Ocata Therapeutics Receives Regulatory Guidance from European Medicines Agency
March 17 2015 - 9:02AM
Business Wire
Pivotal Clinical Trial Program Design for
Stargardt’s Macular Degeneration
Ocata Therapeutics, Inc. (“Ocata”; NASDAQ: OCAT), a leader in
the field of regenerative ophthalmology, today announced that the
company has received written formal guidance from the European
Medicines Agency (EMA) related to the advancement of its Retinal
Pigment Epithelium Program (RPE) into a pivotal clinical trial for
Stargardt’s Macular Degeneration (SMD).
"We are pleased with the guidance we’ve received from the
European Medicines Agency which means that our SMD program can be
initiated as a pivotal clinical trial, potentially allowing us to
apply for marketing authorization upon its completion,” said Paul
K. Wotton, President and Chief Executive Officer of Ocata
Therapeutics who added, “As a result of these discussions we plan
to enroll a total of approximately 100 patients, including an
untreated control arm to more closely match guidance received from
FDA. This would harmonize the development approach resulting in a
more effective program.”
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 the potential
application to the European Medicines Agency for marketing
authorization regarding treatments for SMD, plans for patient
enrollment in clinical trials, the protocols governing such
clinical trials and potential effects on development approaches,
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
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