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Racing for a CLI Treatment Option

With a number of Critical Limb Ischemia (NYSE:CLI) trials being initiated, the real race at this point will be to enroll sites and patients for these trials.


PSTI (PSTI.TA) said it will go solo in developing its stem cell therapy to treat severe obstruction of arteries that can lead to amputation, but will look for a marketing partner to launch the therapy.

“We do not need to raise money and PSTI has sufficient capital to complete the end of the Phase III studies,” states CEO, Zami Aberman. Pluristem had raised about $38M in a public offering, plans to start a Phase II/III trial in both EU and the US to treat critical limb ischemia (CLI) in the 2nd half of the year. PSTI believes their “treatment on demand” off-the-shelf product is crucial, since CLI patients require immediate treatment.

PSTI expects to sign a marketing deal before completing late-stage trials. “We have been approached by a variety of pharmaceutical companies interested in cooperating not only on CLI but (also) for additional indications like inflammatory bowel disease, multiple sclerosis and orthopedic indication. (HWM and Reuters)

The Bottom Line: PSTI’s allogeneic approach in processing stem cells from donors’ placenta enables the development of “off-the-shelf, or ready to use” treatment for CLI patients. Aastrom Biosciences (ASTM) who favors an autologous therapy to process stem cells from a patient’s bone marrow is still awaiting (10/10 filing) the FDA response to their SPA P3 approval to initiate CLI treatment.  Another ringer in the CLI treatment race is the FDA’s approval of Harvest Technologies’ (NYSE:HT) sponsored 210 patient IDE clinical trials to be conducted at 25 sites in the US using proprietary Bone Marrow Aspiration Concentrate (BMAC) System to also treat CLI patients. This pivotal study will enroll 210 patients with enrollment beginning early in Q2/11. Biomet Biologics and UC Davis are also launching a CLI stem cell study. This is an early phase trial, but the desktop application like Harvest’s resounds! There are currently no drugs approved by the US FDA for CLI. Experimental medicines of companies including Vical Inc (VICL.O) and Sanofi-Aventis (SASY.PA) failed late-stage trials. Mid-day, ASTM was trading down $0.01 (-0.45%) to $2.20 post approval of the special shareholder meeting increasing the outstanding shares for a potential financing with PSTI is trading down -$0.08 (-$3.12%) to $2.48 while Harvest and Biomet are private.