SAN DIEGO, Oct. 22, 2013 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced the initiation of a Phase 1b/2 randomized clinical trial (S1313) of Halozyme's investigational drug PEGPH20 (PEGylated Recombinant Human Hyaluronidase) in combination with modified FOLFIRINOX chemotherapy (mFOLFIRINOX) compared to mFOLFIRINOX treatment alone in patients with metastatic pancreatic adenocarcinoma. The trial, which will enroll approximately 144 patients, is being sponsored by SWOG, a cancer research cooperative group of more than 4,000 researchers in over 500 institutions around the world.
"Existing PEGPH20 data are intriguing, and warrant further investigation and comparison to the current standards of care to better understand its safety and efficacy profile," said trial investigator Philip A. Philip, M.D., Ph.D., Clinical Professor of Oncology at the Barbara Ann Karmanos Cancer Institute.
The initial Phase 1b run-in arm of the trial is designed to confirm the optimal dose of PEGPH20 for the Phase 2 portion of the trial. The primary endpoint from Phase 2 is overall survival (OS) of patients receiving mFOLFIRINOX in combination with PEGPH20 compared to those receiving mFOLFIRINOX alone. Secondary endpoints include progression free survival (PFS), objective tumor response as well as the frequency, severity and tolerability of adverse events. Additional evaluations include expression of tumor target hyaluronan (HA) in patient biopsies.
"Despite recent advancements, pancreatic cancer still has one of the lowest survival rates of any malignancy. The S1313 trial, coupled with our internally sponsored Phase 2 trial of PEGPH20 in combination with nab-paclitaxel and gemcitabine, will provide important safety and efficacy data on the potential of PEGPH20 in combination with the most advanced chemotherapeutic regimens available to patients with pancreatic cancer today," said Gregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme Therapeutics.
Additional Study Details
The Phase 1b run in portion of the S1313 study will be a limited dose de-escalation clinical trial examining the dose-limiting toxicities (DLT) in six evaluable patients to identify the optimal dose for PEGPH20 in the Phase 2 study. The Phase 2 portion will be a randomized, multicenter, parallel arm study enrolling approximately 138 evaluable patients. In addition to the endpoints of the study described above, the study will also explore the treatment impact on carbohydrate antigen 19-9 (CA 19-9), a biomarker often associated with tumor cell burden1, as well as the correlation of plasma hyaluronan (HA) and tumor HA with OS, PFS and overall response rate (ORR). The mFOLFIRINOX treatment regimen consists of oxaliplatin, leucovorin, irinotecan and 5-fluorouracil. Additional study details can be found at http://www.clinicaltrials.gov using the study identifier NCT01959139.
In April 2013, Halozyme initiated a Phase 2 multicenter, randomized clinical trial of nab-paclitaxel and gemcitabine with and without PEGPH20 to assess the combination treatment effect as measured by ORR, PFS and OS. The study is expected to enroll approximately 124 patients with stage IV pancreatic ductal adenocarcinoma. Halozyme is also developing an HA diagnostic tool to evaluate the potential treatment benefit based on tumor HA levels at baseline. This diagnostic approach may enable additional PEGPH20 combination clinical studies in other HA-rich tumor types. Additional information about this trial can be found at http://www.clinicaltrials.gov using the study identifier NCT01839487.
PEGPH20 is an investigational PEGylated form of Halozyme's proprietary recombinant human hyaluronidase under development for the systemic treatment of tumors that accumulate hyaluronan (HA). Emerging data show that most pancreatic cancers surround themselves with a protective hyaluronan-rich matrix, which makes the disease difficult to treat and is an indicator of poor prognosis. PEGPH20 has been shown to deplete this matrix component from the tumor that rapidly changes the tumor microenvironment and metabolism, which may render the tumor more vulnerable to therapy as well as inhibit tumor growth.
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 6 percent five-year relative survival rate, leading to more than 38,000 deaths from the disease each year.2-3
SWOG is a cancer research cooperative group that designs and conducts multidisciplinary clinical trials to improve the practice of medicine in preventing, detecting, and treating cancer, and to enhance the quality of life for cancer survivors. The more than 4,000 researchers in the group's network practice at more than 500 institutions nationwide, including 24 of the National Cancer
Institute (NCI)-designated cancer centers, as well as cancer centers in almost a dozen other countries. Formerly the Southwest Oncology Group, SWOG is supported primarily through NCI research grant funding. Learn more at swog.org.
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, 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 and follow us on www.twitter.com/HALOTherapeutic.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of PEGPH20, the possible method of action of PEGPH20 and its application in a new potential paradigm for treatment of pancreatic cancer, potential results and data from this clinical trial and future clinical trials for PEGPH20, the development of the HA diagnostic tool and its potential uses, and the possible utility of PEGPH20 in pancreatic cancer and other tumors. 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 August 7, 2013. Halozyme does not undertake to update these forward-looking statements.
1. Pancreatic Cancer Treatment, National Cancer Institute, http://www.cancer.gov/cancertopics/pdq/treatment/pancreatic/HealthProfessional/page1/AllPages, Accessed May 21, 2013. 2. American Cancer Society, Cancer Facts & Figures 2013. Atlanta: American Cancer Society; 2013. 3. Pancreatic Cancer, American Cancer Society, http://www.cancer.org/cancer/pancreaticcancer/detailedguide/pancreatic- cancer-key-statistics, Accessed April 18, 2013.
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