Celator Announces Phase 3 Trial for VYXEOS
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PR Newswire
EWING, N.J., March 14, 2016
EWING, N.J., March 14, 2016 /PRNewswire/ -- Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) today announced positive results from the Phase 3 trial of VYXEOS™ (cytarabine: daunorubicin) Liposome for Injection (also known as CPX-351) in patients with high-risk (secondary) acute myeloid leukemia (AML) compared to the standard of care regimen of cytarabine and daunorubicin known as 7+3. The trial met its primary endpoint demonstrating a statistically significant improvement in overall survival. Data will be submitted for presentation at the American Society of Clinical Oncology 2016 Annual Meeting.
The median overall survival for patients treated with VYXEOS in the study was 9.56 months compared to 5.95 months for patients receiving 7+3, representing a 3.61 month improvement in favor of VYXEOS. The hazard ratio (HR) was 0.69 (p=0.005) which represents a 31 percent reduction in the risk of death versus 7+3. The percentage of patients alive 12 months after randomization was 41.5% on the VYXEOS arm compared to 27.6% on the 7+3 arm. The percentage of patients alive 24 months after randomization was 31.1% on the VYXEOS arm compared to 12.3% on the 7+3 arm. .....
http://www.ariva.de/news/...t-Improvement-in-Overall-Survival-5681976
The phase 3 trial of Celator Pharmaceuticals' Vyxeos (CPX-351) in patients with high-risk acute myeloid leukemia (AML) demonstrated statistically significant improvement in overall survival.
In the phase 3 study of 309 patients with secondary, or high risk, acute myeloid leukemia, those who received Vyxeos on average lived for 9.56 months after the start of the trial, compared with 5.95 months for those who got the standard combination treatment of cytarabine and daunorubicin.
Two years after the start of the study, 31.1% in the Vyxeos group were still alive, compared to 12.3% for the standard treatment group. ......
http://...monstrates-survival-benefit-in-phase-3-trial-150316-4839208
Ich bin Rentner und kann es mir leisten hier und da mal reinzuschauen. Vielleicht ist der Weltenbummler ja auch einer. - Wer weiß das schon.