Serbia First in Europe to Participate in Phase 3 Clinical Trial of Lung Cancer Vaccine
NovaRx Corporation announced the opening of the company’s pivotal Phase 3 clinical trial of Lucanix(R) (belagenpumatucel-L) in the treatment of advanced non-small cell lung cancer (NSCLC) in Serbia. Serbian oncology centers participating in the trial include the Clinical Hospital Center Benzanijska Kosa in Belgrade, the Clinic for Pulmonary Diseases and TB “Knez Selo” in Nis, and the Institute for Pulmonary Disease of Vojvodina in Sremska Kamenica.
Serbia is the first European country to open the Lucanix(R) study for enrollment. The study is an international, multicenter, randomized, double-blind study involving up to 700 individuals with advanced stage NSCLC, and will be conducted at approximately 90 clinical sites in the U.S., Canada, Europe, and India. Treatment of patients in the Phase 3 Lucanix(R) trial at multiple clinical centers began in the United States in August 2008.
“For my team and Institution, the Lucanix(R) trial will be a challenge and also an affirmation of innovation in the development of lung cancer treatments,” stated Dr. Vladimir Kovcin, Head of Oncology at the Clinical Hospital Center Bezanijska Kosa in Belgrade, Serbia. “Given the expense of current therapies for NSCLC, many advanced-stage Serbian lung cancer patients do not have many treatment options for their disease. Lucanix(R) is unique from other therapies because it enhances the immune system in a natural way. It is a great pleasure to participate in this clinical trial.”
In a previous Phase 2 clinical trial, survival ranges among advanced-stage non-small cell lung cancer patients who received Lucanix(R) after receiving chemotherapy were more than double the survival ranges of individuals being treated with the current standard of care. Patients on Lucanix(R) demonstrated a one-year survival of 61% and a median survival of 16 months. Late-stage NSCLC patients typically demonstrate a less than 30% one-year survival. A second, investigator-initiated Phase 2 study supported these results.
Importantly, there were no significant toxicities related to Lucanix(R) in these trials. Side effects have been generally mild and similar to brief influenza symptoms.
“The safety and side effect profile of Lucanix(R) seems to be acceptable for patients’ quality of life, which is very important,” Kovcin stated. “If the Phase 3 clinical trial is successful, Lucanix(R) could change lung cancer treatment strategy in Serbia and the rest of the world.”
According to the WHO-Europe, lung cancer represents one of the leading causes of death for males and females in Serbia. In 2006, there were 5,400 new cases of lung cancer diagnosed in Serbia, and 4839 deaths from the disease. Lung cancer represents the number one cause of cancer death throughout the world.
“We are aggressively expanding the reach of our international Phase 3 trial of Lucanix(R) and we are pleased Serbia is the first of many countries in Europe where this experimental treatment will be available for patients.” said Dr Norrie Russell, President and Chief Operating Officer of NovaRx. “We are grateful to those centers and those patients who are helping establish whether, one day, Lucanix(R) will provide a much-needed option for lung cancer patients worldwide.”
In contrast to conventional cancer therapies, where systemic chemotherapeutic drugs nonspecifically kill normal cells as well as tumor cells, Lucanix(R) induces the patient’s immune system to specifically target the cancer.
Lucanix(R) consists of four non-small cell lung cancer cell lines that have been gene-modified to block a molecule called transforming growth factor-beta (TGF-beta), which is commonly produced by cancer cells. The molecule allows cancer to hide from the body’s natural immune system. When TGF-beta is blocked, the immune system can see, find, and destroy the cancer naturally.
United States Food & Drug Administration granted NovaRx Fast-Track approval for the Phase 3 Lucanix(R) trial in March of 2007, and Special Protocol Assessment approval in January of 2008.
Lucanix(R) currently is under clinical investigation and has not been approved for use in the United States, Canada, Europe or elsewhere. The product has not been proved to be safe or effective, and any claims of safety and effectiveness can be made only after regulatory review of the data and approval of the labeled claims.
Source: NovaRx Corporation