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Replies to post #192818 on Biotech Values
12/02/15 11:16 AM
Kamada Ltd…announces it will unblind the current clinical trial of the Company’s proprietary human Alpha-1 Antitrypsin (AAT) to treat newly diagnosed pediatric and young adult patients with type 1 diabetes (T1D) at the planned interim analysis. This change will accelerate the timeline for future commercialization of the product, should the analysis be positive.
...“The planned interim analysis was intended to establish trial safety and provide futility analysis for approximately 90 patients after one year in the trial, while maintaining the blinding of the trial. After thorough examination of the content of such an analysis, we have concluded that the blinded results will not provide us with sufficient information for discussions with potential strategic partners and/or to determine whether to continue with the study.
In consultation with our regulatory and clinical advisors, as well as the trial investigators [but not with regulators themselves, apparently], we have decided to generate the final report based on clinical data from 60 patients who have completed one year of therapy by the end of 2016, with results expected in the first half of 2017…
01/06/16 12:13 PM
AI
