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:2/10/2016)... ... February 10, 2016 , ... HOLLOWAY AMERICA, ... Pharmaceutical Engineering (ISPE) Rocky Mountain Chapter 21st Annual Vendor Exhibition on Thursday, February ... than 100 tables for its annual event, which will run from 3:00 p.m. ...
(Date:2/10/2016)... ... February 10, 2016 , ... Curoverse announced today that ... Arvados provides capabilities for managing and processing genomic and health data at petabyte ... institutions collecting and analyzing genomic data,” said Adam Berrey chief executive officer at ...
(Date:2/9/2016)... (PRWEB) , ... February 09, 2016 , ... With a ... 2016 Wharton Health Care Business Conference will bring together over 500 top healthcare leaders ... an industry in transformation. The conference, organized by MBA students of the University of ...
(Date:2/9/2016)... ... February 09, 2016 , ... ... on its free and validated Electronic Data Capture (EDC) system ClinCaptureand its new ... Clinical Trials West Coast 2016 Conference in San Mateo, California on February 10th ...
Breaking Biology Technology:
(Date:1/15/2016)... Rico , Jan. 15, 2016 Recent ... and small to find new ways to ensure data ... iOS and Android that ... on biometrics, transforming it into a hardware authorization token. ... users swipe their fingerprint on their KodeKey enabled device ...
(Date:1/13/2016)... 13, 2016 ... of the  "India Biometrics Authentication & ... (2015-2020)"  report to their offering.  ... announced the addition of the  "India ... Estimation & Forecast (2015-2020)"  report ...
(Date:1/11/2016)... , Jan. 11, 2016  higi, the leading ... 10,000 retail locations, web and mobile, today announced ... million from existing investors. --> ... devoted to further innovate higi,s health platform – ... web portal – including expanding services and programs ...
Breaking Biology News(10 mins):