BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Cytochroma Inc. Announces Positive Phase 2b Results for CTAP101 Capsules at National Kidney Foundation Meeting


5/14/2012 10:11:48 AM

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.

About Cytochroma

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.

SOURCE Cytochroma



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES