Investors Applaud Galena Biopharma Getting Fast Track Status for Its NeuVax PRESENT Clinical Study

Galena Biopharma, Inc.

disclosed that the Food and Drug Administration (FDA) has designated its NeuVax (nelipepimut-S), combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF), as a Fast Track development program. The drug candidate is for the treatment of patients with early stage, node positive breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or 2+, following standard of care. Galena said that its PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical study was an international, final stage study to evaluate NeuVax plus GM-CSF versus placebo plus GM-CSF to prevent cancer recurrence. The company's President and CEO, Mark Schwartz, said, "This Fast Track designation by the FDA reflects the importance of NeuVax as a potential treatment option addressing an unmet medical need in a serious medical condition. With the number of cancer survivors in the United States projected to increase by 31% to almost 19 million by 20241, there is a clear need to prevent recurrence in women with breast cancer who have completed their standard of care, but have limited therapies to maintain their disease free status. As we approach our interim safety and futility analysis for PRESENT, and initiate our efforts towards the filing of a Biologics License Application (BLA), this Fast Track designation will be extremely valuable to us as we seek marketing authorization for NeuVax." Similarly, its EVP and Chief Medical Officer, Bijan Nejadnik, commented, "Fast Track designation provides us with opportunities for frequent interactions with the FDA review team for our NeuVax development program in breast cancer, including the PRESENT trial, as we prepare our BLA for filing. As such, assuming a successful clinical readout in the PRESENT trial, we may be eligible for a rolling review. We look forward to collaborating closely with the FDA at this critical stage for NeuVax development." Galena said that this designation was planned to facilitate development, as well as, expedite review of drugs to treat serious and life-threatening conditions so that an approved product could reach the market expeditiously. Also, the designation meant that the FDA will take such actions as are appropriate to expedite the development and review of the application for approval of such product. In the pre-market trading on Wednesday, the stock traded 14.9 percent higher.