Millennium Pharmaceuticals said on Tuesday initial results from a large trial of its cancer drug Velcade as an initial treatment for multiple myeloma were so good that the trial was stopped early to allow patients in the control group to receive the therapy.
Shares of the Cambridge, Massachusetts-based biotechnology company rose 12% in premarket trading on optimism the data will open a broader section of the market for the drug.
Velcade, which is already approved to treat patients with multiple myeloma who have failed at least one other therapy, was tested in a large international trial in patients with newly diagnosed multiple myeloma.
Data showed that patients taking Velcade in combination with the standard treatments melphalan and prednisone showed a statistically significant benefit across several measures, including overall survival, compared with patients receiving melphalan and prednisone alone.
Based on the recommendation of an independent data monitoring committee that conducted an interim analysis, the trial was stopped early to allow patients in the control group to have Velcade added to their therapy.
The company said it plans to file an application with U.S. regulators to allow it to market the drug as an initial therapy in the first quarter of 2008.
"An approval in front-line multiple myeloma would double the number of patients eligible to receive the benefit of Velcade," said Dr. Nancy Simonian, Millennium's chief medical officer.
Millennium is conducting the trial, known as VISTA, with a unit of Johnson & Johnson .
The company's shares rose 12% to $11.10 in electronic trading from a close of $9.77 on Monday on Nasdaq.