Marillion Pharmaceuticals, Inc. has announced that its investigational new drug application (IND) has been cleared by the FDA. Marillion is now able to proceed with its planned Phase 1 human clinical trial for the company’s lead product candidate, MN-201, an orally administered vitamin D5 analog for the treatment of cancer.
The Phase I trial will be an open-label, dose-escalation study to evaluate the safety and pharmacology of 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.
“MN-201 is the first synthetic vitamin D5 receptor ligand (VDRL) to be advanced into clinical trials for a variety of cancers including breast, prostate and colon cancers,” said Zahed Subhan, Ph.D, chief executive officer of Marillion Pharmaceuticals.
“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,” added Dr. Subhan.
In preclinical studies, MN-201 demonstrated broad anti-tumor activity in cancer cells. In animal models, oral administration of 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.