WASHINGTON, April 4 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. , a biopharmaceutical company developing and commercializing recombinant human enzymes, presented new preclinical data and pharmacokinetic data from a Phase I clinical trial of Chemophase(R) combined with chemotherapy at the American Association For Cancer Research Annual Meeting in Washington, D.C. The results support the safety profile for Chemophase, a high dose formulation of the recombinant human hyaluronidase enzyme, rHuPH20, 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. The study was conducted at BCG Oncology in Phoenix, Arizona under the supervision of Donald L. Lamm, MD, the principal investigator.
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. Furthermore, 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.
"We are very encouraged to see this safety profile in both toxicology models and by pharmacokinetic analysis of patient sera," said Gregory Frost, PhD, Halozyme's Vice President and Chief Scientific Officer. "Achieving effective penetration into residual tumor without elevating systemic mitomycin levels could potentially enhance efficacy without increasing risk in this population of patients in need of more effective therapies."
Halozyme's rHuPH20 is a highly purified, recombinant form of the naturally occurring human enzyme and is being investigated for its ability to break down hyaluronic acid (HA), the space-filling "gel"-like substance that is a major component of tissues throughout the body. Hyaluronidase instilled into the bladder through intravesical administration may temporarily digest the HA gel found around bladder tumor cells to potentially enhance the penetration and diffusion of other administered drugs, such as chemotherapy.
According to data from the American Cancer Society, National Cancer Institute, American Urological Association, and Southwest Oncology Group Study, more than 100,000 patients have new or recurrent superficial bladder cancer in the U.S. every year. All of these patients may be potential candidates for Chemophase in the event it is approved as first-line treatment with mitomycin.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing recombinant human enzymes for the drug delivery, palliative care, oncology, and infertility markets. The company's portfolio of products is based on intellectual property covering the family of human enzymes known as hyaluronidases. Halozyme's recombinant human enzymes may replace current animal slaughterhouse-derived extracts that carry potential risks of animal pathogen transmission and immunogenicity. The company has received FDA approval for two products: Cumulase(TM), the first and only recombinant human hyaluronidase for cumulus removal in the IVF process; and Hylenex(TM), for use as an adjuvant to increase the absorption and dispersion of other injected drugs. The versatility of the first enzyme, rHuPH20, enables Halozyme to develop the product as a medical device, drug enhancement agent, and therapeutic drug.
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Halozyme Contact Investor Relations Contacts David A. Ramsay Zachary Bryant Chief Financial Officer Lippert/Heilshorn & Associates (858) 794-8889 (310) 691-7100 dramsay@halozyme.comzbryant@lhai.com Media Contacts Kathy Sweeney / Joleen Schultz Mentus 858-455-5500, x230/x215 kwitz@mentus.comjschultz@mentus.com
Halozyme Therapeutics, Inc.CONTACT: David A. Ramsay, Chief Financial Officer of HalozymeTherapeutics, Inc., +1-858-794-8889, dramsay@halozyme.com; or InvestorRelations, Zachary Bryant of Lippert/Heilshorn & Associates,+1-310-691-7100, zbryant@lhai.com, for Halozyme Therapeutics, Inc.; orMedia, Kathy Sweeney, ext. 230, kwitz@mentus.com, or Joleen Schultz, ext.215, jschultz@mentus.com, both of Mentus, +1-858-455-5500 for HalozymeTherapeutics, Inc.
