Clinical Trials

NovaRx reached an agreement with the United States Food and Drug Administration (FDA) on the design of the Lucanix^® Phase III clinical trial in January of 2008. Fast-Track Status and Special Protocol Assessment (SPA) approval for the trial has been granted by the FDA. Non-small cell lung cancer (NSCLC) patients are now being treated in the Phase III trial globally. Clinical centers enrolling patients in the Phase III trial can be viewed on the NIH clinical trials website at:
http://www.clinicaltrial.gov/ct2/show/NCT00676507

The title of the study is:

Registration Phase III Study of Lucanix^® (belagenpumatucel-L) in Advanced Non-small Cell Lung Cancer:  An International Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Lucanix^® Maintenance Therapy for Stages III/IV NSCLC Patients Who Have Responded to or Have Stable Disease Following One Regimen of Front-line, Platinum-based Combination Chemotherapy.

The trial will evaluate the ability of Lucanix^® to significantly prolong the overall survival of patients when compared to best supportive care.  The trial will also evaluate other endpoints including quality of life, progression-free survival (PFS), time-to-progression, tumor response, response duration, the development of brain metastases, and overall safety.

Glionix^™ (Glioma vaccine) trial design is underway and the trial is anticipated to commence in late 2009.