Something has changed! Back in March Dr. Mittendorf gave a speech at the 32nd Annual Miami Breast Cancer Conference.
Is immunotherapy ready for prime time in breast cancer?
Elizabeth A. Mittendorf, associate professor of surgical oncology at The University of Texas MD Anderson Cancer Center in Houston, needs only a single word to answer this question: No.
The most advanced treatment candidates are just beginning later stage trials. That said, their performance so far suggests that immunotherapy may become a powerful tool against breast cancer for those oncologists who follow the research and prepare for its arrival. -
Galena Biopharma Announces Reduction Of Cardiac Toxicity Study For Neuvax Trial
By Terry Chrisomalis
Monday, August 24, 2015 6:39 PM EDT
Shares of Galena Biopharma, Inc. (GALE) closed the day with 11% up, after the company had announced that the independent data monitoring committee - IDMC - reduced the monitoring of the cardiac toxicity study for the Neuvax trial known as "PRESENT".
This is important because other breast cancer studies targeting the HER2 expression have seen some safety issues of cardiac toxicity. The fact that the IDMC recommended the reduction of such a study shows the continued safety for Neuvax in these patients with breast cancer.
The IDMC is a group of physicians that consists of oncologists, cardiologists, and an independent statistician who are all responsible for determining whether a study is safe enough for patients to continue. In addition this group also monitors other areas such as efficacy and recommend whether or not the study should be done to completion.
Galena Biopharma Receives A Recommendation That Excites Investors
Galena Biopharma Inc (NASDAQ: GALE)
Finally, Galena Biopharma is having a great day in the market today. Not only is the stock bouncing back from Friday’s declines, investors are extremely excited about a recent recommendation from the Independent Data Monitoring Committee. The recommendation was simple, GALE can reduce cardiac toxicity monitoring in it’s current Phase 3 study of NeuVax. No other suggestions were offered; insinuating that the Phase 3 study is going well. As a result, investors are pushing GALE higher in the market today and likely to continue doing so moving forward.
24-AUG-2015 07:05AM, Press Release: Galena Biopharma Announces Independent Data Safety Monitoring Committee Recommends Reduction of Cardiac Toxicity Monitoring for NeuVax(TM) PRESENT Trial
Galena Biopharma Announces Independent Data Safety Monitoring Committee Recommends Reduction of Cardiac Toxicity Monitoring for NeuVax(TM) PRESENT Trial
PORTLAND, Ore., Aug. 24, 2015 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced that the Independent Data Monitoring Committee (IDMC) has recommended to the Company that it can reduce the cardiac toxicity monitoring for patients in its NeuVax(TM) (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial. The trial is being run under a Special Protocol Assessment (SPA) approved by the U.S. Food and Drug Administration (FDA).
Following its most recent IDMC meeting in June 2015, the IDMC recommended routine cardiac monitoring could be reduced in the PRESENT trial and that such a reduction is justified and consistent with the pre-specified Cardiac Toxicity Monitoring Stopping Rules defined in the study protocol. The IDMC concluded that cardiac toxicity monitoring by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans could be reduced. The IDMC had no other suggestions and recommended the trial continue as planned.
Mark W. Schwartz, Ph.D., President and Chief Executive Officer, stated, "We are pleased to see that cardiac events have not appeared as a safety issue thus far in the study, relative to published reports of cardiac toxicity associated with other HER2 directed therapies. Importantly, the recommendation by the IDMC to reduce the frequency of cardiac assessments, per the protocol, facilitates the ongoing compliance and patient retention on trial.