Halozyme commences HTI-501 clinical trial for cellulite in women

Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the diabetes, cancer, dermatology and drug delivery markets, today announced the commencement of a Phase 1/2 clinical trial with HTI-501 (rHuCAT-L) in women with moderate to severe edematous fibrosclerotic panniculopathy (also known as cellulite).

"We are looking forward to the results of this proof-of-concept and local tolerability study," said Dr. Francisco Perez, President of the 8th World Congress of Cosmetic Dermatology and principal clinical investigator for the trial. "If HTI-501 proves to be pharmacologically active and well tolerated, it could represent a completely novel approach to the treatment of cellulite."

HTI-501 is a recombinant human proteinase known as cathepsin-L (rHuCAT-L), under development by Halozyme. HTI-501 is being explored as a potential treatment for dermatologic and aesthetic conditions, as well as other indications. As a conditionally active biologic, HTI-501 is designed to allow local degradation of the collagenous fibrous components of the extracellular matrix at the injection site by tightly controlling the extent and duration of enzyme activity once injected into the body. The Phase 1 dose escalation portion of the trial will evaluate a single injection of different HTI-501 formulations into dimpled lesions of the skin followed by a Phase 2 portion of the trial where multiple lesions will be targeted with the optimal dose and formulation. Up to 48 and 76 subjects may be enrolled in the Phase 1 and Phase 2 portions of the trial, respectively.