FDA approves Marillion NDA for novel cancer treatment

MALVERN, Pa. Marillion Pharmaceuticals has received approval from the Food and Drug Administration for it investigational new drug application for its lead product candidate MN-201, a vitamin D5 analog for the treatment of cancer.

The drug will now proceed to Phase 1 human clinical trial for patients with advanced tumors in various cancers.

In preclinical studies, MN-201 performed well against cancer cells. In animal models, MN-201 also resulted in anti-tumor activity including tumor regression in xenograft models of major solid tumor types. In contrast to treatment with other vitamin D(3) analogs and the naturally occurring vitamin D hormone, calcitriol, favorable anticancer effects with MN-201 were observed in the absence of significantly raised calcium levels.