Two studies start simultaneously to verify the toxicological safety profile of SI-053
Today, a pre-clinical toxicological GLP study will start to verify the safety profile of SI-053 in a certified laboratory in Italy. The possibility to conduct this study is a result of a successful pre-study and a fruitful cooperation between two laboratories that developed an administration method that resembles the planned intracerebral administration in humans. The experimental part of the study will take about 3 weeks and the final report with all data evaluated is expected in July. This toxicological study is in accordance with European guidelines for drug development (GLP) and will be a crucial part of the pre-clinical information package for the clinical trial application.
Simultaneously, a long-term study will be conducted in Belarus to verify that the ingredients of SI-053 are harmless and cause no persistent damages to the brain after intracerebral administration.
” The possibility to initiate two technically challenging studies simultaneously is a result of a successful collaboration between scientists and technicians from Italy and Belarus, - comments Igor Lokot, CEO at Double Bond Pharmaceutical (DBP). - It is always challenging to transfer knowledge at this level and we are proud to have access to laboratories that can perform advanced administration techniques and who are willing to adjust and develop according to what is required for the SI-053 studies. To be able to run two studies at the same time saves us both time and resources.”
” The pre-clinical studies are mainly aimed to gain as good understanding as possible of the drug and how it will act in humans, - says Emelie Perland, Director of Pre-clinical Development at DBP. – In these initiated studies, the drug will be injected directly into the brain to mimic the administration method used in humans. Both the regulatory authorities and we are convinced this to be the right approach to conduct the pre-clinical safety and toxicity studies, because the mode of administration in this case is the key. With these two studies we intend to finalize the pre-clinical work needed for applying for the clinical trials.”
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. 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 20 of March 2018.
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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. 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.