lead
product candidate, OpRegen at the annual
meeting of the Association for Research in Vision and Ophthalmology
(ARVO) in May. The findings demonstrated the product's potential to
preserve vision and retinal structure when transplanted into the
leading animal model of retinal disease.
In May, Cell Cure Neurosciences was awarded a grant for 2015 of 6.24
million shekels (approximately $1.61 million) from Israel's Office of
the Chief Scientist (OCS) to help finance the development of OpRegen .
The OCS has previously supported Cell Cure Neurosciences, providing
grants totaling approximately $8.0 million to date in non-dilutive
Asterias Biotherapeutics, Inc. (NYSE MKT: AST)
Asterias Biotherapeutics, Inc. (Asterias) promoted Edward Wirth, M.D.,
Ph.D. to Chief Medical Officer.
In June, Asterias announced that the first patient had been dosed at
the Atlanta-based Shepherd Center in a Phase I/IIa clinical trial
evaluating the activity of escalating amounts of AST-OPC1
(oligodendrocyte progenitor cells) in newly injured patients with
sensory and motor complete cervical spinal cord injury (SCI). The
Phase I/IIa trial is part of the planned registration program for
AST-OPC1, with neurologically complete cervical SCI as the first
targeted indication.
Also in June, Asterias announced positive long-term follow-up data
from a Phase II clinical trial of AST-VAC1 in patients with acute
myelogenous leukemia (AML). The results showed that more than 50% of
those who received AST-VAC1 had prolonged relapse-free survival, even
patients with high-risk AML, including those over 60 years of age and
patients in second remission. The data were presented during an oral
presentation at the annual meeting of the American Society of Clinical
Oncology (ASCO) in May.
Asterias was added to the Russell 3000 , Russell
Global, and Russell Microcap Indexes on June 26, 2015
as part of Russell Investments' annual reconstitution of its
comprehensive set of U.S. and global equity indexes. The Russell
indexes are widely used by investment managers and institutional
investors for index funds and they serve as benchmarks for passive and
active investment strategies.
During the second quarter, Asterias raised a total of $14.5 million in
aggregate gross proceeds through various private and public offerings,
as well as receiving $1.1 million from the California Institute of
Regenerative Medicine (CIRM) in accordance with a quarterly
disbursement schedule under the $14.3 million grant award related to
the AST-OPC1 development program. Year-to-date payments from CIRM
total $3.3 million in non-dilutive funding.
Cell Delivery Matrices
Earlier this year, BioTime announced the successful treatment of the
first patient in the Company's pivotal clinical trial in Europe of Renevia
for HIV-associated lipoatrophy, which was chosen as the clearest
regulatory pathway as the first indication. Patient enrollment is
ongoing with completion of enrollment in the trial expected by early
next year. Renevia , BioTime's proprietary cell delivery
matrix, is specifically designed to facilitate the stable engraftment
and proliferation of transplanted cells.
The results of the Renevia trial could ultimately lead
to a submission in 2016 for CE Mark approval in Europe for the
treatment of HIV-associated facial lipoatrophy. Positive outcomes of
this trial could greatly accelerate the potential development of
future therapeutics for other lipoatrophy-related conditions, as well
as the potential to expand the use of BioTime's cell delivery matrices
for a number of additional cell types.
Cancer Diagnostics Platform
OncoCyte Corporation
William Annett was named Chief Executive Officer of OncoCyte
Corporation (OncoCyte) on June 16, 2015. Bill has extensive experience
as a CEO of diagnostics companies and as an executive with Genentech
and Accenture, among other companies. His deep experience with product
commercialization at leading companies is of particular importance as
OncoCyte prepares to launch its first liquid biopsy cancer diagnostic
test, currently scheduled for 2016.
OncoCyte also reported positive results from its proprietary,
non-invasive, liquid biopsies diagnostics at the American Association
for Cancer Research (AACR) for bladder and breast cancer and the
American Thoracic Society (ATS) for lung cancer diagnostics.