Stan
AFAIK Prochymal is the same as Temcell - otherwise any changes would presumably have to be subject to a new clinical trial. I think MSB just reanalysed the data to demonstrate efficacy. I'm not sure about Temcell vs the product in the aGvHD trial.
Interesting to read the Australian TGA analysis (and rejection) of the Prochymal application:
Prochymal assessment
They recommended the application be rejected on the basis of:
"The failure of Study 280 (pivotal study) to demonstrate a statistically significant difference between Prochymal and placebo for the primary efficacy endpoint of complete response of ≥ 28 days duration in the overall ITT population (aGvHD Grade B/C/D): that is, 34.7% (60/173) and 29.9% (26/87), respectively, p = 0.423
The failure of Study 280 (pivotal study) to demonstrate a statistically significant difference between Prochymal and placebo for the secondary efficacy endpoint of overall survival > 100 days in the overall mITT population (aGvHD Grade B/C/D): that is, 52.1% (85/163) and 50.6% (41/81), respectively, p = 0.780
The failure of Study 280 (pivotal study) to demonstrate a statistically significant difference between Prochymal and placebo in the secondary efficacy endpoint of overall survival > 180 days in the overall mITT population (aGvHD Grade B/C/D): that is, 34.4% (56/163) and 42.0% (34/81), respectively, p = 0.274"
Cell Therapy News/Articles, page-45
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