WHAT TO EXPECT AND WHEN?
ISLA-101 Phase2a Trial DESIGN
TIMELINE (derived from trial plan and announcements)
Day 0: ASX Ann. 03 October 2024: Allsubjects dosed! CONGRATULATIONS!!
START theCLOCK!
·Day10: 13 October 2024
·Day20: 23 October 2024
·Day28: 31 October 2024
·Day45: 17 November 2024
·Day90: 1 January 2025 – HAPPY NEW YEAR EVERYONE!
What we gotso far?
ASX Ann. 18November 2024 (UPDATE)
“Weare very pleased to be able to report that 46 days into the trial, we’vecollected the key data required for evaluation by the Safety Review Committee.From here, while we will continue to check in with patients up to 90 dayspost dosing, we look forward to providing all the data to the SRC forevaluation....”a)Theseare the 'required samples to analyse how the viremia (viral load) levels in theblood of trial subjects have changed through the study'.
b)Othersamples are being analysed for pharmacokinetic data as well as other bloodanalyses.
c)Thisdata is currently being consolidated for review by the Safety Review Committee(SRC), who will meet in the coming weeks.
d)TheSRC will evaluate the safety of ISLA-101 in dengue infected individuals andconsider if there is evidence of anti-dengue activity.
e)Theywill then make a recommendation regarding advancing the trial to the Phase 2bcohort before the end of the calendar year.
ASX Ann. 27November 2024 (The READOUT)"The SRC …recommended that Island proceed with the therapeutic Phase 2b cohort. Thatrecommendation will now be filed with the FDA 30 days before starting the Phase2b cohort. The planned submission to the FDA would support a January 2025study start..."
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WELCOME TO 2025!
What toexpect1)TheDay 90 UPDATE (due around the 2nd of January) is expected in the next week (or two – allowing for the holiday)!
2)Notification (perhaps not necessary) that we have filed the Phase 2a data with the FDA (should be done 30 days before starting Phase 2b).Note that Phase 2b is meant to start in January 2025 (DF reaffirmed this) so,either we have done that already, or we will do so in the next 24 hours!
BUT: we are IN CRISIS!
The SPILL MEETING on 28th of January 2025 is an unwelcome distraction. Let us hopethat the Boardroom shenanigans don’t torpedo all great efforts so far!
MILESTONES TABLE
Here (below) is the FullMilestones Table.
Regards,
Happy NewYear to All Holders!
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- Ann: ISLA-101 shows anti-dengue activity in Phase 2a readout
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WHAT TO EXPECT AND WHEN?ISLA-101 Phase2a Trial DESIGNTIMELINE...
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