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2021-06-14

DBP International AB: The CTA for SI-053 has been sent - the tenth and the last milestone for the clinical trial of SI-053 has been completed

Double Bond Pharmaceutical International AB (publ) ("DBP") takes a final step towards the start of the phase 1 clinical trial of its front-line product SI-053 in patients with glioblastoma - Clinical Trial Application (CTA) for SI-053 has been submitted.

Double Bond Pharmaceutical reports that the CTA for SI-053 has been submitted to the competent National Regulatory Authorities, including the Ethics Committee. The process was carried out by DBP in cooperation with a company specializing in managing clinical trials located in the EU, on behalf of pharmaceutical companies. A CTA provides comprehensive information about the investigational medicinal product and planned trial, enabling regulatory authorities to assess the suitability and safety of conducting the study.

"It is very pleasing that our hard work with the development of SI-053 has yielded satisfying results. Moreover, we are extremely proud of the good cooperation between us and our CMO and we are happy to commence our highly anticipated clinical trial." - comments Sayeh Erfan, Director of Manufacturing Operations at DBP.

"In this first-in-human trial for SI-053, this novel TMZ-based formulation will be administered intracranially, as an add-on to Standard Of Care in subjects with newly diagnosed GBM. This is an important milestone in the clinical development of SI-053, our lead candidate. The main objective of this trial is to evaluate the safety and tolerability of SI-053 and, to establish the maximum tolerated dose and/or the recommended Phase 2 dose of SI-053. As part of our clinical development program, we aim to see if we can also obtain evidence for preliminary efficacy in those patients, thus providing a promising candidate for the treatment of this devastating disease."- comments Breezy Lindqvist, CMO and Head of Clinical Development at DBP.

"We are very pleased to have succeeded to reach this important milestone in the development of SI-053 in order to satisfy the unmet medical needs of patients suffering from Glioblastoma." - 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 Finalized Done
mice
Preclinical: Biodistribution of SI053 after intracerebral Finalized Done
administration in rats
Preclinical: Toxicity studies of SI-053 after intracerebral Finalized Done
administration in rats
Clinical: Key Opinion Leader (KOL) meeting, an important Finalized Done
milestone for SI-053 Phase 1 clinical study
Clinical: Feasibility studies for clinical site selection Finalized Done
for Phase 1 SI-053 clinical study
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
Financing phase 1 Finalized Done
Regulatory: Clinical trial application (CTA) for Phase 1 SI Finalized Done
-053 clinical study

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