Halozyme Initiates Randomized Phase 2 Trial of PEGPH20 in Pancreatic Cancer Randomized trial to test PEGPH20 in conjunction with most advanced chemotherapy backbone
SAN DIEGO, April 23, 2013 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced the initiation of a Phase 2 multicenter, randomized clinical trial evaluating PEGPH20, a proprietary, investigational drug, 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. The primary outcome will be to measure progression-free survival between patients administered PEGPH20 to those who are not.
"Pancreatic cancer is an extremely difficult disease to treat, in part because of a hyaluronan-rich matrix which shields these tumors against chemotherapy," said Daniel D. Von Hoff, M.D., F.A.C.P., lead principal investigator of the study and Chief Scientific Officer for Scottsdale Healthcare's Virginia G. Piper Cancer Center Clinical Trials and Physician-In-Chief for the Translational Genomics Research Institute (TGen). "Ongoing translational studies indicate that PEGPH20 may deplete this matrix component from pancreatic tumors and alter the tumor environment in a way that renders these cancers more vulnerable to therapy."
In most patients presenting 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. Its tendency to spread prior to diagnosis makes it the fourth deadliest cancer with a less than 6% five-year relative survival rate, with more than 38,000 people succumbing to the disease each year.1-2
"We are hopeful that these studies with PEGPH20 will improve patient outcomes for this insidious disease while advancing our general understanding of the unique tumor environment," said Gregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme.
Halozyme recently completed enrollment of a single-arm Phase 1B trial in a similar patient population treated with PEGPH20 and gemcitabine. Two abstracts have been submitted and a discussion session from this study has been selected for the 2013 American Society of Clinical Oncology (ASCO) annual meeting May 31–June 4 in Chicago.
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. 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2013. Halozyme does not undertake to update these forward-looking statements.
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
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SOURCE Halozyme Therapeutics, Inc.