MARKHAM, ON, March 6 /PRNewswire/ - Cytochroma Inc. announced today that it has completed the enrollment of patients in a Phase II clinical trial of CTA018 Cream for chronic plaque psoriasis.
The ongoing Phase II trial is a randomized, double-blind, placebo-controlled study being conducted in 16 dermatology clinics located throughout the continental United States. A total of 147 subjects with chronic plaque psoriasis have been enrolled and are undergoing a 12-week course of treatment with one of three different concentrations of CTA018 Cream or a matching placebo. All subjects are receiving once daily topical treatment over a maximum of 15% body surface area. The primary efficacy endpoint of the trial is the Physician Static Global Assessment, which is a commonly used psoriasis severity assessment scale required by the United States Food and Drug Administration. The primary safety endpoints of the trial include adverse events and clinical laboratory measurements. Patient perceptions of CTA018 Cream are being evaluated in addition to several other secondary endpoints.
“We are pleased that enrollment has been completed ahead of schedule by Mayo Clinical Trial Services of Rochester, MN,” said Jukka Karjalainen, M.D., Ph.D., Executive Director, Product Development (Dermatology) at Cytochroma. “Based on the results obtained in two earlier clinical trials, we anticipate that CTA018 Cream, with its novel dual mechanism of action, will show a clear benefit over current treatment options when the results of this trial are released in July 2007.”
“Many chronic plaque psoriasis patients are not satisfied with the efficacy of current topical treatments, and even products that are effective are often discontinued over time due to side effects or treatment resistance,” said Dr. Mark Lebwohl, Chairman of the Medical Board of the National Psoriasis Foundation and Professor and Chairman, Department of Dermatology, The Mount Sinai Medical Center, New York. “Topical treatments with greater efficacy and tolerability are needed to address this patient population, which represents the majority of the nearly 7 million psoriasis patients in the United States.”
About CTA018
CTA018 is a novel vitamin D analog with a dual mechanism of action designed to be both a strong activator of the vitamin D signaling pathway and a potent inhibitor of CYP24 activity (the enzyme responsible for the catabolism of vitamin D). This compound was specifically designed by Professor Gary H. Posner, Ph.D. and is protected under patents and patent applications exclusively licensed to Cytochroma Inc. from the Johns Hopkins University. CTA018 Cream was previously studied in two Phase I clinical trials and demonstrated to be both well tolerated and efficacious in the treatment of patients with psoriasis.
About Psoriasis
Psoriasis is a common immune-mediated chronic skin disease often characterized by red, scaly plaques that itch, burn, sting, and bleed easily. It afflicts approximately 125 million people worldwide; more than 70% of patients have the mild to moderate form. Psoriasis is found in all age groups and often seriously compromises the quality of life of those affected. Current methods of treatment are either inconvenient, show poor remission rates, and/or have serious side effects. Cytochroma has recognized that there is a need for improved therapies.
About Cytochroma Inc.
Cytochroma (www.cytochroma.com) is an integrated specialty pharmaceutical company engaged in the development and commercialization of proprietary products to treat and prevent the clinical consequences of diseases and disorders related to vitamin D hormone deficiency. The company has an advanced portfolio of new products targeting vitamin D deficiency and secondary hyperparathyroidism in patients with moderate to severe chronic kidney disease and end-stage renal disease. In addition, the company is developing novel vitamin D therapies to treat hyperproliferative disorders such as cancer and psoriasis.
Cytochroma Inc.
CONTACT: Eric J. Messner, Vice President, Commercial Operations, (905)479-5306 ext. 338, eric.messner@cytochroma.com
