Halozyme Therapeutics, Inc. Presents Interim Results from the Phase 1 Proof-Of-Concept and Local Tolerability Study of Hti-501
January 31, 2012 at 04:05 pm EST
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Halozyme Therapeutics, Inc. presented interim results from the Phase 1 proof-of-concept and local tolerability study of HTI-501 (an investigational, conditionally active recombinant human cathepsin) at the 8th World Congress of the International Academy of Cosmetic Dermatology in Cancun, Mexico. Data from the study support commencement of the Phase 2 portion of the clinical trial. The Phase 1/2 trial of HTI-501 is in female patients with moderate to severe fibrosclerotic panniculopathy, more commonly known as cellulite. In the ongoing Phase 1 portion no serious or severe adverse events have been reported and the injection has been well tolerated. The most common adverse event has been mild to moderate pain at the injection site that was generally bilateral, lasted a few minutes and did not require treatment. The Phase 1 enzyme dose escalation portion of the trial continues and is evaluating a single injection of two different HTI-501 formulations into dimpled lesions of the skin. The Phase 2 portion of the trial will target multiple lesions 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.
Halozyme Therapeutics, Inc. is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. The Companyâs ENHANZE drug delivery technology with the proprietary enzyme rHuPH20, its commercially validated solution is used to facilitate the subcutaneous (SC) delivery of injected drugs and fluids, with a focus on reducing treatment burden for patients. It also develops, manufactures, and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies. The Company has two commercial proprietary products, Hylenex and XYOSTED, partnered commercial products and ongoing product development programs with several pharmaceutical companies. It markets and sells Hylenex recombinant, which is a formulation of rHuPH20. It markets and sells its proprietary product XYOSTED for SC administration of testosterone replacement therapy (TRT) in adult males.