| Return Of North-American Rights And Approval Of Clinical Development Plan |
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Return Of North-American Rights And Approval Of Clinical Development Plan For RP101 In Advanced Pancreatic Cancer Patients By European AuthoritiesDresden/Germany, June 28, 2011 – RESprotect announces today that it has received back the North-America rights for RP101, RESprotect's anticancer drug with proven efficacy to combat chemoresistance and improve chemosensitivity, from its former North American partner. In addition, RESprotect has gained approval from German Authorities for the adapted development plan of RP101. According to this plan, development of RP101 will be reinitiated still in 2011 to proceed into a pivotal phase IIb study with late-stage pancreatic cancer patients soon. It was further reiterated by the German Authorities that this pivotal study could be sufficient to file for marketing authorization in the EU. RESprotect is currently aiming for strategic partnerships to develop and market RP101 in pancreas carcinoma and follow-up indications on a worldwide basis. Historic clinical development of RP101: RP101 has demonstrated its potential to enhance survival of pancreatic cancer patients in several human clinical studies. 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. In brief, above a certain BSA threshold (which relates to a certain body weight), co-treatment with RP101 provides a strong and meaningful survival benefit. "We observed a significant trend between a rising body surface area (BSA) and the enhancement of survival after RP101 treatment," said Prof. Rudolf Fahrig, Chief Executive Officer of RESprotect. „In one subgroup we observed an even statistically significant enhancement of survival after treatment with RP101. This clearly demonstrates that the pharmacodynamic interaction between RP101 and gemcitabine has to be addressed in an appropriate manner - RP101 has to be dosed depending on the BSA like other anticancer drugs. This fact will be the basis for future pivotal clinical trials with RP101 to enable market approval soon". Details of the analysis and the main characteristics of RP101 have been accepted for publication by the “Journal of Cancer Research and Clinical Oncology” and will be available soon. About RP101: RESprotect is developing RP101 for the treatment of pancreatic and other cancers. RP101, given in a combination with chemotherapy, is able to inhibit chemoresistance thereby maintaining sensitivity against chemotherapy. RP101 is the first small molecule known which specifically binds to heat shock protein 27 (Hsp27) and inhibits its effects in establishing cancer chemoresistance. Recently, RP101 was granted Orphan Drug designation for the adjunct treatment of pancreatic cancer by the FDA and the EMA. About RESprotect: RESprotect GmbH is a privately owned Biotech Company located in Dresden/Germany. RESprotect is focusing on building a strategic alliance for the final clinical development and market introduction of RP101, a first-in-class small molecule addressing chemoresistance in human cancers with initial focus on pancreatic carcinoma. Both together, the SME (small and medium enterprise) status of RESprotect and the orphan drug status of RP101 will facilitate an accelerated approval at low costs.
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