FDA approves SPA Protocol Amendment for Lucanix Phase III clinical trial
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.