Navigation Links
Halozyme Resumes Patient Enrollment And Dosing In PEGPH20 Clinical Program In Pancreatic Cancer

SAN DIEGO, July 22, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that it has resumed enrollment and dosing of patients in its ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer under the revised clinical protocol agreed to with the FDA in June. PEGPH20 is an investigational PEGylated form of Halozyme's proprietary recombinant human hyaluronidase under development for the systemic treatment of tumors that accumulate hyaluronan.

"Our diligent effort to rapidly re-initiate patient enrollment and dosing of both previously enrolled and new patients in this trial underscores our commitment to evaluating the potential role of PEGPH20 in patients with stage 4 metastatic pancreatic cancer. Approximately 50% of the anticipated clinical sites have received IRB approvals, and we anticipate continued IRB approvals in the coming weeks," commented Dr. Helen Torley, President and Chief Executive Officer.

Study 202 Trial Design
Study 202 (Halo 109-202) is a Phase 2 multicenter, randomized clinical trial evaluating PEGPH20 as a first-line therapy for treatment of patients with stage 4 metastatic pancreatic cancer. The primary outcome of the trial is to measure improvement in progression-free survival in patients receiving PEGPH20 in combination with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel alone. A second primary endpoint will assess the thromboembolic event rate in the PEGPH20 treatment arm. Secondary endpoints also include objective response rate and overall survival.

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

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 such as additional approvals of clinical sites by IRBs 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 the approval of clinical sites by IRBs, the possibility that the revised protocol may not address the apparent increased rate of thromboembolic events observed with the use of PEGPH20 in the trial or satisfy future regulatory requirements, the possibility of additional safety events, 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 Halozyme's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 12, 2014.

Investor Contact:
Schond Greenway
Halozyme Therapeutics

Media Contact:
Susan Neath Francis

Logo -

SOURCE Halozyme Therapeutics, Inc.
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. Halozyme Therapeutics Provides an Update on Anticipated Milestones for 2014 at the 32nd Annual J. P. Morgan Healthcare Conference
2. Halozyme Secures Additional $20 Million Term Loan
3. Portfolio Expansions, Product Data, and Announcements by Healthcare Companies - Research Report on Life Technologies, OncoMed, Halozyme Therapeutics, Infinity, and PTC Therapeutics
4. Halozyme Therapeutics Announces Executive Transitions
5. Halozyme Therapeutics To Present At The Piper Jaffray Healthcare Conference
6. Halozyme Therapeutics To Present At The Credit Suisse Healthcare Conference
7. Halozyme to Host Third Quarter 2013 Financial Results Conference Call
8. SWOG Initiates Randomized Phase 2 Clinical Trial of Halozymes PEGPH20 in Combination with modified FOLFIRINOX for Advanced Pancreatic Cancer
9. Halozyme Presents PEGPH20 Phase 1b Clinical Trial Data at European Cancer Congress 2013
10. Commercial Launch of Herceptin SC in EU Triggers Milestone Payment to Halozyme from Roche
11. Halozyme Therapeutics To Present At The BioCentury Newsmakers In The Biotech Industry Conference
Post Your Comments:
(Date:11/26/2015)... DUBLIN , Nov. 26, 2015 ... the addition of the "2016 Future Horizons ... Monitoring (TDM) Market: Supplier Shares, Country Segment Forecasts, ... offering. --> ... comprehensive analysis of the Japanese therapeutic drug monitoring ...
(Date:11/26/2015)... , November 26, 2015 ... Juntendo universitetssjukhus ser potential att använda ... magnetresonansbilder (MR-bilder) för patienter med multipel ... ett forskningsavtal med SyntheticMR AB för att ... forskningsprojekt på sjukhuset. Med SyMRI kan man ...
(Date:11/26/2015)... -- ) has announced the ... Viscosity Drugs" report to their offering. ... of the "Self Administration of High Viscosity ... Research and Markets ( ) has ... of High Viscosity Drugs" report to their ...
Breaking Medicine Technology:
(Date:11/26/2015)... Omaha, NE (PRWEB) , ... November 26, 2015 , ... ... careers searched by healthcare professionals and offered by healthcare staffing agency Aureus Medical ... top during the month of October 2015 among those searching for healthcare jobs through ...
(Date:11/26/2015)... ... November 26, 2015 , ... Pixel ... self-animating trailer titles with ProTrailer: Vintage. This newly styled ProTrailer pack comes with ... work with any font, giving users limitless opportunities to stylize and create designs ...
(Date:11/25/2015)... ... November 25, 2015 , ... Additional breast cancers found ... mammography, according to a study published online in the journal Radiology. Researchers said ... may necessitate a change in treatment. , Breast MRI is the most sensitive ...
(Date:11/25/2015)... ... November 25, 2015 , ... Finnleo, a leader in the ... several models of traditional and far-infrared saunas. , For traditional saunas, Finnleo ... most traditional Finnish sauna wood, and Finnleo uses only European Grade A Nordic White ...
(Date:11/25/2015)... ... November 25, 2015 , ... Dr. John Pierce, Medical Director ... about hair loss treatment with the Capillus272™ Pro laser therapy cap. FDA cleared for ... and fuller hair, without the need for surgery, prescription pills, or topical foams. ...
Breaking Medicine News(10 mins):