Cytochroma announces initiation of Phase II clinical trial of CTA018 for chronic...

Cytochroma announces initiation of Phase II clinical trial of CTA018 for
chronic kidney disease patients

MARKHAM, ON, Oct. 23 /PRNewswire/ - Cytochroma today announced that it has
initiated a Phase II clinical trial of CTA018 Injection, the Company's product
candidate for the treatment of secondary hyperparathyroidism (SHPT) in
patients with chronic kidney disease (CKD). The Phase II clinical trial is an
open label, dose escalating pharmacokinetic, pharmacodynamic, efficacy and
safety study of CTA018 Injection in CKD patients with SHPT undergoing
hemodialysis.
Joel Z. Melnick, M.D., Cytochroma's Vice-President, Clinical Research and
Development, stated, "Secondary hyperparathyroidism is a serious condition
associated with chronic kidney disease and remains difficult to manage. CTA018
has the unique ability to activate vitamin D signaling pathways as well as
inhibit the CYP24 catabolic enzyme. We believe that CTA018 will provide
improved control of serum parathyroid hormone without the adverse impact on
serum levels of calcium and phosphorus caused by existing agents."
The Phase II study is being conducted in Canada and will enroll approximately
40 hemodialysis patients in a maximum of five dose groups. Each dose group
will consist of eight subjects treated for four weeks. Efficacy will be
evaluated by the proportion of subjects who achieve at least a 30% reduction
in intact parathyroid hormone (iPTH) from pre-treatment baseline. The safety
endpoints in this study will include adverse events, physical assessment,
clinical laboratory assessment, selected measures of adjusted serum total
calcium (Ca), serum phosphorus (P), albumin, calculated Ca x P product, and
iPTH.
In a previous Phase I clinical trial, CTA018 Injection was well tolerated and
produced clinically meaningful reductions in blood levels of iPTH after less
than two weeks of administration. No increases in urinary calcium excretion
were seen.

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 a strong activator
of the vitamin D signaling pathway as well as a potent inhibitor of CYP24, the
intracellular enzyme responsible for the inactivation of vitamin D hormones.
Based on its mechanism of action, CTA018 is expected to be safer and more
effective in treating SHPT 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 from
the Johns Hopkins University. CTA018 is partnered with Mitsubishi Tanabe
Pharma Corporation under a co-development, and co-promotion arrangement in the
U.S., and an exclusive royalty-bearing license in Asia.

About Chronic Kidney Disease

According to the National Kidney Foundation, more than eight million patients
in the U.S. suffer from moderate CKD (Stages 3 and 4) to severe CKD (Stage 5).
Stages 3 and 4 are characterized by progressively decreasing kidney function
as measured by glomerular filtration rate. In Stage 5, kidney function is
minimal to altogether absent and patients require regular dialysis or kidney
transplant for survival. An estimated 70-90% of CKD patients have vitamin D
insufficiency, which can lead to SHPT and resultant debilitating bone
diseases. Mounting evidence continues to link vitamin D insufficiency with
progression of CKD and death. CKD is caused most frequently by diabetes or
hypertension, both of which are consequences of a growing obesity epidemic in
countries worldwide.

About Secondary Hyperparathyroidism

SHPT is a condition commonly associated with CKD in which the parathyroid
glands secrete excessive amounts of iPTH. This excess iPTH secretion arises as
a result of impaired kidneys that are neither able to produce sufficient
quantities of active vitamin D hormone nor maintain a state of balance
(homeostasis) between calcium and phosphorus in the body. Prolonged elevation
of iPTH causes excessive calcium to be released from bone into the blood,
leading to softening of the bones (osteomalacia), and calcification of
vascular tissues. SHPT affects approximately 90% of severe, and 40-60% of
moderate CKD patients.

About Cytochroma

Cytochroma is a clinical stage specialty pharmaceutical company focused on
developing and commercializing proprietary products to treat and prevent the
clinical consequences of Vitamin D insufficiency and SHPT associated with CKD.
The Company's Vitamin D-based therapeutics are designed to safely and
effectively treat patients with Stage 3, 4 or 5 CKD. Cytochroma has three lead
product candidates in development for CKD patients: CTA018 Injection and
CTAP201 Injection are being developed for the treatment of SHPT, while CTAP101
Capsules are being developed for the treatment of Vitamin D insufficiency. In
addition, Cytochroma is developing novel therapies to treat hyperphosphatemia
in these same patients.
For more information, please visit www.cytochroma.com.

SOURCE Cytochroma

Cytochroma Investors: Gordon Ngan, Executive Director, Corporate Development,
Tel: (905) 479-5306, ext. 333, gordon.ngan@cytochroma.com; Cytochroma Media:
Robert Stanislaro (FD), Tel: (212) 850-5657, robert.stanislaro@fd.com