Pharmaceutical Business review

Pluristem wins approval for Phase II Buerger’s disease trial in India

The Phase II trial will be potentially followed by a larger multi-national Phase III study in the US, Europe and India, according to the company.

Pluristem chairman, president and CEO Zami Aberman said the company is beginning Phase II study for the treatment of Buerger’s Disease in India.

"The information gathered in this trial will be a valuable step towards our goal of successfully developing a PLX cell-based product for the treatment of the entire spectrum of peripheral vascular diseases," Aberman added.

Buerger’s Disease is highly prevalent in India, particularly high among smokers, affecting approximately 45% to 63% of the patients who have peripheral artery disease.