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Double Bond Pharmaceutical International AB (publ) ("DBP") is delighted to announce that the long term GLP toxicity study of SI-053 in rats has been successfully completed.
The purpose of this study was to evaluate the potential toxicity of intracerebral administration of SI-053 in combination with subsequent adapted chemo-radiation treatment (Standard of Care for Glioblastoma).
The in vivo model consisted of application of SI-053 at low, middle, and high doses which were followed by one cycle of oral Temozolomide and irradiation in rats.
The study also revealed that the excipient showed no toxicity. Additionally, the study results support the safety of the starting dose in the planned clinical trial.
`'The study was elegantly designed according to EMA's scientific advice, which provided a proper marginal of safety for the starting dose in humans. Together with efficacy and PK studies, the whole preclinical data package strengthens the scientific rationale for the clinical trial of SI-053 and supports DBP's goal to improve the treatment of Glioblastoma,'' - comments Dr. Lili Li, Vice Director of Preclinical Development and Senior Medical Director of Clinical Development.
"Our team has done a great job by managing the preclinical development for SI-053," - comments Igor Lokot, CEO of DBP, - "Success leads to success: we are very enthusiastic about the next phase of the SI-053 development - planned clinical trials."
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: Q2 2021
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