Cell Therapeutics issued the following statement regarding the notification of the FDA partial clinical hold on tosedostat, the company's aminopeptidase inhibitor under development for the treatment of blood-related cancers, that is being studied in an investigator-sponsored trial and not by CTI. CTI's 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. Under a partial clinical hold, although 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 reached with the FDA. After a study has been placed on partial clinical hold, the sponsor provides additional information and discusses the adverse event with the FDA to understand whether or not it was associated with the drug or due to another cause. 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. For additional information, please refer to the Current Report on Form 8-K filed by the company on June 24.
- Health Care Industry