Multi-Pronged Therapeutic Cancer Vaccine Regimen to be Studied in Melanoma Patients



    PARIS, and TORONTO, Sept. 17 /CNW/ -- Sanofi pasteur, the vaccines
division of the sanofi-aventis Group, announced today that it is sponsoring a
Phase II clinical study exploring a multi-pronged treatment approach to high
risk and advanced-stage melanoma -- an often fatal form of cancer for which
there are limited treatment options.  Patients are being enrolled in the
United States and Canada. The trial, called MEL11, will investigate the safety
and efficacy of a therapeutic cancer vaccine regimen aimed at stimulating the
body's immune system to fight melanoma.
    

    
    "The MEL11 study uses an entirely new treatment approach to
advanced-stage melanoma," said Teresa Petrella, MD, Medical Oncologist and
Clinical Researcher at the Odette Cancer Centre at the Sunnybrook Health
Sciences Centre in Toronto and the lead investigator of the trial. "The study
protocol combines the use of a vaccine with more traditional anti-cancer
agents to bolster the effectiveness of the immune system.  Melanoma is an
increasing concern in the cancer community; its incidence is on the rise and
there are very few available treatment options."
    

    
    The vaccine candidate is uniquely designed to stimulate the body's own
defenses -- the immune system -- to find and fight cancer cells. It makes use
of a modified canarypox virus, ALVAC(2), which has been shown in an extensive
body of research to promote immune responses in humans.  The ALVAC(2) virus
contains the genes for five antigens -- molecules that induce an immune
response -- that are commonly found in melanoma tumors. These antigens
stimulate T-cells within the immune system to hone in on melanoma cells, and
are expected to halt or slow cancer progression. The vaccine also contains the
genes for three proteins called co-stimulatory molecules, which increase the
immune response of T-cells to the antigens. In addition to the vaccine,
patients in this trial will be treated with two other agents that augment the
immune response: GM-CSF and interferon-alpha-2b.
    

    About the Clinical Trial
    
    The randomized, open-label trial involves 120 participants at 23 centers
across the United States and Canada.  Stage IIIc, IVa and IVb melanoma
patients with at least one measurable lesion and a life expectancy of at least
six months will be included in the study.  Participants will be randomized to
one of two study groups.  The first group will receive vaccine treatment
consisting of a series of ALVAC and GM-CSF injections, followed by
administration of interferon. The second group will receive administration of
interferon alone.
    

    
    The study is designed with the primary objective of progression-free
survival (tumor stabilization) and the secondary objective of evaluation of
safety, other efficacy endpoints (response rates), and the ability of the
treatment regimen to induce an immune response.
    

    
    The first cycle of vaccine treatment is conducted for a period of
16-weeks. If there is no evidence of disease progression during the first
cycle, vaccine treatment is extended to a second 16 week cycle of treatment.
In the study, patients in Group 2 whose disease has progressed during the
first treatment cycle may be offered the vaccine regimen as the next cycle of
treatment.
    

    About Melanoma
    
    Melanoma is the most serious form of skin cancer, accounting for 80
percent of all skin cancer deaths. Incidence and mortality rates for melanoma
are rising faster than those for any other cancer.  According to the American
Cancer Society and Canadian Cancer Society, this year nearly 65,000 people in
North America will be diagnosed with melanoma and more than 9,000 will die
from the disease.  By the year 2010, it is estimated that one in 50 people
will have been diagnosed with melanoma.  Standard treatments have minimal
effect on survival, and sometimes cause significant toxicity.
    

    About Therapeutic Cancer Vaccines
    
    Therapeutic cancer vaccines represent an emerging, experimental type of
immunotherapy, which are being used in combination with standard cancer
treatments. They are different from preventive or prophylactic vaccines, which
are used to prevent initial infection and disease. Researchers believe
therapeutic cancer vaccines may help inhibit the progression of existing
cancers, prevent recurrence of cancers, or destroy remaining cancer cells not
killed by prior treatments.
    

    For more information on this program visit www.cancervaccines.com.

    About sanofi-aventis
    
    Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives of
everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York
(NYSE:   SNY).
    Sanofi pasteur, the vaccines division of sanofi-aventis Group, provided
more than 1.6 billion doses of vaccine in 2007, making it possible to immunize
more than 500 million people across the globe. A world leader in the vaccine
industry, sanofi pasteur offers the broadest range of vaccines protecting
against 20 infectious diseases. The company's heritage, to create vaccines
that protect life, dates back more than a century. Sanofi pasteur is the
largest company entirely dedicated to vaccines. Every day, the company invests
more than EUR1 million in research and development. For more information,
please visit: www.sanofipasteur.com.
    

    Forward Looking Statements
    
    This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.  Forward-looking
statements are statements that are not historical facts.  These statements
include financial projections and estimates and their underlying assumptions,
statements regarding plans, objectives, intentions and expectations with
respect to future events, operations, products and services, and statements
regarding future performance.  Forward-looking statements are generally
identified by the words "expects," "anticipates," "believes," "intends,"
"estimates," "plans" and similar expressions.  Although sanofi-aventis'
management believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and uncertainties,
many of which are difficult to predict and generally beyond the control of
sanofi-aventis, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements.  These risks and uncertainties
include those discussed or identified in the public filings with the SEC and
the AMF made by sanofi-aventis, including those listed under "Risk Factors"
and "Cautionary Statement Regarding Forward-Looking Statements" in
sanofi-aventis' annual report on Form 20-F for the year ended December 31,
2007.  Other than as required by applicable law, sanofi-aventis does not
undertake any obligation to update or revise any forward-looking information
or statements.
    


    

    
    Global Media Relations                  U.S. Media Relations
    Pascal Barollier                        Len Lavenda
    T. +33-(0)4-37-37-50-38                 T. +1-570-839-4446
    Pascal.barollier@sanofipasteur.com      len.lavenda@sanofipasteur.com
    www.sanofipasteur.com                   www.sanofipasteur.us
    Canadian Media Relations
    Nancy Simpson
    T. +1-416-667-2955
    nancy.simpson@sanofipasteur.com
    www.sanofipasteur.ca



    




For further information:

For further information: Global Media Relations, Pascal Barollier,
+33-(0)4-37-37-50-38, Pascal.barollier@sanofipasteur.com, or U.S. Media
Relations, Len Lavenda, +1-570-839-4446, len.lavenda@sanofipasteur.com, or
Canadian Media Relations, Nancy Simpson, +1-416-667-2955,
nancy.simpson@sanofipasteur.com, all of sanofi pasteur Web Site:
http://www.cancervaccines.com                 http://www.sanofipasteur.ca   
             http://www.sanofipasteur.com

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