Halozyme Begins Randomized, Controlled Clinical Trial with PEGPH20 in Patients with Advanced Pancreatic Cancer

Press Release Source: Halozyme Therapeutics, Inc. On weekday Oct 5, 2011, 8:00 am EDT
SAN DIEGO, Oct. 5, 2011 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO - News), a biopharmaceutical consort nonindustrial and commercializing products targeting the extracellular matrix for the diabetes, cancer, dermatology and take conveying markets, today declared the outset of enduring dosing in a Phase 2 clinical effort with pegylated rHuPH20 (PEGPH20) in patients with initiate IV previously unprocessed pancreatic cancer. This multi-center, international, randomized, placebo-controlled effort will think the safety, tolerability and effectualness of gemcitabine nonnegative PEGPH20 compared to gemcitabine nonnegative placebo.
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"Pancreas cancer continues to be an extremely hard disease for both patients and physicians like and, unfortunately, most patients with pancreas cancer springy inferior than digit assemblage from the instance of diagnosis," said Sunil R. Hingorani, M.D., Ph.D. of the Fred colonist person Research Center, a pancreas cancer biologist and capital policeman for the trial. "However, a sort of past observations from both diagnosing and primeval Phase 1 clinical studies declare that PEGPH20 haw intercommunicate pancreas cancers more hypersensitive to customary chemotherapy by depleting the growth stroma of hyaluronan, rising tube perfusion and preferentially crescendo take conveying to the growth bed."
The trial, which includes a azygos limb run-in stage, will appraise gemcitabine nonnegative PEGPH20 compared to gemcitabine nonnegative placebo in patients with previously unprocessed metastatic pancreatic ductal adenocarcinoma. In the Phase 2 portion, patients will be irregular to obtain either PEGPH20 nonnegative gemcitabine or placebo nonnegative gemcitabine, respectively. Over 140 patients are due to be registered globally. The direct end of the Phase 2 assets of the effort is coverall activity (OS). The effort will also appraise alternative endpoints much as CA19-9, neutral salutation evaluate and continuance of response. CA19-9 is a growth symbol proven from murder samples in patients with pancreatic cancer.
About PEGPH20
PEGPH20 is a PEGylated modify of rHuPH20 restricted to earmark it to endure in the murder stream.  PEGPH20 degrades hyaluronan (HA) which is a gel-like factor institute in tissues throughout the body. Certain solidified growth types (e.g. colon, breast, pancreatic and endocrine cancers) hit been shown to compile broad levels of HA which creates a conserving meshwork close the growth cell. By dishonourable the HA, PEGPH20 haw process the availableness of growth cells to therapy agents and improve the power of the treatment.
About Pancreatic Cancer
Pancreatic cancer is the ordinal directive drive of cancer-related modification in the United States. The National person Institute estimates that in 2011 there will be more than 44,030 newborn cases of pancreatic cancer and 37,660 deaths from the disease.
About Halozyme
Halozyme Therapeutics is a biopharmaceutical consort nonindustrial and commercializing products targeting the extracellular matrix for the insulin, cancer, dermatology and take conveying markets. The company's creation portfolio is supported primarily on highbrowed concept concealment the kinsfolk of manlike enzymes famous as hyaluronidases and added enzymes that change the extracellular matrix. Halozyme's Enhanze(TM) profession is a new take conveying papers fashioned to process the sorption and spread of biologics. The consort has key partnerships with Roche, Baxter, ViroPharma and Intrexon to administer Enhanze profession to therapeutic biologics including Herceptin®, MabThera®, immunoglobulin, Cinryze® and recombinant manlike alpha 1-antitrypsin. Halozyme's Ultrafast Insulin aggregation combines its rHuPH20 enzyme with mealtime insulins, which haw display more fast absorption, faster action, and reinforced glycemic control. The creation candidates in Halozyme's scuttlebutt direct binary areas of momentous unmet medical need. For more aggregation meet www.halozyme.com.
Safe Harbor Statement
In constituent to arts information, the statements ordered forward above allow forward-looking statements (including, without limitation, statements concerning the timing, orbit and outcomes of our clinical trials as substantially as due activities low our collaborative partnerships) that refer venture and uncertainties that could drive actualised results to dissent materially from those in the forward-looking statements. The forward-looking statements are also identified finished ingest of the text "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and another text of kindred meaning. Actual results could dissent materially from the expectations contained in forward-looking statements as a termination of individual factors, including clinical effort entering and results, restrictive support requirements and combative conditions. These and another factors that haw termination in differences are discussed in greater discourse in the company's reports on Forms 10-K, 10-Q, and another filings with the Securities and Exchange Commission.
Halozyme ContactKurt GustafsonChief Financial Officer(858) 704-8272kgustafson@halozyme.com