Navigation Links
Cytochroma initiates Phase I/II clinical trial of CTAP101 Capsules for vitamin D insufficiency in chronic kidney disease
Date:11/20/2007

MARKHAM, ON, Nov. 20 /PRNewswire/ - 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 < 15 ml/min/1.73m(2), patients require more drastic treatments including dialysis or kidney transplant.

About Cytochroma Inc.

Cytochroma (http://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.


'/>"/>
SOURCE Cytochroma Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
2. Dawson James Securities Initiates Research Coverage on CryoCor, Inc. (Nasdaq: CRYO) with a Strong Buy Rating and $6.00 Target Price
3. Spectrum Pharmaceuticals Initiates Second Registrational Phase 3 Clinical Trial for EOquin(R) in Patients With Non-Invasive Bladder Cancer
4. XTL Biopharmaceuticals Initiates Phase IIb Clinical Trial of Bicifadine for the Treatment of Diabetic Neuropathic Pain
5. Nventa Initiates HspE7 Phase 1 Cervical Dysplasia Trial
6. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
7. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
8. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
9. ONCOSCIENCE AG, THE EUROPEAN PARTNER OF YM BIOSCIENCES, ANNOUNCES COMPLETION OF PATIENT ENROLLMENT IN PHASE III BRAIN CANCER TRIAL OF NIMOTUZUMAB
10. Evotec to Present Details of the Positive Phase II Study in Insomnia With EVT 201 at the Worldsleep07 Congress in Cairns/Australia
11. Phase III Trial Finds Pharmaxis Bronchitol Effective
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... ... April 29, 2016 , ... Summit for Stem Cell has ... development of a patient-specific stem cell therapy for the treatment of Parkinson’s disease. The ... Jeanne Loring at The Scripps Research Institute in San Diego, CA. , ...
(Date:4/28/2016)... ... April 28, 2016 , ... ... support for Connecticut's innovative, growing companies, today announced the launch of VentureClash ... technology (fintech) companies. , “VentureClash looks to attract the best early-stage ...
(Date:4/27/2016)... ... April 27, 2016 , ... ... testing technology at the Spring 2016 Marijuana Business Conference and Expo. Shimadzu’s high-performance ... solvents, heavy metals, and more. Expo attendees can stop by booth 1021 to ...
(Date:4/27/2016)... ... April 27, 2016 , ... The Board of ... appointment of John Tilton as Chief Commercial Officer.  Mr. Tilton joined Biohaven from ... founding commercial leaders responsible for the commercialization of multiple orphan drug indications. ...
Breaking Biology Technology:
(Date:3/14/2016)... March 14, 2016 NXTD ) ("NXT-ID" ... commerce market, announces the airing of a new series of ... week of March 21 st .  The commercials will air ... popular Squawk on the Street show. --> NXTD ... growing mobile commerce market, announces the airing of a new ...
(Date:3/11/2016)... 11, 2016 --> ... report "Image Recognition Market by Technology (Pattern Recognition), by ... by Deployment Type (On-Premises and Cloud), by Industry Vertical ... by MarketsandMarkets, the global market is expected to grow ... Billion by 2020, at a CAGR of 19.1%. ...
(Date:3/9/2016)... March 9, 2016 This BCC Research report ... of the RNA Sequencing (RNA Seq) market for the ... instruments, tools and reagents, data analysis, and services. ... of the RNA-Sequencing market such as RNA-Sequencing tools and ... main factors affecting each segment and forecast their market ...
Breaking Biology News(10 mins):