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.