While the incidence of ovarian cancer is around a fifth of that of breast cancer, the number of deaths from the disease is about half of the more common breast cancer. Despite surgery and chemotherapy, the majority of women will relapse. But Galena Biopharma ($GALE) is developing a folate-binding protein vaccine that could prevent disease recurrence in ovarian and endometrial cancer, and the company has moved it into clinical trials.
The Phase I/II dose-escalating trial is designed to confirm the safety of the vaccine. Investigators will also try to determine the best dose and evaluate early signs of efficacy, including an immune response to folate-binding protein, as well as time to disease recurrence. The study will involve women previously treated for ovarian or endometrial cancer with no evidence of disease.
"Initially, we will seek the appropriate dose and monitor the safety and efficacy of the FBP vaccine, but given the high recurrence rate of these cancers, we expect that we may see initial clinical efficacy data within two years," said Mark Ahn, Galena's president and CEO.
The folate-binding protein vaccine, also known as E39, combines the E39 peptide with granulocyte macrophage-colony stimulating factor (GM-CSF) as an adjuvant. Folate-binding protein is overexpressed on more than 90% of ovarian and aggressive endometrial cancers.
- read the press release