-APF530 tQT and Metabolism Studies Complete-
-APF530 NDA Resubmission Expected Mid-2012-
Report is Available for Download at: www.lifesciadvisors.com/clients/ap
Last week, A.P. Pharma, Inc. (OTC BB: APPA.OB) issued a press release announcing earnings and updating investors on progress made during the first quarter of 2012. We report that the thorough QT study and metabolism study are now complete and the non-human clinical factors validation study is expected to be complete this quarter. All three will be included in the APF530 NDA resubmission.
Two APF530 Studies Down, One to Go. In the first quarter of 2012, A.P. Pharma made significant progress towards completing the last studies required per the previously-issued CRL. Two of the studies that were requested by the FDA in the CRL were completed in the first quarter and will be included in the APF530 NDA resubmission, which is expected to occur Mid-2012. An event that was highly anticipated by investors was the completion of the thorough QT (tQT) study. The results of the study demonstrated that APF530 (granisetron) does not have an effect on cardiac repolarization as measured by prolongation of the QT interval. To read more about these study results and additional background on currently marketed CINV drugs, please view our previous note here: http://lifesciadvisors.com/news/a-p-pharma-reported-4q11-and-full-year-2011-results-and-clean-apf530-thorough-qt-results/. The Company also reported that a separate metabolism study was completed during the first quarter that examined how APF530 is processed in the body and the results corroborated the existing preclinical animal data.
Currently, A.P. Pharma is waiting for the FDA to review its non-clinical human factors validation study protocol. This validation study protocol is based upon previously completed formative studies. We expect the Company to complete this last study in the second quarter of 2012 and it, along with the completed tQT and metabolism studies, will be included in the APF530 NDA resubmission.