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news.Germany-based privately owned biotech company RESprotect has regained the North-America rights for RP101 from its former North American partner.
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RP101, a first-in-class small molecule addressing chemo resistance in human cancers with initial focus on pancreatic carcinoma, is to be given in a combination with chemotherapy.
Recently, RP101 was granted orphan drug designation for the adjunct treatment of pancreatic cancer by the US Food and Drug Administration and the EMA.
Further, RESprotect has gained approval from German Authorities for the adapted development plan of RP101, according to which RP101 development will be reinitiated still in 2011 to proceed into a pivotal phase IIb study with late-stage pancreatic cancer patients soon.
German Authorities reiterated that this pivotal study could be sufficient to file for marketing authorization in the EU.
A detailed meta-analysis of a recently performed double-blind phase II multicenter study initiated by RESprotect elucidated a direct correlation of ‘body-surface-area’ (BSA) and survival benefit after treatment of RP101 in combination treatment with gemcitabine.
RESprotect is focusing on building a strategic alliance for the final clinical development and market introduction of RP101.