MARKHAM, ON, Nov. 20 /CNW/ - 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 (less than) 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.
For further information:
For further information: Eric J. Messner, Vice President, Commercial
Operations, (905) 479-5306 ext. 338, firstname.lastname@example.org