The USA's Pharmion Corp and Germany-based GPC Biotech AG say that an expedited interim analysis of data from the Phase III study of their co-developed drug satraplatin will be conducted before the end of the second quarter of the year at the request of the trial's independent Data Monitoring Board.
Industry observers have been quick to note that the move cannot be interpreted as either a good or bad sign for the future of the platinum-based anticancer drug. Lehman Brothers' analsyts, who currently value GPC Biotech at 17 euros ($22) per share, say that, if the DMB urges the companies to immediately forward the data to the US Food and Drug Administration, it will raise the value to 20 euros per share. However, they noted that termination the trial would slash the share price to 3 euros.
Following the interim efficacy analysis in April, the DMB recommended that the SPARC trial continue as planned. Its focus then was progression-free survival, which remains the endpoint of the evaluation for accelerated approval in the USA, and is also the basis, along with supporting overall survival data, for clearance in Europe.
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