MARKHAM, ON, May 11, 2012 /PRNewswire/ - Cytochroma today announced positive
clinical trial results for its lead product, CTAP101 Capsules. In a
recently completed Phase 2b trial, CTAP101 Capsules effectively and
safely lowered elevated plasma intact parathyroid hormone (iPTH) in
patients with Stage 3 or 4 chronic kidney disease (CKD) and vitamin D
insufficiency. These findings, as well as two other presentations on
CTAP101 Capsules, are being featured at the National Kidney Foundation
(NKF) 2012 Spring Clinical Meetings in Washington, DC taking place from
May 9-13, 2012.
"CTAP101 Capsules performed well above our expectations in the Phase 2b
study," stated Dr. Charles W. Bishop, President and CEO of Cytochroma.
"No marketed therapy both effectively controls elevated serum
parathyroid hormone levels and corrects the underlying vitamin D
insufficiency in CKD patients. These strong data indicate that CTAP101
Capsules is a highly differentiated product compared to current
treatment options. We look forward to initiating Phase 3 trials later
The Phase 2b study was a randomized, double-blind, placebo-controlled
evaluation of 78 subjects with secondary hyperparathyroidism (SHPT),
stage 3 or 4 CKD and vitamin D insufficiency. Subjects were recruited
from 17 sites in the United States (US) and treated daily with one of
three doses of CTAP101 Capsules (30, 60, or 90 mcg) or a matching
placebo for 6 weeks. During treatment, serum total 25-hydroxyvitamin D
(25D), plasma iPTH, serum calcium and serum phosphorus were monitored
at least weekly. CTAP101 Capsules increased serum total 25D and reduced
plasma iPTH significantly, in a dose-proportional manner compared to
placebo therapy. Low serum total 25D was corrected to adequate levels
(30 ng/mL) in nearly every treated subject. Plasma iPTH was reduced by
30% from pre-treatment baseline in 39%, 65%, and 63% of
intent-to-treat subjects treated with doses of 30, 60, and 90 mcg,
respectively (p-values < 0.05). CTAP101 Capsules had no adverse
effects on serum calcium, serum phosphorus, or urine calcium throughout
the 6-week treatment period, or the 6-week follow-up period. The
presentation of this study at the NKF 2012 Spring Clinical Meetings
occurred under abstract #97, titled "CTAP101 Capsules Significantly
Increases Serum 25D and Lowers Plasma iPTH Levels in Stage 3 and 4 CKD
Two other presentations appearing at the NKF 2012 Spring Clinical
Meetings will be:
Abstract #96, titled "CKD Patients May Require Higher Serum Total 25D
Levels to Normalize Elevated iPTH"
Abstract #91, titled "Gradual vs. Rapid Repletion of D Deficient Rats"
Meeting abstracts can be viewed online at: http://www.kidney.org/news/meetings/clinical/pdf/CM12_Abstracts.pdf.
About CTAP101 Capsules
CTAP101 Capsules is a first-in-class treatment under development for
SHPT in patients with Stage 3 or 4 CKD and vitamin D insufficiency.
The product is designed to reliably correct vitamin D insufficiency by
raising serum vitamin D pro-hormone (25D) concentrations to adequate
levels and, thereby, control elevated plasma iPTH without the side
effects often associated with vitamin D hormone therapies.
About Chronic Kidney Disease
CKD is characterized by a progressive decline in kidney function. The
kidney normally removes waste, as well as excess phosphate and water
from the blood and regulates circulating vitamin D hormones. As CKD
advances, blood levels of vitamin D prohormones and hormones decrease,
causing vitamin D insufficiency and SHPT. Phosphate levels also rise in
these patients, elevating FGF23 and risk of cardiovascular disease and
death. CKD is classified in five different stages - mild (stage 1) to
severe (stage 5) disease - as measured by glomerular filtration rate.
According to the National Kidney Foundation, CKD afflicts over 26
million people in the US, including more than eight million patients
with moderate (stages 3 and 4) CKD. In stage 5 CKD, kidney function is
minimal to absent and patients require regular dialysis or a kidney
transplant for survival.
About Secondary Hyperparathyroidism
SHPT is a condition in which the parathyroid glands secrete excessive
amounts of PTH into the blood due to renal and/or vitamin D
insufficiency. Prolonged and excessive PTH secretion causes excessive
calcium and phosphorus to be released from bone into the blood, leading
to elevated serum calcium and phosphorus, various bone diseases and
calcification of cardiovascular tissues. SHPT affects 40-60% of
patients with moderate CKD and approximately 90% of patients with
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 SHPT
associated with CKD. The Company specializes in developing new
therapies which are designed to safely and effectively treat patients
with stage 3, 4 or 5 CKD. Cytochroma also has a portfolio CYP24 and
phosphate-uptake inhibitors in early stage development.
For more information about Cytochroma, please visit www.cytochroma.com.