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PHARMA - BLADDER CANCER THERAPY |
Halozyme gets FDA nod for bladder cancer therapy
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BY OUR PHARMA CORRESPONDENT
13th August,2005:Halozyme Therapeutics,
Inc. has received clearance from the U.S. Food and
Drug Administration (FDA) for its Chemophase
Investigational New Drug (IND) application.
The initial clinical protocol under this IND is a
phase I study designed to evaluate a single
intravesical administration of Chemophase along
with mitomycin in patients with superficial
bladder cancer, the company announced.
This novel therapeutic biologic is being developed
to enhance the delivery of chemotherapy. Based on
the promising pre-clinical data gathered to date,
and the previous clinical work done with bovine
hyaluronidase in bladder cancer, co-delivery of
Chemophase may increase the penetration of
mitomycin throughout the tumour and reach residual
tumor cells that otherwise might develop into
recurrent tumors. Halozyme expects to bring this
therapeutic into the clinic in the fourth quarter,
a company release said.
According to data from the American Cancer
Society, National Cancer Institute, American
Urological Association, and Southwest Oncology
Group Study, over 180,000 patients present with
new or recurrent cases of superficial bladder
cancer in the US every year, all of whom would be
potential candidates for Chemophase in the event
it is approved as first line treatment with
mitomycin. The clinical protocol has received
Institutional Review Board approval, and the Phase
1 study will enroll up to ten patients to obtain
five evaluable patients with superficial bladder
cancer. The objectives of the Chemophase clinical
trial are to determine the safety, tolerability
and pharmacokinetics of Chemophase administered
intravesically with mitomycin.
Halozyme is a biopharmaceutical company engaged in
developing and commercializing recombinant human
enzymes for the infertility, ophthalmology, and
oncology communities. The company's portfolio of
products under development is based on
intellectual property covering the family of human
enzymes known as hyaluronidases. Halozyme's
recombinant human enzymes may replace current
animal slaughterhouse-derived enzymes that carry
potential risks of animal pathogen transmission
and immunogenicity.
BY OUR PHARMA CORRESPONDENT |
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