MolMed suspends enrollment in phase III study of Zalmoxis.
MolMed S.p.A. announced the suspension of the enrollment of new patients in the phase III clinical trial with Zalmoxis named TK 008 .In reviewing the product development plan, the Company decided to conduct an unplanned interim analysis on the first 90 patients included in the study, representing approximately 50% of the total number of patients required by the protocol. This analysis, although not conclusive, has not shown an advantage of the arm treated with Zalmoxis compared to the control arm treated with the standard of care, with reference to the primary endpoint of the study, namely disease-free survival.
The Company is now in the process of completing the available data analysis and interacting with the Regulatory Authorities and the centers involved in the clinical trial in order to define the next steps of the study and the future development of the product.
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