DBP International AB: The EC/CA submission for SI-053 has been sent to the Netherlands
Double Bond Pharmaceutical International AB (publ) ("DBP") takes another step towards the start of the phase 1 multinational multicentral clinical trial of its front-line product SI-053 in patients with glioblastoma - the Ethical Committee/Competent Authority submissions for SI-053 in The Netherlands has also been sent.
As previously was reported (https://mb.cision.com/Main/12720/3366132/1431310.pdf ) the Clinical Trial Application (CTA) was sent and the CTA concerned 3 sites in Germany. With the current submission in the Netherlands DBP adds additionally a site for the trial.
The process was carried out by DBP in cooperation with a company specializing in managing clinical trials located in the EU, on behalf of pharmaceutical companies. A CTA provides comprehensive information about the investigational medicinal product and planned trial, enabling regulatory authorities to assess the suitability and safety of conducting the study.
"We are very pleased to have succeeded to reach this important milestone in the development of SI-053 to satisfy the unmet medical needs of patients suffering from Glioblastoma." - comments Igor Lokot, CEO of DBP. “The CTA process is now completed for the whole planned trial in both countries and their Authorities”.
More about Temodex/SI-053: 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 under the name SI-053 to pass through all the tests and trials required for registration within the EU and globally. Video presentation: https://youtu.be/iweOQPq316o
More about phase I of SI-053: A Dose Escalation Study to Estimate MTD, DLTs and Pharmacokinetics After a Single Intracranial Dose of SI-053 as an add-on to the Current Standard of Care, in Adult Patients With Newly Diagnosed GBM (TARGLIO) https://clinicaltrials.gov/ct2/show/NCT04967690
Information about 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.
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Full Company Name: Double Bond Pharmaceutical International AB (publ)
Corporate identity: 556991-6082
Stock short name: DBP B
Share ISIN code: SE0007185525
For more info, contact
Igor Lokot, CEO
Homepage: http://www.doublebp.com/
E-mail: info@doublebp.com
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