Pluristem Therapeutics, Inc. (PSTI) recently announced that the Indian Ministry of Health has given the company permission to conduct a phase II clinical trial for the treatment of thromboangiitis obliterans (Buerger's disease). The company intends to study placental expanded (PLX) cells for the effective treatment of Buerger’s disease.
Buerger's disease is widespread among Indians and is estimated to affect around 45%–63% patients suffering from peripheral artery disease (PAD). As per Pluristem, approximately 20 million people in India are afflicted by PAD, particularly smokers, among which 11 million are suffering from Buerger's disease.
Currently, there is no proper treatment available for this disease in India. As a result, the approval of the candidate for this indication will open a large market for Pluristem. The company plans to initiate a larger multi-national phase III study in the US, Europe and India, following the phase II trial.
Earlier this month, Pluristem’s PLX cell for the treatment of Buerger's disease was granted orphan status by the US Food and Drug Administration (FDA).
Apart from the Indian approval, Pluristem got approval from the Paul-Ehrlich-Institute, the medical regulatory body in Germany, for a phase I/II study with PLX cells. The randomized, double blind, placebo control study will evaluate the safety and efficacy of PLX cells for the regeneration of injured gluteal musculature after total hip replacement.
Moreover, in July this year, results from Pluristem’s new preclinical tests showed that PLX cells might be effective in treating interstitial lung disease.
Our Take
With no existing treatment available for Buerger's disease in India, the Indian Ministry of Health’s approval can be a good opportunity for the company. We expect investor focus to stay on the company’s progress with its pipeline.
We currently have a Neutral recommendation on Pluristem. The stock carries a Zacks #3 Rank (Hold rating) in the short run.
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