The clinical protocol is an important document that forms the basis for applying for approval to authorities. It must, among other things, contain trial objectives and endpoints, overview that summarizes previous research results in the research area, trial description with presentation of design, treatment regimens including doses and dose justification, study indication, inclusion and exclusion criteria, reasoning for the number of trial participants, trial duration, trial procedures and assessments, and a brief account of the study's significance for the research area.

Preparation of the trial protocol was accomplished in close collaboration with Investigators as well as contract research organization, CATO SMS.

"The completion of the protocol is an important milestone in the development of SI-053 and we are very pleased to come 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