aragingo
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Non commento l'utimo form 8 appena depositato alla Sec. A qualcuno del tipo "vedremo. vedremo" consiglio di leggere, traducendoselo, l'ultima parte di quello che ha scritto la FDA.
Item 8.01. Other Events.
On June 17, 2013, the U.S. Food and Drug Administration (the “FDA”) notified Cell Therapeutics, Inc. (the “Company”) that a partial clinical hold has been placed on Tosedostat (IND 075503), the Company’s aminopeptidase inhibitor under development for the treatment of blood-related cancers. A partial clinical hold is a delay or suspension of only part of the clinical work requested under the investigational new drug (“IND”) application (e.g., a specific protocol or part of a protocol is not allowed to proceed; however, other protocols or parts of the protocol are allowed to proceed under the IND). Under the partial clinical hold, the Company may not enter new patients onto any of the ongoing Tosedostat protocols until agreement is reached with the FDA.
Recently, a patient, who was in their seventies and was being treated with Tosedostat in combination with 5-azacitine or cytarabine on an investigator sponsored trial in patients with relapsed or refractory acute myeloid leukemia or high risk myelodysplastic syndrome (MDS), died of myocarditis. The FDA has requested additional data on patients treated with Tosedostat, including additional information about the patient that died, a detailed review of all grades of cardiac adverse events or cardiac-related investigations in patients treated with Tosedostat, as well as benefit-risk analysis based on the data presented. 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.
Non commento l'utimo form 8 appena depositato alla Sec. A qualcuno del tipo "vedremo. vedremo" consiglio di leggere, traducendoselo, l'ultima parte di quello che ha scritto la FDA.
Item 8.01. Other Events.
On June 17, 2013, the U.S. Food and Drug Administration (the “FDA”) notified Cell Therapeutics, Inc. (the “Company”) that a partial clinical hold has been placed on Tosedostat (IND 075503), the Company’s aminopeptidase inhibitor under development for the treatment of blood-related cancers. A partial clinical hold is a delay or suspension of only part of the clinical work requested under the investigational new drug (“IND”) application (e.g., a specific protocol or part of a protocol is not allowed to proceed; however, other protocols or parts of the protocol are allowed to proceed under the IND). Under the partial clinical hold, the Company may not enter new patients onto any of the ongoing Tosedostat protocols until agreement is reached with the FDA.
Recently, a patient, who was in their seventies and was being treated with Tosedostat in combination with 5-azacitine or cytarabine on an investigator sponsored trial in patients with relapsed or refractory acute myeloid leukemia or high risk myelodysplastic syndrome (MDS), died of myocarditis. The FDA has requested additional data on patients treated with Tosedostat, including additional information about the patient that died, a detailed review of all grades of cardiac adverse events or cardiac-related investigations in patients treated with Tosedostat, as well as benefit-risk analysis based on the data presented. 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.
