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:6/23/2016)... 2016 Houston Methodist Willowbrook Hospital has ... Association to serve as their official health care ... Willowbrook will provide sponsorship support, athletic training services, ... coaches, volunteers, athletes and families. "We ... Association and to bring Houston Methodist quality services ...
(Date:6/23/2016)... 23, 2016  The Prostate Cancer Foundation (PCF) is pleased to ... faster cures for prostate cancer. Members of the Class of 2016 were selected ... Read More About the Class of 2016 PCF Young Investigators ... ... ...
(Date:6/23/2016)... --  EpiBiome , a precision microbiome engineering company, today ... from Silicon Valley Bank (SVB). The financing will allow ... drug development efforts, as well as purchase additional lab ... been an incredible strategic partner to us – one ... provide," said Dr. Aeron Tynes Hammack , EpiBiome,s ...
(Date:6/23/2016)... ... June 23, 2016 , ... STACS DNA Inc., the sample tracking software ... State Crime Laboratory, has joined STACS DNA as a Field Application Specialist. , ... Tremblay, President and COO of STACS DNA. “In further expanding our capacity as a ...
Breaking Biology Technology:
(Date:6/9/2016)... Finland , June 9, 2016 ... National Police deploy Teleste,s video security solution to ensure the ... France during the major tournament ... data communications systems and services, announced today that its video ... Prefecture to back up public safety across the ...
(Date:6/2/2016)... June 2, 2016   The Weather Company , an ... Ads, an industry-first capability in which consumers will be able ... to ask questions via voice or text and receive relevant ... Marketers have long sought an advertising solution ... can be personal, relevant and valuable; and can scale across ...
(Date:5/20/2016)... -- VoiceIt is excited to announce its new marketing ... working together, VoiceIt and VoicePass will offer an ... slightly different approaches to voice biometrics, collaboration between ... Both companies ... "This marketing and technology partnership allows VoiceIt ...
Breaking Biology News(10 mins):