NovaRx Corporation Announces FDA Approval of Protocol Amendment to Special Protocol Assessment (SPA) for Phase III Lucanix(R) Study in Non-Small Cell Lung Cancer (NSCLC)
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® 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.
"We are very excited by the approval of this protocol amendment," stated Justin Murdock, CEO of NovaRx. "It confirms the FDA's willingness to work with us in the Phase III process, enables the trial's clinical sites and investigators to screen more patients, and, most importantly, will make far more patients eligible for the study. Reaching and potentially benefitting as many patients as possible is NovaRx's utmost priority."
"The protocol amendment will strengthen the Lucanix®( )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."
According to the American Cancer Society (ACS), lung cancer is the single largest cause of cancer deaths among men and women in the United States and is responsible for nearly 30 percent of all cancer deaths. The ACS estimates that in 2009 more than 200,000 Americans were diagnosed with lung cancer and close to 160,000 died of the disease. NSCLC is the most common type of lung cancer.
In contrast to conventional cancer therapies, where systemic chemotherapeutic drugs nonspecifically kill normal cells as well as tumor cells, Lucanix® induces the patient's immune system to specifically target the cancer.
Lucanix® 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 III Lucanix® trial in March of 2007, and Special Protocol Assessment approval in January of 2008. The Phase III study commenced in August 2008 and over 90 global clinical sites are expected to enroll NSCLC patients in the trial.
Lucanix® 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®'s intended use.
About NovaRx Corporation
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® is based has been exclusively licensed to NovaRx on a worldwide basis. Lucanix® is a registered trademark of NovaRx Corporation.
Although the company's current clinical trials are for the treatment of advanced non-small cell lung cancer, the majority of other forms of cancer are expected to be susceptible to NovaRx's vaccine approach. NovaRx is in discussions with the FDA to initiate a clinical trial for one of its promising pipeline vaccines, Glionix(TM), for the treatment of brain cancer. A version of this vaccine has already been tested in patients with provocative results.
CONTACT: Carissa Schumacher for NovaRx Corporation at +1-310-499-8970 or email@example.com
SOURCE NovaRx Corporation