Bifogade filer
Kurs & Likviditet
Beskrivning
Land | Sverige |
---|---|
Lista | Spotlight |
Sektor | Hälsovård |
Industri | Bioteknik |
Double Bond Pharmaceutical AB (publ) ("DBP") has yesterday 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 the planned SI-053 study in order to ensure that the trial will be conducted in compliance with the Clinical Study Protocol, guidelines and applicable regulations.
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.
"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. With their valuable insights we can now proceed with finalizing Clinical Study Protocol and proceed with the CTA", 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