FDAnews
www.fdanews.com/articles/69340-myriad-initiates-phase-i-trial-of-mpc-6827-in-metastatic-brain-cancer

Myriad Initiates Phase I Trial of MPC-6827 in Metastatic Brain Cancer

March 2, 2005

Myriad Genetics will begin a second Phase I clinical trial with its investigative cancer drug, MPC-6827, under an FDA-approved investigational new drug application.

This new human clinical study will evaluate the potential of MPC-6827 to treat metastatic brain cancer by achieving therapeutic concentrations in the brain that are sufficient to treat tumors without significant systemic exposure or toxicity. The Phase I clinical study will be performed at Memorial Sloan-Kettering Cancer Center in New York City.

In preclinical studies, MPC-6827 was demonstrated to reach approximately 1,500 percent greater concentration in the brain than in the blood. This high brain concentration was achieved at a safe therapeutic dose for the treatment of peripheral tumors in mice. The company, however, believes a much lower dose in humans should result in brain concentrations of MPC-6827 sufficient for antitumor activity yet without peripheral toxicity. The highest brain penetration percentage of drugs that are currently used in treating brain cancer is that of temozolomide, which reaches a peak brain concentration level that is just 29 percent of the blood plasma concentration.