The review was undertaken to assess the safety of the drug, MKC-1 in a phase II trial in patients with advanced or metastatic breast cancer who have failed conventional therapies.
The board concluded that the apparent risk, based on the current safety data review for MKC-1, was appropriate for the population under study. The board also felt that the study did not require any modification, and that the phase II study in patients with metastatic breast cancer should continue as currently designed. Preliminary results from the metastatic breast cancer clinical trial are expected during the first half of this year.
EntreMed also recently completed the purchase of all remaining bulk quantities of the active pharmaceutical ingredient for MKC-1 from Roche. EntreMed has a worldwide, exclusive license from Roche to develop and commercialize MKC-1.
In addition to the trial in metastatic breast cancer, MKC-1 is currently in phase I and II clinical studies in patients with non-small cell lung cancer and hematological malignancies.
“Given questions about the toxicity of MKC-1 observed in prior clinical studies using higher doses and shorter schedules, it was important for us to demonstrate MKC-1's safety and tolerability using the 14-day schedule,” commented James Burns, EntreMed's president and CEO.