prochymal® significant survival benefit!

Now that's worth cheering about... these patients have gone from 26% to 75% survival rate!! The relevant agencies can't ignore that result. Product approval will have to be fast tracked IMO.... The news keeps flowing.... re-rate imminent surely...

Key findings in the trial were:
? At day 28, 61% of patients were responders to Prochymal® (improvement in at least one grade of organ involvement).
? Responses to Prochymal® were seen across all disease grades and involved organs.
? In 87% of patients, no new therapy for acute GVHD was introduced after Prochymal® therapy.
? Response at day 28 to Prochymal® therapy was a significant predictor of improved survival at day 100.
? Day 100 survival was 76% in Prochymal® responders, compared to 28% in non-responders (p value <0.001, log rank test).
? Excellent safety profile with only 2 reactions reported across more than 500 MSC infusions, and no hematologic or renal toxicity, which is commonly seen with other approaches to prophylaxis against or treatment of acute GvHD.
Mesoblast Chief Executive Silviu Itescu said:”For these children, no other effective therapy exists. Seeing these very encouraging results with respect to response and survival rates following Prochymal® therapy, Mesoblast plans to analyze the existing data set generated under the Expanded Access Program and engage with the regulatory authorities in major jurisdictions as early as possible to discuss product approval options.”