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| Land | Sverige |
|---|---|
| Lista | Spotlight |
| Sektor | Hälsovård |
| Industri | Bioteknik |
The manufacturing of the excipient for SI-053 has been carried out in a European GMP-certified facility, a contract-based manufacturer within the EU. This product will be used for the manufacturing of SI-053 which is scheduled to start next month and which will be used for DBP's clinical trials. DBP has previously reported on successful technical transfer of the excipient for SI-053 and successful SI-053 manufacturing for CTA with associated stability studies, in European GMP-certified environments, which is the basis for today's successful work.
"This is an important success for us, which means that we are now taking another step closer to our first clinical trial" - comments Igor Lokot, CEO of DBP. "The next step is to manufacture SI-053 and provide the sites with a product to undergo clinical phase 1."
More about manufacturing of the excipient and SI053:
https://mb.cision.com/Main/12720/2565722/871224.pdf
https://mb.cision.com/Main/12720/2291123/689873.pdf
https://mb.cision.com/Main/12720/3240609/1337710.pdf
https://mb.cision.com/Main/12720/3272439/1362375.pdf
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