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Uppsala, Sweden, 28 September 2020 - DBP has recently concluded KOL meeting with Professor Dr. Manfred Westphal (Department of neurosurgery, University Hospital Hamburg, Germany) and Professor Dr. Clemens M. F. Dirven (Department of Neurosurgery Erasmus Medical Center, The Netherlands), which has resulted in fine-tuning the Phase 1 clinical plan. This Phase 1 open-label dose escalation study is scheduled to begin in the first half of 2021. The aim of this study is to estimate the maximum tolerated dose (MTD) and safety of SI-053, when used as an add-on to standard of care in adult patients with newly diagnosed glioblastoma and will identify the recommended phase 2 dose (RP2D).
"As we are in the preparatory phase for the upcoming Phase 1 study, concluding KOL meeting with experts in the field is an important milestone. Their valuable opinion will help us to develop a well-designed study protocol, which is necessary for the efficient conduct of the planned Phase 1'', says Dr. Breezy Lindqvist, CMO, Double Bond Pharmaceutical.
The clinical phase 1 study will be conducted in highly regarded sites in Germany and Netherlands. Currently feasibility studies for clinical site selection is ongoing, and is expected to be finalised in autumn 2020, to meet the Clinical trial application (CTA) milestone in Q1 2021.
Gliomas are the most common primary malignancies of the brain in adults and have a poor prognosis, with direct repercussion on cognition and quality of life. Glioblastoma is the most severe grade of gliomas, representing 55% of all glioma, with a 5-year relative survival of less than 5% and disease progression within 1 year in 70% of the patients. All therapies beyond radiation have limited efficacy because of poor penetrance into the brain across the blood brain barrier, and many are burdened with systemic toxicity or side effects. Therefore, therapies based on local delivery are continuously explored.
"We are excited to continue our successful collaboration with Double Bond Pharmaceutical in their clinical phase 1 study for SI-053 and their development program addressing such an important and unmet need. CATO SMS is committed to support Double Bond Pharmaceutical, utilizing our vast early phase oncology trials experience and dedicated experts team through our proven center of excellence in oncology", says Philine van den Tol, President Clinical Trial Operations from CATO SMS, the CRO supporting the Swedish pharmaceutical company in this trial.
10 communicated milestones
between Q3 2020 to Q1 2021 (more
information, in swedish:
https://mb.cision.com/Main/12720/3
191146/1304323.pdf
Milestone Comments Status
Preclinical: Efficacy of SI-053 Report in preparation
in subcutaneous tumor in mice
Preclinical : Biodistribution of Waiting for finalization in Q4 2020
SI053 after intracerebral
admnistration in rats
Preclinical : Toxicity studies of Waiting for finalization in Q4 2020
SI-053 effects after
intracerebral admnistration in
rats
Clinical: Key Opinion Leader Release at Q3 2020 Done
(KOL) meeting, an important
milestone for SI-053 Phase 1
clinical study
Clinical : Feasibility studies Ongoing, to be finalised in Q4 2020
for clinical site selection for
Phase 1 SI-053 clinical study
CMC: Sterilization of SI-053 will Ongoing, to be finalized in Q4 2020
be validated
CMC: Stability study for SI-053 Ongoing, to be finalized in Q4 2020
has been started
CMC: The IMPD is completed Ongoing, to be finalized in Q1 2021
Regulatory: Clinical trial Q1 2021
application (CTA) for Phase 1 SI
-053 clinical study
Financing phase 1 Q4 2020