Ocata Therapeutics Receives Important New U.S. Patent for its RPE Therapy for Macular Degenerative Diseases
June 02 2015 - 8:01AM
Business Wire
Fortified Patent
Portfolio Covers RPE Products from All
Pluripotent Stem Cell Sources
Ocata Therapeutics, Inc. (“Ocata” or “the Company”; NASDAQ:
OCAT), a leader in the field of
Regenerative Ophthalmology™, today announced that
it continues to fortify the scope of protection covering
its retinal pigment epithelium (RPE) transplant
technology with the issuance by the United States Patent and
Trademark Office (USPTO) of U.S. Patent No 9,045,732. This new
patent further strengthens the Company’s comprehensive suite of
intellectual property which the Company believes to be an important
component of its sustainable competitive advantage in Regenerative
Ophthalmology. Ocata recently announced the issuance of three new
patents and the Company believes it now has protection for the
manufacture of all RPE cell products from pluripotent stem
cell sources, including the manufacturing of all formulations,
(e.g. suspensions and sheets of cells), for use as therapeutic
agents, as well as the use of these formulations for treating
ophthalmic diseases, such as dry age related macular degeneration
(“dry AMD”) and Stargardt’s macular degeneration (“SMD”).
"We continue to expand and strengthen our patent estate as we
increase our worldwide leadership position
in RPE products derived from any pluripotent
cell source," said Paul K. Wotton, President and
Chief Executive Officer of Ocata Therapeutics. “Our emphasis and
ongoing investment in a comprehensive patent strategy has
Ocata well positioned to initiate the next phase of our clinical
development program; phase 2 trials for dry AMD and a pivotal trial
for SMD. The development and commercialization of our
breakthrough, fully differentiated cell therapies remains our
key objective and we are committed to bringing these novel
therapies to patients in need.”
This issued patent strengthens Ocata’s broad intellectual
property portfolio of more than 60 granted patents and
approximately 200 patent applications globally. The current
intellectual property estate, which incorporates additional filings
around the core RPE cell therapy discovery and improvements the
Company has made, may provide additional coverage for the Company’s
pharmaceutical preparations of RPE cells, methods of use,
manufacturing processes, and products for the next 20 years or
longer.
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 beliefs
regarding the scope and duration of protection provided by its new
and existing patents, the effect of such patents on the Ocata’s
clinical development plans, the existence and sustainability of any
competitive advantages due to Ocata’s intellectual property
position, plans to initiate a pivotal trial for Stargardt’s Disease
and phase 2 clinical trials for dry AMD, 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150602006066/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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