Completed enrollment in VITAL-1 Phase III trial 7/07; an independent data monitoring committee recommended that the trial continue 1/08; terminated one of its two Phase III trials after a routine safety review turned up an imbalance in deaths between the treatment and control arms 8/08; FDA placed a partial clinical hold on the Phase III program as a result of the company's announcement to terminate the VITAL-2 trial 9/08; company ended its second Phase III trial citing a low probability of
Data showed that treatment prolonged overall survival when compared to conventional care regimens; the two-year survival rate was almost double the rate for convenient care regimens 6/08; data indicated that Vidaza demonstrated a significant extension of overall survival compared to conventional care regimens 2/09
Phase III trial was discontinued 10/05; data from discontinued Phase III trial in Stage IV disease showed median survival of 31.5 months vs. 38.7 months for placebo; trial in Stage III disease showed median overall survival for both groups of more than 69 months 3/06
Company is working with the FDA to design a Phase III trial with a primary endpoint of median overall survival 12/06; began enrolling patients in a Phase III program 7/08; company said site initiation delays would prevent it from completing enrollment in an ongoing trial 2/09
Phase III data demonstrated its efficacy and its ability to improve disease-free survival by 100% 6/08; met its primary endpoint of significantly improving disease-free survival in a Phase III trial 7/08; data showed the product prolonged cancer-free survival by 13.6 months 10/08
Phase III trials did not meet primary endpoints related to neuropathy and tumor shrinkage 7/06; Phase III data showed a positive trend, though it failed to reach statistical significance 3/08
Began a Phase III trial to enroll 105 patients 11/06; enrolled about two-thirds of the patients for its Phase III trial 5/08; completed recruitment in its initial registration trial 03/09
Submitted an NDA 10/07; FDA accepted for filing its NDA 1/08; data showed the sum of pain intensity differences at 30 minutes was significantly greater with BEMA Fentanyl than placebo 5/08; FDA completed its review of Onsolis 8/08; resubmitted its NDA 12/08
Approved for marketing in Australia 7/00; FDA letter addressed reasons M-Vax and O-Vax ovarian cancer trials were put on hold 4/01; FDA requested more information on Avax's responses 9/01; Avax responded to FDA 10/01; submitted IND to FDA 10/02; received OK from FDA to start trials 12/04; product approved in Switzerland 10/05; reached agreement with FDA on SPA for pivotal Phase III trial 10/06; FDA cleared launch of study 11/06; began a pivotal trial 11/07
Company changed the planned primary endpoint for an upcoming Phase III trial, from progression-free survival to overall survival 4/07; launched a Phase III trial 9/07
Began a global Phase III program 1/07; trial met its primary efficacy endpoint and demonstrated superiority over immediate-release morphine sulfate 5/09
Completed enrollment in VITAL-1 Phase III trial 7/07; an independent data monitoring committee recommended that the trial continue 1/08; terminated one of its two Phase III trials after a routine safety review turned up an imbalance in deaths between the treatment and control arms 8/08; FDA placed a partial clinical hold on the Phase III program as a result of the company's announcement to terminate the VITAL-2 trial 9/08; company ended its second Phase III trial citing a low probability of