SAN DIEGO, April 26 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. , a biopharmaceutical company developing and commercializing recombinant human enzymes, today announced it has initiated patient enrollment and dosed the first patient in its Chemophase(R) Phase I/IIa clinical trial. Chemophase is a novel recombinant investigational therapeutic being developed to enhance the delivery of chemotherapy.
This second clinical protocol for Chemophase is designed to evaluate multiple intravesical (into the bladder) administrations of Chemophase along with the widely used anticancer drug mitomycin in patients with superficial bladder cancer, and follows the completion of the initial Phase I trial of single-administration Chemophase and mitomycin. This dose-finding Phase I/IIa study will enroll up to 36 evaluable patients with superficial bladder cancer. The objectives of the study include determining the maximum tolerated dose and dose-limiting toxicities, if any, of escalating doses of Chemophase in combination with mitomycin administered as weekly intravesical instillations for five weeks according to the usual standard of care; establishing the optimal dose of Chemophase with mitomycin to be recommended for future studies; and observing patients for any preliminary evidence of anti-tumor activity of this combination therapy. The study is being conducted at several study centers in the United States.
“I’m very pleased with the continued progress of our Chemophase development program, and having several renowned physician investigators in this field helping to conduct this study provides validation of the strong interest in this product candidate,” said Jonathan Lim, MD, Halozyme’s President and CEO. “By initiating Phase I/IIa enrollment and dosing, we are continuing to meet our previously announced clinical milestones right on schedule.”
Last month, Halozyme presented new preclinical data along with pharmacokinetic data from the Phase I clinical trial of Chemophase 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.
In the Phase I trial, pharmacokinetic data were obtained from the plasma of five bladder cancer patients dosed intravesically with 20,000 units of Chemophase along with 40 mg of mitomycin. The observed plasma levels of mitomycin 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.
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(R), the first and only recombinant human hyaluronidase for cumulus removal in the IVF process; and Hylenex, 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.
Web site: http://www.halozyme.com//
