New study confirms safety of Temodex and shows it to be restrictive to the right organ
Double Bond Pharmaceutical has now completed a study investigating how much Temodex - the novel drug against brain cancer - spreads in the brain in rat. The purpose of the study was to follow and chart the concentration of the active substance and its metabolite in both brain and blood circulation. The study is one in the line of complementary preclinical studies to prove and strengthen proof of concept for the company's drug candidate against brain cancer - Temodex.
The results show, among other things, that the concentration of active substance in rat brain is several times above the level achieved by a standard treatment of glioblastoma in humans. When studying the rat brain, a good spread of active substance was observed without causing serious brain changes.
"The study results show that the concentration is fully comparable to that achieved with regular treatment of glioblastoma and is remains that way for a long time without causing serious side effects," said Stellan Swedmark, Director of Preclinical Development / Regulatory Affairs at Double Bond Pharmaceutical ( DBP). "In addition, we also see that the active substance is spread to a very limited extent outside the brain, which is very beneficial for the efficiency and safety of the treatment of brain cancer. Therefore, we can also conclude that the risk of side effects in patients treated with Temodex should be very small."
"I'm not surprised with the results we achieved in this study," said Igor Lokot, CEO of DBP. - The high brain concentration suggests that Temodex is more efficient than standard treatment without giving more side effects, which is very in line with the results of clinical trials previously conducted for Temodex in Belarus that have shown 9-month prolonged survival, which is really an achievement in brain cancer and many other types of cancer. This study will naturally be a cornerstone of the Temodex portfolio that we will send to the regulatory authorities to apply for clinical trials in the EU.
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 9 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.