MARKHAM, ON, Nov. 20 /PRNewswire/ - Cytochroma Inc. announced today that it has commenced dosing in a Phase I/II clinical trial of CTAP101 Capsules, the Company's product candidate for the treatment of vitamin D insufficiency in chronic kidney disease (CKD).
This Phase I/II clinical trial is a four-week, open label trial designed to establish the pharmacokinetic profile and safety of CTAP101 Capsules in subjects with vitamin D insufficiency. The product's pharmacokinetic profile will be characterized at low-, mid- and high-dosages in subjects with normal renal function, and at a single mid-dosage in subjects with Stage 3 and 4 CKD. The safety endpoints for the trial include serum and urine calcium, serum phosphorus and the serum calcium times serum phosphorus product.
"We are pleased to be advancing this first-in-class prohormone therapy into the clinic," stated Dr. Joel Melnick, Vice President, Clinical & Regulatory Affairs. "CTAP101 Capsules are designed specifically to address the marginal effectiveness of high-dose ergocalciferol (vitamin D(2)) in treating vitamin D insufficiency in CKD while providing a safer alternative to current off-label use of vitamin D hormone replacement therapies."
About CTAP101 Capsules
CTAP101 Capsules are a first-in-class treatment for vitamin D insufficiency in CKD patients. CTAP101 Capsules are designed to reliably boost circulating vitamin D prohormone levels to above the minimum adequate level established by the National Kidney Foundation (NKF) in its Kidney Disease Outcomes Quality Initiative (K/DOQI) Guidelines. CTAP101 Capsules can potentially help nephrologists treat and/or prevent secondary hyperparathyroidism which develops in most CKD patients in part because of vitamin D insufficiency.
About Chronic Kidney Disease and Vitamin D Insufficiency
According to the NKF, more than nine million North American patients
suffer from moderate CKD (Stage 3 and 4) to severe CKD (Stage 5). An
|SOURCE Cytochroma Inc.|
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