Halozyme Announces Positive Results From Phase 1/2 Clinical Trial In Cellulite With HTI-501

SAN DIEGO, March 25, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced top-line data from a proof of concept Phase 1/2 clinical trial evaluating the use of HTI-501 in the treatment of cellulite. The primary endpoint of the clinical trial was met, showing a statistically significant improvement in the appearance of cellulite in the areas of the patients' skin treated with HTI-501 as determined by physician assessment 28 days after treatment compared to the same skin areas prior to treatment and skin areas treated with vehicle control. In follow up, the effect, as assessed by physician assessment, was maintained at three and six months.

"We are very pleased that this study has shown successful proof of concept of the activity of this novel enzyme," said Francisco Perez, M.D., past President of World Congress of Cosmetic Dermatology and principal clinical investigator for the study. "These data support further development of HTI-501 as a potential treatment for cellulite, a highly prevalent condition with very limited therapeutic options."

In the 36 evaluable patients, the skin areas treated with HTI-501 showed a statistically significant reduction in the appearance of cellulite at the primary 28 day observation point, with a mean improvement of 53% (p<.001) compared to the same skin area pretreatment, as assessed by the treating physician. The mean improvement from pretreatment was 33% at 28 days (p<.001) for the skin areas treated with the control vehicle injection, significantly less than the mean improvement for HTI-501 (p=.005).

The Phase 1 dose-escalation portion of the trial was completed in 2012. The Phase 2 portion completed dosing in July 2013 and was designed to assess the pharmacologic activity of HTI-501 and extend the safety evaluation to include multiple injections in a treatment area. The primary endpoint was physician assessment at day 28 with continued follow-up of patient responses through six months following treatment. The trial was conducted in Mexico in healthy adult females with cellulite, known medically as edematous fibrosclerotic panniculopathy.

Additional Study Details

In addition to the primary assessments and to better understand the placebo effect, an independent blinded panel evaluation was performed on images from the evaluable patients. Three board certified dermatologists independently reviewed and categorized paired images of treated skin areas as better, slightly better, not different, slightly worse, or worse at 28 days after treatment compared to the same skin areas pretreatment. Panel members were blinded as to which images were pre- and post-treatment and whether the treatment was with HTI-501 or the vehicle control. The panel found that at day 28, the appearance of cellulite was improved from pretreatment for areas of skin treated with HTI-501 (p=.017). In contrast, the appearance of cellulite was not significantly different from pretreatment for areas of skin treated with the vehicle control (p=.20). Furthermore, HTI-501 treatment showed a statistically significant improvement relative to treatment with the vehicle control (p=.007).

Based on the treating physician assessment, the reduction in the appearance of cellulite was also observed at three months and maintained through the final month six follow up observation in this trial. For 35 subjects who remained on study at the three month observation point, the physician assessment showed a mean improvement of 57% (p<.001) from the same skin area pretreatment for the patients treated with HTI-501. In comparison, the mean improvement from pretreatment was 43% at three months (p<.001) for the skin areas treated with the control vehicle injection. For 34 subjects who remained on study through the final six month observation point, the physician assessment showed a mean improvement of 61% (p<.001) from the same skin area pretreatment for patients treated with HTI-501. In comparison, the mean improvement from pretreatment was 43% at six months (p<.001) for the skin areas treated with the control vehicle injection. The independent expert panel also reviewed the three month and six month images from the treatment and control arms compared with the skin areas pretreatment, and noted a significant improvement in the treatment arm at six months, but not at three months, with skin areas treated with HTI-501, and no difference at either three or six months with skin areas treated with vehicle control.

HTI-501 was well tolerated in this trial at all doses and formulations tested, with no serious adverse events. The most common side effects were mild to moderate transient injection site discomfort and bruising that resolved without intervention within about two weeks.

About HTI-501

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 cellulite. 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.

About Halozyme

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 dispersion and absorption of biologics, drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including oncology, diabetes and dermatology that have significant unmet medical need today. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer and Baxter. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com and follow us on Twitter @HALOTherapeutic.

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 including exploration as a treatment for cellulite, anticipated study design, 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 Annual Report filed on Form 10-K with the Securities and Exchange Commission on February 28, 2014.

SOURCE Halozyme Therapeutics, Inc.

Posted: March 2014

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