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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - Simecos (A New Adjuvant Nutraceutical from the North Atlantic Ocean for Breast, Lung and Pancreatic Cancer Patients)

Teaser

Summary

Genis is a biotechnology company founded in 2005 in Iceland. We develop health products based on chitin-derived products made from the North Atlantic shrimp exoskeleton, which is a waste product of the fishing industry which we transform into a valuable product. Our economic activity is exclusively related to products from a natural marine source. All of our production processes are designed to ensure the highest product quality. Our policy when it comes to production is to deliver greater value to the local society with less input, using resources in a sustainable way while minimizing environmental impact.
Genisâ€™ approach to the nutraceutical market started with the development and commercialization of BenectaÂ®, the food supplement composed by T-ChOSâ„¢ molecules of short chain chitosan purified from shrimp exoskeleton. Genis obtained a purer T-ChOSâ„¢ composition derived from BenectaÂ® to develop the novel nutraceutical, SIMECOS, which will improve quality of life of cancer patients when combined with chemotherapy treatments.
In Europe, there are more than 780,000 patients diagnosed with breast, pancreatic and lung cancer per year. To alleviate the side effects of the current treatments for cancer, many patients turn to dietary supplements and nutraceuticals to control the symptoms of cancer, alleviate the unwanted side effects of certain therapies, preventing future disease, and aid in the treatment of current disease. However, it is good to note that none of them have advanced to the point of clinical trial validation as we reach with SIMECOS. The results of our extensive research in various biological models, in vitro and in vivo, strongly suggest anti-inflammatory, tissue protective activity, and enhancement of response to chemotherapy in selected cancer cell lines without any adverse effects, morbidity or mortality in these pre-clinical studies.
Because of these evidences, Genis will bounce into the nutraceuticals market with SIMECOS, the first nutraceutical used as an adjuvant in lung, breast and pancreas cancer derived from a marine natural source and the first nutraceutical with scientifically proved and clinically validated health benefits. With SIMECOSâ„¢, we will give response to the urgent need of better treatments to increase life expectation of these cancer patients, especially for lung and pancreatic cancer, and increased quality of life due to the reduction of side effects.

Work performed

The overall objectives of the SIMECOS project is to chemically design, optimize manufacturing, validate through clinical trial and bring to market the SIMECOSâ„¢ product: A nutraceutical for cancer patients derived from T-ChOSâ„¢ molecules. Genis has planned a 24 months project to complete technical, legal and commercial activities needed to ensure a success entry into the market of SIMECOS. Technically, we have already chemically designed, manufactured and characterized the SIMECOSâ„¢ product with specification drafted. Optimization on the SIMECOSâ„¢ production line has been carried out and scale-up is ongoing to increase productivity (in terms of batches per week). Production of the SIMECOSâ„¢ material for pharmacokinetic and clinical studies is finished and capsuling is ongoing. SIMECOS and placebo will be sent to Herlev Hospital for patient provision when capsuling is finished. Legally, we plan to carry out pre-clinical studies based on requirements for approval of Health Claim by the EC (EFSA). Commercially, we plan to entry first into the European market, so we have design a commercialization strategy to focus in this area to gain more commercialization agreements with different institutions. Two Scandinavian clinical centres, in Iceland and in Denmark, have already been visited. Attendance to international scientific meetings will contribute to present our solution to European cancer community. Genis will exert direct communication actions, such as presentations on congress, as well as joining related cancer associations and contact with cancer patientsâ€™ organizations. We have planned to attend to the 2019 World Cancer Congress (San Francisco, CA, USA, September 4-6 2019) and the European fair of Nutraceuticals Europe â€“ Summit & Expo in 2020, when we are closer to marketing the SIMECOSâ„¢ product.

Final results

We have developed methods to isolate and purify T-ChOSâ„¢ from chitin extracted from the exoskeleton of North Atlantic shrimps, using as raw material, a by-product of the fishing industry.
Genis has also developed a production line, which is located at SiglufjÃ¶rur. It is comprised of pharmaceutical grade stainless steel equipment and operated in a closed system with no connection to open air. There, the chitin biopolymer is chemically modified through controlled partial deacetylation; enzyme catalysed hydrolysis, and finally refined by series of filtration steps and spray dried to form SIMECOSâ„¢ powder.
Genis has conducted extensive biological evaluation of T-ChOSâ„¢ in various biological models, in vitro and in vivo. The results from these studies strongly suggest anti-inflammatory and tissue protective activity on cartilage and bone tissues in osteoarthritis, osteoporosis and rheumatoid arthritis and enhancement of response to chemotherapy in selected cancer cell lines.