The Cancer Center of Santa Barbara will be participating in a Phase III clinical trial in order to evaluate the effectiveness of Lucanix, a new vaccine designed to fight lung cancer.
The new cell-based therapeutic vaccine — developed by the NovaRx Corporation — is designed for patients with non-small cell lung cancer (NSCLC). According to the NovaRx Web site, Lucanix consists of four NSCLC gene-modified cell lines that block secretion of TGF-β, a protein that controls cell proliferation and differentiation and protects tumors by acting as an immunosuppressant.
Unlike traditional chemotherapy treatments, the vaccine is designed to induce the patient’s immune system to specifically target the tumor cells, sparing the lives of normal cells in the process. Barbara Conviser, CCSB Director of Research and Quality Services, said the overarching goal of the treatment is to enhance the lives of those dealing with the chronic condition.
“The drug is designed to prolong the quantity of life, while, at the same time, prolonging the quality of life,” Conviser said. “The substance that’s under investigation prompts the person’s own immune system to keep the lung cancer at bay.”
The vaccine was tested in a Phase II clinical trial in 2006, determining a median survival of 16 months. The results revealed that 61 percent of advanced-stage NSCLC patients who had received zero to five prior chemotherapies demonstrated a one-year survival rate, while 41 percent showed a two-year survival.
After receiving successful results in the early testing stages, NovaRx contacted UCLA Translational Oncology Research International (T.O.R.I.) to begin the final phase of testing required for FDA approval. As part of the T.O.R.I. network, the Clinical Research Dept. at CCSB is the first of several trials available for patients in the Central Coast region.
Moreover, Dr. Frederic Kass, CCSB medical director of research and wellness, said the positive results of Lucanix are part of a broader trend in cancer treatment today.
“In general, we are turning incurable cancers into chronic diseases,” Kass said. “What’s happening now is that we’re developing more and more tools to transform life threatening diseases into chronic, but manageable conditions. Patients might not be cured, but they are better able to cope with serious diseases.”
The Phase III trial commenced in August of 2008 and NSCLC patients are currently being treated in the global trial. Researchers hope the experiment will reach completion in September 2011.
According to a press release, the trial, which is limited to a total of 506 individuals, is open to participants between 19 and 74 years of age who meet the advanced stage disease presentation and treatment status requirements. Once accepted, participants will visit the clinic monthly to receive an injection of either the vaccine or placebo. Their progress will then be assessed.
As long as the patient’s health remains stable, the injections will be given consistently for an 18-month period and then repeated at 21 and 24 months.
If granted approval by the FDA, Lucanix could drastically improve the lives of both NSCLC patients and their loved ones. Fourth-year sociology major Alexis Calimeris, after seeing the devastating effects of lung cancer on her aunt, said the vaccine has been anticipated for quite some time.
“She’s always been a very strong woman in the family, but with her development of lung cancer, she’s really feeling the effects of aging,” Calimeris said. “I think that the new development could be really beneficial and give her a new hope for improvement.”