OncoVAX® Phase IIIa Study (8701) Results in Stage II Colon Cancer
- Statistically significant survival benefit in stage II colon cancer
- Results published in The Lancet
The Company believes that OncoVAX®, now optimized for dose and regimen, is the first patient-specific vaccine to significantly reduce the risk of stage II colon cancer recurrence after surgical resection. In a Phase IIIa study, OncoVAX® reduced the risk of recurrence in stage II colon cancer patients from one in three patients to one in ten.
Five clinical studies of OncoVAX®, including 8701 which established optimum dose and regimen, have been completed as of 2014. 757 subjects with colorectal cancer, of which 720 had colon cancer, have been enrolled in OncoVAX® trials.
We conducted a small bioequivalency study (2002-01) of 15 patients to ensure the newly developed, sterile manufacturing process did not change the clinical outcome observed in 8701. This was necessary because that study did not require a sterile product. The results of the follow-up study concluded the immunogenicity of OncoVAX® was unaffected by the sterilization process.
In these trials, excluding the bioequivalency study, 385 subjects (of the 757 subjects) were randomized to receive OncoVAX®, of which 353 received at least one vaccination and the other 372 subjects were treated with surgery alone. In addition, subjects with colorectal cancer were enrolled in three separate trials that assessed the effects of ASI with OncoVAX® in combination with chemotherapy as adjuvant therapy to surgical resection. Lastly, two trials have also been performed using autologous tumor cells/BCG in melanoma (n=86) and renal cell carcinoma (n=14).
For the full publications of these results and other relevant studies prepared by third parties related to patient-specific cancer vaccines that may provide some background, please visit the following:
Harris, Jules E., et al. (2002) Adjuvant Active Specific Immunotherapy for Stage II and III Colon Cancer with an Autologous Tumor Cell Vaccine: Eastern Cooperative Oncology Group Study E5283. Classic Papers and Current Comments, Journal of Clinical Oncolo.
Hoover, Jr., Herbert C., et al. (1993) Adjuvant Active Specific Immunotherapy for Human Colorectal Cancer: 6.5-Year Median Follow-up of a Phase III Prospectively Randomized Trial. Journal of Clinical Oncology 11:390-399.