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Halozyme Therapeutics Announces Positive Findings With Pegylated Enzyme in Prostate Cancer Models
Date:7/22/2008

ack tumor interstitial fluid pressure and combined with chemotherapy, reduce tumor burden for a significant number of patients."

Halozyme is continuing its pharmacology, manufacturing and toxicology studies as part of its PEGPH20 development program in oncology. The company is making preparations for a pre-IND meeting with the FDA later this year to seek advice with regard to the design of its first-in-human clinical trial and plans to initiate studies in cancer patients with PEGPH20 during the first half of 2009.

Study Details and Background

This study utilized three widely accepted animal cancer models: xenograft PC3, xenograft Du145luc, and PC3-M-luc bone metastases. For the HA-producing xenograft PC3 model, animals received an intramuscular inoculation with PC3 prostate carcinoma cells in the hind leg in order to generate tumors with high IFP. When tumor volume reached 400-500 mm(3), a high tumor burden, animals were randomized to receive one of four possible treatments: PEGPH20 alone, chemotherapy alone, chemotherapy plus PEGPH20, or placebo. Two chemotherapeutic agents, docetaxel and liposomal doxorubicin, were tested in this model. The non-HA-producing xenograft Du145luc model was utilized in a similar manner with docetaxel. Finally, an HA-producing PC3-M-luc disseminated bone metastasis model was used to test PEGPH20 alone and in combination with docetaxel.

Xenograft PC3 results

-- Tumor volume growth suppressed significantly. Tumor volume growth over time was significantly lower in the PEGPH20 plus docetaxel (p<0.01) and PEGPH20 plus liposomal doxorubicin (p<0.05) groups compared to chemotherapy alone. These results clearly indicate a synergistic effect with the addition of PEGPH20 to the docetaxel regimen. Furthermore, a significant reduction in tumor volume was observed following administration of PEGPH20 alone.

-- Survival for combination treatment was significantly increased. Docetaxel plus PEGPH20 increased lif
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SOURCE Halozyme Therapeutics, Inc.
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