Press Release:

CYTOCHROMA INITIATES PHARMACOKINETIC STUDY OF CTAP101 CAPSULES IN CHRONIC KIDNEY DISEASE PATIENTS

Markham, Ontario, Canada — July 15, 2009 — Cytochroma today announced the initiation of a pharmacokinetic study of CTAP101 Capsules in patients with vitamin D insufficiency, secondary hyperparathyroidism (SHPT) and stage 3 or 4 chronic kidney disease (CKD).

“Vitamin D insufficiency and associated SHPT are highly prevalent in CKD patients. These conditions are associated with poor outcomes including accelerated progression of kidney disease, cardiovascular disease and death,” stated Joel Z. Melnick, M.D., Cytochroma’s Vice President, Clinical Research and Development.  “There are no treatments indicated for correcting vitamin D insufficiency in these patients and traditional vitamin D supplementation has been shown to be generally ineffective.  We believe that CTAP101 Capsules will be the first effective treatment.”

Cytochroma is developing CTAP101 Capsules for the treatment of vitamin D insufficiency in patients with stage 3 or 4 CKD.  The newly initiated trial is a randomized, open-label, single-dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of various CTAP101 doses in approximately 30 patients with stage 3 or 4 CKD.  The endpoints in this study will include vitamin D status, adverse events, physical and clinical laboratory assessments, and changes in serum calcium, phosphorus and intact parathyroid hormone. A previously completed Phase I trial for CTAP101 Capsules demonstrated that a single-dose of CTAP101 Capsules was safe and well tolerated in healthy volunteers.

About CTAP101 Capsules
CTAP101 Capsules is being developed as a first-in-class treatment for vitamin D insufficiency in CKD patients.  The product is designed to boost circulating vitamin D pro-hormone levels reliably above the minimum adequate level established by the National Kidney Foundation in its Kidney Disease Outcomes Quality Initiative (K/DOQI) Guidelines, while also lowering the risk of vitamin D-related side effects.  CTAP101 Capsules are intended to help nephrologists treat and/or prevent SHPT associated with vitamin D insufficiency.

About Chronic Kidney Disease
Chronic kidney disease is a condition characterized by progressive deterioration of the kidney, the organ responsible for excreting waste and excess water from the body as well as regulating vitamin D hormone production.  CKD is classified into 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 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 Vitamin D Insufficiency
Vitamin D insufficiency is a condition in which the body has low blood levels of vitamin D prohormones, collectively known as 25-hydroxyvitamin D.  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, cardiovascular morbidity, and increased mortality.

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 clinical development for CKD patients: CTA018 Injection and CTAP201 Injection are being developed for the treatment of SHPT in stage 5 CKD, while CTAP101 Capsules are being developed for the treatment of vitamin D insufficiency and associated SHPT in stage 3 and 4 CKD.  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

< go back >