Ocata Therapeutics Receives Advanced Therapy Medicinal Product Designation from the European Medicines Agency
November 24 2014 - 9:22AM
Business Wire
Advanced Medicinal Product Designation Granted
for its Retinal Pigment Epithelium Programs, in clinical trials for
Stargardt’s Macular Degeneration (SMD) and dry Age-related Macular
Degeneration (AMD)
Ocata Therapeutics, Inc., (OTCBB:OCAT) today announced that it
has been granted Advanced Therapy Medicinal Product (ATMP)
designation for its RPE therapy for macular degeneration. This
designation is an essential step in allowing companies to
commercialize products effectively across the European Union.
Dr. Eddy Anglade, Chief Medical Officer of Ocata Therapeutics,
said: “We are pleased to receive ATMP status from the EMA. We view
this as an important step to further enable the development of our
novel biological therapy in the EU with the aim of seeking
marketing authorization approval. Additionally, we interpret this
as a favorable indication for how the European regulators view our
therapy.”
Dr. Paul Wotton, President and Chief Executive Officer of Ocata
Therapeutics, commented: “This milestone is particularly timely as
we prepare to dose our first patient in the Phase 2 trial for
Stargardt's patients by the end of this year. Last month The Lancet
published results from our Phase 1/2 studies. The positive safety
data along with signals of visual improvement realized by many of
our patients, gives us great confidence to move forward with this
important therapy. There are currently no approved treatments for
either SMD, an orphan condition or dry AMD, both of which result
frequently in devastating vision loss. We are committed to
advancing our programs through clinical trials and to ultimately
delivering them to patients in need.”
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 ATMP Classification: The aim of the ATMP classification is
to regulate cell and gene therapy and tissue-regulated medicinal
products. The European regulation provides guidelines to developers
for non-clinical and manufacturing development as well as product
quality testing. The regulation also offers incentives to companies
involved in developing ATMP’s in the European Union, including fee
reductions for scientific advice, scientific recommendations on
ATMP classification and evaluation and certification of quality and
non-clinical data.
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 relevance and
applicability of clinical trials, potential new applications of and
expanded indications covering Ocata’s technology, the effect of
Ocata’s products on the medical needs and quality of life of study
subjects or other patients, Ocata’s potential product pipeline and
development efforts, 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;, the 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 the Company’s
product candidate claims; even if approved, the risk that
physicians and patients may not accept or use Ocata’s products;
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 Quarterly Report on Form 10-Q for the three
and nine months ended September 30, 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