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news.Galena Biopharma has commenced Phase 1/2 study of its Folate Binding Protein (FBP) (E39) vaccine in ovarian and endometrial adenocarcinomas.
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The FBP vaccine comprises E39 peptide integrated with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF).
The study will examine if the FBP vaccine is safe and effective at inducing an anti-tumor immune response.
The trial will also determine the optimal dose of the vaccine to produce the immunity against ovarian and aggressive endometrial cancer.
The primary endpoints of the study are the safety and optimal dosing of the vaccine to induce an in vivo peptide-specific immune response, and the clinical endpoint is time to recurrence.
Galena Biopharma president and CEO Mark J Ahn said they will seek the appropriate dose and monitor the safety and efficacy of the FBP vaccine.
"We expect that we may see initial clinical efficacy data within 2 years," Ahn added.