Manhattan Pharmaceuticals, Inc, of New York City, announced the initiation of a phase IIa clinical study of PTH 1-34, a parathyroid hormone-related peptide analog, for the topical treatment of psoriasis. The double-blind, placebo-controlled trial, which is scheduled to enroll 40 adult patients with psoriatic lesions, will be conducted at Boston University Medical Center.

Patients will receive daily application of a placebo or two strengths of PTH 1-34 delivered in the proprietary Novasome® lipid vesicle encapsulation base developed by IGI, Inc. 

When applied to psoriatic lesions in an earlier phase I/II study, PTH 1-34, a peptide believed to be a regulator of epidermal cell growth, restored the normal development and migration of skin cells, preventing cell overgrowth and the formation of plaques. Because PTH 1-34 is the active ingredient in a US Food and Drug Administration (FDA)-approved injectable formulation for osteoporosis, Manhattan expects to seek FDA approval without having to generate extensive systemic safety data.     

IGI recently sublicensed the rights to approval and marketing of the PTH 1-34 compound using the Novasome technology for psoriasis to Tarpan Therapeutics, Inc, which was acquired by Manhattan in April 2005. 

―A. Techman