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HTI-501 Data Support Commencement of Phase 2 Portion of Clinical Trial
Date:1/31/2012

SAN DIEGO, Jan. 31, 2012 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today 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.

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"We are pleased with the emerging safety profile of HTI-501. Initial results of the Phase 1 study demonstrate that the enzyme has been well tolerated with no dose-limiting side effects," said Dr. Francisco Perez, President of the 8th World Congress of Cosmetic Dermatology and principal clinical investigator for the trial. "We look forward to advancing this program to the next phase as HTI-501 could offer an innovative approach to treating cellulite – a disease that currently has few viable treatment options."

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 portion
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SOURCE Halozyme Therapeutics, Inc.
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