Media Statement:
CYTOCHROMA COMPLETES ENROLLMENT IN
PHASE II PSORIASIS TRIAL
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 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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