Canine Patients Treated with Ocata’s Hemangio-derived Mesenchymal Cells (HMC™) Achieve Remission in a Model of Crohn’s ...
September 22 2015 - 9:00AM
Business Wire
Results Published in Regenerative Medicine
Demonstrate Potent Therapeutic Effect
Ocata Therapeutics, Inc. (NASDAQ:OCAT), a leader in the field of
regenerative medicine, and its collaborators today reported in
Regenerative Medicine that it has successfully used its proprietary
hemangio-derived mesenchymal cell (HMCTM) technology to treat dogs
with canine anal furunculosis (CAF), which shares many features
with Crohn’s disease.
“This study provides the first evidence of the safety and
therapeutic potential of human pluripotent stem cell-derived
mesenchymal stem cells in a large animal model,” said Robert Lanza,
M.D., Chief Scientific Officer of Ocata. “Canines have a physiology
and sophisticated immune system that closely resembles that of
humans, and canines are the only species that naturally develop
symptoms and pathology similar to human fistulizing Crohn’s
disease, including recurrent fistula activity, a difficult-to-treat
manifestation of this chronic inflammatory bowel disorder. We
treated six canines that were refractory to standard treatment,
including cyclosporine therapy, and all of the canines were found
to be completely free of fistulas at three months
post-injection.”
Crohn’s disease (CD) is a chronic inflammatory bowel disorder
that affects an estimated 1.0 to 1.3 million Americans. A
combination of environmental and genetic factors is thought to lead
to an autoimmune attack against cells of the gastrointestinal tract
or associated microbial antigens. Affected regions of the GI tract
vary from patient to patient and ulceration with cutaneous or
recto-cutaneous fistulae within the perianal tissues is present in
up to a third of CD patients. The most widely used treatments for
CD-associated perianal fistulas include antibiotics and
immune-suppressants such as azathioprine and cyclosporine, yet
long-term use comes with serious adverse effects or potential
reemergence of fistulas upon dose-lowering.
“Ocata has developed a mesenchymal stem cell population from its
proprietary hESC-derived hemangioblasts called HMCs, which are a
self-renewing source of starting material, capable of generating a
significant supply of minimally expanded cells with potent
immunomodulatory and therapeutic properties,” said Paul K. Wotton,
President and CEO who added “This successful study, along with
other work we have conducted, provides a unique platform that can
potentially be used to target significant autoimmune related
disorders with high unmet needs such as Crohn’s disease and Lupus
Nephritis.”
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.
Forward-Looking Statements
All statements, other than historical facts, contained in this
news release, including statements regarding Ocata’s belief
regarding the continued development of its HMC product, the ability
to produce and the potential effectiveness of a pluripotent stem
cell-derived product to treat auto immune diseases, the effect of
Ocata’s pre-clinical research and patent estate on the development
of its product platforms, 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 its 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/20150922005715/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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