NewLink Genetics (NLNK) announced that it will begin an investigator initiated, randomized, double blind placebo controlled Phase 2 study entitled "Phase II Study of sipuleucel-T (PROVENGE) plus indoximod (D-1MT/NLG8189) in the treatment of patients with asymptomatic or minimally symptomatic metastatic hormone refractory prostate cancer."
The company said that the study is done in collaboration with Dendreon Corp.(DNDN) and the Masonic Cancer Center, University of Minnesota.
Dr. Gautam Jha, assistant professor of medicine at the University of Minnesota will lead this multicenter study with a planned enrollment of 50 patients. Men with hormone refractory metastatic prostate cancer, eligible for therapy with sipuleucel-T (PROVENGE) will be enrolled to evaluate the safety and efficacy of the combination of NewLink's indoximod with Dendreon's PROVENGE.
PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
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