First Patient Enrolled in Ocata Therapeutics’ Phase 2 Study for Dry AMD
September 08 2015 - 9:00AM
Business Wire
Results from First Cohort Expected in the
Second Quarter of 2016
Ocata Therapeutics, Inc. (NASDAQ:OCAT), a leader in the field of
Regenerative Ophthalmology™, today announced that the first patient
has been enrolled in the company’s Phase 2 clinical trial using
Ocata’s proprietary RPE cells in patients with atrophic (dry)
age-related macular degeneration (AMD). The purpose of the trial is
to evaluate safety and explore efficacy as compared to a parallel
control group. Interim top-line results from the first cohort is
expected in the second quarter of 2016 and the interim read-out on
the second two cohorts is expected by the end of 2016.
Age-related macular degeneration is the leading cause of vision
loss in people over the age of 50. Every year in the United States
there are an estimated 1.8 million patients newly diagnosed with
dry AMD, which occurs when light-sensitive photoreceptor cells in
the macula, located in the center of the retina, slowly break down,
causing vision loss. Photoreceptor breakdown is a consequence of
loss or damage to the RPE layer. As the disease progresses,
patients may have difficulty reading and recognizing faces. There
is currently no proven medical therapy for dry AMD.
“We expect this Phase 2 clinical study will provide important
information about the ability of Ocata’s fully differentiated RPE
cells to treat dry age-related macular degeneration, when
transplanted into the retina,” commented Carl D. Regillo, MD, FACS,
Director, Retina Service at Wills Eye Hospital and Professor of
Ophthalmology, Jefferson Medical College. “We are pleased to be a
participating site in this clinical trial, as we believe that
Ocata’s RPE program has the potential to be an effective treatment
option for dry AMD, as well as other ophthalmological indications,
such as Stargardt’s Disease.”
This Phase 2 study will include up to three cohorts of up to 20
subjects each. Each of the cohorts will receive one week of immune
suppressive therapy prior to surgery and then different immune
suppression regimens following transplantation of the cells, to
determine the safety and tolerability of 0, 6 and 12 weeks of
post-transplant systemic immune suppression. Untreated patients
will receive placebo treatment similar in appearance and
administration to those who have received cellular transplants.
“A key goal of this study is to more fully explore the efficacy
signal that we reported in the Lancet in October of last year, with
comparison to a control group of untreated patients rather than
using the fellow eye for comparison. We believe that the data
developed in this Phase 2 study will allow us to optimize the
addressable patient population using well-controlled data while
assessing potential endpoints for efficacy,” said Eddy Anglade,
M.D., Chief Medical Officer of Ocata. “We look forward to advancing
into this next phase of development and we are grateful to the
physicians and the patients who partner with us on these important
programs. We expect that the data produced by this study will
provide valuable guidance for the design of a Phase 3 program and
could ultimately inform our commercial strategies.”
About Ocata Therapeutics, Inc.
Ocata Therapeutics, Inc. is a clinical stage biotechnology
company focused on the development and commercialization of
regenerative ophthalmology therapeutics. Ocata’s most advanced
products are in clinical trials for the treatment of Stargardt’s
macular degeneration, dry age-related macular degeneration, and
myopic macular degeneration. Ocata’s intellectual property
portfolio includes pluripotent stem cell platforms – hESC and
induced pluripotent stem cell (iPSC) – and other cell therapy
research programs. For more information, visit www.ocata.com.
Forward-Looking Statements
All statements, other than historical facts, contained in this
news release, including statements regarding Ocata’s belief
regarding the continued clinical and commercial development of its
RPE programs, the expected timing of the completion of its Phase 2
AMD clinical trial and each cohort as well as related top-line
results and interim read-outs, the ability to optimize the
addressable patient populations and otherwise further advance the
RPE programs based on the data from this trial, the effect of such
data on its potential commercial strategy, and any other statements
about Ocata’s future expectations, beliefs, goals, plans, results
or prospects expressed by management constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Any statements that are not statements of
historical fact (including statements containing the words “will,”
“believes,” “plans,” “anticipates,” “expects,” “estimates,” and
similar expressions) should also be considered to be
forward-looking statements. There are a number of important factors
that could cause actual results or events to differ materially from
those indicated by such forward-looking statements, including: the
fact that Ocata has no product revenue and no products approved for
marketing; Ocata’s limited operating history; Ocata’s need for and
limited sources of future capital; potential failures or delays in
obtaining regulatory approval of products; risks inherent in the
development and commercialization of potential products; reliance
on new and unproven technology in the development of products; the
need to protect Ocata’s intellectual property; the challenges
associated with conducting and enrolling clinical trials; the risk
that the results of clinical trials may not support Ocata’s product
candidate claims or commercialization plans; the risk that
physicians and patients may not accept or use Ocata’s products,
even if approved; Ocata’s reliance on third parties to conduct its
clinical trials and to formulate and manufacture its product
candidates; and economic conditions generally. Additional
information on potential factors that could affect our results and
other risks and uncertainties are detailed from time to time in
Ocata’s periodic reports, including its Annual Report on Form 10-K
for the fiscal year ended December 31, 2014. Forward-looking
statements are based on the beliefs, opinions, and expectations of
Ocata’s management at the time they are made, and Ocata does not
assume any obligation to update its forward-looking statements if
those beliefs, opinions, expectations, or other circumstances
should change. Forward-looking statements are based on the beliefs,
opinions, and expectations of Ocata’s management at the time they
are made, and Ocata does not assume any obligation to update its
forward-looking statements if those beliefs, opinions,
expectations, or other circumstances should change. There can be no
assurance that Ocata’s future clinical trials will be successful or
that the results of previous clinical studies will lead to
commercialization or products or therapies.
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version on businesswire.com: http://www.businesswire.com/news/home/20150908005926/en/
Ocata Therapeutics, Inc.Investors:Westwicke PartnersJohn
Woolford, 443-213-0506john.woolford@westwicke.comorPress:Russo
PartnersDavid Schull,
858-717-2310david.schull@russopartnersllc.com
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