Press Release:

CYTOCHROMA INITIATES PHASE I STUDY OF CTAP201 INJECTION IN CHRONIC KIDNEY DISEASE PATIENTS

Markham, Ontario, Canada — January 6, 2009 — 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 information contact:

Investors:
Gordon Ngan
Executive Director, Corporate Development
Tel: +1 (905) 479-5306 ext. 333
gngan@cytochroma.com

Media:
Robert Stanislaro (FD)
Tel: +1 (212) 850-5657
robert.stanislaro@fd.com

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