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news.OncoVista Innovative Therapies has announced that patient recruitment has started in the company's Phase I/II study of cordycepin for the treatment of patients with terminal deoxynucleotidyl transferase-positive refractory leukemia.
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The goals of the Phase I portion of the cordycepin study are to establish the recommended dose in the target population, determine drug-related dose-limiting toxicities, and assess pharmacokinetics.
The goals of the Phase II portion of the study are to evaluate efficacy at the recommended dose and confirm the safety profile established in Phase I.
OncoVista has received orphan drug designation from the FDA for cordycepin in this indication, which affords the company seven years of market exclusivity once the drug is approved for this indication.
Alexander Weis, president and CEO of OncoVista, said: “Initiation of this Phase I/II clinical trial of cordycepin is an important milestone for OncoVista. We believe cordycepin will prove to be an effective and well-tolerated treatment option for many leukemia patients who do not respond to other therapies.”