EntreMed has launched a first round of human trials on lung cancer patients for a drug already in clinical tests to battle other forms of cancer.
The Rockville company is starting Phase I trials of MKC-1, its small-molecule drug to treat lung cancer -- the same drug it began testing in Phase I for leukemia one month ago and in Phase II trials for advanced breast cancer 10 months ago.
The lung-cancer trial is taking place at various medical centers, but the lead institution is Indiana University Cancer Center, which is also a site for EntreMed's trials of another drug candidate, Panzem, which treats advanced breast and prostate cancer.
MKC-1 will be administered to volunteers in conjunction with another federally approved drug that blocks folic acid activity and helps treat lung cancer as well.
EntreMed will determine the effectiveness of MKC-1 in that combination in a Phase I trial, followed by a Phase II trial with up to 60 patients, including those who need further treatment after the first phase.
Earlier this year, EntreMed started Phase I and Phase II trials of Panzem.
MKC-1 is a small molecule cell cycle inhibitor (think mitosis). Specifically, MKC-1 arrests cellular mitosis by inhibiting a novel intracellular target important in cellular trafficking that has been shown to be involved in cell division. MKC-1 binds to tubulin and thus inhibits the mitotic phase of the cell cycle.
A Phase 2 clinical trial of MKC-1 in metastatic breast cancer patients commenced in January of this year and a Phase 1 study of MKC-1 in hematological(blood) cancers commenced in September. The Company anticipates that a second Phase 2 trial with MKC-1 in non-small cell lung cancer will commence in the fourth quarter of 2006.
EntreMed (NASDAQ:ENMD) is on average volume at 1.99 in afternoon trading.
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