DBP International AB: investigators’ meeting for the SI-053 Phase I study was held
Double Bond Pharmaceutical AB (publ) (“DBP”) has today hosted an investigators’ meeting for the planned SI-053 Phase I study. This is an open label dose escalation and dose expansion study, to estimate maximum tolerated dose (MTD), identify dose-limiting toxicities (DLTs) and recommended Phase 2 Dose of SI-053 and the first-patient-in is expected to be enrolled during the second quarter of 2021.
The meeting gathered investigators from 4 clinics in 2 countries together with the Clinical Trial Team from DBP and key personnel from the contract research organization (CRO) CATO-SMS Oncology. The purpose of the meeting was to meet the investigator’s and go through some practical aspects of the planned SI-053 study in order to ensure that the trial will be conducted in compliance with the Clinical Study Protocol.
The SI-053 study is an open-label dose escalation study to estimate MTD, identify DLTs following a single dose of intracranially administered temozolomide-based SI-053 as an add-on to the current standard of care, in adult patients with newly diagnosed glioblastoma.
The clinical trials application (CTA) for SI-053 has been submitted to the competent National Regulatory Authorities, including the Ethics Committee, in Germany and the Netherlands in June- August (https://mb.cision.com/Main/12720/3366132/1431310.pdf). DBP received a positive response from the Competent Authority in the Netherlands (https://mb.cision.com/Main/12720/3418468/1470737.pdf) and currently DBP is providing some additional information to Ethical committees in the Netherlands and Germany and to the Competent Authority in Germany.
“Investigators’ meetings are critical for the success of clinical trials, and we are incredibly pleased with the interest and engagement that the investigators showed during the meeting”, comments Breezy Lindqvist, CMO and Director of Clinical Development at DBP.
“We are very pleased to have managed bringing the best expertise in the field of neuro-surgery in EU to clinical development of SI-053 in order to fully explore therapeutic potential of the product,’’ - comments Igor Lokot, CEO at DBP.
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
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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
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Igor Lokot, CEO
Homepage: http://www.doublebp.com/
E-mail: info@doublebp.com
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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.