LUCANIX®, an experimental therapeutic vaccine is being investigated in this Phase III clinical trial. Lucanix® is an allogeneic therapeutic vaccine, which consists of NSCLC cells derived from lung cancer patients. Tumors produce substances that hide them from the immune system. In Lucanix, cells are genetically engineered to expose the tumors to the immune system. Engineering of the vaccine cocktail was with a transforming growth factor-beta (TGF-β) antisense vector that blocks the production of TGF-β, the most immune suppressive substance that is produced by all tumor cells to both fuel their own growth and to hide themselves from the body’s immune system. Once injected into the skin of the upper arm, Lucanix® deactivates the tumor cells, stripping the tumor of its invisibility cloak. This allows the immune system to attack and destroy the NSCLC tumor, as well as any other NSCLC tumor cells circulating in the body. The only side effect that Lucanix® demonstrated in clinical trials conducted to date was redness and soreness at the site of the injection, very similar to what one could experience after receiving a flu shot. In a Phase II clinical trial conducted in subjects with NSCLC, Lucanix® demonstrated an acceptable safety profile and a survival improvement in response to treatment with Lucanix®
In the Phase II study, Lucanix®, which was tested to treat advanced stage NSCLC patients (stages IIIB and IV) who had received zero to five prior chemotherapies, demonstrated a one-year survival of 61%, a two-year survival of 41%, and a median survival of 16 months. These late-stage patients typically demonstrate a less than 30% one-year survival. Typical two year survival for stage IV patients is 5% and for stage IIIB is 10% on average. Currently, 50% of the patients who received Lucanix® following one frontline regimen of chemotherapy and entered the trial with stable disease have lived over 60 months. The results of the Phase II NSCLC Lucanix® trial are published in the Journal of Clinical Oncology (Vol. 24, No. 29, October 10, 2006, pages 4721-4730 and can be downloaded here. The Phase III trial is a clinical trial of Lucanix® as maintenance therapy for stages IIIa (T3N2), IIIb, and IV NSCLC subjects who have responded to or have stable disease following one regimen (up to 6 cycles) of front-line platinum-based combination chemotherapy. The study is an international, multicenter, randomized, double-blinded, placebo-controlled study. Participants will receive best supportive care with monthly injections of Lucanix® in the treatment group or best supportive care with a placebo injection in the control group.