Developing treatments for chronic diseases
 

Hillsboro doctor develops new experimental diabetic neuropathy treatment

Highland County Press Dr. Amol Soin, Medical Director of the Ohio Pain Clinic, with an office in Hillsboro, has announced the development of a treatment for diabetic neuropathy pain. Dr. Soin and his team filed a patent last February for an investigational, non-addicting/sedating pill and filed an Investigational New Drug Application with the FDA in December 2014, paving the way for clinical tests to be done locally starting within a few months. A co-inventor of this medication, Dr. Soin points out that over 300 million people worldwide suffer from diabetes, and this number is expected to grow by over 50 percent by 2035. News reports note that the diabetes epidemic shows no signs of slowing in the United States and around the world. This new pill features enteric-coated, time-released sodium nitrite, which stimulates blood vessel growth and has been shown in a previous study to significantly reduce pain in patients suffering from diabetic neuropathy without being addicting or sedating. With the rise of drug abuse and addiction in patients who take narcotics for relief of their symptoms, having an option to treat neuropathy with a new modality could potentially change the entire paradigm for pain treatment. By stimulating blood vessel growth in diabetics, the drug has added advantages of helping increase blood flow to the feet which may aid in wound healing, diabetic foot ulcer prevention and may prevent damage/limb loss which often occurs in diabetics by improving circulation. It has been described as “a novel therapeutic approach,” and preliminary testing has been very encouraging and has highlighted the potent effect and benefits of nitrite therapy. The upcoming trial...

Dayton-area entrepreneur on cusp of ‘billion-dollar’ product (Exclusive)

by Tristan Navera Dayton Business Journal – Febuary 4, 2015 Dr. Amol Soin is setting his sights on a new drug with immense potential for pain relief. It also has huge potential for helping to create the next billion-dollar company in the Dayton region. Soin, who is head of Centerville-based Ohio Pain Clinic, is part of a team of physicians developing a drug that treats diabetic neuropathy pain. Soin and his team filed a patent last February and filed an Investigational New Drug Application with the U.S. Food and Drug Administration in December, paving the way for clinical tests to be done locally starting within a few months. If the results continue to be encouraging, the drug could be introduced on a national scale. And it could have a major effect. About 300 million people worldwide suffer from diabetes, a number expected to grow to 450 million by 2035. “It’s got the potential to be a $1 billion-a-year drug,” Soin said, noting major national drugs intended to treat pain, like Lipitor and Lyrica, exceed $1.5 billion a year in sales. The drug Soin co-invented features enteric coated, time-released sodium nitrite, which is intended to stimulate blood vessel growth and has been shown in early tests to reduce pain in patients with diabetic neuropathy, but it is not a narcotic or a sedative. “A non-narcotic, non-sedative, non-addicting drug to treat pain – really could be the holy grail,” Soin said. “I think this will be a real game-changer. For far too long we have been treating pain with addicting narcotics and finally we will have an option that treats the...

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

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...

TheraVasc’s clinical trial of PAD drug shows safety in diabetic patients

A phase 1 trial of a peripheral artery disease drug candidate from TheraVasc demonstrated safety in diabetic patients. The positive clinical trial data reported by Cleveland-based TheraVasc potentially puts the young company one step closer to a development partnership with a big drug maker or a venture round between $10 million and $20 million. The company will likely need to achieve one of those milestones to continue funding expensive trials of the drug, known as TV1001. The single-dose, 12-patient phase 1 trial was intended to assess safety and blood levels of the drug. “Few” adverse events were reported, according to a statement from TheraVasc. The company is reformulating a drug — sodium nitrite — for the treatment of peripheral artery disease (PAD), a condition in which narrowed arteries reduce blood flow to the limbs. The condition often afflicts diabetics and can result in the amputation of patients’ feet. Advertisement TheraVasc plans to complete a phase 2a clinical trial this year. In addition to measuring the drug’s safety and tolerability, the phase 2a trial’s design calls for assessments of vascular integrity in patients, along with their walking abilities and quality of life improvements at the end of the trial period. Animal studies have shown the drug to lead to the generation of new blood vessels in oxygen-deprived limbs, improvement in wound healing and inhibition of tissue necrosis, according to the statement. “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,” CEO Tony Giordano said. TheraVasc...

Startup Stories: A Race for Better Healing Therapies

Tony Giordano / President & CEO of TheraVasc – I am a molecular biologist with a Ph.D. from Ohio State University, and a serial entrepreneur, having started several venture-backed biotech companies in Pennsylvania. I founded TheraVasc two years ago in Cleveland, OH because I want to bring a promising new therapy from the lab to the marketplace.  My team of a dozen leading researchers and clinicians from around the country is developing a drug that has the potential to increase new blood vessel formation and promote wound healing when used continuously at very low doses, which could have major benefits for diabetic patients with limb problems and patients with peripheral artery disease. In fact, once the research that was done on this drug at Louisiana State University was published, it became very clear that there was a tremendous unmet medical need. We received calls from across the country inquiring about where to obtain the drug, including one from an 84-year-old woman in Shreveport. She had been ranked 7th on the U.S. tennis circuit in her youth, had walked a mile a day when she was 80, but now, because of peripheral artery disease, she couldn’t even walk down to the mailbox without pain. This is exactly the kind of person we’re trying to help, but unfortunately, the only way we can currently administer the drug is an injectable formulation at doses that are unsafe for the continuous use required for treating vascular diseases. Given the need for truly effective therapies and the properties of this drug, we set up TheraVasc to extend the work initiated at LSU Health Sciences Center to develop a...
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