The DRAXIMAGE
radiopharmaceutical business unit of DRAXIS Health Inc. (TSX: DAX) (NASDAQ:
DRAX) has been approved by the U.S. Food and Drug Administration (FDA) to
run two clinical trials using radioactive Iobenguane I-131 Injection (also
known as (131)I-metaiodobenzylguanidine, or I-131 MIBG) to treat high-risk
neuroblastoma, a rare form of cancer that affects mostly infants and young
children.
DRAXIMAGE will provide I-131 MIBG for two clinical trials approved by
the FDA under a recently submitted Investigational New Drug (IND)
application. One trial is a Phase II study in which I-131 MIBG will be
administered with intensive chemotherapy and autologous stem cell rescue
for high-risk neuroblastoma patients. The second trial is a Phase I study
in which irinotecan and vincristine, two common chemotherapy agents, will
be administered in combination with I-131 MIBG to determine safety and
tolerability in patients with resistant/relapsed high-risk neuroblastoma.
Both clinical trials will be coordinated by a group of 11 children's
hospitals and two universities in the United States known as the New
Advances in Neuroblastoma Therapy (NANT) consortium. These two trials are
continuations of earlier NANT studies. They are expected to start in
December 2006 or early 2007. NANT member institutions are:
- C.S. Mott Children's Hospital, University of Michigan - Ann Arbor, MI
- Children's Healthcare of Atlanta - Atlanta, Georgia
- Children's Hospital and Regional Medical Center - Seattle, WA
- Children's Hospital Boston, Dana-Farber Cancer Institute - Boston, MA
- Children's Hospital Los Angeles - Los Angeles, CA
- Children's Hospital Medical Center - Cincinnati, OH
- Children's Hospital of Philadelphia - Philadelphia, PA
- Children's Memorial Hospital - Chicago, IL
- Lucile Packard Children's Hospital - Palo Alto, CA
- Riley Hospital for Children, Indiana University - Indianapolis, IN
- Texas Children's Cancer Center, Baylor College of Medicine -
Houston, TX
- University of California, San Francisco - San Francisco, CA
- University of Wisconsin Comprehensive Cancer Center - Madison, WI
Patients or caregivers seeking information about participation in the
clinical trials can contact any of the NANT member institutions or go to
nant
DRAXIMAGE will supply I-131 MIBG to the two clinical trials following a
recent decision by the University of Michigan to no longer supply I-131
MIBG to these and other clinical trials. DRAXIMAGE produces I-131 MIBG at
its radiopharmaceutical facility in Montreal, Canada.
About Neuroblastoma
The website of the American Cancer Society (cancer) lists
neuroblastoma as the most common cancer among infants and the fourth most
common type of cancer in children. There are about 650 new cases of
neuroblastoma each year in the United States. Neuroblastoma most often
begins during early childhood, with nearly 90% of cases diagnosed before
the age of 5 years. Only about 2% of cases are found in children 10 years
of age or older.
Neuroblastoma tumors usually occur in the abdomen, in nerve cells
located within the two adrenal glands. The triangular-shaped adrenals are
located above each kidney and they produce important hormones, including
adrenaline, that help control heart rate, blood pressure, blood sugar and
the body's reaction to stress.
About the NANT Consortium
The NANT Consortium is a group of 13 Universities and Children's
Hospitals with strong research and treatment programs for neuroblastoma.
Working closely together, they test promising new therapies for high-risk
and relapsed neuroblastoma. The majority of funding for NANT comes from the
National Cancer Institute. NANT conducts clinical trials that test new
drugs and new combinations of drugs against high-risk neuroblastoma. Those
with promising results will then be considered for more extensive national
testing. For more information go to nant
About DRAXIMAGE
DRAXIMAGE develops, manufactures and markets diagnostic and therapeutic
radiopharmaceuticals for the global marketplace. Products currently include
a line of lyophilized technetium-99m kits used in nuclear imaging
procedures and therapeutic products labeled with a variety of isotopes
including radioiodine.
About DRAXIS Health Inc.
DRAXIS Health, through its wholly owned operating subsidiary, DRAXIS
Specialty Pharmaceuticals Inc., provides products in three categories:
sterile products, non-sterile products and radiopharmaceuticals. Sterile
products include liquid and freeze-dried (lyophilized) injectables plus
sterile ointments and creams. Non-sterile products are produced as solid
oral and semi-solid dosage forms. Radiopharmaceuticals are used for both
therapeutic and diagnostic molecular imaging applications. Pharmaceutical
contract manufacturing services are provided through the DRAXIS Pharma
division and radiopharmaceuticals are developed, produced, and sold through
the DRAXIMAGE division. DRAXIS Specialty Pharmaceuticals Inc. employs
approximately 500 staff in its Montreal facility.
For additional information please visit draxis.
Caution Concerning Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements are not guarantees of future performance. By their nature,
forward-looking statements involve numerous assumptions, known and unknown
risks, uncertainties and other factors that may cause the actual results or
performance of the Company to be materially different from such statements
or from any future results or performance implied thereby. Factors which
could cause the Company's results or performance to differ materially from
a conclusion, forecast or projection in the forward-looking statements
include, but are not limited to: the achievement of desired clinical trial
results related to the Company's pipeline products; timely regulatory
approval of the Company's products; the ability to comply with regulatory
requirements applicable to the manufacture and marketing of the Company's
products; the Company's ability to obtain and enforce effective patents;
the non-infringement of third party patents or proprietary rights by the
Company and its products; factors beyond our control which could cause
interruptions in our operations in our single manufacturing facility
(including, without limitation, material equipment breakdowns);
reimbursement policies related to health care; the establishment and
maintenance of strategic collaborative and commercial relationships; the
Company's dependence on a small number of key customers; the disclosure of
confidential information by our collaborators, employees or consultants;
the preservation of healthy working relationships with the Company's union
and employees; the Company's ability to grow the business; the fluctuation
of our financial results and exchange and interest rate fluctuations; the
adaptation to changing technologies; the loss of key personnel; the
avoidance of product liability claims; the loss incurred if current
lawsuits against us succeed; the volatility of the price of our common
shares; and market acceptance of the Company's products. For additional
information with respect to certain of these and other factors and relating
to the Company generally, reference should be made to the Company's most
recent Form 20-F filed with the United States Securities and Exchange
Commission (available on EDGAR at sec) and with Canadian securities
regulators (available on SEDAR at sedar). Unless otherwise required
by applicable securities laws, the Company disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
DRAXIS Health Inc.
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