ATLANTA, ASCO, June 5 /PRNewswire/ -- NovaRx Corporation announced at the American Society of Clinical Oncology ("ASCO") meeting in Atlanta, GA, that data from the Company's Phase II clinical trial treating individuals with advanced stages of non-small cell lung cancer ("NSCLC") demonstrated two year-survival more than four times that of individuals treated with the current standard of care. The Phase II study of 75 patients was designed to determine the safety and efficacy of Lucanix(TM), a novel therapeutic treatment under development by NovaRx. In contrast to conventional cancer therapies, where systemic chemotherapeutic drugs nonspecifically kill the normal cells as well as tumor cells, the therapeutic vaccine developed by NovaRx specifically induces the patient's immune system to fight the cancer. In clinical studies to date, the side effects of this treatment have been shown to be minimal compared to those associated with traditional therapies.
"These data are extremely encouraging," said John Nemunaitis, M.D., Executive Director at the Mary Crowley Medical Research Center in Dallas, TX, a clinical investigator and presenter of the Lucanix study results. "In addition to significantly increased survival rates, which is the gold standard for oncology clinical trials, we saw virtually no side effects with Lucanix. The unique mechanism of action and resulting efficacy and side effect profile could lead to a significant advancement in patient care. We look forward to initiating Phase III trials."
"The compelling data presented by Dr. Nemunaitis demonstrate that further testing of Lucanix may lead to a commercially viable, effective treatment for this deadly disease," said Dr. Habib Fakhrai, Ph.D., President and CEO of NovaRx and the inventor of the Company's technology. "We are in the final stages of preparing to initiate a pivotal, Phase III trial to test Lucanix in a two-arm, controlled study in approximately 400 individuals with advanced stages of NSCLC."
The therapeutic vaccine being developed by NovaRx consists of four non-small cell lung cancer cell lines that were originally derived from lung cancer patients. These cell lines were engineered to block a molecule called transforming growth factor-beta (TGF-Beta), which is a potent agent commonly produced by cancer cells that paralyzes the patients' immune system. Lucanix has been previously shown to induce immune-mediated antitumor responses in cancer patients, thus "jumpstarting" their immune response. The Phase II data demonstrate that the vaccine significantly improved survival in lung cancer patients by destroying, halting, or delaying disease progression.
There are 170,000 new cases of lung cancer and 160,000 deaths caused by this disease in the United States annually. Non-small cell lung cancer is responsible for approximately 130,000 of lung cancer deaths in the U.S. each year and is the number one cause of cancer death throughout the world.
NovaRx Corporation is a privately held biopharmaceutical company based in San Diego, California. The company is developing new therapeutic approaches for treating cancer with its lead indication focused on non-small cell lung cancer. NovaRx Corporation holds the exclusive worldwide license for this patented technology for the treatment and prevention of all cancers and plans to develop therapies for lung, brain, breast, colon, prostate and melanoma cancers. Patents have been issued in the U.S., Europe and Japan that protect the Company's intellectual property. Additionally, the Company is planning to initiate a multi-center pivotal Phase II/III clinical trial treating individuals with glioblastoma multiforme or gliosarcoma (brain cancers) in 2007. The Company is the recipient of two National Institutes of Health grants. Proceeds from these grants will partially offset the cost of the Phase II lung cancer trial and the planned pivotal Phase II/III brain cancer trial.
Lucanix(TM) is a trademark of NovaRx Corporation.
For more information on the company, please contact Kathy Witz Sweeney with Mentus at 858-455-5500, firstname.lastname@example.org, or visit the NovaRx website at www.novarx.com.