NeoStem Expands Patent Portfolio With Grant of Two European Patents
May 19 2014 - 7:30AM
NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader
in the emerging cellular therapy industry, today announced the
expansion of its intellectual property protection surrounding its
CD34 Cell Program in which it is developing therapeutics to address
ischemia, the process that occurs when the supply of oxygenated
blood in the body is restricted. AMR-001 is the Company's most
clinically advanced product candidate in its CD34 Cell Program and
is being developed to treat damaged heat muscle following a heart
attack.
The European Patent Office has notified the Company that it has
granted patent numbers 1951864 and 2441461 for "Compositions and
Methods of Vascular Injury Repair." These represent NeoStem's first
granted European patents for its CD34 Cell Program and bring the
Program's total worldwide patent coverage to 16 granted and allowed
patents.
"We are pleased to be building our international patent
portfolio in the European Union and other geographic locations,"
said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "We hope that
laying this foundation now will support partnering activities once
data from our Phase 2 PreSERVE clinical trial for AMR-001 becomes
available later this year."
The continued expansion of the Company's intellectual property
portfolio both domestically and internationally expands the
commercial possibilities for its CD34 Cell Program, should any of
these products in development receive regulatory approval. In the
past year, NeoStem has announced expansion of its patent protection
for its CD34 Cell Program in the U.S. and around the globe,
including Japan, Canada, Russia, Malaysia, the Philippines, and now
the European Union.
Heart attacks and cardiovascular disease are significant threats
to public health in many countries, not just the U.S. If approved
by the FDA and other worldwide regulatory agencies, AMR-001 could
address significant unmet medical needs in the treatment of
cardiovascular disease around the world.
It is estimated that each year cardiovascular disease causes
over 1.9 million deaths in the European Union and costs its economy
almost $270 billion. It has further been estimated that in Europe,
6.5 million patients suffer from chronic heart failure and this
number is rising due to the aging of the population. A study
published in The European Heart Journal (2010) found that the
annual incidence of hospital admission for any AMI varied between
90–312 per 100,000 per year, with the incidence of ST segment
elevation myocardial infarction ("STEMI") alone ranging from 44 to
142 per 100,000.
NeoStem announced completion of enrollment in its Phase 2
PreSERVE AMI clinical trial in Q4 2013, a randomized, double-blind
placebo-controlled study testing AMR-001for the treatment of
patients with left ventricular dysfunction following STEMI. Data
read out is expected in 2H 2014 and the Company expects to advance
the technology into other clinical indications, such as chronic
heart failure, traumatic brain injury and/or critical limb
ischemia.
About NeoStem's CD34 Cell Program
NeoStem is developing therapies to address ischemia through its
CD34 Cell Program. Ischemia occurs when the supply of oxygenated
blood in the body is restricted. The Company's therapeutics seek to
reverse this restriction through the development and formation of
new blood vessels. The Program's lead product candidate is
AMR-001, a chemotactic hematopoietic stem cell product comprised of
autologous bone marrow derived CD34/CXCR4 cells selected to treat
damaged heart muscle following AMI (heart attack). AMR-001
works by increasing microvascular blood flow in the heart muscle
via the development and formation of new blood vessels, thereby
reversing the restriction of blood supply caused by a heart attack
and rescuing tissue from eventual cell death.
About NeoStem
NeoStem is a leader in the emerging cellular therapy industry,
pursuing the preservation and enhancement of human health globally
through the development of cell based therapeutics that prevent,
treat or cure disease by repairing and replacing damaged or aged
tissue, cells and organs and restoring their normal function. The
business includes the development of novel proprietary cell therapy
products as well as a revenue-generating contract development and
manufacturing service business. This combination has created an
organization with unique capabilities for cost effective in-house
product development and immediate revenue and cash flow generation.
www.neostem.com
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements reflect management's current
expectations, as of the date of this press release, and involve
certain risks and uncertainties. Forward-looking statements include
statements herein with respect to the successful execution of the
Company's business strategy, the Company's ability to develop and
grow its business, the successful development of cellular therapies
with respect to the Company's research and development and clinical
evaluation efforts in connection with the Company's Targeted
Immunotherapy Program, CD34 Cell Program (including whether or not
the Company's Phase 2 PreSERVE clinical trial will generate
positive data), T Regulatory Cell Program and other cell therapies,
the future of the regenerative medicine industry and the role of
stem cells and cellular therapy in that industry and the
performance and planned expansion of the Company's contract
development and manufacturing business. The Company's actual
results could differ materially from those anticipated in these
forward-looking statements as a result of various factors. Factors
that could cause future results to materially differ from the
recent results or those projected in forward-looking statements
include the "Risk Factors" described in the Company's Annual Report
on Form 10-K filed with the Securities and Exchange Commission
("SEC") on March 13, 2014, the Company's Current Report on Form 8-K
filed with the SEC on May 8, 2014 and in the Company's other
periodic filings with the SEC. The Company's further development is
highly dependent on future medical and research developments and
market acceptance, which is outside its control.
CONTACT: Investor Contact:
LifeSci Advisors, LLC
Michael Rice
Founding Partner
Phone: +1-646-597-6979
Email: mrice@lifesciadvisors.com
Media Contact:
NeoStem, Inc.
Eric Powers
Manager of Communications and Marketing
Phone: +1-212-584-4173
Email: epowers@neostem.com
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