The overall objectives of the SIMECOS project is to chemically design, optimize manufacturing, validate through clinical trial and bring to market the SIMECOS™ product: A nutraceutical for cancer patients derived from T-ChOS™ molecules. Genis had planned the project to complete technical, legal and commercial activities needed to ensure a success entry into the market of the SIMECOS™ product. Technically, we designed, manufactured and characterized the SIMECOS™ product. Optimization on the SIMECOS™ production line has been carried out and scale-up is finished. Legally, we carried out toxicology studies based on requirements for approval of Health Claim by the EC (EFSA) and filed two new patent applications. The original plan was to execute the clinical validation of SIMECOS as an adjuvant to chemotherapy for lung, breast and pancreatic cancer, in collaboration with Herlev Hospital in Denmark. During 1st period of the project, the expected lung and pancreatic adjuvant therapeutic of clinical studies were cancelled due to changes in therapeutic regime unrelated to the SIMECOS project. Breast cancer clinical trial was executed according to plan, however, as recommended by Herlev Hospital based on power calculations, number of patients was increased up to 400 in order to get statistically reliable results. The pandemic COVID-19 had a major impact on our breast cancer clinical trial, subcontracted to Herlev Hospital. COVID-19 was set to top priority at the Hospital and our breast cancer study was temporarily stopped because of the situations that arose in the Hospital. Due to this increase in number of patients and COVID-19, the clinical validations could not be finished before the end of the SIMECOS project, and thus, no clinical results are available from the project. However, the breast cancer clinical trial is currently ongoing and we have planned to prepare a new grant application with the breast cancer clinical trial with increased number of patients.
During the project, we have updated our SIMECOS™ webpage and investigator brochure alongside the projects progress, and prepared scientific articles to present our solution to stakeholders, European specialists, and cancer patients where we share results and explain benefits to our target end-users. One of the key aspect of the original commercialization plan was to use the outcome of clinical trials to market the SIMECOS™ product through European specialists and clinics, starting in Herlev Hospital in Denmark, and to apply for a health claim with EFSA in order to facilitate direct-to-consumer marketing approach of the product. In collaboration with regulatory consultancy, Medfiles, we updated our market and commercialization plan according to the most suitable scenarios as needed underway with the projects progress. Given the delay of our clinical validation results, Genís has set up and is currently following an updated commercialization plan including 3 scenarios for the marketing of SIMECOS™ with the key goal to identify a commercialization strategy which allows a faster time-to-market of the product parallel to the clinical validation .
