SAN DIEGO, June 30, 2013 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced interim results from a proof of concept Phase 1/2 clinical trial evaluating the activity and local tolerability of HTI-501, an investigational biologic, for use in aesthetic dermatology. The data were presented June 29, 2013 at the 9th Annual World Congress of Cosmetic Dermatology in Athens, Greece.
This trial is being conducted outside the US in healthy adult females with cellulite, known medically as edematous fibrosclerotic panniculopathy. The Phase 1 dose-escalation portion of the trial was completed in 2012 while the ongoing Phase 2 portion of the trial is designed to assess the pharmacologic activity of HTI-501 and extend the safety assessment to multiple injections in a treatment area. The primary endpoint is physician assessment at Day 28, supported by secondary endpoints of subject self-evaluations and objective measurements of changes to the skin topography.
The interim results from 12 of the planned 34 evaluable patients from this Phase 1/2 trial indicates pharmacologic activity at the primary 28 day observation point, with 83 percent of subjects (10 of 12) showing improvement from the pretreatment assessment, with a median improvement of 53 percent (p=.006) by the primary physician assessment. In comparison, 75 percent of subjects (9 of 12) showed improvement with a median improvement of 22 percent (p=.009) for the vehicle injection control at the same observation point. The objective measure (skin topography) for the treated area showed modest improvement in 80 percent of evaluable subjects (8 of 10) treated with HTI-501 (p=.042), but was not significantly changed for the vehicle control (p=.84) or a post-hoc evaluation of non-injected areas. To query the robustness of any study conclusions, an independent blinded panel evaluation of images will be performed on the evaluable subjects at one and six months following treatment.
"In the initial patients treated thus far, the response to treatment with HTI-501 has been encouraging. We are particularly interested in subsequent three and six month observations, which have shown further improvement in some subjects treated thus far," said Francisco Perez, M.D., immediate past President of World Congress of Cosmetic Dermatology and principal clinical investigator. "We look forward to completing enrollment this summer and conducting final follow-up observations early next year."
The HTI-501 enzyme and its formulation have been well tolerated so far in this trial at all doses and formulations tested, with no serious or severe adverse events. The most common side effects have been mild to moderate transient injection site discomfort and mild to moderate injection site bruising, resolving within about two weeks without intervention.
HTI-501 is a proprietary recombinant human protease (rHuCAT-L) in a conditionally active formulation discovered and under development by Halozyme. HTI-501 is being explored as a potential treatment for both aesthetic and connective tissue disorders such as keloid and hypertrophic scarring, localized scleroderma, frozen shoulder syndrome and Dupuytren's contracture. As Halozyme's first conditionally active biologic, HTI-501 is designed to degrade the collagenous fibrous components of the extracellular matrix only at the injection site by tightly controlling the extent and duration of enzyme activity once injected into the body.
Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company's research focuses primarily on a family of human enzymes, known as hyaluronidases, which increase the absorption and dispersion of biologics, drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer, Baxter, ViroPharma and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements including without limitation our future development plans for HTI-501, anticipated study design, patient enrollment targets and completion dates for the remainder of the Phase 2 trial for HTI-501 and the hypothesized method of action or potential benefits for HTI-501. These forward-looking statements 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 adverse clinical trial results, delays in development, possible adverse events associated with the use of the product candidate, regulatory approval requirements and competitive conditions. These and other risk factors that may result in differences are discussed in greater detail in the company's Quarterly Report filed on Form 10-Q with the Securities and Exchange Commission on May 8, 2013.
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SOURCE Halozyme Therapeutics, Inc.