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Clinical Trials : Critical Limb Ischemia

Executive Summary

Stempeucel® is a Phase III ready, allogeneic, cultured, pooled, off-the-shelf, bone marrow derived mesenchymal stromal cell ("MSC") product. Stempeucel® is being developed for the treatment of Non Atherosclerotic and Atherosclerotic Critical Limb Ischemia. In 2017 DCGI (Indian FDA) granted limited marketing approval of Stempeucel® product sales for the treatment of CLI patients due to Buerger's disease (Form 46).

Disease overview

CLI is the most serious form of Peripheral Arterial Disease (PAD). PAD patients have severe blockage of the arteries of the lower extremities, leading to markedly reduced blood-flow and ulceration, often leading to lower-limb amputation. Worldwide there are about 25 million patients affected with CLI, yet there are no effective therapies. Mortality rates are very high - the 5 year mortality rate is 67%. Overall, approximately 40% and 50% of CLI patients will lose their leg within 6 – 12 months and approximately 15% will require contralateral amputation within 2 years.

US Disease Burden

Note that the cost per patient of $150K is cost of amputations. It does not account for the cost of pre-amputation treatment and post-operating care.

Product Overview

Stempeucel® is a first of its kind allogeneic, MSC therapy. It is produced by pooling bone marrow-derived MSC's of healthy individuals through a proprietary, patented process. Research conducted at Stempeutics has shown that pooling balances out variations observed with individual donor cells, resulting in a product with strong immune-modulatory properties, broader cytokine / growth factors array, longer lifespan and consistent clinical outcomes. Pooling underpins the clinical success demonstrated by Stempeucel®. Stempeucel® works thru' anti-inflammatory & immuno-modulatory properties and by inducing angiogenesis in ischemic muscle – ultimately leading to improvement in all the clinically relevant endpoints for CLI

Overview of efficacy in CLI

Stempeutics conducted the largest ever Phase II CLI trial in no-option patients with Buerger's disease (n=90)

Stempeucel® demonstrated statistically significant results in cell arm (2million/kg body weight) patients for all critical endpoints:
     Improved rate of ulcer healing
    Improved rest pain
    Increased Ankle Brachial Pressure Index (indicator of blood flow due to vascularization)
    Improvement in Quality of Life

Stempeucel® was well tolerated with no drug-related serious adverse events

Phase II results were consistent with outcomes from an earlier double-blinded, placebo-controlled Phase I trial in 20 patients

Commercial Potential

Stempeucel® offers significant benefits for vascular as well as other regenerative diseases, and has the potential to become a global blockbuster therapy that provides patients with a much needed therapeutic benefit

With no other allogeneic pooled MSC therapy in development, Stempeucel® is expected to re-define the treatment landscape for CLI