SAN DIEGO, Oct. 27 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. , a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced it has initiated patient enrollment for its Chemophase(TM) Phase I clinical trial and has dosed two patients. Chemophase is a novel recombinant therapeutic being developed to enhance the delivery of chemotherapy.
The initial clinical protocol for Chemophase is designed to evaluate a single intravesical (into the bladder) administration of Chemophase along with the widely used anticancer drug mitomycin in patients with superficial bladder cancer. The Phase I study will enroll at least five evaluable patients with superficial bladder cancer. The objectives of the study are to determine the safety, tolerability and pharmacokinetics of Chemophase administered intravesically with mitomycin. The study is being conducted at BCG Oncology in Phoenix, Arizona under the supervision of Donald L. Lamm, MD, the principal investigator.
"I'm very pleased with the progress of our Chemophase development program, and in having Dr. Lamm, a renowned physician investigator in his field, conducting this study," said Jonathan Lim, MD, Halozyme's Chairman and CEO. "By initiating Phase I enrollment and dosing, we are hitting previously announced milestones right on schedule."
Dr. Lamm has authored more than 270 peer-reviewed medical and scientific articles, and has developed new approaches to the treatment of bladder, renal and prostate cancer. His primary interest is Bacillus Calmette Guerin (BCG) therapy of bladder cancer. During his urology residency, he developed an animal model for bladder cancer and found that BCG inhibited tumor growth.
"While BCG has improved the treatment of bladder cancer, more than half of the patients will not respond or will become resistant to BCG treatment. Chemophase potentially could provide the improved treatment required by these patients," stated Dr. Lamm.
Dr. Lamm began his academic career as Assistant Professor of Surgery at the University of Texas Health Sciences Center. During his nine years in Texas, he rose to Professor and Acting Chairman of the Division of Urology. His VA and NIH research resulted in clinical studies that led to the FDA approval of BCG for bladder cancer.
Subsequent work by Dr. Lamm, then Chairman of the Department of Urology at West Virginia University, demonstrated that BCG immunotherapy is superior to adriamycin and mitomycin chemotherapy for superficial bladder cancer, significantly reducing the risk of bladder cancer progression to muscle invasion and metastasis. Dr. Lamm's work is in part responsible for bladder cancer being one of only five cancers in the United States that has seen reduced mortality despite increased incidence. This reduction in mortality coincides with a reduction in the number of patients who lose their bladder as a result of radical cystoprostatectomy for muscle-invasive or aggressive superficial disease.
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 dedicated to developing and commercializing recombinant human enzymes for the infertility, ophthalmology, and oncology communities. The company's portfolio of products under development 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 enzymes that carry potential risks of animal pathogen transmission and immunogenicity. The versatility of the first enzyme, rHuPH20, enables Halozyme to develop the product as a medical device, drug enhancement agent, and therapeutic biologic.
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Halozyme Contact Investor Relations Contacts David A. Ramsay Zachary Bryant / Bruce Voss Chief Financial Officer Lippert/Heilshorn & Associates (858) 794-8889 (310) 691-7100 dramsay@halozyme.combvoss@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, or Bruce Voss, bvoss@lhai.com, both ofLippert/Heilshorn & Associates, +1-310-691-7100, for Halozyme Therapeutics,Inc.; or Media, Kathy Sweeney, ext. 230, kwitz@mentus.com, or JoleenSchultz, ext. 215, jschultz@mentus.com, both of Mentus, +1-858-455-5500,all for Halozyme Therapeutics, Inc.
Web site: http://www.halozyme.com/
