Spectrum Pharmaceuticals decided to axe further development of its LHRH antagonist, ozarelix, for the treatment of benign prostatic hyperplasia (BPH). The drug was poised to enter Phase III trials.
Spectrum says that the decision was made in part because of mixed results from an earlier Phase IIb study in BPH but also in light of the recently announced failure of Aeterna Zentaris’ LHRH antagonist, cetrorelix, in Phase III registrational trials for the same indication.
“Whilst ozarelix is a potent GnRH antagonist, low-dose, intermittent therapy has been disappointing in the treatment of lower urinary tract symptoms in men with BPH,” states Rajesh C. Shrotriya, M.D., chairman, CEO, and president at Spectrum. “By discontinuing the ozarelix program, the savings of more than $40 million we had budgeted for the clinical trials and other related costs will help us advance other programs that have the greatest likelihood of commercial success.”
While details on exactly which program will benefit and by how much are not known, Paul Arndt, senior manager, investor relations, believes that the money will go toward enhancing the uptake of Zevalin, approved for relapsed or refractory non-Hodgkin lymphoma (NHL) and as a first-line consolidation therapy for NHL. He also expects a chunk of money to go toward Fusilev, which is sanctioned for osteosarcoma and under FDA review for colorectal cancer.
The rest of Spectrum’s clinical pipeline comprises additional anticancer agents. EOquin® is the lead candidate in Phase III development for noninvasive bladder cancer. It is a synthetic bioreductive prodrug. The company has two drugs in Phase II: Ortataxel for the treatment of taxane-refractory tumors and Satraplatin for non-small-cell lung cancer. Also, the firm has three drugs in Phase I trials: SPI-1620, an adjunct to chemotherapy, Elsamitrucin for advanced solid tumors, and Lucanthone, a chemotherapy sensitizer in the treatment of recurrent, malignant brain tumors.