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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 Investigator's Brochure (IB) for the coming trial is now compiled.
The Investigator's Brochure (IB) is a comprehensive compilation of pre-clinical and nonclinical data regarding SI-053 maintained by DBP, that contains the body of information about the investigational product obtained before clinical trial. The IB is a document of critical importance throughout the drug development process and is updated with new information as it becomes available. The purpose of the IB is to compile data relevant to studies of SI-053 in human subjects gathered during preclinical and other clinical trials to provide the investigator with information necessary for the management of study conduct and study subjects throughout a clinical trial.
Preparation of the IB was accomplished in close collaboration with Investigators as well as contract research organization, CATO SMS, and in accordance with advice from scientific advising meeting with European Medicines Agency (EMA) (https://mb.cision.com/Main/12720/2774244/1015284.pdf)
"The completion of the IB is an important milestone in the development of SI-053 and we are very pleased to come even closer to start of the clinical study," - comments Igor Lokot, CEO of DBP.
10 communicated
milestones
between Q3 2020
to Q2
2021https://mb.c
ision.com/Main/1
2720/3191146/130
4323.pdf
Milestone Comments Status
Preclinical: Finalized Done
Efficacy of SI
-053 in
subcutaneous
tumor in mice
Preclinical: Finalized Done
Biodistribution
of SI053 after
intracerebral
administration
in rats
Preclinical: Finalized Done
Toxicity
studies of SI
-053 after
intracerebral
administration
in rats
Clinical: Key Finalized Done
Opinion Leader
(KOL) meeting,
an important
milestone for
SI-053 Phase 1
clinical study
Clinical: Finalized Done
Feasibility
studies for
clinical site
selection for
Phase 1 SI-053
clinical study
CMC: Finalized Done
Sterilization
of SI-053 will
be validated
CMC: Stability Finalized Done
study for SI
-053 has been
started
CMC: The IMPD Q2 2021
is completed
Regulatory: Q2 2021
Clinical trial
application
(CTA) for Phase
1 SI-053
clinical study
Financing phase Q2 2021 - issuance of units as a probable alternative
1