Double Bond Pharmaceutical (DBP) and The National Institute for Health Research (NIHR) in the UK have signed an agreement for support with an investigation of rapid study set-up and patient recruitment. The investigation will cover all phases of clinical studies in the UK for DBP project SI053 and include the whole range of services from reviewing protocols, site intelligence and site identification to study set-up and monitoring the performance of the sites. This Study Support Service provided by the National Institute for Health Research is free of charge.
“United Kingdom is known for its clinical expertise and is a very important market for our candidate SI053. Therefore, it would be an advantage to include UK clinical centres in coming trials, – comments Igor Lokot, CEO at DBP, – We are very happy to get support from NIHR to be able to conduct coming trials in UK in the most efficient way”
More about The National Institute for Health Research and Study Support Service Summary
More about SI-053
Temodex, which is a locally acting formulation of temozolomide developed by RI PCP in Minsk, Belarus, is registered for marketing as the first-line treatment of glioblastoma within Belarus since 2014. Temodex was acquired by DBP in autumn 2015 and is now being prepared to pass through all the tests and trials required for registration within the EU and globally. The product has a working name SI-053 in DBP pipeline.
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DBP is a pharmaceutical company with the primary focus on development of therapies against cancer based on the company’s own developed drug delivery technology BeloGal®. The company was granted Orphan Drug Designation status by European Medicines Agency (EMA) in June 2015 for its first product, SA-033, for treatment of hepatoblastoma. Double Bond Pharmaceutical acquired rights to Temodex, a drug registered in Belarus for treatment of brain tumours, in October 2015, and was granted Orphan Drug Designation status by EMA for in July 2016 for this formulation of temozolomide for the treatment of glioma. The formulation is now being further developed for registration in EU and globally and has a working name SI-053 in DBP pipeline.