E! 7090 Development of Foxy-5 as a potential drug against metastatic colon cancer.

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Work Package 3 (WP3) is supposed to be the first clinical trial of Foxy-5; in approximately n=27 colon cancer patients in a phase I setting. The aim would be to study initial safety and toxicology as well as pharmacology in humans, in order to pave the wa y for a proof-of-concept study. Partners in this WP would be University Clinics in either Copenhagen or Lund. Work Package 5 (WP5) POC study in mice, anti-metastasis effect of Foxy-5 on liver metastasis induced by colon cancer. Work Package 6 (WP6) wou ld be a complementary longer pre-clinical toxicology study assessing dose-response in rats and dogs, and according to GLP quality standards. A 4 week pre-clinical toxicology study in rats and dogs under GLP quality standard was performed the second half o f 2011. Work Package 7 (WP7) would then be the major clinical proof-of-concept study, currently supposed to include approx. 150 patients and where time to tumour progression would be an essential efficacy endpoint. Patients would be followed at least for 6 months. The overall approach will follow strict industry standards and International Conference of Harmonization (ICH) guidelines such as Good Clinical Practices. By following the ICH guidelines we ensure the highest degree of research structure, data integrity and regulatory as well as commercial acceptance. All research work will be undertaken according to Standard Operating Procedures. This again increases the chance of a qualified dialogue with regulatory authorities and a seamless development from clinical trials into marketing authorisation. Results will be published, and the study itself will be listed in www.clinicaltrials.gov. Other work packages would include regulatory advice meetings with European and national, and possibly other globally important, medicines agencies; manufacturing of clinical trial materials; bioanalytical tests either as stand-alone WPs or as integrated components of the above listed major WPs.