DBP International: SI-053 GLP toxicity study in rats is completed - six out of ten milestones for the clinical trial of SI-053 have been completed
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.cision.com/Main/12720/3191146/1304323.pdf|
|Preclinical: Efficacy of SI-053 in subcutaneous tumor in mice||Finalized||Done|
|Preclinical: Biodistribution of SI053 after intracerebral administration in rats||Finalized||Done|
|Preclinical: Toxicity studies of SI-053 after intracerebral administration in rats||Finalized||Done|
|Clinical: Key Opinion Leader (KOL) meeting, an important milestone for SI-053 Phase 1 clinical study||Finalized||Done|
|Clinical: Feasibility studies for clinical site selection for Phase 1 SI-053 clinical study||Q2 2021|
|CMC: Sterilization of SI-053 will be validated||Finalized||Done|
|CMC: Stability study for SI-053 has been started||Finalized||Done|
|CMC: The IMPD is completed||Q1 2021|
|Regulatory: Clinical trial application (CTA) for Phase 1 SI-053 clinical study||Q2 2021|
|Financing phase 1||Q2 2021 – issuance of units as a probable alternative|
More about Temodex/SI-053: Temodex, which is a locally acting formulation of temozolomide developed by RI PCP in Minsk, Belarus, is registered for marketing as the first-line treatment of glioblastoma within Belarus since 2014. Temodex was acquired by DBP in autumn 2015 and is now being prepared under the name SI-053 to pass through all the tests and trials required for registration within the EU and globally. Video presentation: https://youtu.be/iweOQPq316o
Information about Double Bond Pharmaceutical International AB:
DBP is a pharmaceutical company with the primary focus on development of therapies against cancer based on the company’s own developed drug delivery technology BeloGal®. The company was granted Orphan Drug Designation status by European Medicines Agency (EMA) in June 2015 for its first product, SA-033, for treatment of hepatoblastoma. Double Bond Pharmaceutical acquired rights to Temodex, a drug registered in Belarus for treatment of brain tumours, in October 2015, and was granted Orphan Drug Designation status by EMA for in July 2016 for this formulation of temozolomide for the treatment of glioma. The formulation is now being further developed for registration in EU and globally and has a working name SI-053 in DBP pipeline.
Full Company Name: Double Bond Pharmaceutical International AB (publ)
Corporate identity: 556991-6082
Stock short name: DBP B
Share ISIN code: SE0007185525
For more info, contact
Igor Lokot, CEO