Celtic Pharma Terminates Transmid Trial KSB311R/CIII/001
BERMUDA, LONDON, and NEW YORK Feb. 7, 2007 – Celtic Pharmaceutical Holdings LP (“Celtic Pharma”), the global private equity fund focused on the biotechnology and pharmaceutical industries, announced today the termination of trial KSB311R/CIII/001 of its investigational new drug Transmid.
Celtic Pharma has been undertaking a clinical trial of TransMID in patients with progressive and recurrent non-resectable primary glioblastoma multiforme, designed to determine whether two intratumoral administrations of TransMID improve overall patient survival compared to Best Standard of Care. At the end of 2006, ahead of incurring significant planned expenditure in 2007, Celtic Pharma undertook a conditional power analysis. The aim of this analysis was to evaluate, on the basis of the first one third of events, the probability of the TransMID treated patients achieving the study’s targeted increase in survival at study end, as defined in the protocol.
The completed analysis showed that it was extremely unlikely that TransMID would meet the trial criteria for efficacy. Accordingly, Celtic Pharma has decided to terminate the trial and further clinical development of TransMID on commercial grounds. The trial Data Monitoring Committee has independently recommended to Celtic Pharma and the Trial Steering Committee that the trial be stopped on medical grounds.
“Celtic Pharma has the advantage as a private equity firm of not being subject to external pressures to continue with programmes whose risk/reward profiles are shifting in the wrong direction. It is an integral part of our investment philosophy to act on failing products early in order to shift resources to more promising programmes in our portfolio”, commented Stephen Evans-Freke and John Mayo, Celtic Pharma’s Managing General Partners.
TransMID is a product which consists of a modified diphtheria toxin conjugated with transferrin. Transferrin receptors are over expressed on the surface of the cells of primary gliomas. TransMID was designed to be selectively toxic to tumour cells, by being internalized before activation of the toxin. Celtic’s indirect subsidiary, Xenova Limited, acquired TransMID through its acquisition of the listed UK biotechnology company, KS Biomedix Holdings PLC (KSB), in August 2003. Transmid was KSB’s lead oncology product and was in Phase III trials for the treatment of high grade glioma. It was partnered with Sosei for Japan, Nycomed (Europe), Ranbaxy (India) and Medison (Israel)...
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Posted: February 2007