DBP International: The clinical protocol for the SI-053 phase I trial is finalized
Double Bond Pharmaceutical International AB (publ) (“DBP”) takes a step further towards the start of the phase 1 clinical trial of it’s front-line product SI-053 in patients with glioblastoma - the clinical protocol for the coming trial is now finalized.
The clinical protocol is an important document that forms the basis for applying for approval to authorities. It must, among other things, contain trial objectives and endpoints, overview that summarizes previous research results in the research area, trial description with presentation of design, treatment regimens including doses and dose justification, study indication, inclusion and exclusion criteria, reasoning for the number of trial participants, trial duration, trial procedures and assessments, and a brief account of the study's significance for the research area.
Preparation of the trial protocol was accomplished in close collaboration with Investigators as well as contract research organization, CATO SMS.
"The completion of the protocol is an important milestone in the development of SI-053 and we are very pleased to come closer to start of the clinical study,” - comments Igor Lokot, CEO of DBP.
| 10 communicated milestones between Q3 2020 to Q2 2021https://mb.cision.com/Main/12720/3191146/1304323.pdf | ||
| Milestone | Comments | Status |
| 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 | Finalized | Done |
| 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 | Q2 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 | |
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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.
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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
Homepage: http://www.doublebp.com/
E-mail: info@doublebp.com
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