The sterilization process for Temozolomide is secured
Double Bond Pharmaceutical reports that technology transfer of the sterilization process for Temozolomide in SI-053 has been conducted with satisfactory results. The process has been carried out by a company specializing in sterilization services located within the EU.
The company has previously reported a successful technology transfer of the sterilization process for the SI-053 excipient in a European GMP-certified environment. This means that the sterilization process for SI-053 has been established and the product can now be manufactured for clinical trials.
“This is a vital success for us, which means that we are now taking a big step in the development of the manufacturing process for the SI-053,” comment by Sayeh Erfan, CMC, Operations & Quality Specialist at DBP”.
“We are hugely pleased with the success and look forward to being able to start manufacturing the clinical material as soon as possible”, comment by Igor Lokot, CEO of DBP.
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 23 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.