drugset / Press release

Halozyme Announces Temporary Halt Of Phase 2 Trial Enrollment And Dosing For PEGPH20

2014-04-04 · Halozyme Therapeutics · original halozyme.com ↗

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." 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 and follow us on Twitter @HALOTherapeutic. 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] Logo - http://photos.prnewswire.com/prnh/20100302/LA63139LOGO SOURCE Halozyme Therapeutics, Inc. View All News Contact Us Tram Bui Vice President, Investor Relations & Corporate Communications 609-333-7668 [email protected] [email protected] [email protected] Quick Links SEC Filings Investor FAQs Resources Investor Email Alerts To opt-in for investor email alerts, please enter your email address in the field below and select at least one alert option. After submitting your request, you will receive an activation email to the requested email address. You must click the activation link in order to complete your subscription. You can sign up for additional alert options at any time. At Halozyme Therapeutics, we promise to treat your data with respect and will not share your information with any third party. You can unsubscribe to any of the investor alerts you are subscribed to by visiting the ‘unsubscribe’ section below. If you experience any issues with this process, please contact us for further assistance. By providing your email address below, you are providing consent to Halozyme Therapeutics to send you the requested Investor Email Alert updates. * Required Email Address * Investor Alert Options Investor Alert Options * News Events & Presentations Quarterly Reports Annual Reports SEC Filings End of Day Stock Quote Unsubscribe Email Alert Sign Up Confirmation Privacy Policy Cookies Policy © Q4 Inc. - All rights reserved Powered By Q4 Inc. 5.187.1.9 (opens in new window)

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