Novel Vaccine Shows Promise in Treating Prostate Cancer
Active immunotherapy is emerging as a potential therapeutic approach for prostate cancer, and new data suggests that a novel vaccine could be a game-changer in the fight against this deadly disease. Researchers in Athens, Greece, have conducted the first phase I trial of an Ii-Key/HER-2/neu(776-790) hybrid peptide vaccine (AE37) with recombinant granulocyte macrophage colony-stimulating factor as adjuvant in patients with HER-2/neu(+) prostate cancer. The trial, published in Clinical Cancer Research, demonstrated that the vaccine is safe and can induce HER-2/neu-specific cellular immune responses in patients with castrate-sensitive and castrate-resistant prostate cancer.
Key Takeaways:
- The trial enrolled 32 HER-2/neu(+), castrate-sensitive, and castrate-resistant prostate cancer patients, of which 29 completed all six vaccination cycles with AE37.
- Immunologic responses in the total patient population were monitored by delayed-type hypersensitivity and IFN-gamma ELISPOT and intracellular staining.
- Regulatory T-cell (Treg) frequency and plasma HER-2/neu and transforming growth factor-beta levels were also determined.
- Seventy-five percent of patients developed augmented immunity to the AE37 vaccine and 65% to the unmodified AE36 peptide as detected in the IFN-gamma-based ELISPOT assay.
- Intracellular IFN-gamma analyses revealed that AE37 elicited both CD4(+) and CD8(+) T-cell responses.
- Eighty percent of the patients developed a positive delayed-type hypersensitivity reaction to AE36.
- Significant decreases could be detected in circulating Treg frequencies, plasma HER-2/neu, and serum transforming growth factor-beta levels.
Statistics:
- 75% of patients developed augmented immunity to the AE37 vaccine.
- 80% of patients developed a positive delayed-type hypersensitivity reaction to AE36.
- 65% of patients developed immunity to the unmodified AE36 peptide.
- 32 patients were enrolled in the trial.
- 29 patients completed all six vaccination cycles with AE37.
- Significant decreases were detected in circulating Treg frequencies, plasma HER-2/neu, and serum transforming growth factor-beta levels.
Sources:
- Perez, S.A., et al. "Results from a phase I clinical study of the novel Ii-Key/HER-2/neu(776-790) hybrid peptide vaccine in patients with prostate cancer." Clinical Cancer Research, 2010; 16(13): 3495-506.
- Biotech Week editors, "Novel Vaccine Shows Promise in Treating Prostate Cancer," Biotech Week, 2010.