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2021-05-31

DBP International: IMPD for the SI-053 phase I trial is finalized - nine out of ten milestones for the clinical trial of SI-053 have been completed

Double Bond Pharmaceutical International AB (publ) ("DBP") takes a step further towards the start of the phase 1 clinical trial of its front-line product SI-053 in patients with glioblastoma - the Investigational Medicinal Product Dossier (IMPD) for the upcoming trial is now compiled.

The IMPD is a document which contains all the relevant drug development and quality information regarding the manufacturing, testing and packaging of APIs, excipients as well as investigational medicinal products. The document is a central piece of Investigational Medicinal Product (IMP) related documents required for the approval of clinical trials provided by the competent authorities in the EU.

Preparation of the IMPD was accomplished in close collaboration with 3 CMOs situated in different EU countries.

"The completion of the IMPD is an important milestone in the development of SI-053 and we are very pleased to come even closer to the start of our clinical study" - comments Sayeh Erfan, Director of Technical and Manufacturing Operations at DBP.

 

10 communicated milestones between Q3 2020 to Q2
2021https://mb.cision.com/Main/12720/3191146/1304323.pdf
Milestone Comments Status
Preclinical: Efficacy of SI-053 in subcutaneous tumor in Finalized Done
mice
Preclinical: Biodistribution of SI053 after intracerebral Finalized Done
administration in rats
Preclinical: Toxicity studies of SI-053 after intracerebral Finalized Done
administration in rats
Clinical: Key Opinion Leader (KOL) meeting, an important Finalized Done
milestone for SI-053 Phase 1 clinical study
Clinical: Feasibility studies for clinical site selection Finalized Done
for Phase 1 SI-053 clinical study
CMC: Sterilization of SI-053 will be validated Finalized Done
CMC: Stability study for SI-053 has been started Finalized Done
CMC: The IMPD is completed Finalized Done
Regulatory: Clinical trial application (CTA) for Phase 1 SI Q2 2021
-053 clinical study
Financing phase 1 Finalized Done

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