Mercator MedSystems Awarded Third NIH Grant
Phase I SBIR Grant to Develop Innovative Sirolimus Anti-Restenosis Therapy for Peripheral Artery Disease
SAN LEANDRO, Calif., August 10, 2010 — Mercator MedSystems announced today that it has been awarded its third small business grant from the National Institutes of Health, a grant that will help Mercator MedSystems develop a therapy to treat arterial restenosis in patients with peripheral artery disease (PAD), using adventitial delivery of the well-known anti-restenotic drug sirolimus.
Mercator will use its FDA-cleared catheter to deliver drugs to the adventitia, the tissue surrounding the artery that becomes inflamed after PAD treatments. Mercator’s Bullfrog® Micro-Infusion Catheter deploys a single microneedle through the vessel wall, allowing direct therapeutic access to the adventitia. Sirolimus prevents restenosis by inhibiting cell proliferation in the adventitia, a critical step in the buildup of re-occlusive tissue. The combination of effective drug with efficient delivery to the adventitia is expected to lead to a successful and elegant method to limit restenosis.
This Phase I award from the National Heart, Lung and Blood Institute within the NIH will also allow Mercator MedSystems to compete for more than $1,000,000 in Phase II funding. A Phase II project would fund more extensive research and development, including human clinical trials to prevent PAD restenosis with adventitial sirolimus therapy.
Mercator’s two previous Phase I awards from the NIH have been used to study the development of an adventitial therapeutic solution for failing dialysis grafts and fistulae, the lifeline of patients on hemodialysis, and to develop catheters able to inject chemotherapeutic drugs into the adventitia of airways for the treatment of bronchial carcinoma. Preclinical success with each of these previous research projects has qualified Mercator to apply for additional Phase II awards to continue development of these life-saving therapies.
About Peripheral Artery Disease (PAD)
Western societies have experienced a dramatic rise in the prevalence of PAD due to the epidemics of obesity, insulin resistance, and diabetes mellitus. This is a significant public health burden, affecting 9 million to 12 million Americans. Peripheral artery disease impairs the ability to walk and causes pain, nonhealing ulcers and gangrene in the lower extremities. At its worst PAD can lead to foot or leg amputations. For the 1.5 million individuals most severely affected each year, the most effective therapy is to open the arteries of the lower extremities and restore circulation. However, due to tissue buildup and re-closure of the artery (restenosis), only one-third of patients have sufficient blood flow through their femoral artery one year after balloon angioplasty. Bare metal stents are prone to fracture and only extend patency to 30% at 2 years, and drug-eluting stents have fared no better than bare stents in limiting restenosis. Drug-coated balloons inefficiently deliver drugs to the blood vessel wall and can lead to drug coatings flaking off of the balloon, occluding or damaging downstream vessels. To date, there has been no safe and effective pharmaceutical strategy to reduce restenosis in peripheral arteries.
About the Cricket™ and Bullfrog® Micro-Infusion Catheters
The patented, proprietary and FDA-cleared Bullfrog® and Cricket™ catheters deliver drugs directly to the adventitia, an active tissue layer surrounding blood vessels, airways, urethra and other body lumens. The catheters can be guided to a target deep within the body, where a balloon is inflated with low pressure so that it touches but does not damage the vessel wall. Inflation of the balloon safely slides a microneedle through the vessel wall, where agents are delivered and diffuse to bathe the vessel cylindrically (circumferentially, longitudinally and transmurally). The effect creates a unique tissue-based drug-eluting reservoir, treating disease by leveraging the adventitia’s biological properties. Delivering drugs through the blood vessel wall into the perivascular space and adventitia allows for direct, highly controllable and concentrated treatment, minimizing the toxicity of systemic administration, while avoiding the dilution of drug in the bloodstream. This reduces or eliminates drug side effects, increases therapeutic effectiveness, decreases the cost of medical treatments and improves patient quality-of-life outcomes.
About Mercator MedSystems, Inc.
Mercator MedSystems, Inc., a privately-held medical device company headquartered in San Leandro, Calif., is developing targeted safe and effective therapies that reduce the expense of treating disease. Mercator is integrating the FDA-cleared Micro-Infusion Catheter with new and repurposed biotherapeutic agents to meet life-threatening medical needs in hypertension, cardiovascular disease, oncology and regenerative medicine. Mercator catheters are also used by several pharmaceutical and biotechnology companies to aid in the development of therapeutics that benefit from the direct targeting and efficiency of site-specific delivery.
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