DBP International: IMPD for the SI-053 phase I trial is finalized – nine out of ten milestones for the clinical trial of SI-053 have been completed
Double Bond Pharmaceutical International AB (publ) ("DBP") takes a step further towards the start of the phase 1 clinical trial of its front-line product SI-053 in patients with glioblastoma – the Investigational Medicinal Product Dossier (IMPD) for the upcoming trial is now compiled.
The IMPD is a document which contains all the relevant drug development and quality information regarding the manufacturing, testing and packaging of APIs, excipients as well as investigational medicinal products. The document is a central piece of Investigational Medicinal Product (IMP) related documents required for the approval of clinical trials provided by the competent authorities in the EU.
Preparation of the IMPD was accomplished in close collaboration with 3 CMOs situated in different EU countries.
"The completion of the IMPD is an important milestone in the development of SI-053 and we are very pleased to come even closer to the start of our clinical study" – comments Sayeh Erfan, Director of Technical and Manufacturing Operations at DBP.
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10 communicated milestones between Q3 2020 to Q2 2021https://mb.cision.com/Main/12720/3191146/1304323.pdf |
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| 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 | Finalized | Done |
| Regulatory: Clinical trial application (CTA) for Phase 1 SI-053 clinical study | Q2 2021 | |
| Financing phase 1 | Finalized | Done |
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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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