Full Press Release Details
Inc. Reports Fourth Quarter and Fiscal Year 2016 Financial Results and
Recent Corporate Accomplishments
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ALAMEDA, Calif.--(BUSINESS WIRE)--March 16, 2017--BioTime, Inc. (NYSE
MKT and TASE: BTX), a clinical-stage biotechnology company developing
and commercializing products addressing degenerative diseases, today
reported financial results for the fourth quarter and year
ended December 31, 2016.
"I'm happy with the tremendous progress we made last year in all three
of our strategic objectives, clinical development, simplification and
unlocking value of non-core programs," said Adi Mohanty, Co-Chief
Executive Officer. "We still have more to do, and are well on our way to
transforming the company in 2017."
"This year is shaping up to be the year of data with top line data from
our registrational trial for Renevia in Europe planned for mid-year,
data from OpRegen in Dry AMD to be reported in early May at ARVO and
then again in the second half of the year, final validation data from
our affiliate OncoCyte on its lung cancer diagnostic leading to a
commercial launch in the second half of the year and additional data on
OPC-1 for spinal cord injury from our affiliate Asterias and several
other data reports from our other pipeline products. These data events
and our planned actions to simplify the company while unlocking value
will lead to continued positive transformation of BioTime," concluded
Renevia (adipose cells + cell delivery matrix)
Positive early Renevia data presented at the International Federation
for Adipose Therapeutics and Science meeting (IFATS) meeting in
November. The data related to the treatment of the initial 9 run-in
patients for BioTime's ongoing pivotal clinical trial in Europe
assessing the efficacy of Renevia for the treatment of HIV-associated
lipoatrophy. In December, achieved the recruitment milestone of 50
patients enrolled in the trial. Data from the run-in portion of the
study (N=9) indicated that adipose progenitor cells (fat cells),
obtained from a liposuction aspirate, remained viable and were
observed to proliferate when combined with Renevia hydrogel. Analysis
suggests that the grafts retain volume over the assessment period, and
the treating physician observed incremental volume was retained in
patients who had progressed to the one-year follow-up evaluation. In
addition, there were encouraging signs of new tissue regeneration
observed. No serious adverse events were noted during the run-in
portion of the study.
Additional positive data from the pivotal trial would allow the
Company to launch a commercial product in about a year and provide
support for future studies of Renevia in certain broader indications
of fat tissue deficits in various medical aesthetics applications,
such as age-related and trauma-related facial fat loss.
Top-line clinical trial results are expected to be read out mid-2017.
If the data are positive, the Company plans to submit an application
for CE Mark approval in Europe at the end of 2017.
OpRegen (retinal pigment epithelial cells)
Presented positive early OpRegen data at the International Symposium
on Ocular Pharmacology and Therapeutics (ISOPT) in December. The data
from the first cohort in the Phase I/IIa clinical trial of OpRegen in
the advanced form of dry age-related macular degeneration (dry-AMD).
The data suggest that OpRegen is safe and well tolerated. Imaging data
from a patient who completed one-year of post-treatment clinical
assessment suggests that the graft can survive for at least 12 months.
Enrollment in the second cohort, in which patients are receiving a
higher and more clinically meaningful 200,000 cell dose started in
2016. The Company intends to approach the DSMB in the second quarter
of this year for approval to begin administering the next higher
500,000 cell dose to the third cohort, and if approved, also begin the
fourth cohort before year end.
An abstract with data from the first and second cohorts in the ongoing
trial has been accepted for poster presentation at the annual meeting
for the Association for Research in Vision and Ophthalmology (ARVO),
which will take place in Baltimore, MD, May 7- 11.
The Company is expanding the trial to U.S. sites and recently
announced that two of the top retinal surgeons will be enrolling
patients at their centers of excellence.
AST-OPC1 (oligodendrocyte progenitor cells)
In November, BioTime's affiliate, Asterias (NYSE MKT: AST) reported
the successful administration of the highest dose of 20 million cells
of AST-OPC1 to a patient with complete cervical spinal cord injury
(SCI) as part of the SCiStar Phase I/IIa clinical trial. In January
2017, they announced positive efficacy results that showed additional
motor function improvement at 6-months and 9-months following
administration of 10 million AST-OPC1 cells in 6 AIS-A patients with
complete cervical SCIAsterias plans to initiate discussions with the
FDA in mid-2017 to determine the most appropriate clinical and
regulatory path forward for AST-OPC1.
Liquid Biopsy (lung cancer confirmatory test)
In early March, BioTime's affiliate, OncoCyte (NYSE MKT: OCX) reported
successful completion of a critical step in the development of its
lung cancer diagnostic test by locking the prediction algorithm. The
cancer diagnostic, has been selected for presentation in a poster
discussion session at the 2017 American Thoracic Society (ATS)
International Conference that will take place May 19-24 in Washington,
The lung cancer diagnostic test targets a multi-billion dollar market
opportunity. On March 6, 2017, OncoCyte announced the successful
completion of the study and that it has locked the prediction
algorithm of the test. Based on the study results, OncoCyte announced
that it will begin ramping-up its commercial capabilities in
anticipation of the potential commercial launch of the test. OncoCyte
will initiate a clinical validation phase for the diagnostic. During
this phase, OncoCyte will also continue to carry out analytical
validation studies to refine its operational stage laboratory
processes, and will apply for certification of its CLIA diagnostic
testing lab. Upon CLIA certification, OncoCyte will conduct a small
CLIA lab validation study to demonstrate that the full assay system
utilized in the CLIA lab provides the same results on clinical samples