Firms confirm plans to start second Phase III refractory bladder cancer trial by year end.
Bioniche Life Sciences earned a $4 million milestone payment from its global licensee Endo Pharmaceuticals on the back of positive one-year data from a registrational trial evaluating Urocidin™ in the treatment of nonmuscle-invasive bladder cancer that is refractory to current first-line therapy with Bacillus Calmette-Guérin (BCG). The product is a formulation of Bioniche’s mycobacterial cell wall-DNA complex (MCC), which is a cell wall-DNA composition prepared from a culture of the bacterium Mycobacterium phlei.
The firms state they expect to start a new, larger Phase III trial with Urocidin before the end of 2010. The completed Phase III study included 105 patients, and the new trial will include about 450 patients, and compare Urocidin with mitomycin C for the intravesical treatment of recurrent or refractory nonmuscle-invasive bladder cancer.
Bioniche says it has now received four milestones from Endo as part of their Urocidin deal. The original agreement, signed in 2009, gave Endo exclusive rights to the drug for the U.S. market, and an option to global rights. This option was exercised in February 2010, at which point Endo took on the responsibility for all future costs associated with development of the drug worldwide. Bioniche could receive up to $110 million in clinical, regulatory and commercial milestones.
Bioniche claims MCC has a dual mode of action that both directly induces apoptosis in cancer cells and stimulates anticancer cytokine production by immune effector cells. The firm is initially focused on developing MCC for a range of cancers. In addition to its lead bladder cancer product, MCC candidates are also in preclinical development against prostate tumors, muscle-invasive bladder cancer, ovarian and colorectal cancers, melanoma, osteosarcoma, and metastatic breast and colon cancers. Phase I trials in prostate cancer have been completed.