Media Statement:
CYTOCHROMA REPORTS POSITIVE PHASE I CLINICAL
DATA FOR CTA018 INJECTION
Markham, Ontario, Canada — June
28, 2007 — Cytochroma Inc. announced today
positive data from a Phase I clinical trial of CTA018 Injection.
The initial
top-line results from this trial showed that CTA018 was safe
and well tolerated. Complete study results are expected in
August 2007.
The recently completed Phase I trial was an
open label, placebo-controlled, randomized study of CTA018
Injection
administered to 20 healthy
volunteers. In this trial, the safety of CTA018 Injection
was evaluated after single doses of up to 180 mcg. Placebo
and
two strengths of CTA018, 90 mcg and 180 mcg, were subsequently
studied during repeated dose administration. The trial was
conducted at a single Canadian center. Key safety evaluations
included adverse events, serum and urine calcium, serum ionized
calcium and serum phosphorus. No drug-related adverse events
were reported.
Significant reduction in the blood levels
of parathyroid hormone (PTH) was observed in this trial, suggesting
that
CTA018 has
potential as a treatment for secondary hyperparathyroidism
in chronic kidney disease (CKD). Blood samples collected
before and after repeated CTA018 administration documented
a mean
reduction in PTH level of more than 20% after five doses
of 180 mcg.
“While this safety trial was not designed to demonstrate efficacy,
we were pleasantly surprised to see a significant reduction
of PTH levels after just a few doses of CTA018,” stated
Dr. Jukka Karjalainen, Executive Director, Product Development. “As
expected, we did not see any elevations in serum or urine
calcium or in serum phosphorus. Serum ionized calcium levels
also remained
unchanged. We believe that the PTH-lowering effect of CTA018
will be even more pronounced in CKD patients with secondary
hyperparathyroidism.”
About CTA018 CTA018 is the first compound in a new class
of active Vitamin D analogs having a novel dual mechanism of
action.
CTA018 is
designed to be both a strong activator of the Vitamin D signaling
pathway and a potent inhibitor of CYP24, the intracellular
enzyme responsible for normal catabolism of Vitamin D hormones.
Based on its mechanism of action, CTA018 is expected to be
effective in treating secondary hyperparathyroidism but safer
than currently available therapies. 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.
About
Chronic Kidney Disease and Secondary Hyperparathyroidism
Vitamin D hormones and their analogues are currently used
to treat secondary hyperparathyroidism in CKD and end-stage
renal
disease. According to the National Kidney Foundation, more
than nine million North American patients suffer from moderate
to severe CKD. Many develop Vitamin D insufficiency and
secondary hyperparathyroidism which, if untreated, can cause
debilitating
bone diseases and increased patient morbidity and mortality.
North American sales of Vitamin D therapies for the treatment
of secondary hyperparathyroidism currently exceed $500
million per year and are expected to grow rapidly with the
increasing
incidence of CKD. CKD is most frequently caused by diabetes
or hypertension, both of which are consequences of the
widening North American epidemic of obesity.
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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