DRAXIS Radiopharmaceutical Unit Approved to Run 2 Clinical Trials to Treat Neuroblastoma
22 Novembro 2006 - 11:00AM
PR Newswire (US)
Targeted radiation therapy with DRAXIMAGE I-131 MIBG to be included
in Phase I and Phase II trials coordinated with 13-member
consortium of U.S. universities and hospitals MISSISSAUGA, ON, Nov.
22 /PRNewswire-FirstCall/ -- 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 http://www.nant.org/ 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
(http://www.cancer.org/) 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
http://www.nant.org/ 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
http://www.draxis.com/. 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 http://www.sec.gov/) and with
Canadian securities regulators (available on SEDAR at
http://www.sedar.com/). 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. DATASOURCE:
DRAXIS Health Inc. CONTACT: DRAXIS Health Inc., Jerry Ormiston,
Executive Director Investor Relations, Tel: 1-877-441-1984;
DRAXIMAGE, Dr. Jean de Serres, Vice President, Clinical Research
and Regulatory Affairs, Tel: 1-888-633-5343
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