(Tromsø 13 November 2018) Biotec Pharmacon’s (OSE:BIOTEC) subsidiary Biotec BetaGlucans has renewed the clinical trial agreement (CTA) with Memorial Sloan Kettering Cancer Center (MSK) to cover the full study period for the ongoing clinical trial called «Phase I/II Trial of a Bivalent Vaccine with the Immunological Adjuvant OPT-821, in Combination with Oral ß-glucan for High-Risk Neuroblastoma”.
The clinical trial combines the use of a Memorial Sloan Kettering developed therapeutic vaccine against high-risk neuroblastoma in children with the use of Biotec BetaGlucans’ immunomodulatory product Soluble Beta-Glucan (SBG®). The CTA regulates the obligation of supply of study drug from Biotec to finalise the study, the obligation for MSK to provide Biotec with study data as well as how intellectual property rights arising from the study shall be handled between the parties.
The study has per end of October 2018 accrued 200 patients and has now been expanded to treat up to 260 patients having high-risk neuroblastoma. In the expanded and now randomised study, patients will either continue to be given SBG from week 6 after the 3rd vaccination, or from start of the vaccine treatment in order to investigate if SBG could induce an earlier adjuvant effect to the GD2 cancer antigen. The additional 60 patients are expected to be recruited to the study protocol by end of 2019.
“Neuroblastoma is a devastating disease and we are proud to be associated with research into finding treatment options for it. We are equally excited to extend our long-lasting relationship with Memorial Sloan Kettering Cancer Center, and look forward to follow the progress of the study”, says CEO Christian Jørgensen