Ocata Therapeutics Successfully Completes Dosing in Phase 1/2 RPE Studies
March 31 2015 - 8:58AM
Business Wire
SMD Pivotal Trial and AMD Phase 2 Trial to
be Initiated
Ocata Therapeutics, Inc. (“Ocata”; NASDAQ:OCAT), a leader in the
field of regenerative ophthalmology, today announced that the
company has completed dosing of its Phase 1/2 studies for dry
age-related macular degeneration (AMD) and Stargardt’s Macular
Degeneration (SMD). A total of 38 patients have been safely dosed.
The 200,000 cell cohort, the highest level planned was successfully
completed, paving the way for the next phase of the programs.
“With successful completion of dosing for the phase 1/2 studies
at the highest dose level, and following safety data review by the
Data and Safety Monitoring Board, we are now able to focus on
initiation and execution of our Phase 2 study for AMD and our
pivotal study for SMD,” said Paul K. Wotton, President and Chief
Executive Officer of Ocata Therapeutics, who added, “We believe
that data from the AMD studies will also be an important inflection
point for the entire retinal pigment epithelium (RPE) program. As
we have previously announced, we have received guidance from the
European Medicines Agency indicating that our SMD program can be
initiated as a pivotal clinical trial.”
The objective of the SMD trial will be to assess the safety and
efficacy of subretinal transplantation of RPE cells compared to an
untreated control group. The endpoints of the trial include
functional and anatomic outcome parameters. The AMD trial will
evaluate the safety of different regimens of immunosuppressive
therapy while exploring functional and anatomic efficacy outcome
parameters.
Ocata previously announced that it has been granted Advanced
Therapy Medicinal Product (ATMP) designation for its RPE therapy
for macular degeneration. The SMD program has orphan status both in
Europe and the US.
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.
About Age-related Macular Degeneration
Age-related macular degeneration is the leading cause of vision
loss in people over the age of 50. Every year in the USA there are
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 as a
result. 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 and the projected number of
people worldwide with age-related macular degeneration in 2020 is
196 million, increasing to 288 million in 2040 underscoring the
urgent need for new treatments.
About Stargardt’s Disease
Stargardt’s macular degeneration is a form of juvenile macular
degeneration that affects vision in children and young adults
between the ages of six and 20, with a prevalence of approximately
one in 10,000 people in the United States. It is an orphan disease
and loss of vision is an inevitable aspect of SMD, with more than
half of the patients experiencing vision loss in the range of
20/200-20/400. Like dry AMD, it occurs as a result of damage to the
RPE layer and there are no treatments currently approved to prevent
or slow the vision loss associated with SMD.
Forward-Looking Statements
All statements, other than historical facts, contained in this
news release, including statements regarding, Ocata’s belief that
data from the AMD studies will be an important inflection point for
the broader RPE program, the planned objective and endpoints of the
SMD trial, the planned objective and endpoints of the AMD trial 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;
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 the 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.
Investors:Westwicke PartnersJohn Woolford,
443-213-0506john.woolford@westwicke.comorPress:Russo PartnersDavid
Schull, 858-717-2310david.schull@russopartnersllc.com
Ocata Therapeutics, Inc. (NASDAQ:OCAT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Ocata Therapeutics, Inc. (NASDAQ:OCAT)
Historical Stock Chart
From Sep 2023 to Sep 2024