No serious adverse effects in GLP-tox preliminary study for Temodex
Double Bond Pharmaceutical (DBP) has initiated the toxicological evaluation of the company's drug candidate against brain cancer, Temodex, as announced earlier. This study package is intended to demonstrate the safety of Temodex in the brain in rats to clarify the improved safety profile seen in previous studies. The toxicological package begins with a preliminary study followed by the major GLP study.
The first animals have now been dosed in the preliminary study without observing any serious adverse effects.
"The preliminary results we have obtained are entirely in line with the previous results we have seen," says Stellan Swedmark, Director of Preclinical Development/Regulatory Affairs at DBP. - We can therefore look forward to the final major study with confidence. "
"These toxicological studies constitute an substantial and important part of the preclinical package we earlier discussed with the authorities”, says Igor Lokot, CEO of DBP. "The preliminary results look very promising and further strengthen our trust in the project."
Temodex, which is a locally acting formulation of temozolomide, was developed by RI PCP in Minsk, Belarus, and is registered for marketing within Belarus since 2014 as the first-line treatment of glioblastoma. 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. Find out more here.
About the company: www.doublebp.com
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 16 of October 2017.
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Igor Lokot, CEO
Information on Double Bond Pharmaceutical International AB
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. DBP acquired rights to Temodex, a drug registered in Belarus for treatment of brain tumours, in October 2015. The company was granted Orphan Drug Designation status by EMA for Temodex in July 2016.