Double Bond Pharmaceutical reports that transfer of the sterilization process for the excipient in SI-053 has been completed with satisfactory results. The process has been performed by a contract sterilization company in the EU.
“This is an important step in the technology transfer process before manufacturing a GMP batch for our upcoming clinical trial”, says Igor Lokot, CEO at Double Bond Pharmaceutical.
This information is information that Double Bond Pharmaceutical International AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 2 of July 2018.
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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.