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news.Marillion Pharmaceuticals has reported that its investigational new drug application has been cleared by the FDA and the company plans to start its Phase I trial for its orally administered vitamin D5 analog for the treatment of cancer.
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The trial will evaluate the safety and pharmacology of vitamin D5 analog, MN-201 in patients with advanced tumors in various cancers. The protocol for the clinical trial is currently before institutional review boards (IRBs) at the sites selected for the trial and clinical supplies are being prepared.
Zahed Subhan, CEO of Marillion Pharmaceuticals, said: “MN-201 is the first synthetic vitamin D5 receptor ligand to be advanced into clinical trials for a variety of cancers including breast, prostate and colon cancers. Based on a novel mechanism of action, MN-201 could have utility as both a monotherapy in the treatment of various malignancies and for use in combination with other chemotherapeutic agents where synergistic benefits may be possible.”