Atlanta-based pharmaceutical company Celtaxsys has received regulatory clearance to commence a phase II trial for its flagship compound, CTX-4430, in patients with moderate to severe facial acne vulgaris. This approval triggers site engagement to screen and enroll appropriate patients with acne.

This proof-of-concept study will assess the efficacy and safety of 100mg CTX-4430 administered as a once daily oral dose for 12 weeks. Effects on inflammatory lesion counts will serve as the primary efficacy outcome. Effects on non-inflammatory lesion counts as well as an Investigator's Global Assessment (the physician's overall assessment of the patient's disease) also will be studied.

"The regulatory clearance for this trial in New Zealand marks the entry of CTX-4430 into phase II development, with other phase II studies soon to follow," said Greg Duncan, Celtaxsys CEO. "The dermatology community consistently has supported our hypothesis regarding the therapeutic benefits of an anti-inflammatory agent, either as a complement to existing therapeutic regimens or as a possible alternative to reduce the reliance on chronically administered antibiotics or other options that may be effective, but have significant side effects, including toxicity associated with long term usage."

This phase II acne vulgaris study will be conducted at approximately 10 sites in Australia and New Zealand with Dr. Lynda J. Spelman, MBBS FACD, as the Principal Investigator.

Sanjeev Ahuja, M.D. MBA FACP, Celtaxsys chief medical officer, said, "The need for innovative treatments for acne vulgaris is high, especially for anti-inflammatory treatments like CTX-4430 that are not based on chronic antibiotic therapy or retinoids. In addition, having a once daily oral treatment like CTX-4430 potentially provides improved convenience for patients as well as an opportunity to treat the disease from the depths of the skin, where it starts."

Acne vulgaris, or simply acne, is an extremely common skin disease affecting an estimated 650 million worldwide and starts most often in adolescents during the onset of puberty. AV is characterized by the proliferation of inflammatory and non-inflammatory skin lesions, hyperactive sebaceous glands, and permanent skin scarring in some cases. Moderate to severe AV can reduce the quality-of-life of those afflicted due to negative effects on a person's self-esteem and the social stigma associated with the disease.