Meeting with management of Pluristem Therapeutics Print E-mail
By Ray Dirks   
Friday, 21 January 2011 01:53
I  had breakfast with management of Pluristem Therapeutics (NASDAQ: PSTI) yesterday and the discussion turned towards the next indication the Company will focus on using their proprietary PLX cells. PLX cells are placental-derived mesenchymal stromal cells grown via a proprietary three dimensional (3D) technology.  Pluristem is actively working on the use of PLX cells for Intermittent Claudication (IC) where a Phase II trial will begin in the spring and Critical Limb Ischemia (CLI) where a Phase II/III trial will begin in the fall. 

The Company indicated that their PLX cells are essentially a sophisticated drug delivery vehicle for diseases where there is an “ischemic/inflammatory” element. The Company is considering neuropathic pain as a next indication after PAD because neuropathic pain has a significant “ischemic-inflammatory” element, PLX cells have shown to be extremely effective for neuropathic pain in animal studies, the cells can be easily injected locally for this indication, and the Company can go immediately into Phase II clinical trials.

Neuropathic pain is a chronic condition caused by inflammatory diseases such diabetes, viral infections and chemotherapy. The market for neuropathic pain has been estimated to increase from $6 billion in 2008 to $9.7 billion in 2018 worldwide.

My hypothesis is that Pluristem’s PLX cells may be able to fill the void in the neuropathic pain market created by the failure of anti-nerve growth factors.  On December 28, 2010, it was announced that the U.S. Food and Drug Administration (FDA) notified Johnson & Johnson (NYSE:JNJ) that the development program for their drug fulranumab had been put on hold over concerns that this drug and others in the class of compounds categorized as the anti-nerve growth factors (NGF) may be associated with a condition representing either rapidly progressive osteoarthritis or a disease known as osteonecrosis. These conditions may result in the need for total joint replacement. Similar drugs in this class that are under development by AstraZeneca PLC (NYSE:AZN) and Regeneron Pharmaceuticals (NASDAQ: REGN) have also reportedly been put on hold.

Pluristem’s PLX cells treat neuropathic pain via a different mechanism of action than nerve-growth inhibitors, acting by secreting a blend of therapeutic proteins in response to signals sent by inflamed, ischemic tissue. Pluristem, together with its scientific collaborators and experts in the field, have performed preclinical studies in two animal models of inflammatory and neuropathic pain.  Inflammation was induced via chemicals in a rat model and PLX cells were injected locally into the inflamed area two days later with pain levels assessed daily. A second model involved a chronic constriction injury (CCI) of the sciatic nerve in the mouse where PLX cells were subsequently injected. The results of these experiments showed that treatment with Pluristem’s PLX cells had a dramatic beneficial effect on pain. In the first model, animals injected with PLX cells achieved a reduction in pain, which was achieved and maintained longer than with standard opiate treatments. In the second model, PLX cells injected at the nerve injury site attenuated both mechanical and thermal sensitivity.

These studies suggest that Pluristem’s proprietary PLX cells can be a viable new therapy for the treatment of neuropathic and inflammatory pain. PLX cells may fill the void in the development of new products for neuropathic pain and ergo, my recommendation.

Disclosure: No Positions



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