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 estimated 70-90% of these patients have vitamin D insufficiency, which can lead to secondary hyperparathyroidism and resultant debilitating bone diseases. There is growing evidence that vitamin D insufficiency is linked to the progression of CKD and to increased morbidity and mortality in CKD patients. CKD is most frequently caused by diabetes or hypertension, both of which are consequences of a growing obesity epidemic in countries worldwide. Stage 3 and Stage 4 CKD are characterized by level of kidney function in terms of decreased glomerular filtration rate (GFR) - 30-59 ml/min/1.73m(2) for Stage 3 CKD and 15-29 ml/min/1.73m(2) for Stage 4 CKD. As CKD progresses to Stage 5 and GFR decreases to < 15 ml/min/1.73m(2), patients require more drastic treatments including dialysis or kidney transplant.
About Cytochroma Inc.
Cytochroma (www.cytochroma.com) is a specialty pharmaceutical company engaged in the development and commercialization of proprietary products to treat and prevent the clinical consequences of Vitamin D insufficiency. The Company has an advanced portfolio of new therapies for Vitamin D insufficiency and secondary hyperparathyroidism associated with CKD. In addition, the Company is developing novel therapies to address the cause of vitamin D deficiency in CKD and to treat hyperphosphatemia.
CONTACT: Eric J. Messner, Vice President, Commercial Operations, (905)
479-5306 ext. 338, eric.messner@cytochroma.com
