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 this year."
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 Patients".
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 severe CKD.
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.