SAN DIEGO, May 15, 2013 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that clinical data from a Phase 1b trial of PEGPH20 (PEGylated Recombinant Human Hyaluronidase), an investigational new biologic, in combination with gemcitabine for treatment of patients with stage IV metastatic pancreatic cancer will be presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting.
In this Phase 1b study, 28 stage IV pancreatic ductal adenocarcinoma patients were treated with PEGPH20 in combination with gemcitabine. The overall response rate (CR+PR) was 42 percent* (n=24) as assessed by independent review at therapeutic dose levels of PEGPH20 (1.6 and 3.0 µg/kg). Treatment was generally well tolerated and the adverse event profile was consistent with those seen in previous studies of PEGPH20 as a single agent and as previously reported for gemcitabine alone. There was no evidence of new observed toxicity. Detailed clinical data, including CA 19-9 and pharmacodynamic results will be presented at the meeting.
Emerging data show that most pancreatic cancers surround themselves with a protective hyaluronan-rich matrix, which makes the disease difficult to treat and is itself an indicator of poor prognosis. PEGPH20 depletes this matrix component from the tumor and rapidly changes the tumor microenvironment and metabolism, which may render it more vulnerable to therapy as well as inhibit tumor growth.
"Data from this single arm Phase 1b study clearly reinforce the hypothesis of treating pancreatic cancer with PEGPH20 in conjunction with chemotherapeutic agents," said Joy Zhu, M.D., Ph.D., Vice President, Oncology Clinical Development, Halozyme. "We look forward to the study investigators presenting the updated study results at the poster session and ensuing discussion."
Based on the magnitude of response and safety observed in the Phase 1b study, Halozyme announced in April the initiation of a Phase 2 multicenter, randomized clinical trial evaluating PEGPH20 as a first-line therapy for patients with stage IV metastatic pancreatic cancer. Approximately 124 patients will participate in the study and receive gemcitabine and nab-paclitaxel either with or without PEGPH20. Secondary endpoints of the trial include clinical evaluation of patient response in both treatment arms by tumor biopsy hyaluronan (HA) status.
Halozyme is also developing a HA diagnostic tool that will help evaluate potential treatment benefit based on HA levels for use in the randomized Phase 2 trial. Clinically validating this HA-diagnostic approach in the pancreatic cancer trial may also provide proof-of-concept for use of PEGPH20 in other HA-rich tumor types.
Halozyme Abstracts at ASCO:
- Poster Presentation/Discussion: (E Hall D1): "A Phase 1b Study of Gemcitabine Plus PEGPH20 (PEGylated Recombinant Human Hyaluronidase) in Patients with Stage IV Previously Untreated Pancreatic Cancer" will be presented by Sunil R. Hingorani M.D., Ph.D., Fred Hutchinson Cancer Research Center on Monday, June 3 at 1:15PM-5:15PM CDT; discussion from 4:45 PM-5:45PM CDT. (Abstract #4010)
- Educational Book Abstract: "Pharmacokinetic (PK)/Pharmacodynamic (PD) Results From a Phase 1b Study of PEGylated Hyaluronidase PH20 (PEGPH20) in Combination with Gemcitabine (Gem) in Patients with Pancreatic Cancer" (Abstract # e15005)
*33 percent response rate reported in the ASCO abstract based on partial data available at the time of abstract submission.
About Pancreatic Cancer In most patients diagnosed with metastatic pancreatic adenocarcinoma, survival rates are the lowest of any cancer. In 2013, it is estimated that almost 45,000 new cases of pancreatic cancer will be diagnosed. About one-in-78 people in the U.S. will develop the disease, affecting equal numbers of men and women, almost always after the age of 45. Its tendency to spread prior to diagnosis makes it the fourth deadliest cancer with a less than six percent five-year relative survival rate, with more than 38,000 people succumbing to the disease each year.1-2
About Halozyme Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company's research focuses primarily on a family of human enzymes, known as hyaluronidases, which increase the absorption and dispersion of biologics, drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer, Baxter, ViroPharma and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com.
Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible benefits and attributes of PEGPH20, the anticipated enrollment of patients and possible outcomes for the referenced Phase 2 clinical trial, the possible method of action of PEGPH20 and the anticipated presentation of data from Halozyme's Phase 1b trial and the development of the HA diagnostic tool and the potential uses of such tool. The forward-looking statements are usually (but not always) 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 risks and uncertainties including clinical trial enrollment and results, regulatory approval requirements, unexpected expenditures and costs, unexpected results or delays in development and regulatory review, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 8, 2013. Halozyme does not undertake to update these forward-looking statements.
References 1. American Cancer Society, Cancer Facts & Figures 2013. Atlanta: American Cancer Society; 2013 2. Pancreatic Cancer, American Cancer Society, http://www.cancer.org/cancer/pancreaticcancer/detailedguide/pancreatic-cancer-key-statistics Accessed April 18, 2013
Investor Contact: Kurt Gustafson Halozyme Therapeutics 858-704-8272 email@example.com
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SOURCE Halozyme Therapeutics, Inc.