Researchers at the EVMS Strelitz Diabetes Center are part of a U.S./Canadian team of investigators that has received a $3 million NIH grant to study a potentially revolutionary treatment for diabetic neuropathy.
The Principal Investigator for the EVMS site is Elias S. Siraj, MD, Chief of Endocrine and Metabolic Disorders, the David L. Bernd Distinguished Chair for Cardiovascular and Diabetes, Associate Dean for Clinical Research and Director of the EVMS Diabetes Center. His co-investigators are Henri Parson, PhD, Associate Professor of Internal Medicine and Director of Microvascular Biology; and Carolina Casellini, MD, Assistant Professor of Internal Medicine.
The EVMS scientists collaborated with the University of California – San Diego and the Canadian drug development firm WinSanTor to land the NIH-NIDDK Small Business Innovation Research (SBIR) grant. The EVMS team has received about $1 million to conduct the “phase 2” clinical study of the medication Pirenzepine for neuropathy. EVMS is the sole site for the study of this medication in the U.S.
The joint nature of the grant — one shared by an academic institutions and a private company — is an exciting development for EVMS, according to William Wasilenko, PhD, Vice Dean for Research.
“I applaud Dr. Siraj and his team for their role in this innovative research collaboration that has the potential to advance diabetes care in our region,” Dr. Wasilenko says.
There are currently no FDA-approved drugs for preventing the progression of diabetic neuropathy. Current therapeutic options for patients are limited to tight control of blood sugars and the use of pain medications that provide temporary relief. Pirenzepine is one of the first medications to target nerve regrowth rather than just treat pain.
“This can be a game-changer, and we are very excited to continue our work on nerve regeneration,” Dr. Casellini says.
Neuropathy is the most common complication of type 2 diabetes and has been a key focus of the EVMS Diabetes Center for decades. Aaron Vinik, MD, PhD, former Director of Research at the center and a world renowned pioneer in neuropathy treatments, collaborated with Nigel Calcutt, PhD, a basic science researcher at the University of California – San Diego, in the development of new compounds for the treatment of this disease.
In a pilot study of Oxybutinin (a similar “muscarinic antagonist”) done in cooperation with the University of California – San Diego, Dr. Vinik and his team found good results among the study’s 46 patients in terms of nerve regrowth, a reduction in pain and improved quality of life.
“We are very excited that we can build on the diabetic neuropathy research that Dr. Vinik pioneered for decades,” Dr. Siraj says, “and be able to investigate pirenzepine as a novel agent to treat neuropathy.”
Pirenzepine is not a new drug. It was developed a number of years ago to treat ulcers. It has been reformulated for topical use, and research has shown its potential to regrow nerves in animal and human pilot studies with a very good safety profile, according to the researchers.
The new study will involve the topical gel form of Pirenzepine. Once daily for six months, participants will rub the gel on their legs and feet where neuropathy most commonly occurs. The study is seeking to investigate the drug in over 100 participants.
There are a number of neuropathy treatments on the market, but none like Pirenzepine.
“Most current medications only to treat the symptoms,” Dr. Parson says. “So, they treat the pain but not the underlying disease.”
Diabetic neuropathy is not only uncomfortable, it also can be dangerous. Patients often report their feet and toes become numb, and they can lose their ability to sense temperatures. This can ultimately lead to skin ulceration, infections and amputations.
Dr. Parson recalls a patient who could not sense that her bath water was too hot. She burned her legs and feet.
“It’s not just pain, it’s not just numbness or tingling,” she says. “It affects everything we do.”
To participate in the research, contact the EVMS Strelitz Diabetes Center at 446-7933 or by email: DiabetesResearch@evms.edu.