DBP International: the feasibility studies for clinical site selection for Phase 1 SI-053 clinical trial is finalized - seven out of ten milestones for the clinical trial of SI-053 have been completed

Double Bond Pharmaceutical International AB (publ) (“DBP” or “Double Bond Pharmaceutical”) reports that the feasibility studies for clinical site selection for SI-053 Phase 1 clinical trial have been completed which resulted in the selection of four sites within the EU. This process of the feasibility studies has included: identify clinical investigators who are interested in participating in the trial, assessing site facilities, obtain input from investigators on trial design to align study procedures with clinical practice and support optimal patient recruitment, as well as to understand the local regulatory environment to assess the potential for conducting clinical trial in a member-state. DBP has completed the process together with the clinical CRO, CATO-SMS Oncology.

“Clinical trial feasibility is a huge and important process of evaluating the possibility of conducting a particular clinical program in a defined geographical region with the overall objective of optimal project completion in terms of timelines, targets and cost,” - says Dr. Breezy Lindqvist, Chief Medical Officer and Head of Clinical Development at Double Bond Pharmaceutical, - “We are extremely happy and relieved that this process is finalized and now we can focus on the activities to come.”“This is the seventh important milestone which is reached by our team in order to start clinical phase of SI-053,” - comments Igor Lokot, CEO of Double Bond Pharmaceutical, - “We are thrilled to have finished another important milestone which brings us another step closer towards the CTA”.

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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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