US FDA puts partial clinical hold on Cell Thera's blood cancer drug tosedostat trial

US biotech firm Cell Therapeutics (Nasdaq: CTIC) revealed this week in a filing with the Securities Exchange Commission that, on June 17, 2013, the US Food and Drug Administration notified the company that a partial clinical hold has been placed on tosedostat (IND 075503), its aminopeptidase inhibitor under development for the treatment of blood-related cancers. Myocarditis - an inflammation of heart muscle. Cell Thera’s shares reacted with an initial fall of 11% $1.09, but rebounded to $1.13 Tuesday before markets opened.

A partial clinical hold is a delay or suspension of only part of the clinical work requested under the Investigational New Drug application (eg, 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.

Decision result of a patient death