Is the PRESENT study the key for a new vaccine for breast cancer?

flower A small biopharma company (Galena) released crucial information on it's breast cancer vaccine (NeuVax).

The 70th patient qualifying for disease free survival was realized in the PRESENT study of a new breast cancer vaccine on March 29th. From the press release:

"The NeuVax™ (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. NeuVax is a peptide immunotherapy vaccine currently being evaluated for the prevention of cancer recurrence and is Galena’s lead development agent in multiple ongoing and planned clinical trials."

The importance of this information is that the 70th patient trigggers an interim analysis (early look at results) WHICH MAY WELL PROPEL THE EXPERIMENTAL VACCINE TO FDA APPROVAL.

"The Interim Analysis is a pre-specified futility and overall safety analysis to evaluate the likelihood of the study to achieve its primary objectives. Upon completion of this prospective analysis, the IDMC will provide a recommendation to the Company regarding further continuation of the trial."

These results certainly give hope to many many breast cancer patients. More to follow as usual...


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