NeoStem Announces Grant of Two U.S. Patents for CD34 Cell Program
May 27 2014 - 7:30AM
NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader
in the emerging cellular therapy industry, today announced the
expansion of intellectual property protection surrounding its CD34
Cell Program. That program is developing therapeutics to address
ischemia, the process that occurs when the supply of oxygenated
blood in the body is restricted. The recently granted U.S. patents
relate to AMR-001, the Company's most clinically advanced product
candidate in its CD34 Cell Program, which is designed to treat
damaged heart muscle following acute myocardial infarction (AMI or
heart attack).
United States patents 8,637,005 and 8,709,403 are entitled
"Compositions and Methods of Vascular Injury Repair" and serve to
further expand the range of serum concentrations used to deliver
CD34 cells from claims of previously granted patents. These patents
bring the total number of granted and allowed patents for the
Company's CD34 cell program to 16.
Heart attacks and cardiovascular disease are a significant
physical and economic burden on society. If approved by the FDA and
other worldwide regulatory agencies, AMR-001 for AMI patients could
address significant unmet medical need in the treatment of
cardiovascular disease around the world. AMI patients are at
significant risk of downstream adverse events, including chronic
heart failure, re-current AMI, significant arrhythmias, premature
death or acute coronary syndrome. A statistical report from
Agency for Healthcare Research and Quality (2011) surveyed the most
expensive hospitalization conditions by payer and lists AMI as the
sixth most expensive condition treated in U.S. hospitals, with a
national hospital bill of more than $37 billion annually.
"As we continue to develop our therapeutic candidates,
advancement in our intellectual property profile, in the U.S. and
globally, expands the potential for partnership discussions," said
Dr. Robin Smith, Chairman and CEO of NeoStem.
NeoStem is increasing its patent portfolio for its CD34 Cell
Program both domestically and internationally, including recent
patent grants in the European Union, Japan, Canada, Russia,
Malaysia, and the Philippines. In Q4 2013 the Company announced
completion of enrollment in its Phase 2 PreSERVE AMI clinical
trial, a randomized, double-blind placebo-controlled study testing
AMR-001for the treatment of patients with left ventricular
dysfunction following ST segment elevation myocardial infarction
("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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