Full Press Release Details
Inc. Reports First Quarter Results and Recent Corporate Accomplishments
First Cohort in OpRegen
Management to Host Investor Conference Call on May 17, 2016 at 4:30 p.m.
ALAMEDA, Calif.--(BUSINESS WIRE)--May 10, 2016--BioTime, Inc. (NYSE MKT
and TASE: BTX), a clinical-stage regenerative medicine company with a
focus on pluripotent stem cell technology, today reported financial
results for the first quarter ended March 31, 2016 and provided a
corporate update. The Company also announced that management will host a
conference call with investors to discuss the recent operating progress
and corporate developments on Tuesday, May 17, 2016 at 4:30 p.m. Eastern
/ 1:30 p.m. Pacific. Details on how to access the call are provided
later in this news release.
"We are off to a strong start in 2016 as we continue to make progress
with BioTime's key clinical therapeutic programs, Renevia
in medical aesthetics and OpRegen in dry AMD,"
said Adi Mohanty, Co-Chief Executive Officer. "We are also pleased with
the significant operating progress achieved by our non-core assets as
these companies mature towards standalone businesses. In particular, we
are excited to see our digital health subsidiary, LifeMap Solutions,
gaining more traction with clients and partners, including best-in-class
institutions. Meanwhile, we in the BioTime organization continue to
sharpen our focus on clinical progress and simplifying our corporate
structure and seeking ways to unlock the value of our more mature
revenue-generating subsidiaries for BioTime shareholders."
First Quarter and Recent Highlights
OpRegen (retinal pigment epithelial cells)
The first cohort was successfully dosed earlier this year in a Phase
I/IIa clinical trial evaluating the safety and efficacy of OpRegen
for the treatment of the advanced form of dry age-related macular
degeneration (AMD). The trial is evaluating three different dose
regimens. BioTime expects the Data Safety Monitoring Board (DSMB), an
independent group of experts established for the Phase I/IIa trial,
will complete its review of the initial safety data from the first
cohort and recommend dose escalation to the second cohort during the
second quarter of 2016. The second cohort will receive a higher, more
clinically significant, dose of OpRegen . The
Company expects to complete enrollment in the second cohort in 2016
and, if the data are positive, anticipates DSMB approval to proceed to
the third cohort by the end of 2016. OpRegen has
received Fast Track designation from the U.S. Food and Drug
Administration for the treatment of dry AMD, which occurs in
approximately 90% of those afflicted with AMD.
Renevia (adipose cells + cell delivery matrix)
The Company expects to complete enrollment for its Renevia pivotal
clinical trial in Europe in the second half of 2016 with top line data
availability in early 2017. If the data are positive, BioTime plans to
submit an application for CE Mark approval in the first half of 2017.
The objective of the trial is to assess the efficacy of Renevia ,
which consists of BioTime's HyStem
hydrogel cell-transplantation delivery matrix combined with the
patient's own adipose cells, in restoring normal skin contours in
patients whose subcutaneous fat, or adipose tissue, has been lost due
to antiviral drug treatment for HIV. Positive data from the pivotal
trial is expected to provide the foundation for studying Renevia
in the much broader applications of fat tissue deficits in
various medical aesthetics applications, such as for age-related and
trauma related facial fat loss.
AST-VAC1 (antigen-presenting autologous dendritic cells)
In February, BioTime's subsidiary Asterias Biotherapeutics, Inc.
completed the End-of-Phase 2 meeting with the U.S. Food and Drug
Administration (FDA) for AST-VAC1, the company's lead clinical program
targeting maintenance of relapse-free-survival in acute myeloid
leukemia (AML) patients. Asterias is planning for the initiation of a
single pivotal Phase 3 trial that could support an accelerated
development pathway towards a potential future biologic license
application (BLA) filing.
Asterias presented data from the Phase II clinical trial of its cancer
immunotherapy AST-VAC1 in acute myeloid leukemia (AML) at the American
Society of Gene and Cell Therapy (ASGCT) 19th Annual Meeting on May 5,
AST-OPC1 (oligodendrocyte progenitor cells)
Asterias Biotherapeutics presented an overview of the AST-OPC1
therapeutic development program that is currently in a Phase I/IIa
dose escalation clinical trial in spinal cord injury at the Stem Cell
Summit 2016 meeting on April 27, 2016.
OncoCyte Corporation, the cancer diagnostics subsidiary of BioTime and
developer of novel, non-invasive blood and urine based tests for the
early detection of cancer, announced that its bladder cancer abstract
has been selected for presentation in a poster session, including a
live panel discussion on the results, at the 2016 American Society of
Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois to be
held on June 3-7, 2016. The study to be presented at the upcoming ASCO
annual meeting is based on the continued development of the diagnostic
first reported at the American Association for Cancer Research (AACR)
2015 Annual Meeting. At AACR, OncoCyte presented interim clinical
study data for the non-invasive detection of bladder cancer that
demonstrated a high level of sensitivity and specificity in the
detection of urothelial carcinoma, the most common type of bladder
On April 4, 2016, OncoCyte and the Wistar Institute, an international
biomedical research leader in cancer, immunology and infectious
diseases, announced positive research results for a lung cancer
diagnostic test being developed at Wistar. This study of 620 subjects
replicates a previous study that was carried out at Wistar, which was
presented at the American Thoracic Society conference in May 2015. The
results of this study are being further evaluated by OncoCyte and mark
a successful transition of the assay platform from Illumina
microarrays to a Nanostring nCounter machine, which
is the platform that OncoCyte intends to use for commercialization.
OncoCyte has exclusive commercial rights to the lung cancer diagnostic
test developed by Wistar. OncoCyte must now independently validate
these results in its own follow-up study based on the results of