Kythera Biopharmaceuticals completes enrollment in Phase II actinic keratosis trial

Kythera Biopharmaceuticals, Inc. announced today that it has initiated and completed enrollment of its Phase II study of ATX-201 for actinic keratosis

LOS ANGELES | June 26, 2007 |
Kythera Biopharmaceuticals, Inc. (“Kythera”) announced today that it has initiated and completed enrollment of its Phase II study of ATX-201 for actinic keratosis (AK).

The ongoing Phase II trial is a randomized, double-blind, placebo-controlled study of 48 patients being conducted in France. Subjects with actinic keratoses on the scalp and face are undergoing at least one course of treatment with ATX-201 or placebo over a 4 to 12-week period. An assessment of efficacy, safety and tolerability will be made in multiple treatment regimens based on both primary and exploratory scales.

“We hope ATX-201 will offer patients a safe and efficacious alternative to existing topical therapies that can have significant side effects and damage surrounding tissue,” said the study lead investigator, Professor Jean-Paul Ortonne, MD, Department of Dermatology, Archet 2 Hospital, Nice, France.

Dr. Patricia Walker, Kythera’s Chief Medical Officer added, “We are pleased with the rapid enrollment in this trial. It is a clear indication of the unmet medical need and the promise of ATX-201 in this setting.”

In November, Kythera was granted exclusive worldwide rights from Novartis Pharma AG to obtain, develop and commercialize ATX-201, one of a family of novel compounds that inhibits microtubule polymerization.

About Actinic Keratosis (AK)
Actinic keratosis (AK) is a hyperproliferative skin condition caused by excessive sun exposure and initially appears as a dry scaly lesion on the skin. The onset of AK is often subtle and can pass unnoticed for some time before diagnosis. If untreated,

AKs can progress from an aesthetically undesirable mark on the skin to a type of invasive skin cancer known as squamous cell carcinoma (SCC). AKs are the most common pre-cancerous skin lesions worldwide and the treatment of AKs is the most common dermatologic procedure performed in the outpatient setting. In the US, AK affects about one percent of the population. More than five million AKremoval procedures are performed annually. Kythera Biopharmaceuticals

About Kythera Biopharmaceuticals
Kythera is a privately held biopharmaceutical company focused on science and innovation in aesthetic and medical dermatology. These markets are expanding rapidly driven by an aging population, increasing discretionary income, and an evolution of patient preference toward restorative and preventative care. The company uses the tools of biotechnology to develop prescription therapeutics for these emerging markets. Kythera has active or exploratory programs in adipolysis, photoaging and dermal contouring and topical neuromodulation. For more information about Kythera, please visit the company’s Web site at www.kytherabiopharma.com.

SOURCE: Kythera Biopharmaceuticals, Inc.

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