NeoStem Announces Licensing Agreement and Plans to Begin Phase 2 Hepatocellular Carcinoma Trial in China
May 13 2014 - 7:30AM
NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader
in the emerging cellular therapy industry, announced today that the
Company has signed an exclusive license agreement with China-based
Cellular Biomedicine Group (OTCQB:CBMG) ("CBMG") to begin a Phase 2
clinical trial in patients with late stage liver cancer. The trial,
to be conducted in China in accordance with international
standards, will investigate the use of the Company's
developmental patient-specific cancer immunotherapy known as
"DC-TC", in patients with hepatocellular carcinoma ("HCC").
Pursuant to the terms of the license agreement, the cost of the
Phase 2 trial will be borne by CBMG, and CBMG will also be
responsible for all clinical, marketing, and, should a product be
approved, commercialization activities in China. NeoStem will be
responsible for all regulatory filings and will directly control
and manage all manufacturing processes and procedures relating to
the development of its DC-TC product. NeoStem could receive up to
$30 million in licensing milestone fees over the life of the
agreement, with $1 million payable upon enrollment of the first
patient in the currently planned Phase 2 trial. Royalties and
sublicense fees may also be payable.
The Company's DC-TC therapy involves growing cancer initiating
(stem) cells that have been isolated from a patient's resected
tumor sample, and then enriching and inactivating them. This newly
created cancer initiating (stem) cell line is then combined with
dendritic cells, a type of antigen-presenting immune cell that is
derived from the same patient's blood. The product is then
reintroduced to the patient via a series of subcutaneous
injections.
The planned study follows a Phase 1 trial which demonstrated
safety in HCC patients. There were no serious adverse events
related to the treatment in patients who co-presented with active
hepatitis B and underlying cirrhosis, commonly associated with
liver cancer in China, and patients were not charged for treatment.
"We were very pleased to have concluded a Phase 1 trial with
positive safety outcomes and look forward to continuing to work to
develop this treatment in a country where so many people are
greatly affected by this disease," said Dr. Hans Keirstead,
President of NeoStem Oncology, LLC, the Company's wholly-owned
subsidiary developing targeted immunotherapies for cancer
treatment. "Patients with this stage of disease are not eligible
for curative resection or transplantation."
"The planned Phase 2 study in China is seeking to assess the
efficacy and safety of our new DC-TC platform technology in
treating hepatocellular carcinoma, and we look forward to working
with CBMG to develop this indication in Asia," said Dr. Robin L.
Smith, Chairman and CEO of NeoStem. "China holds more than 45% of
the world's HCC patients, being responsible for 395,000, or roughly
50%, of new cases in 2012."
The Company has also recently reached agreement with the U.S.
Food and Drug Administration to begin a Phase 3 clinical trial for
its lead product candidate, Melapuldencel- T, in metastatic
melanoma, expected to begin in 2014. Melapuldencel-T's Phase 3
protocol has been granted Special Protocol Assessment ("SPA") and
the product candidate has received Fast Track designation for
metastatic melanoma, as well as Orphan Drug designation. Five year
survival data from the Phase 2 clinical trial in metastatic
melanoma has been accepted for a poster presentation at The
American Society of Clinical Oncology's 2014 annual meeting in
June.
About the DC-TC Treatment
The Company's DC-TC treatment is based on recent clinical
findings that the rapid proliferation and subsequent spreading of
cancer throughout a patient's body may be fueled by a small number
of cancer initiating (stem) cells. Through proprietary processes,
our researchers have refined isolation and expansion of these
cancer initiating (stem) cells to clinically useful numbers, which
are then combined with autologous dendritic cells, and reintroduced
into the patient with the intention of training and bolstering the
patient's immune system to target the cancer stem cells that have
the ability to metastasize and create new tumors.
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, including with respect to the
Company's ability to consummate the CSC acquisition and the
Company's ability to develop and grow its business, the successful
development of cellular therapies (including in hepatocellular
carcinoma) 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 and 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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