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2020-10-16

DBP International AB: the SI-053 efficacy was successfully proven in in vivo study in mice

The main results obtained from this study which have demonstrated the efficacy of SI-053 showed that:

  • The animals tolerated the SoC and showed reduced tumor volume when compared to non-treated animals;
  • All SI-053 doses showed statistically significant superiority in reducing the tumor volume even before starting the SoC;
  • The effect of SI-053 was potentiated when combined with the SoC, resulting in 34% of the tumor growth inhibition;

"The study was carefully designed to imitate the clinical conditions and well-performed which resulted in a robust proof of concept'', says Dr. Carolina Araújo, Preclinical Development Director at Double Bond Pharmaceutical.

"This is the second important milestone which is reached by our team in order to start clinical development of SI-053", - comments Igor Lokot, CEO of Double Bond Pharmaceutical.

10 communicated milestones
between Q3 2020 to Q1 2021
Milestone Comments  Status
Preclinical: Efficacy of SI-053 Report in preparation  Done
in subcutaneous tumor in mice
Preclinical: Biodistribution of Waiting for finalization in Q4 2020
SI053 after intracerebral
administration in rats
Preclinical: Toxicity studies of Waiting for finalization in Q4 2020
SI-053 effects after
intracerebral administration in
rats
Clinical: Key Opinion Leader Release at Q3 2020   Done
(KOL) meeting, an important
milestone for SI-053 Phase 1
clinical study
Clinical: Feasibility studies Ongoing, to be finalized in Q4 2020
for clinical site selection for
Phase 1 SI-053 clinical study
CMC: Sterilization of SI-053 Ongoing, to be finalized in Q4 2020
will be validated
CMC: Stability study for SI-053 Ongoing, to be finalized in Q4 2020
has been started
CMC: The IMPD is completed Ongoing, to be finalized in Q1 2021
Regulatory: Clinical trial Q1 2021
application (CTA) for Phase 1 SI
-053 clinical study
Financing phase 1 Q4 2020

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