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Home » HALOZYME ANNOUNCES IND APPLICATION FOR CHEMOPHASE
HALOZYME ANNOUNCES IND APPLICATION FOR CHEMOPHASE
July 1, 2005
Halozyme Therapeutics, a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, announced it has submitted its investigational new drug (IND) application for Chemophase to the FDA.
Chemophase is a formulation of recombinant human hyaluronidase being developed as a chemoadjuvant for the treatment of cancer. This IND was submitted to enable the initiation of the first clinical trial with Chemophase, administered intravesically with the chemotherapeutic agent mitomycin to patients with bladder cancer.
Patient enrollment may not begin until the FDA IND review period has passed and the clinical protocol has received Institutional Review Board approval. If accepted, the Phase I study will enroll up to ten 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.
KEYWORDS Drug Pipeline Alert
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