Support for Eurostar application submission: SALMON ROE EXTRACT WOUND HEALING

Eurostar: Regenics has done initial feasability pilots to prepare for a first human clinical trial with VERNEX and planned first patient is in January 2015. If succesfull the Eurostar project will contribute to fund 2 small phase II studies on skin and oral mucosa, supported with an ex-vivo human skin model. The indication or target product claim (TPC) and thus the target population will be adults, where the testing model will be for the first study a contralateral forearm testing protocol, with n=12 s ubjects. For the oral mucosal project adults with oral cavity sores, such as mouth ulcers will be tested, either in an micropuncture wound model or with oral aphtous sores. A n= 20 subjects in a two arm double-blind study with an inert protein control is planned. As VERNEX is considered completely safe, (there are no sensitization or irritation reported so far, its non-allergenic) , inclusion of this wound healing ingredient in a testing protocol for treatment of oral conditions and on human epidermis is a priori expected to carry no side effects concerns. Regenics AS has patented the use of embryonal protein extracts from unfertilized salmon roe in biological applications. Patents include wound healing PCTIB 2007003266 PCTIB2009005836 PCTIB2011001488. 6 patents have been granted (US, AU, CA, RU) and the company holds 12 pending applications. The business model also have generated an ingredient for the vast cosmetics market (LEX), that can eneble funding of the R&D development . In 2014 the company h as signed exclusivity contracts for delivery of extract a.o. to a large listed (OSE) company, for delivery > 100 kg material. The company is thus in commerfcial phase to support the R&D of the wound healing indication.