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Double Bond Pharmaceutical International AB (publ) ("DBP", "Double Bond" or "Double Bond Pharmaceutical") reports today that the in vivo proof-of-concept study of SI-053 was successfully finished. The in vivo study of the efficacy of SI-053, Double Bond's front-line product for local treatment of primary malignancies in the brain, was designed and set up in accordance with recommendations from the European Agency of Medicines (EMA). It consisted of using an immunodeficient nude mouse with an injection of human glioblastoma cells to mimic the brain tumor in a subcutaneous model. The efficacy was evaluated by the single intratumoral injection of SI-053 (either low, middle or high dose) combined with a standard of care (SoC), which is equivalently adapted from patient to mouse.
- 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