SAN DIEGO, March 28 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. , a biopharmaceutical company developing and commercializing recombinant human enzymes, today announced that it will present new findings from animal studies and its recently completed Phase I Chemophase(R) clinical trial in bladder cancer patients on April 4th at the AACR Annual Meeting in Washington, D.C.
Pre-clinical data on the pharmacology and toxicology of rHuPH20, a recombinant human hyaluronidase, with mitomycin will be presented along with clinical data from the recently completed Chemophase Phase I clinical trial. The initial clinical protocol for Chemophase was 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 objectives of the study were to determine the safety, tolerability and pharmacokinetics of Chemophase administered intravesically with mitomycin. The Phase I study completed its target enrollment of five patients with superficial bladder cancer. 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 infertility, palliative care, and oncology 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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In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning pre-clinical data, the potential effectiveness of products under development, the timing and nature of clinical trials for products under development, and the demand and potential market for these products, if approved by the FDA) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-KSB, 10-QSB and other filings with the Securities and Exchange Commission.
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; or Media, Kathy Sweeney,+1-858-455-5500, ext. 230, kwitz@mentus.com, or Joleen Schultz,+1-858-455-5500, ext. 215, jschultz@mentus.com, both of Mentus, forHalozyme
Web site: http://www.halozyme.com//
