DBP International AB: The stability study has been started
Double Bond Pharmaceutical International AB ("DBP") reports that the stability studies for SI-053 have been started. The study is conducted by a company specializing in manufacturing and stability processes and is located within the EU. The studies required for CTA regarding the stability of SI-053 have now been completed and will be added to the regulatory documentation, IMPD.
"This enormous milestone takes us one step closer to clinical phase 1. With this, we can state that the product is stable, sterile and can be used safely and securely in humans." - comments Sayeh Erfan, Director of Manufacturing Operations at DBP.
"This is an important part of the product development, which means that we will provide patients with a sterile and safe product, according to EU requirements" - comments Igor Lokot, CEO at DBP.
| 10 communicated milestones between Q3 2020 to Q1 2021https://mb.cision.com/Main/12720/3191146/1304323.pdf | ||
| Milestone | Comments | Status |
| Preclinical: Efficacy of SI-053 in subcutaneous tumor in mice | Report in preparation | Done |
| Preclinical: Biodistribution of SI053 after intracerebral administration in rats | Waiting for finalization in Q4 2020 | |
| Preclinical: Toxicity studies of SI-053 effects after intracerebral administration in rats | Waiting for finalization in Q4 2020 | |
| Clinical: Key Opinion Leader (KOL) meeting, an important milestone for SI-053 Phase 1 clinical study | Release at Q3 2020 | Done |
| Clinical: Feasibility studies for clinical site selection for Phase 1 SI-053 clinical study | Ongoing, to be finalized in Q4 2020 | |
| CMC: Sterilization of SI-053 will be validated | Ongoing, to be finalized in Q4 2020 | |
| CMC: Stability study for SI-053 has been started | Ongoing, to be finalized in Q4 2020 | Done |
| CMC: The IMPD is completed | Ongoing, to be finalized in Q1 2021 | |
| Regulatory: Clinical trial application (CTA) for Phase 1 SI-053 clinical study | Q1 2021 | |
| Financing phase 1 | Q4 2020 | |
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 on 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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