Written by Kymberlie McNicholas, Founder of The Way to My Heart
“It (the drug being studied) addresses the root cause of the problem attributed to PAD, which poor circulation in lower extremities,” explains Dr. Arshed Quyyimi. “By creating new collateral arteries, this drug can improve blood flow through the lower extremities without surgical intervention.”
As part of our ongoing Vascular Innovation Series in conjunction with The Way to My Heart, Emmy Award-winning Journalist Kym McNicholas interviews the Director of the Emory University Emory Clinical Cardiovascular Research Institute Dr. Arshed Quyyimi.
Walking can be a powerful medicine when it comes to treating Peripheral Artery Disease, a narrowing of the arteries in the peripherals, mainly the legs. Why? When a main artery is narrowed, walking can signal the body to form new routes for blood to flow to keep the leg nourished. Every step a person takes can help the body to facilitate the growth of what are called, “collateral vessels.” Some doctors call it a ‘Do-it-yourself bypass.’
What if a patient can’t walk more than a few steps or blocks due to the onset of pain? Doctors may try drug therapy which may include blood thinners, vasodilator agents, phosphodiesterase inhibitors, and statins to help improve intermittent claudication. Statins demonstrated the highest benefit in improving walking distance with and without pain in a systematic review of multiple drug therapy studies. But stains are not a cure for claudication and vascular specialists may end up offering surgical intervention as the next step, where risks are higher and long-term success rates vary. As the authors of that review stated, “…additional trials to develop therapies are needed.”
About a year after that study was published a relevant discovery was made by Emory University Researchers that found a drug currently on the market to stimulate stem cell production in Leukemia patients also stimulated the growth of collateral vessels, especially in the lower extremities. So, they set out to study the drug called granulocyte-macrophage colony-stimulating factor (GM-CSF) to see if it might improve the symptoms of Peripheral Artery Disease by increasing levels of the body’s vascular stem cells. They are in the middle of their Phase 2 clinical trial to determine the risks and benefits of the treatment. Emory University’s Clinical Cardiovascular Research Institute’s Director and Principal Investigator of this study, Dr. Arshed Quyyumi, talks about the importance of this discovery and the potential it might have to provide more minimally-invasive treatment options for patients with PAD.
What is the story behind the trial? How did it originate?
Experimental studies had shown that mobilization of stem cells from the bone marrow will benefit the growth of new blood vessels and improve circulation when the circulation is blocked or obstructed. We have conducted two previous studies with GM-CSF, a drug that stimulates the bone marrow to release stem cells, in patients with blocked arteries in the legs, a condition known as a peripheral arterial disease (PAD). The previous trials indicated some improvement in the walking ability of patients with PAD treated with GMCSF. This is a Phase 2B trial where will administer the drug twice, 3 months apart to see if there will be further improvement in symptoms in patients with PAD and claudication.
What need does it address?
It addresses the root cause of the problem attributed to PAD, which poor circulation in lower extremities. By creating new collateral arteries, this drug can improve Blood Flow through the Lower extremities without surgical intervention.
What is the potential for patient impact?
Patients with PAD can get pain in the legs when walking. The goal is improvement in symptoms. Many patients have had notable improvement. Here are a few words from our esteemed study subjects about the clinical trial:
A 64-year-old female who has been in the study for 4 months states, “My walking time has improved.” The exercise is helping her, and the Fitbit gives her motivation to walk. “The Study team is helpful, and they genuinely care about her condition.”
A 62-Year-old male Subject who has been in the Study for 3 months states, “I feel great.” Although the improvement of his symptoms is slight, he is very optimistic. “The study team is phenomenal. Very knowledgeable and explain everything very nicely. They are so courteous that it helps me a lot psychologically”.
Where is the technology in development and what is next for the company?
The Trial is in its phase 2B of human clinical trials. If successful, it will lead to a Phase 3 trial and we will file to get FDA approval for use in PAD.
How can patients or advocates get involved?
Contact our research coordinators (contact info provided) and we will review your medical history. After a detailed screening of your medical history to ensure safety protocols and to make sure you meet our Inclusion Criteria, we can enroll you in the study.
Here is the Website Link: http://www.eccri.emory.edu/gpad3.html
Anything else we should know?
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This interview was produced by The Way To My Heart in partnership with Vascular Cures. Neither The Way To My Heart nor Vascular Cures endorse any specific products, entrepreneurs, companies, organizations, drug or device trials, and/or healthcare professionals, including diagnosis or treatment programs. The information, advice, and views shared in this interview are that of the individual speakers and are offered for educational and informational purposes only.
This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Don’t act on any information provided in this interview without the explicit consent of your own healthcare provider who knows your situation best.
The safety and efficacy of the investigational use of the product discussed by Emory University’s Dr. Arshed Quyyumi has not been determined. There is no guarantee that the investigational use discussed will be filed with and/or approved for marketing by a regulatory agency.
If you think you are having a medical emergency, please go to the nearest emergency room or dial 911.
Momsen, A.H., et al. “Drug Therapy for Improving Walking Distance in Intermittent Claudication: A Systematic Review and Meta-Analysis of Robust Randomised Controlled Studies.” Journal of Vascular Surgery, vol. 50, no. 4, 2009, pp. 962–963., doi:10.1016/j.jvs.2009.08.014.