HALOZYME RECEIVES FDA CLEARANCE TO BEGIN CHEMOPHASE TRIAL

Halozyme Therapeutics has received clearance from the FDA for its Chemophase investigational new drug (IND) application. The initial clinical protocol under this IND is a Phase I study designed to evaluate a single intravesical administration of Chemophase along with mitomycin in patients with superficial bladder cancer.

According to data from the American Cancer Society, National Cancer Institute, American Urological Association, and Southwest Oncology Group Study, over 180,000 patients present with new or recurrent cases of superficial bladder cancer in the U.S. every year, all of whom would be potential candidates for Chemophase in the event it is approved as first line treatment with mitomycin. The clinical protocol has received Institutional Review Board approval, and the study will enroll up to ten patients to obtain five evaluable patients with superficial bladder cancer. The objectives of the Chemophase clinical trial are to determine the safety, tolerability and pharmacokinetics of Chemophase administered intravesically with mitomycin.