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2021-09-20

DBP International AB: positive response for SI-053 from Competent Authority in the Netherlands has been received

Double Bond Pharmaceutical International AB (publ) ("DBP") takes another step towards the start of phase 1 multinational multicentral clinical trial of its front-line product SI-053 in patients with glioblastoma - positive response from Competent Authority in the Netherlands has been received.

As previously reported (https://mb.cision.com/Main/12720/3404124/1459642.pdf ) the Clinical Trial Application (EC/CA submission) was sent in the Netherlands. Today DBP received a positive response from the Competent Authority in the Netherlands, Centrale Commissie Mensgebonden Onderzoek, which did not find any objection against the execution of the clinical trial within the Netherlands.

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.

"We are very pleased to have succeeded in reaching 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. "We are looking forward to receiving approval from the Ethics Committee in order to start clinical trials in the Netherlands".

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.

This disclosure contains information that DBP is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 20-09-2021 21:33 CET.

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