Cell Therapeutics, Inc. or CTI (CTIC) has issued a statement on the notification of the U.S. Food and Drug Administration or "FDA" partial clinical hold on tosedostat, the company's aminopeptidase inhibitor under development for blood-related cancers treatment, that is being studied in an investigator-sponsored study and not by CTI. The company said its primary development programs are the ongoing Phase 3 trial of pacritinib, the company's JAK2/FLT3 inhibitor being evaluated for patients with myelofibrosis, and the post-approval commitment study of PIXUVRI.
This is a partial clinical hold of only part of the clinical work requested under the investigational new drug or "IND" application. As part of the partial clinical hold, though a specific protocol or part of a protocol is not allowed to proceed, other parts of such protocol or other protocols are allowed to proceed under the IND. With this partial clinical hold, the company may not enter new patients onto any of the ongoing tosedostat protocols until agreement is signed with the FDA.
The company has begun work to comply with the FDA request and expects to be able to submit these data to the FDA in the coming weeks.
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