By: Danae Roumis for Fibroids1Neuvenge is a new vaccine-type treatment developed by biotechnology company Dendreon. It is designed to give women with HER2/neu-positive (fast-growing) metastasized breast cancer an option for treatment after having exhausted other methods. The August 20 issue of the Journal of Clinical Oncology has published the results of a preliminary study of the drug conducted by researchers from Dendreon as well as the University of California, San Francisco. The study affirmed the safety and promising anti-cancer effects of Neuvenge.
| Take Action |
Scheduling an annual mammogram starting at age 40 (or before if you have a family history) is the best way to detect early signs of breast cancer.
Ask your physician about once-per-month breast self-exams. If you notice any breast changes such as lumps, discharge, or inflammation, call your doctor. |
The purpose of the Phase 1 study was to test the safety of the drug and monitor its anti-tumor behavior. The study involved 19 subjects, 18 of whom were inoculated with Neuvenge at weeks zero, two and four. None of the subjects suffered side effects more serious than low-grade fevers or chills – which lasted no more than one or two days. No subjects discontinued treatment due to toxicity. Though the study was done on a small scale, researchers are optimistic about the early, encouraging results. Lead author of the study, Dr. John Park of UCSF, told Reuters that “a reduction in the size of tumor area in one patient…was certainly attributable to the treatment.” This patient’s immune system displayed anti-tumor activity for about six months, while three others’ showed signs of disease stabilization for about a year. These four subjects were given booster shots of the same initial dosage at the one-year mark, which resulted in good immune response. The research team concluded that the drug is “feasible and well-tolerated.” Second phase research will be designed to specifically test the efficacy of the drug.
Neuvenge (lapuleucel-T) is a development born out of Dendreon’s concentration on Active Cellular Immunotherapies (ACIs), which stimulate the body’s immune system to re-boot in order to fight off disease. This study suggests that ACIs may provide patients with effective treatment at low toxicities. Since ACIs work with what is already in the body by enlisting CD4 helper T-cells, there is the possibility that ACIs could be tailored for different types of cancer. This is exactly the hope of Dendreon researchers. Their ACI for prostate cancer, Provenge (sipuleucel-T), has the FDA’s safety approval and is waiting in line for further approval before being put on the market. Neuvenge is the next step in that tailoring process – it is specifically targeted toward breast cancer in which the HER2/neu-protein is over-expressed. The same protein is over-expressed in a variety of other tumors as well, including colorectal cancer and ovarian cancer. If Neuvenge is a success, there is a great chance that more types of ACIs will be developed.
