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Halozyme Therapeutics Completes Enrollment in Chemophase Phase I/IIa Clinical Trial for Superficial Bladder Cancer
Date:9/25/2007

e of anti-tumor activity of this combination therapy. The trial is ongoing, as the most recently enrolled patients complete their initial six weekly treatments, all patients are monitored according to standard of care for tumor recurrence, and the patients enrolled at the MTD cohort continue maintenance dosing until the end of Year 2 of the study.

"We are pleased to have reached another important milestone in the development of Chemophase, which is proceeding along our expected timeline. We hope to announce interim data from this ongoing trial during the first half of next year," said Jonathan Lim, MD, Halozyme's President and CEO.

In the Chemophase Phase I trial, pharmacokinetic data were obtained from the plasma of five bladder cancer patients dosed intravesically with 20,000 units of Chemophase along with 40 mg of mitomycin. The observed plasma levels of mitomycin were less than 1/40th of the levels reported to be predictive of suppression of white blood cell production. The study was conducted at BCG Oncology in Phoenix, Arizona under the supervision of Donald L. Lamm, MD, the principal investigator.

The American Cancer Society estimates that there are approximately 67,000 new cases of bladder cancer diagnosed in the United States annually. At any given time, it is estimated that there are more than 500,000 bladder cancer patients in the U.S. According to Botteman et al., (PharmacoEconomics 2003), bladder cancer is the fifth most expensive cancer to treat. The initial treatment of this cancer is surgical removal of the tumor. Because of the high frequency of early recurrences of the tumor, patients are usually prescribed additional therapy to prevent or delay such recurrences. This additional therapy generally consists of immunotherapy or chemotherapy drugs instilled directly into the bladder.

About Halozyme Therapeutics, Inc.

Halozyme is a biopharmaceutical company developing and commercializing products based on the extracellular
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SOURCE Halozyme Therapeutics, Inc.
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