Bladder
FDA Clearance to Initiate Chemophase Clinical Trial for Superficial Bladder Cancer
By Halozyme Therapeutics, Inc.
Aug 11, 2005 - 11:28:00 PM

Halozyme Therapeutics, Inc.(Amex: HTI), a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for its Chemophase(TM) 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.

"We are thrilled to be able to begin our Chemophase study," said Jonathan Lim, MD, Halozyme's Chairman and CEO. "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 tumor and reach residual tumor cells that otherwise might develop into recurrent tumors. We are excited about potentially bringing this therapeutic into the clinic in the fourth quarter, which will represent another important milestone for Halozyme."

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.

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