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Double Bond Pharmaceutical International AB (publ) ("DBP" or "Double Bond Pharmaceutical") reports that the feasibility studies for clinical site selection for SI-053 Phase 1 clinical trial have been completed which resulted in the selection of four sites within the EU. This process of the feasibility studies has included: identify clinical investigators who are interested in participating in the trial, assessing site facilities, obtain input from investigators on trial design to align study procedures with clinical practice and support optimal patient recruitment, as well as to understand the local regulatory environment to assess the potential for conducting clinical trial in a member-state. DBP has completed the process together with the clinical CRO, CATO-SMS Oncology.
"Clinical trial feasibility is a huge and important process of evaluating the possibility of conducting a particular clinical program in a defined geographical region with the overall objective of optimal project completion in terms of timelines, targets and cost," - says Dr. Breezy Lindqvist, Chief Medical Officer and Head of Clinical Development at Double Bond Pharmaceutical, - "We are extremely happy and relieved that this process is finalized and now we can focus on the activities to come.""This is the seventh important milestone which is reached by our team in order to start clinical phase of SI-053," - comments Igor Lokot, CEO of Double Bond Pharmaceutical, - "We are thrilled to have finished another important milestone which brings us another step closer towards the CTA".
10 communicated
milestones
between Q3 2020
to Q2 2021
https://mb.cisio
n.com/Main/12720
/3191146/1304323
.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 Q1 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