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Halozyme Therapeutics Announces That Chemophase Meets Primary Endpoint in Phase I/IIa Clinical Trial
Date:6/30/2008

irst year. The clear need for more effective treatment creates an opportunity for a therapeutic approach that improves disease-free survival for these patients.

Although this Phase I/IIa study was designed primarily to assess safety and optimal dosing of Chemophase, each patient is to be followed on study until the time of tumor recurrence. The clinical course and risk of recurrence and progression for this cancer are highly variable and tumor recurrence data are collected in the study for descriptive-only purposes. As of this time, each of the 27 patients has been on study for at least 10 months (or had recurrence prior to 10 months). As of the 10-month follow-up, tumor recurrence in all 5 cohorts has been reported for 8 of the 27 patients (30%).

The single-arm, non-comparative design of this trial does not facilitate drawing conclusions on the secondary study objective of anti-tumor activity based on tumor recurrence rates. Non-muscle-invasive bladder cancer is markedly heterogeneous due to variability in tumor and histological grading, risk factors such as tumor size and multiplicity, number of prior recurrences, and the significant variety of different post-resection therapeutic regimens employed, which makes comparison of tumor recurrence data across different clinical trials difficult. Without proper controls and an adequate balance of risk factors, reliable conclusions may not be drawn from these descriptive- only data.

About Bladder Cancer

The American Cancer Society has estimated that 67,000 new cases of bladder cancer would be diagnosed in the U.S. in 2007. Globocan Data estimated that 147,000 new patients would be diagnosed with bladder cancer in Europe in 2007. According to these sources, there are 500,000 bladder cancer patients in the U.S. and more than 900,000 in Europe. Published research by Botteman et al. (PharmacoEconomics 2003) indicates that bladder cancer is the fifth most expensive cancer to treat. The initial treat
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SOURCE Halozyme Therapeutics, Inc.
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