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

- Product appears safe with no dose-limiting toxicities -

- Chemophase dose for pivotal trials successfully determined - - Halozyme to seek input from regulatory authorities in order to advance

into pivotal clinical program in 2009 -

SAN DIEGO, June 30 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced a status update for its continuing Phase I/IIa Chemophase(R) clinical trial in the treatment of superficial bladder cancer. Based on the results, the Chemophase combination treatment of mitomycin plus the recombinant human hyaluronidase (rHuPH20) enzyme was well tolerated and appears safe. The study reported no dose-limiting toxicities and no observed side effects attributable to the enzyme, and established the dose for subsequent clinical trials, therefore achieving the pre-defined primary objective of the study. In addition, there were no neutralizing antibodies to rHuPH20 detected and the plasma concentration of mitomycin was either non-measureable or negligible and well below the threshold that may be predictive for myelosuppression (a decrease in bone marrow activity, resulting in fewer red blood cells, white blood cells, and platelets).

The study also provided support for future pivotal trial development that will incorporate the highest combination dose studied in the current trial, mitomycin plus 800,000 Units of rHuPH20. Commenting on the results, Richard C. Yocum, M.D., Vice President of Clinical Development and Medical Affairs at Halozyme stated, "We are pleased the study demonstrated that Chemophase was well-tolerated and produced no dose-limi
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SOURCE Halozyme Therapeutics, Inc.
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