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Press Release
CYTOCHROMA COMPLETES ENROLLMENT IN PHASE II PSORIASIS
TRIAL
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Markham, Ontario, Canada March 6, 2007 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.
For Information Contact:
Eric J. Messner
Vice President, Commercial Operations
905-479-5306 ext. 338
eric.messner@cytochroma.com
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