Cytochroma initiates Phase I study of CTAP201 Injection in chronic kidney disease patients



    MARKHAM, ON, Jan. 6 /CNW/ - Cytochroma today announced that it has
initiated a Phase I trial of CTAP201 Injection in hemodialysis patients.
CTAP201 Injection is being developed for the treatment of mild-to-moderate
secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease
(CKD).
    "In patients with SHPT, the parathyroid glands produce and secrete
excessive amounts of parathyroid hormone, ultimately causing bone softening
and vascular tissue calcification," stated Joel Z. Melnick, M.D., Cytochroma's
Vice President, Clinical Research and Development. "Additionally, a majority
of CKD patients with SHPT are unable to reach the treatment goals established
by the National Kidney Foundation as a result of hyperphosphatemia. CTAP201
Injection may be a valuable alternative to current therapies for CKD patients
as it has potent parathyroid hormone-lowering effects in preclinical CKD
models with less effect on serum calcium and phosphorus."
    The Phase I clinical trial is an open label, dose determination study
which will be conducted in the United States with approximately 24
hemodialysis patients in two treatment cohorts. The first cohort will receive
a single dose of 1 mcg of CTAP201 Injection and the second cohort will receive
a single dose of either 0.5 or 3 mcg, depending on the data obtained from the
first cohort. The pharmacokinetic profile of CTAP201 Injection will be
evaluated post-dosing in both cohorts. Safety endpoints in this study will
include adverse events, physical and clinical laboratory assessments, and
measurements of adjusted serum total calcium (Ca), serum phosphorus (P), and
calculated serum Ca x P product.

    About CTAP201 Injection

    CTAP201 Injection is a potent vitamin D hormone being developed to treat
SHPT in CKD patients. In preclinical CKD models, the product has exhibited
potent parathyroid hormone-lowering effects with limited effects on serum
calcium and phosphorus. Following additional development and conduct of human
trials, this promising product may provide nephrologists with a new
alternative to treat SHPT more safely and effectively.

    About Chronic Kidney Disease

    CKD is a condition characterized by a progressive decline in the function
of the kidney, which is normally responsible for excreting waste and excess
water from the body, and for regulating various hormones. CKD is classified in
five different stages - mild (stage 1) to severe (stage 5) disease - as
measured by the kidney's glomerular filtration rate. According to the National
Kidney Foundation, CKD afflicts over 26 million people in the United States,
including more than eight million patients with moderate (stages 3 and 4) and
severe (stage 5) forms of CKD. In stage 5 CKD, kidney function is minimal to
absent and patients require regular dialysis or a kidney transplant for
survival.

    About Secondary Hyperparathyroidism

    SHPT is a condition commonly associated with CKD in which the parathyroid
glands secrete excessive amounts of parathyroid hormone (PTH). Excess PTH
secretion arises as a result of impaired kidneys that are unable to produce
sufficient quantities of vitamin D hormones to maintain a state of balance
(homeostasis) between calcium and phosphorus in the body. Prolonged elevation
of PTH 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 40-60% of patients with moderate CKD and approximately
90% of patients with severe CKD.

    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 secondary
hyperparathyroidism (SHPT) associated with chronic kidney disease (CKD). The
Company specializes in developing new vitamin D therapies which 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 is being developed for the treatment of vitamin D
insufficiency. In addition, Cytochroma is developing novel therapies to treat
hyperphosphatemia in CKD patients.
    For more information about Cytochroma, please visit www.cytochroma.com.





For further information:

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

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Cytochroma

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