SAN DIEGO, Sept. 18, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on patient enrollment and dosing of PEGPH20 in SWOG's ongoing Phase 1b/2 clinical trial (S1313). The trial is designed to evaluate Halozyme's investigational drug PEGPH20 (PEGylated Recombinant Human Hyaluronidase) in combination with modified FOLFIRINOX chemotherapy (mFOLFIRINOX) in patients with metastatic pancreatic adenocarcinoma. The study will resume under a revised protocol, and patient enrollment is anticipated to recommence upon review and approval of the amended protocol by the Independent Review Boards at the participating clinical trial sites.
The trial, which will enroll approximately 170 patients, is being sponsored by SWOG, a cancer research cooperative group of approximately 5,000 researchers in more than 650 institutions nationwide.
"Study S1313, along with our 202 Study, will provide important data for evaluating the potential role of PEGPH20 in patients with stage 4 metastatic pancreatic cancer," commented Dr. Helen Torley, President and CEO. "We are pleased that SWOG is able to continue enrolling patients in this clinical program as there remains a significant need for new treatment options for pancreatic cancer patients."
Additional Information On Study S1313
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 6 to 18 patients, to identify the optimal dose for PEGPH20 used in combination with mFOLFIRINOX in patients with newly diagnosed metastatic pancreatic adenocarcinoma in the Phase 2 portion of the study. The Phase 2 portion will be a randomized, multicenter, parallel arm study enrolling approximately 152 patients to yield 138 evaluable patients. The primary end point of the trial is overall survival (OS) and secondary endpoints include progression-free survival (PFS), overall response rate (ORR), and toxicity. In addition, 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 ORR. Additionally, low-molecular weight heparin and aspirin may be used to manage thromboembolic events. 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.
About PEGPH20
PEGPH20 is an investigational PEGylated form of Halozyme's proprietary recombinant human hyaluronidase under development for the systemic treatment of tumors that accumulate hyaluronan.
About SWOG
SWOG Cancer Research is a consortium 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 approximately 5,000 physician-researchers in the group's network practice at more than 650 institutions nationwide, including 28 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 part of the NCI's National Clinical Trials Network and is supported primarily through NCI research grant funding. The group is headquartered at the Knight Cancer Institute at Oregon Health & Science University in Portland, Oregon, (503494-5586), has an operations office in San Antonio, Texas, and has a statistical center in Seattle, Washington. Learn more at swog.org.
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 dispersion and absorption of biologics, drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including oncology, diabetes and dermatology that have significant unmet medical need today. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer and Baxter. 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 future actions relating to the development of PEGPH20 including anticipated patient enrollment numbers in the trial and the possibility that PEGPH20 may be used to address pancreatic cancer) 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 typically, 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 several factors, including delays in completion of clinical trials and other development activities, the possibility of safety events, unexpected expenditures and costs, unexpected results or delays in regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 11, 2014.
References
1. Pancreatic Cancer Treatment, National Cancer Institute, http://www.cancer.gov/cancertopics/pdq/treatment/pancreatic/HealthProfessional/page1/AllPages, Accessed September 16, 2014.
Investor Contact:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com
Media Contact:
Susan Neath Francis
212-301-7182
sfrancis@wcgworld.com
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SOURCE Halozyme Therapeutics, Inc.