Peripheral Ischemia

A Gene Therapy Opportunity Utilizing Mirus Bio's Pathway IV ™ Delivery Technology

Medical Need

Peripheral ischemia is a condition in which reduced blood supply to limbs causes claudication (cramping), chronic pain, and in extreme cases loss of limb. The disease occurs in ~12% of the U.S. adult population or ~8-10 million people. The illness is common in diabetics and the elderly, where up to 20% of those over age 70 experience intermittent claudication¹. The disease is managed in its early stages by control of risk factors, exercise therapy and pharmacological treatment (pentoxifylline or cilostazol). As cases advance, interventional procedures such as balloon angioplasty or vascular surgery may be utilized. Approximately 20-30% of patients with critical limb ischemia cannot be treated and lead to amputation², which impacts 50,000 patients annually in the U.S.³

Product Description and Rationale

Mirus’ treatment strategy is based upon delivery of a gene(s) encoding an angiogenic factor to the affected limb, thus inducing revascularization of the limb. The product candidate will be comprised of plasmid DNA encoding the selected gene(s), administered by Mirus’ Pathway IV ™ delivery technology to a localized region of the patient’s leg skeletal muscles. The clinical objective is to reduce ischemia and to delay or prevent loss of limb, thereby enhancing the patient’s quality of life.

Partners

Independent

Development Status

The program is in research. Mirus is currently evaluating various candidate angiogenic genes in model systems. Please contact us for more information.

References

¹ Regensteiner et al. 2002 Treatment of Peripheral Arterial Disease. Clinical Cornerstone 4(5): 26-40
² Rissanen et al. 2001 Gene therapy for therapeutic angiogenesis in critically ischemic lower limb – on the way to the clinic. European Journal of Clinical Investigation 31, 651-666
³ Messina et al. 2002 Therapeutic angiogenesis for critical limb ischemia: invited commentary. Journal of Controlled Release 78, 285-294