Halozyme data support enzyme-chemotherapy combination in bladder cancer

By Elaine Rigoli

Tampa, Fla., April 4 - Halozyme Therapeutics, Inc. presented new preclinical data and pharmacokinetic data from a phase 1 clinical trial of Chemophase combined with chemotherapy at the annual meeting of the American Association for Cancer Research being held in Washington, D.C., this week.

The results support the safety profile for Chemophase, a high dose formulation of rHuPH20, a naturally occurring human enzyme, under investigation for its potential ability to increase the effectiveness of chemotherapy in the treatment of superficial bladder cancer.

Pharmacokinetic data were obtained from the plasma of five bladder cancer patients dosed intravesically with 20,000 units of rHuPH20 along with 40 mg of the commonly used chemotherapy agent mitomycin (MMC).

The observed plasma levels of MMC were less than 1/40th of the levels reported to be predictive of suppression of white blood cell production, according to a news release.

Preclinical pharmacology and toxicology studies tested the effects of rHuPH20 with MMC in animals bearing human tumors, as well as the effects of multiple exposures of increasing doses of the combined therapy in toxicology models.

Imaging studies in animals bearing two different human bladder cancer lines carrying a fluorescent protein tag showed no increase in metastasis with multiple injections of high doses of rHuPH20 alone or in combination with chemotherapy, the release said.

Further, studies demonstrated significant tumor suppression in animal models with the combination of rHuPH20 with MMC in larger tumors that were unresponsive to chemotherapy alone at the same dose.

Located in San Diego, Halozyme is a biopharmaceutical company developing and commercializing recombinant human enzymes for the drug delivery, palliative care, oncology and infertility markets.

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