-- Pivotal Phase 3 study for subcutaneous Herceptin in the treatment of HER2-positive breast cancer completed enrollment of 595 patients --
SAN DIEGO, Dec. 7, 2010 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced that Roche has completed patient enrollment for the pivotal Phase 3 study of Herceptin SC (trastuzumab subcutaneous), a subcutaneous formulation that uses Halozyme's Enhanze™ technology (rHuPH20, recombinant human hyaluronidase). Patients in the study receive chemotherapy concurrent with either Herceptin intravenous (IV) or Herceptin SC every three weeks for the first 8 cycles. Herceptin is approved to treat HER2-positive breast and gastric cancer and currently is given intravenously over 30 to 90 minutes. This innovative subcutaneous alternative is expected to take less than five minutes to administer and should allow patients with HER2-positive breast cancer to receive their treatment in their physician's office or potentially at home without having to go to a hospital.
"The timely completion of patient enrollment for this multicenter Phase 3 clinical trial marks a significant achievement for the Herceptin SC development program and exemplifies the full support and commitment of the Halozyme-Roche alliance to offering patients more advanced treatment options," said Gregory Frost, Ph.D., Halozyme's president and CEO. "Herceptin SC has the potential to offer both patient benefits and treatment efficiencies, and I congratulate the team on this important accomplishment."
The Phase 3 trial is a randomized, open-label, non-inferiority design that has enrolled 595 patients with early stage HER2-positive breast cancer. The study will evaluate two primary endpoints that compare Herceptin administered IV and SC for complete pathologic response between treatment cycles 8 and 9 and serum concentration during the first 8 cycles. Secondary endpoints will also be measured in this investigational study including an evaluation of safety and tolerability. Additional information about this Phase 3 trial can be found at clinicaltrials.gov and roche-trials.com.
About Breast Cancer
Breast cancer is the most common cancer among women worldwide(i). Each year more than one million new cases of breast cancer are diagnosed worldwide, and nearly 400,000 people will die of the disease annually(ii). In HER2-positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumor cells. This is known as 'HER2 positivity' and affects approximately 20-25% of women with breast cancer.
Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company's product portfolio is based primarily on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme's Enhanze™ technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche to apply Enhanze technology to Roche's biological therapeutics, including Herceptin® and MabThera®, and with Baxter BioScience to apply Enhanze technology to immunoglobulin. Halozyme's Ultrafast Insulin program combines its rHuPH20 enzyme with mealtime insulins, which may produce more rapid absorption, faster action, and improved glycemic control. The product candidates in Halozyme's pipeline target multiple areas of significant unmet medical need. For more information visit www.halozyme.com.
i World Health Organization, http://www.who.int/cancer/detection/breastcancer/en/
ii Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. 2004
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning, (i) Roche's progress under the collaboration, (ii) the potential achievement of various milestones, and (iii) the advantages of subcutaneous Herceptin) 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 also 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 regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission.
Robert H. Uhl
Senior Director, Investor Relations
SOURCE Halozyme Therapeutics, Inc.