Ocata Therapeutics Announces Positive Results in Treating Macular Degeneration Using Fully Differentiated Stem Cell-Derived R...
April 30 2015 - 12:30PM
Business Wire
Study Sponsored by CHA Biotech in South
Korea Supports Earlier Findings Reported in The Lancet
Ocata Therapeutics, Inc. (“Ocata” or “the Company”; NASDAQ:
OCAT), a leader in the field of Regenerative Ophthalmology™,
announced that a study has been published that includes top-line,
positive results in Asian patients who were treated with Ocata’s
proprietary RPE cells, manufactured using its DeltaCell™
Technology.
These new data support previously reported positive long-term
safety and signs of visual improvement, as presented in The Lancet
of October 15th, 2014. The Korean study published online in Stem
Cell Reports features twelve months of post-transplant follow-up
data from four Asian patients; two with Stargardt’s macular
degeneration (SMD) and two with dry age-related macular
degeneration (AMD).
“The results of this study conducted by CHA Biotech in Asian
patients support the findings published in The Lancet in October
2014 and further underscores our leadership in regenerative
ophthalmology,” said Paul K. Wotton, Ph.D., President and Chief
Executive Officer. “The safe treatment of a total of forty two
patients across multiple studies with this novel therapeutic
approach in geographically distinct patient populations is
encouraging. We look forward to the planned initiation of our
comprehensive Phase 2 safety study in dry AMD and a pivotal study
in SMD, two disabling diseases where there is no cure available
today.”
In this study there was no evidence of adverse proliferation,
tumorigenic behavior, ectopic tissue formation, or other serious
safety issues related to the transplanted cells. Although designed
as a safety study, visual acuity improved 9–19 letters in three
patients and remained stable (+1 letter) in one patient. Vision was
measured using the widely accepted standard for visual acuity
testing, the Early Treatment Diabetic Retinopathy Study visual
acuity exam.
Robert Lanza, M.D., Chief Scientific Officer of Ocata
Therapeutics and co-senior author of the paper, commented, “These
results support the potential safety and efficacy of hESC-derived
cells in Asian patients and provides further evidence that
hESC-derived cells could serve as a potentially safe new source for
regenerative medicine.”
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, Ocata’s plans to commence a comprehensive
Phase 2 safety study in dry AMD and a pivotal study in SMD,
hESC-derived cells’ potential as a safe new source for regenerative
medicine, the planned objective and endpoints of the AMD trial and
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
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