Full Press Release Details
SAN DIEGO , April 4, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO ) today announced that as a result of a recommendation received yesterday from an independent Data Monitoring Committee (DMC), it is temporarily halting patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer. The DMC is assessing clinical data that indicates a possible difference in the thromboembolic event rate between the group of patients treated with PEGPH20, nab-paclitaxel and gemcitabine versus the group of patients treated with nab-paclitaxel and gemcitabine without PEGPH20. The Company is halting enrollment and dosing of PEGPH20 as precautionary actions while the DMC's full evaluation of the data is ongoing.
"Patient safety is our first priority," stated Dr. Helen Torley , President and CEO. "We will be providing additional information to the DMC as quickly as possible so they can complete their assessment and we can determine next steps."
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) 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 unexpected expenditures and costs, unexpected results or delays in development and 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 the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2014 .
Investor Contact: Schond Greenway Halozyme Therapeutics 858-704-8352 [email protected]
Media Contact: Denise Powell 510-703-9491 [email protected]
SOURCE Halozyme Therapeutics, Inc.