Pluristem has announced its pivotal Phase III clinical trial to treat critical limb ischemia received clearance from regulatory authorities in the United States, United Kingdom and Germany. Based on these clearances, the Company expects to begin enrolling patients in this study in the coming months.

Pluristem’s PLX-PAD cells will be evaluated in a double blind, randomized, placebo controlled trial in 250 patients.

The global market for treating critical limb ischemia is $12 billion globally. 1.7 million patients who live in world’s largest and most advanced pharmaceutical markets suffer from this limb-threatening and life-threatening disease. This number is expected to top 2 million in the next five years.

Pluristem’s critical limb ischemia program has been selected by the European Medicines Agency for its Adaptive Pathways pilot project. This allows for faster marketing approval in Europe after a single pivotal Phase III trial.

In the current Phase III trial, an interim analysis of data will be made for the first 125 patients, potentially leading to early marketing approval in Europe. Full enrollment is to be completed as planned to pursue full marketing approval in the U.S.

Regenerative medicines like PLX cells will have tremendous benefits on healthcare economics based on their efficacy and their non-invasive nature.

Can-Fite has reported that it is commencing patient recruitment in its global, pivotal Phase III trial of its lead drug candidate Piclidenoson in the treatment of rheumatoid arthritis.  The study, titled ACRobat, will enroll 500 patients in Europe, Israel and Canada.

The company reported drug supplies for trial have been manufactured and are ready for administration. The trial will have an estimated cost of $5 million, a modest cost when considering the global market for rheumatoid arthritis drugs is currently $38.5 billion.

Can-Fite’s drug is being developed as a first line therapy and replacement for the current standard of care, Methotrexate. Methotrexate is the most widely used drug for rheumatoid arthritis.

90% of rheumatoid arthritis patients receive Methotrexate at some point in their disease, but 40-50% of patients stop taking it after five years, due to its serious side-effects.

Over 1,000 patients have been safely treated with Piclidenoson, which has shown no series side effects and has proven to be safe. Piclidenoson can offer a superior alternative to Methotrexate for patients who need a safe and effective drug that can be taken long term.