Halozyme Therapeutics, Inc. (HALO) Announces Completion of Enrollment of Phase III Study
Biopharmaceutical company Halozyme Therapeutics, Inc. announced today that Roche has completed patient enrollment for the pivotal Phase III study of Herceptin SC. The compound is a subcutaneous formulation that uses Halozyme's Enhanze technology. The Phase III 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…