Ocata Therapeutics Announces Positive Results Reported in a Late Breaking Abstract at the Annual Meeting of the International...
June 24 2015 - 9:15AM
Business Wire
Follow up Results for Thirty-One Patients who
Received Retinal Pigmented Epithelium Cell Therapy for Macular
Degeneration
Ocata Therapeutics, Inc. (“Ocata” or “the Company”; NASDAQ:
OCAT), a leader in the field of Regenerative Ophthalmology™,
announced today that data will be presented in a Late Breaking
Abstract at the International Society for Stem Cell Research
(ISSCR) 13th Annual Meeting being held in Stockholm, Sweden, June
24-27.
The presentation will provide a follow-up of four prospective
safety trials carried out in the United States and also in South
Korea. The results of these trials in 31 patients with dry
Age-related Macular Degeneration (AMD) and Stargardt’s Macular
Dystrophy (SMD) provide additional evidence supporting the safety
and tolerability of hESC-derived retinal pigment epithelium (RPE).
Some patients were followed for up to 4 years and none of the
patients showed evidence of hyperproliferation, rejection or
serious adverse ocular or systemic safety issues related to the
transplanted tissue.
The abstract reported that all of the patients, 26 from the US
studies and 5 from the South Korean study, experienced improved or
stable, best-corrected visual acuity (BCVA). These studies suggest
that hESC-derived cells could provide a potentially safe new source
of cells for regenerative medicine.
“This late breaking abstract presented at the leading stem cell
meeting is indicative of the significance and importance of our new
potential breakthrough treatments for these disabling diseases
where there is no cure available today,” said Paul K. Wotton,
Ph.D., President and Chief Executive Officer. “We now look forward
to the planned initiation of our Phase 2 safety study in dry AMD
and our pivotal study in SMD.”
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
updated data presented at this conference are indicative of the
efficacy of its product candidates and the ultimate results for its
planned trials, Ocata’s belief that hESC-derived cells could
provide a potentially safe new source of cells for regenerative
medicine, the planned objective, endpoints and initiation of the
Ocata’s clinical 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150624005284/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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