Re: Farmas USA
APTO
Con halt por problemas de fabricación
Aptose will have to repeat the production of the fourth batch, a 40L batch that was the intended clinical supply, because of a correctable engineering design incompatibility during the filling process. Aptose expects the batch records and release specifications from such a new batch, along with the stability and sterility data, to be provided to the FDA during the first quarter of 2017.
The need to strengthen the filling process is not a reflection on the drug substance or new formulation, both of which continue to perform favorably. Indeed, the new formulation demonstrates an increase of three times plasma drug exposure as compared to the prior formulation and may have the potential to create additional intellectual property for the company. Aptose also demonstrated that APTO-253 acts by inhibiting expression of the c-Myc oncogene without toxicity to normal bone marrow and blood cells, thereby potentially increasing the likelihood of application to additional cancer indications.
http://www.econotimes.com/Aptose-Biosciences-Provides-Update-on-APTO-253-Development-467870
Edito: dentro corto 1,33
«Después de nada, o después de todo/ supe que todo no era más que nada.»
