Oregon's Galena Biopharma ($GALE) is edging closer to a submission for NeuVax after the initiation of a Phase III trial for its vaccine to prevent HER2 1+ and 2+ breast cancer recurrence in the adjuvant setting. The trial--the timing of which beats some analyst predictions--could help stealthy Galena land an approval for a potential blockbuster, Zacks notes.
Each year, more than 200,000 women in the U.S. are diagnosed with breast cancer, and 75% test positive for HER2. However, only 25% are eligible for Roche-Genentech's Herceptin. Looking to aid those patients who can't be helped by Herceptin, Galena's multinational Present study will enroll about 700 breast cancer patients, and follows on the heels of a Phase I/II study that showed NeuVax could provide a significant benefit in maintaining disease-free survival, explains University of Texas MD Anderson Cancer Center's Beth Mittendorf, who is also the principal investigator, in a statement.
"NeuVax addresses a critical unmet medical need, well-recognized by investigators, and the interest from potential patients is very high," said CMO Rosemary Mazanet in a statement. "We are grateful to our investigators and our clinical trial sites for their ongoing feedback and support in reaching this crucial first step of enrolling patients ahead of schedule."
As FierceVaccines noted last week, the therapeutic vaccine combines the E-75 peptide with the HER2/neu protein and an immune system stimulant. It was developed by the Cancer Vaccine Development Program at the San Antonio Military Medical Center. As the American Forces Press Service reported Jan. 6, the upcoming study will take roughly 5 years to complete, and the endpoint is recurrence rate after three years.
Galena got its start last fall after RXi Pharmaceuticals ($RXII) announced that it would split up its work. It changed its name to Galena as it looked to focus on experimental cancer vaccines while spinning off its RNAi technology under the RXi Pharmaceuticals banner.
- check out Galena's release
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