Navigation Links
TheraVasc Releases Phase I Trial Data Demonstrating Safety of Drug in Diabetic Patients
Date:9/20/2011

CLEVELAND, Sept. 20, 2011 /PRNewswire/ -- TheraVasc (www.theravasc.com) 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:
*Name:
*Comment:
*Email:
(Date:9/19/2017)... 2017   ZirMed Inc ., a recognized leader in ... it has been ranked #1 by its users for the ... 2017 User Survey. ZirMed was recognized as the top-ranked end-to-end ... medical centers over 200 beds and holds one of the ... survey history. ...
(Date:9/18/2017)... 18, 2017 EpiVax, Inc. ("EpiVax") ... and immune engineering, today announced a new ... (H7N9) vaccine. ... influenza and presents a challenge for traditional ... to be effective. Using state-of-the-art bioinformatics and molecular ...
(Date:9/12/2017)... NEW YORK , Sept. 12, 2017   EcoVadis , ... supply chains, has published the first annual edition of its Global CSR ... than 20,400 companies evaluated by EcoVadis, based on Scorecard Ratings that analyzed ... ... & Performance Index ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 2017 , ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out ... free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting ... children of all ages; it is a non-competitive, non-timed event, which is all about ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader ... been awarded a contract by the Center for Medicare and Medicaid Services (CMS). ... the enterprise use of Agile methodologies in a consistent and high value manner ...
(Date:10/12/2017)... Del. (PRWEB) , ... October 12, 2017 , ... ... and advisory services for healthcare compliance program management, will showcase a range of ... National Association for Assisted Living (NCAL) Convention and Expo to be held October ...
(Date:10/12/2017)... Wis. (PRWEB) , ... October 12, 2017 , ... ... standard products to meet the demand of today’s consumer and regulatory authorities worldwide. ... of probiotic experts and tested to meet the highest standard. , These ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... leader in post-acute health care, have expanded their existing home health joint venture ... , AccentCare has been operating a joint venture home health company with Asante, ...
Breaking Medicine News(10 mins):