Capricor Therapeutics (NASDAQ:CAPR) today announced it has
entered into an agreement with the U.S. Army Institute of Surgical
Research (USAISR) to study the potential for the company’s
next-generation investigational therapeutic platform, designated
CAP-2003, which represents extracelluar vesicles (e.g., exosomes
and microvesicles) to address a wide spectrum of trauma-related
injuries and conditions, which are now the third leading cause of
death in the U.S.
CAP-2003 is derived from Capricor’s proprietary
cardiosphere-derived cells (CDCs), which comprise adult cardiac
progenitor cells from donor heart tissue. CAP-2003 has shown
promising results in various pre-clinical experiments using
established animal models of diseases by exerting
anti-inflammatory, anti-fibrotic, pro-angiogenic, and
anti-apoptotic effects.
“In developing CAP-2003, Capricor has distilled
the active pharmaceutical ingredient (API) of the cells and created
a therapeutic that may be easier to use than cell-based
therapeutics,” said Linda Marbán, Ph.D., Capricor president and
CEO. “CAP-2003 doesn’t require refrigeration or special handling,
potentially making it well suited for treating and stabilizing
injured soldiers in the field, potentially improving their chances
of surviving until they can be transported and receive treatment at
medical facilities.”
USAISR entered into the collaboration with
Capricor after determining cell-free therapies offer great promise
for treating conditions that contribute to soldier morbidity and
mortality. Capricor will provide CAP-2003 for testing of function,
potency and safety for eventual use in therapeutic indications.
Because this is potentially a very important clinical use of
CAP-2003, Capricor will work closely with USAISR on its studies and
in publishing results of those studies in peer-reviewed
journals.
“We were very pleased to enter into this
collaboration with Capricor and look forward to studying the
utility and delivery of exosomes for trauma-related injuries that
soldiers experience on the battlefield,” said James Bynum, Ph.D.,
USAISR principal investigator. “One of the goals of this
collaboration is to test whether CAP-2003 will provide a useful
tool on the battlefield to stabilize injured soldiers while they
wait for transport to a medical facility. If we can achieve this
goal, we will be able to potentially make a meaningful difference
in the preservation of life. One of the reasons exosomes are so
exciting as a potential therapeutic is their stability, which may
allow them to be carried in a medic’s pack and deployed
immediately. This is in contrast to earlier cell-based therapies
where the necessity of a frozen product prevented easy access. This
could be the beginning of a completely new therapeutic paradigm in
stabilizing injured warriors.”
The exosomes produced by the CDCs are
quantitatively different in terms of contents compared to
mesenchymal stem cells (MSC) and other types of exosomes.
Preclinical studies suggest that CAP-2003 might lead to different
and perhaps augmented clinical benefit when directly compared to
other types of exosomes.
“This collaboration will provide the much-needed
standardization of extracellular vesicle production, usage and
identification for this rapidly growing field, further positioning
us as one of the leaders in the development of therapeutic
exosomes,” said Dr. Marbán. “This endeavor stands to open up a new
arena in biotechnology, where the benefits of cells can be
distilled down to the API now known to be extracellular vesicles.
Our work with USAISR is also important for the further development
of our CAP-2003 technology because if it proves to be promising, we
will work on developing large-scale manufacturing as well as
clinical development as a result of it.”
About CAP-2003CAP-2003 is being
developed as a next-generation therapeutic platform in regenerative
medicine. CAP-2003 is comprised of nano-sized extracellular
vesicles, including exosomes and microvesicles, which exert
anti-inflammatory, pro-angiogenic, anti-apoptotic, and
anti-fibrotic effects. CAP-2003 contains several characteristic
lipids, proteins, and RNA molecules (e.g., microRNAs). They act as
messengers to regulate the functions of neighboring cells.
Pre-clinical research has shown that exogenously-administered
extracellular vesicles can direct or, in some cases, re-direct
cellular activity, supporting their therapeutic potential. Their
size, ease of crossing cell membranes and ability to communicate in
native cellular language make them an exciting class of potential
therapeutic agents.
About Capricor Therapeutics Capricor
Therapeutics, Inc. (NASDAQ:CAPR) is a clinical-stage biotechnology
company focused on the discovery, development and commercialization
of first-in-class biological therapeutics for the treatment of rare
disorders. Capricor’s lead candidate, CAP-1002, is an allogeneic
cell therapy that is currently in clinical development for the
treatment of Duchenne muscular dystrophy. Capricor has also
established itself as one of the leading companies investigating
the field of extracellular vesicles and is exploring the potential
of CAP-2003, a cell-free, exosome-based candidate, to treat a
variety of disorders. For more information, please visit
www.capricor.com.
Keep up with Capricor on social media:
www.facebook.com/capricortherapeutics,
www.instagram.com/capricortherapeutics/ and
https://twitter.com/capricor.
Cautionary Note Regarding Forward-Looking
Statements
Statements in this press release regarding the
efficacy, safety, and intended utilization of Capricor's product
candidates; the initiation, conduct, size, timing and results of
discovery efforts and clinical trials; the pace of enrollment of
clinical trials; plans regarding regulatory filings, future
research and clinical trials; regulatory developments involving
products, including the ability to obtain regulatory approvals or
otherwise bring products to market; plans regarding current and
future collaborative activities and the ownership of commercial
rights; scope, duration, validity and enforceability of
intellectual property rights; future royalty streams, expectations
with respect to the expected use of proceeds from the recently
completed offerings and the anticipated effects of the offerings,
and any other statements about Capricor's management team's future
expectations, beliefs, goals, plans or prospects 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 "believes," "plans," "could," "anticipates," "expects,"
"estimates," "should," "target," "will," "would" 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. More information
about these and other risks that may impact Capricor's business is
set forth in Capricor's Annual Report on Form 10-K for the year
ended December 31, 2017 as filed with the Securities and Exchange
Commission on March 22, 2018, in its Registration Statement on Form
S-3, as filed with the Securities and Exchange Commission on
September 28, 2015, together with the prospectus included therein
and prospectus supplements thereto and in its Quarterly Report on
Form 10-Q for the quarter ended March 31, 2018, as filed with the
Securities and Exchange Commission on May 14, 2018. All
forward-looking statements in this press release are based on
information available to Capricor as of the date hereof, and
Capricor assumes no obligation to update these forward-looking
statements.
CAP-1002 is an Investigational New Drug and is
not approved for any indications. CAP-2003 has not yet been
approved for clinical investigation.
For more information, please contact:
AJ Bergmann, Chief Financial Officer
+1-310-358-3200
abergmann@capricor.com
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