Press Release:
CYTOCHROMA INITIATES PHASE I/II CLINICAL
TRIAL OF CTAP101 CAPSULES FOR VITAMIN D INSUFFICIENCY IN
CHRONIC KIDNEY DISEASE
Markham, Ontario,
Canada — November 20, 2007 — 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 D2) 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/1.73m2 for
Stage 3 CKD and 15-29 ml/min/1.73m2 for
Stage 4 CKD. As CKD progresses to Stage 5 and GFR decreases
to <15 ml/min/1.73m2,
patients require more drastic treatments including dialysis
or kidney transplant.
About
Cytochroma
Cytochroma 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 information
contact:
Eric J. Messner
Vice President, Commercial
Operations
905-479-5306 ext.
338
eric.messner@cytochroma.com
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