KGaA of Darmstadt, Germany
, and its U.S. affiliate, EMD Serono, Inc., resumed the worldwide clinical development program for Stimuvax(R) in non-small cell lung cancer (NSCLC), including the Phase 3 START and INSPIRE trials, following a decision by the U.S. Food and Drug Administration (FDA) to partially lift the clinical hold it placed on the Investigational New Drug (IND) application for Stimuvax in March 2010
. Treatment of existing patients and enrollment of new patients in START is again underway at most centers. The clinical hold for the Phase 3 STRIDE trial in advanced breast cancer was not lifted by the FDA, and in July Merck Serono decided to close this trial.
PX-866 - Phase 1 clinical trial data for PX-866, an irreversible inhibitor of PI-3 kinase, were presented at the American Society of Clinical Oncology meeting in June. The trial was an open-label, dose escalation study in patients with advanced metastatic cancer of both an intermittent and a continuous dosing schedule, including an expansion cohort at the maximum tolerated dose for each schedule.
PX-866 was well-tolerated in both arms of this trial. The most common adverse events were mild to moderate in severity, and included diarrhea, nausea, vomiting, fatigue and reversible elevation of liver enzymes. There was no significant increase in adverse events noted in patients receiving more than two cycles of treatment in either arm of the trial.
In the continuous dosing arm, 6 of 8 patients evaluable at the time of the presentation (or 75 percent) had stable disease as the best response. In the intermittent dosing arm, 7 out of 45 evaluable patients (or 16 percent) experienced stable disease. Enrollment of additional patients in the continuous dosing arm has now been completed; additional data will be presented at the 22nd EORTC-NCI-AACR symPage: 1 2 3 4 5 6 7 8 Related biology technology :1
. Oncothyreon announces second quarter 2010 financial results conference call2
. Oncothyreon announces presentations at upcoming investor conferences in June3
. Oncothyreon to present at the Rodman & Renshaw Annual Global Investment Conference4
. Oncothyreon reports full year and fourth quarter 2009 financial results5
. Oncothyreon reports first quarter 2010 financial results6
. Oncothyreon announces temporary suspension of Stimuvax clinical trials by Merck Serono7
. Oncothyreon consults with Division of Corporation Finance about accounting for 2008 License Agreement8
. Oncothyreons PX-866 PI-3 kinase inhibitor named among Top 10 most promising oncology products for partnering by Windhover9
. Oncothyreon reports third quarter 2009 financial results & provides product pipeline update10
. Oncothyreon announces webcast of third quarter 2009 financial results conference call11
. Oncothyreon announces appointment of Douglas E. Williams, Ph.D., to board of directors