NovaRx Initiates Pivotal Phase III Clinical Trial in Lung Cancer Patients
The study is designated as the STOP trial because of its expectedendpoints: Survival; Tumor-free, Overall; and Progression-free. It is aninternational, multicenter, randomized, double-blind study involving up to 700individuals with advanced stage NSCLC, and will be conducted at approximately90 clinical sites in the U.S., Canada, India, and Europe.
In a Phase II clinical trial, two-year survival among patients with stagesIIIB and IV disease who received Lucanix(R) was significantly longer than thatof individuals being treated with the current standard of care. A second,investigator-initiated phase II study supported these results.
In contrast to conventional cancer therapies, where systemicchemotherapeutic drugs nonspecifically kill normal cells as well as tumorcells, the therapeutic vaccine developed by NovaRx induces the patient'simmune system to specifically target the cancer. In phase II clinical studiesto date, the side effects of this treatment have included redness or sorenessat the injection site.
"In medical research, you see something like this once in a lifetime,"said John Nemunaitis, M.D., executive director at the Mary Crowley MedicalResearch Center in Dallas, TX and principal investigator of both the Phase IILucanix(R) study and the investigator-initiated Phase II trial.
"This is a very promising approach to cancer treatment, and resultsreported so far are beyond anyone's expectations. I am very excited to be apart of this confirmatory effort, and to be able to offer this uniquetreatment option to my patients," said Dr. Lyudmila Bazhenova, principalinvestigator of the STOP trial at the Rebecca and John Moore's Cancer Centerof UCSD. "Traditional chemotherapy for stage IV NSCLC still yieldsdisappointing results, and my hope is that this trial will improve thenatural history of the disease." The FDA granted NovaRx Fast-Track approvalfor the Lucanix(R) trial in March of 2007, and Special Protocol Assessmentapproval in January of 2008.
According to the American Cancer Society, in 2008 there will be anestimated 215,000 new cases of lung cancer diagnosed, and 162,000 deathscaused by this disease in the United States alone. Lung cancer is the numberone cause of cancer death throughout the world. "The statistics for globallung cancer deaths are staggering. I am confident that this Phase III trialwill establish Lucanix(R) as a viable treatment option for patients with thisdreaded disease," said Dr. Habib Fakhrai, president and co-founder of NovaRx.
In Phase II testing, 50 percent of patients entering the trial with stabledisease who received Lucanix(TM) following one frontline regimen ofchemotherapy lived more than 44 months, compared to less than 10-12 months forsuch patients under the current standard of care. In addition, patients withadvanced disease who received Lucanix(TM) after zero to five priorchemotherapy treatments demonstrated a one-year survival of 61 percent and atwo-year survival of 41 percent. Such late-stage patients typicallydemonstrate one-year survival of less than 30 percent. Lucanix(TM) was shownto produce only insignificant side effects.
"In addition to significantly increased survival," Fakhrai continued, "wesaw virtually no side effects in the patients treated in phase II trials.Based on our previous trial results, we think Lucanix(R) may lead
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