Los Angeles, CA, October 26, 2009 --(PR.com
)-- A study to develop a new genetically engineered vaccine opened officially Friday Oct 16. The program has begun screening patients and will expand a promising initial clinical trial for which a published case report documented the rapid shrinkage and/or disappearance of widespread tumors within eight weeks, with few side effects.
These regressions found in the preliminary study were seen even in tumors spread beyond the breast to other sites, including lung and brain—a result unlike anything yet reported in the world literature. While the effect was not permanent or curative, a new analysis in press describes a threefold prolongation of expected survival in several additional patients, especially notable because the tumors were resistant to previous chemotherapy.
The new regimen now underway will involve skin injections of a vaccine containing laboratory-prepared, x-ray inactivated tumor cells, to help support an immune response to cancerous cells hopefully without affecting healthy ones. Other medications are also used before and after for their possible effects on the immune system. The vaccine tumor cell line also has been genetically engineered to release at the injection site larger amounts of an important immune-stimulating protein naturally produced by white blood cells, a protein that may be deficient in patients having impaired immunity.
Unlike the preventative vaccines such as the common flu vaccine, cancer vaccines are administered after a person has developed cancer, to boost killer cells and antibodies to mount an immune response against each remaining cancer cell. Compared with chemotherapy and other standard modalities, vaccines are expected to be less toxic and more selective.
The research team is led by Charles Wiseman, MD, FACP, formerly Director of the Breast Cancer Basic Research Laboratory at the University of Texas M.D. Anderson Hospital in the 1970s and more recently, the Principal Investigator for several clinical trials at the St. Vincent Medical Center in Los Angeles. According to Dr. Wiseman, “We are very happy now to have all the regulatory approvals to expand and enlarge our research, not only in breast cancer but also other kinds of cancer. But our first target is breast cancer. About one out of eight American women will develop breast cancer in her lifetime and about 500,000 die worldwide each year. Further research offers hope for change.“
“For people whose standard-treatment chemotherapy hasn’t helped, nothing says you should wait until you’ve exhausted every other option before considering clinical trials. Furthermore, there’s some possibility seen in other studies to suggest that treatment-resistant patients who have had a vaccine may respond better to the next line of chemotherapy, even if the vaccine initially didn’t appear to be effective. We need to research this much more intensively.”
Dr. Wiseman adds that, “Our very early positive results show tumor regression and possibly improved survival, and are based on direct human responses, not mouse or laboratory experiments. It’s critical that we expand the study widely. We need to determine if other patients might enjoy similar positive responses, how frequently, or if there are related negative side effects.”
Dr. Wiseman’s team involves doctors from Hollywood Presbyterian Hospital and the Glendale Memorial Hospital, with technical support from the Beverly Hills Cancer Center. Several other centers are expected to become qualified in the near future. The official title of the trial is: A Phase I/II Study of Tumor Cell Line Vaccine in Patients With HER2/neu-Positive Breast Cancer, HER2/neu-Negative Breast Cancer, or other HER2/neu-Positive Solid Tumors, and has FDA approval for clinical trial in almost all eligible breast cancer patients. Additionally, the FDA has approved the study for selected patients with certain other cancers, such as those in the prostate, lung, ovary or bladder.
Similar clinical trials are underway in a number of centers, and just last month a study appeared in a scientific journal showing possible benefit of a comparable vaccine approach in leukemia patients. Such vaccines, while promising, are considered preliminary and not an established or proven method.
Dr. Wiseman’s investigation addresses advanced, treatment-resistant breast cancer as well as some other cancers, differing from many other programs that are often only for patients whose tumors have certain chemical features, and then only for people in remission. While experimental, clinical trials play a vital role in the rigorous testing necessary before releasing new approaches to the general public. They support medical research, and they make cutting-edge technology available years before it might otherwise enter the mainstream. Vaccine research programs, as well as others, require the patient to meet certain eligibility conditions, and usually exclude persons with medical conditions that might increase risk of side effects. To reach the clinical trial stage, a new treatment must show considerable promise, and is permitted only after very detailed review by the FDA and other regulatory agencies.
The principal investigator performing the vaccine inoculations is Ghassan Al-Jazayrly, MD. The trial will take place in his offices in two locations, one in Los Angeles and one in Glendale. For further information, please call 213-483-8464 or 323-660-6200 to speak to a research coordinator or visit wisemanresearch.com.