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Published on 10/27/2005 in the Prospect News Biotech Daily.

Halozyme enrolling bladder cancer patients in phase I trial for Chemophase

By E. Janene Geiss

Halozyme Therapeutics, Inc. announced Thursday that it has begun patient enrollment for its Chemophase phase I clinical trial and has dosed two patients.

The initial clinical protocol for Chemophase, a novel recombinant therapeutic being developed to enhance the delivery of chemotherapy, is designed to evaluate a single intravesical (into the bladder) administration of Chemophase along with the widely used anticancer drug mitomycin in patients with superficial bladder cancer, according to a company news release.

The phase I study will enroll at least five patients with superficial bladder cancer. The objectives of the study are to determine the safety, tolerability and pharmacokinetics of Chemophase administered intravesically with mitomycin, officials said.

The study is being conducted at BCG Oncology in Phoenix under the supervision of Donald L. Lamm, the principal investigator, officials said.

"By initiating Phase I enrollment and dosing, we are hitting previously announced milestones right on schedule," Jonathan Lim, Halozyme's chairman and chief executive officer, said in the release.

According to data from the American Cancer Society, National Cancer Institute, American Urological Association, and Southwest Oncology Group Study, more than 100,000 patients have new or recurrent superficial bladder cancer in the United States every year. All of these patients may be potential candidates for Chemophase in the event it is approved as first-line treatment.

Halozyme Therapeutics is San Diego-based biopharmaceutical company.


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