MARKHAM, ON, March 6 /CNW/ - 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."
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.
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
For further information:
For further information: Eric J. Messner, Vice President, Commercial
Operations, (905) 479-5306 ext. 338, firstname.lastname@example.org