Halozyme Begins Clinical Trial with HTI-501 in Women with Edematous Fibrosclerotic Panniculopathy

Phase 1/2 Clinical Trial to Assess Safety, Tolerability and Pharmacologic Activity of First Conditionally Active Biologic For Aesthetic Indications

Sep 28, 2011, 08:00 ET from Halozyme Therapeutics, Inc.

SAN DIEGO, Sept. 28, 2011 /PRNewswire/ -- 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).

(Logo:  http://photos.prnewswire.com/prnh/20100302/LA63139LOGO)

"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.

About Edematous Fibrosclerotic Panniculopathy

Edematous Fibrosclerotic Panniculopathy, more commonly known as cellulite, is a condition found in 80 to 90 percent of post-adolescent women. It presents as a modification of skin topography evident by skin dimpling that occurs mainly in women on the pelvic region. In the normal subcutaneous tissue, fibrous septae, made of types I and III collagen, connect the dermis to the deeper hypodermis creating a network of compartmentalized adipose deposits.  In cellulite, subcutaneous fat cells swell and push upwards while the septae act as an anchor to pull the epidermis downwards to form the classic cellulite dimple lesion.

About Halozyme

Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the insulin, cancer, dermatology and drug delivery markets. The company's product portfolio is based primarily on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme's Enhanze(TM) technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche, Baxter, ViroPharma and Intrexon to apply Enhanze technology to therapeutic biologics including Herceptin®, MabThera®, immunoglobulin, Cinryze® and recombinant human alpha 1-antitrypsin. Halozyme's Ultrafast Insulin program combines its rHuPH20 enzyme with mealtime insulins, which may produce more rapid absorption, faster action, and improved glycemic control. The product candidates in Halozyme's pipeline target multiple areas of significant unmet medical need. For more information visit www.halozyme.com.

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the timing, scope and outcomes of our clinical trials as well as expected activities under our collaborative partnerships) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including clinical trial results, regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission.

Halozyme Contact   Kurt Gustafson Chief Financial Officer (858) 704-8272 kgustafson@halozyme.com

SOURCE Halozyme Therapeutics, Inc.



RELATED LINKS

http://www.halozyme.com