NovaRx Corporation Completes Enrollment in Lucanix Pivitol Phase III Therapeutic Vaccine Trial for Post Frontline Maintenace Therapy in Non Small Cell Lung Cancer
Published: Jun 20, 2012
SAN DIEGO, June 20, 2012 /PRNewswire-iReach/ -- NovaRx Completes Enrollment in Lucanix® Pivotal Phase III Therapeutic Vaccine Trial for Post-frontline Maintenance Therapy in Non-small Cell Lung Cancer.
First Interim Analysis for NSCLC Trial in Third Quarter 2012.
NovaRx Corporation announced that it has recently completed the planned enrollment in its Phase III clinical trial of Lucanix® (belagenpumatucel-L). Lucanix is an investigational whole tumor cell vaccine for the treatment of non-small cell lung cancer. The clinical trial, which is operating under a Special Protocol Assessment (SPA) from FDA, is designed to enroll 506 patients to test the efficacy of Lucanix when used to treat patients who have a good response to initial chemotherapy.
The first interim analysis of overall survival in the trial will be performed by the independent Data Monitoring Committee (DMC) sometime in the third quarter of 2012. If the DMC concludes that the trial meets the pre-specified endpoints for statistical significance, NovaRx would anticipate filing a Biologics License Application (BLA) based on the interim results. If the pre-specified endpoints are not met, NovaRx will continue treating patients in the trial and anticipates performing the second interim analysis in the fourth quarter of 2012.
"This is the beginning of the end of a long journey that began 12 years ago to fulfill our goal of bringing a safe and effective therapy for this devastating disease. This milestone was achieved because of the hard work and dedication of our great team of employees at NovaRx," said Dr. Habib Fakhrai, inventor of the technology and founder of NovaRx
"We are excited to complete the enrollment phase of this important clinical trial and we look forward to the results of the first interim analysis in the third quarter. Approval of this vaccine will allow us to develop the remainder of our pipeline, including our universal vaccine that targets many other tumor indications and can be used prophylactically as well as therapeutically," said Justin Murdock, Chief Executive Officer.
About the Study Design
The clinical trial is an international, multicenter, randomized, double-blind, placebo-controlled Phase III study, which enrolled over 506 patients with advanced non-small cell lung cancer who had a good response to frontline chemotherapy. The trial is being conducted under a Special Protocol Assessment (SPA) agreed upon between NovaRx and FDA. Based on the SPA, the primary endpoint of the trial is overall survival. "This is an important clinical trial. Lucanix will provide a safe and effective treatment alternative to people with this dreadful disease," said Daniel Shawler, Senior Vice President of Operations and a co-developer of the technology.
About Non-small Cell Lung Cancer
Non-small cell lung cancer is the leading cause of death among cancers. In the United States more than 160,000 people will die from lung cancer this year, more than the next four types of cancer combined. Worldwide, close to two million people are expected to die from lung cancer this year. Currently only a handful of treatment options are available to people with lung cancer, most of which have significant toxic side effects. Lucanix can provide an alternative option to these drugs.
About Lucanix Whole Tumor Cell Vaccine
Lucanix may represent the first product in a new class of tumor vaccines designed to use whole tumor cells to stimulate the patient's own immune system to attack the patient's tumor. Lucanix is an off-the-shelf allogeneic vaccine unlike other cellular immunotherapies. The tumor cells in Lucanix have been modified to block production of transforming growth factor beta (TGF-), which is one of the primary methods tumors use to hide from the immune system. Blocking TGF- is designed to allow the vaccine to initiate strong immune responses with the goal of inducing a long-term clinical benefit with minimal toxicity.
NovaRx Corporation is a private biotechnology company whose mission is to develop novel tumor cell vaccines characterized by strong efficacy with little toxicity. The Company views its TGF--blocking technology as a platform and is developing other whole tumor cell vaccine that effectively target other forms of cancer. The Company is headquartered in San Diego, California. For more information about NovaRx, visit www.NovaRx.com.
This press release contains forward-looking statements that are subject to risks and uncertainties surrounding the safety and efficacy of Lucanix to treat people with non-small cell lung cancer. There are also inherent risks and uncertainties surrounding the approval of a new drug product by FDA.
SOURCE NovaRx Corp.