Roche Holding subsidiary Genentech is responsible for providing Herceptin for the trial at no charge. Galena began enrolling patients in the trial in March 2013. The trial has been designed to randomize 300 breast cancer patients (1:1) – node positive or negative – who are disease-free following standard of care, comparing NeuVax plus Herceptin vs. Herceptin alone with a primary endpoint of disease-free survival (DFS) at 24 months.
Galena also recently reported data from its ongoing Phase I/IIa trial of FPB (folate binding protein or E-39) in ovarian cancer (OC) and endometrial cancer (EC). FBP is overexpressed in more than 90% of OC and EC, compared with limited expression in nonmalignant tissues, which is a feature that makes the drug a good immunotherapy target. Galena uses FBP (plus GM-CSF) as an adjuvant treatment for preventing cancer recurrence in high-risk OC and EC. Enrollment in the study begun in February 2012, and 20 patients have been enrolled to date. FBP-treated patients had an 11.1% recurrence, while untreated patients had a 27.3% occurrence – representing a 59% reduction.
Galena’s Abstral (fentanyl) sublingual tablets, which are indicated for managing breakthrough pain in cancer patients 18 years and older who are already receiving and are tolerant to opioid therapy, is projected to contribute $1.5 million in revenue in 2013 and $8.2 million in 2014. This is contrasted with management’s guided revenues of $1.5 million to $3 million in 2013 and $8 million to $12 million in 2014. The company’s 10-year DCF values NeuVax at $4/share and Abstral at $1/share. At this stage, Galena is not assigning a market value to FBP. The company believes its long-term risk-reward profile is favorable.
A biopharmaceutical company based in Portland, Ore., Galena Biopharma is engaged in the development of innovative, targeted oncology treatments to address major unmet medical needs in the advancement of cancer care. For more information about Galena Biopharma, visit www.galenabiopharma.com.
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