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Zelos Therapeutics Completes Enrollment in Two Ostabolin-C Phase 2 Clinical Trials Print E-mail
09 Feb 2006
WEST CONSHOHOCKEN, PA, USA and OTTAWA, Canada | Feb. 9, 2006 | Zelos Therapeutics, Inc. announced today that the Company has completed enrollment in each of its Phase 2 clinical trials for Ostabolin-C(TM). Injectable Ostabolin-C is Zelos' Phase 2 candidate for the treatment of osteoporosis. Zelos also has Ostabolin-C gel in Phase 2 for the topical treatment of psoriasis.

"The completion of enrollment for these Phase 2 studies is an important milestone for the Ostabolin-C clinical program, and we are on track to receive the first clinical data in both programs by mid-year," commented Brian MacDonald, MB, ChB, PhD Chief Executive Officer of Zelos. "We are particularly enthusiastic about the potential for Ostabolin-C as an important new treatment for patients with osteoporosis. We anticipate that the lack of bone resorption associated with this compound in preclinical studies, combined with a strong stimulation of bone formation will deliver greater bone-strengthening benefit than has been reported for other drugs in this class. At the same time, the lack of bone resorption may reduce the incidence and severity of hypercalcemia, which is a common side effect of PTH therapy."

About Injectable Ostabolin-C for Osteoporosis

Ostabolin-C is a next-generation PTH analog for the treatment of osteoporosis. Zelos began a multi-center Phase 2 clinical trial for Ostabolin-C injection in May 2005 that has enrolled 261 post-menopausal women with low bone mineral density. The trial is a placebo-controlled, double blind, dose finding study. Subjects randomized into the study receive daily injections of one of four doses of Ostabolin-C or placebo for up to twelve months. Zelos previously completed three Phase 1 trials involving approximately 100 patients.

About Topical Ostabolin-C for Psoriasis

Zelos' second program is a topical formulation of Ostabolin-C for the treatment of psoriasis. In August 2005, Zelos began a multi-center Phase 2 proof-of-principle trial to assess efficacy prior to a formal Phase 2 clinical trial. That trial has enrolled 48 patients with mild to moderate plaque psoriasis. Subjects will receive twice daily treatment with one of two doses of Ostabolin-C gel over a three-month period.

About Zelos

Zelos Therapeutics, Inc. is a private biopharmaceutical company that is developing breakthrough discoveries in Parathyroid Hormone (PTH) research. Product programs include the development of a next-generation PTH analog, Ostabolin-C, for the treatment of osteoporosis that is currently in Phase 2 trials and for the topical treatment of psoriasis, also in Phase 2 clinical development. The Company has a collaboration with Nektar Therapeutics for the development of a pulmonary formulation of Ostabolin-C for the treatment of osteoporosis. More information is available at www.zelostherapeutics.com.

SOURCE: Zelos Therapeutics, Inc




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