Recent
Press Releases:
CYTOCHROMA
GRANTED FDA APPROVAL TO COMMENCE PHASE II CLINICAL TRIAL FOR
NOVEL TOPICAL TREATMENT OF PSORIASIS
Markham, Ontario, Canada — February
20, 2006 — Cytochroma
Inc. announces that it has received approval from
the U.S. Food and Drug Administration to proceed with a Phase
II clinical
trial for CTA018, a novel vitamin D analog developed for
the treatment of psoriasis. The trial, a multicenter, randomized,
double-blind, parallel-group comparative study in subjects
with chronic plaque psoriasis, will evaluate the efficacy
of
CTA018 when applied topically once daily over a maximum of
15% body surface area.
The anticipated enrolment for the trial
is 140 subjects at 14 clinical sites in the United States.
Subjects will be placed into one of four separate dosing
groups comprised of three different concentrations of CTA018
and corresponding
cream base (vehicle control). All subjects will receive
once daily topical treatment for 12 consecutive weeks.
The
primary
efficacy endpoint of the trial will be the Physician
Static Global Assessment. Local and systemic safety and patient
perception of CTA018 cream will be evaluated in addition
to several secondary
endpoints including a Quality of Life assessment.
“We
were very encouraged by the results of the previous two
Phase I trials.”, stated James M. Rae, Chief Executive
Officer of Cytochroma Inc., “We are optimistic
that CTA018 will prove to be a valuable alternative to
current
therapies.”
About
CTA018
CTA018 is a novel vitamin D analog with a
dual mechanism of action. It is a strong activator of the
vitamin D signaling
pathway and also a potent inhibitor of CYP24 activity
(the enzyme responsible for the breakdown of vitamin
D). CTA018
was specifically designed by Prof. Gary H. Posner and
is protected under patents and patent applications exclusively
licensed
to Cytochroma Inc. from the Johns Hopkins University.
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 Inc. is
a specialty drug development company targeting hyperproliferative
disorders,
autoimmune diseases and chronic kidney disease.
The company
is currently focused on developing and commercializing
innovative vitamin D analogs, significantly having
a dual mechanism
of action, which address major medical needs in
the treatment of psoriasis, secondary hyperparathyroidism,
autoimmune
disorders and cancer. For more information, please
visit
www.cytochroma.com.
For information contact:
Sheldon Kawarsky,
Ph.D.
Director, Business Development
Cytochroma Inc.
330 Cochrane Drive
Markham, Ontario L3R 8E4
CANADA
Phone: (905) 479-5306 ext. 337
Fax: (905) 479-1287
sheldon.kawarsky@cytochroma.com
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