Pluristem Therapeutics, Inc.
) 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
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.
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.
PLURISTEM THERA (PSTI): Free Stock Analysis
To read this article on Zacks.com click here.