SAN DIEGO, Nov. 4 /PRNewswire/ -- NovaRx Corporation announced today that the Company has successfully negotiated and received FDA approval for a Special Protocol Assessment (SPA) Protocol Amendment to the pivotal Lucanix(R) Phase III clinical trial in patients with Non-Small Cell Lung Cancer (NSCLC). The amendment will expand patient eligibility and enable study investigators to treat patients with stable brain metastases. As many as one in three NSCLC patients have such metastases, thus the amendment will make significantly more patients eligible for the trial. Other approved protocol changes include expanded stratification criteria and the ability for investigators to treat patients with decreased serum albumin levels.
"The protocol amendment will strengthen the Lucanix(R)( )Phase III study greatly," said Dr. Habib Fakhrai, Executive Vice Chairman of the Board and Chief Scientific Officer of NovaRx. "We thank the FDA for the speed in which they approved the amendment and look forward to continuing to successfully work with them and our clinical sites throughout this pivotal Phase III trial."
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.
Lucanix(R) is currently under clinical investigation and has not been approved for use in the United States, Canada, Europe or elsewhere. Any claims of safety and efficacy can only be made after the FDA reviews the data and approves all labeling claims for Lucanix(R)'s intended use.
NovaRx Corporation is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of novel cell-based therapeutic vaccines for the treatment of cancer. The company's headquarters and manufacturing operations are in San Diego, California. The proprietary core technology upon which Lucanix(R) is based has been exclusively licensed to NovaRx on a worldwide basis. Lucanix(R) is a registered trademark of NovaRx Corporation.
CONTACT: Carissa Schumacher for NovaRx Corporation at +1-310-499-8970 or firstname.lastname@example.org