Scientific Advice from EMA is due the first week of March
As previously announced, Double Bond Pharmaceutical has submitted a Protocol Assistance request to EMA to obtain scientific advice regarding SI-053 (https://mb.cision.com/Main/12720/2693686/958625.pdf). The advice from EMA will be based on a number of questions from DBP mainly regarding the preclinical development of SI-053 and the planned Phase I trial in glioblastoma patients. DBP expects useful advice for the product development.
Yesterday, DBP were noticed that a final advice letter will be obtained from EMA during the first week in March.
The Protocol Assistance is free of charge since SI-053 has orphan drug designation. After the scientific advice is obtained in March, the company aims to finalize all documentation required for a Clinical Trial Application in order to start the clinical trial as soon as possible.
“I am happy that the development of SI-053 is progressing according to plan and that we have the opportunity to obtain feedback from EMA regarding our plans”, comments Igor Lokot, CEO at Double Bond Pharmaceutical.
More about Protocol Assistance meeting: /mbpublicbinaryproxy/Main/12720/2664607/939724.pdf
More about Temodex: 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. Video presentation: https://youtu.be/iweOQPq316o
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 19 of February 2019.
For more info, contact
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. DBP has during the past year also started two subsidiaries, Drugsson AB for the distribution of fully developed human pharmaceutical and medical device products and dietary supplements in Scandinavia, and FarmPharma AB for the development of innovative veterinary products.