Navigation Links
TheraVasc Releases Phase I Trial Data Demonstrating Safety of Drug in Diabetic Patients

CLEVELAND, Sept. 20, 2011 /PRNewswire/ -- TheraVasc ( announced the successful completion of a Phase I clinical trial of a drug, TV1001, to diabetic patients. The trial included 12 diabetic patients who each received a single dose of two different oral formulations of TV1001, an enteric coated and a non-enteric coated capsule, to determine safety and blood levels of the drug.  Based on prior studies conducted in animals, the circulating blood levels in all patients were in the range believed to be therapeutic.

"Many of the patients treated in this study have severe chronic wounds for which no effective treatments are available. Based on the safety of the drug we observed in this study and the ability to achieve a therapeutic benefit in animals at the dose tested in this study, this drug offers hope that someday we might have a way of effectively treating these diabetic ulcers," said Dr. Frank Greenway, the Principal Investigator of the Study and Director of the Outpatient Clinic at the Pennington Biomedical Research Center.

Few adverse events were reported during the trials and there was no significant increase in methemoglobin levels, which would have prevented the release of oxygen in the blood, at the dose tested, the most likely adverse event associated with the treatment.  

TheraVasc's previously conducted animal studies using TV1001 showed that when taken chronically, similar blood levels resulted in the generation of new blood vessels in oxygen-deprived limbs, improvement in wound healing, and inhibition of tissue necrosis. The company expects to complete Phase IIa trials in mid-2012 in which the safety of multiple doses of chronically administered TV1001 will be assessed, along with testing for evidence of biological activity.

TheraVasc is initially developing TV1001 as a treatment for diabetic patients with Peripheral Arterial Disease (PAD), a condition affecting 14 million people in the United States leading to significant pain in the limbs that can ultimately result in amputation. "Based on the safety, circulating half life levels of the drug and blood levels achieved in this study, we believe that chronic use of TV1001 will provide a disease altering benefit to diabetic patients with PAD," said TheraVasc President and CEO, Tony Giordano, Ph.D.  

About TheraVasc

TheraVasc Inc., located in Cleveland, Ohio is dedicated to reducing the risk, cost, and time associated with drug development by focusing on developing repurposed drugs for unserved vascular disease markets. TheraVasc's initial product, TV1001 (an oral formulation of sodium nitrite) targets patient populations with poor blood flow to the extremities, such as those with diabetic leg and foot problems or those with peripheral artery disease.

SOURCE TheraVasc Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Sarasotas Roskamp Institute Releases Study Defining a Mechanism for Development of Obesity and the Metabolic Syndrome, Forerunners of Type 2 Diabetes
2. CEL-SCI Corporation Releases Letter to Shareholders
3. AcroMetrix Releases New OptiQuant(R) HIV-1 Quantification Panel
4. Cardinal Health Releases New Tool to Combat MRSA Infections in Hospitals
5. Immunosyn Corporation Releases SF-1019 Study Results
6. TCS Healthcare Technologies Releases Three New Clinical Care Programs Within ACUITY
7. Immunosyn Releases Wound Healing Photographs From the First Phase Proof of Concept Trial in Europe for Treatment of Diabetic Ulcers With Biopharmeceutical SF-1019
8. QRxPharma Releases Successful Phase 3 Study Results for Dual Opioid Pain Therapy
9. CenterWatch Releases State of the Clinical Trials Industry 2008 - A Key Industry Resource for Market Research and Competitive Intelligence
10. QRxPharma Releases Additional Phase 3 Data for Q8003IR Dual Opioid Pain Therapy
11. Genaera Releases Phase 1 Data and New Preclinical Data on the CNS Function of Trodusquemine (MSI-1436) at CBI Obesity Summit
Post Your Comments:
(Date:9/27/2017)... , Sept. 27, 2017  Commended for their devotion ... notable awards. Ranked as number one in the South Florida ... time in Inc. 5000 yearly list, the national specialty pharmacy ... Armando Bardisa will soon be honored by SFBJ ... Set to receive his award in ...
(Date:9/25/2017)... 25, 2017   Montrium , an industry ... today—from the IQPC Trial Master Files & Inspection ... that EastHORN Clinical Services has selected eTMF ... TMF management. EastHORN, a leading European contract research ... increase transparency to enable greater collaboration with sponsors, ...
(Date:9/23/2017)... Sept. 22, 2017 Janssen Biotech, Inc. (Janssen) ... letter from the U.S. Food and Drug Administration (FDA) ... sirukumab for the treatment of moderately to severely active ... clinical data are needed to further evaluate the safety ... active RA. ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to the Mission ... lost souls in the Philippines. “The Journey: From the Mountains to the Mission Field” ... the Bible. She has taught all ages and currently teaches a class of ladies ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of ... announced today its plans to open a flagship location in Covington, LA at 401 ... Rooms To Go store next to Office Depot in the Holiday Square shopping center. ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, ... post-acute health care, have expanded their existing home health joint venture through an ... has been operating a joint venture home health company with Asante, delivering clinically ...
(Date:10/12/2017)... ... ... Leading pediatric oncology experts at Children’s National Health System will join ... International Society of Paediatric Oncology (SIOP) Oct. 12-15. Chaired by Jeffrey Dome, ... at Children’s National, and Stephen P. Hunger, M.D., Chief of the Division of ...
(Date:10/12/2017)... ... 2017 , ... In the United States, single-family home owners ... New York, New Jersey, Massachusetts, Texas, Virginia, Connecticut, and California—the average is $7,000 ... property-tax rates, which contributes to the relatively lower cost of living in places ...
Breaking Medicine News(10 mins):