Millennium Pharmaceuticals Inc. initiated a Phase III trial of newly named Velcade, its drug candidate most recently known as MLN341, in patients with multiple myeloma.

The company said it filed for trademark registration for the name Velcade (bortezomib) for injection, which also has been known previously as LDP-341 and PS-341.

Cambridge, Mass.-based Millennium said the Phase III trial will be a randomized, open-label, multicenter trial to compare Velcade with high-dose dexamethasone. The trial is planned for 60 sites in the U.S., Canada and Europe with about 600 patients participating, all of whom have experienced disease progression despite one to three previous therapies.

Millennium officers were unavailable to discuss the Phase III trial launch, but said in a press release that the primary endpoint will be time to disease progression. Secondary endpoints include survival, measurements of clinical benefit, quality of life and response rates.

There will be two arms of the study, including one arm for patients receiving dexamethasone and not responding. In those instances, the patients will be given Velcade in a single-arm trial of that drug.

"This news is a positive since it almost doubles the [net present value] of the drug, since a drug's probability of approval usually increases to 50 percent to 60 percent from 30 percent to 35 percent when it advances from Phase II to Phase III," wrote analyst James Reddoch at Banc of America Securities in New York in a research note.

"The timing and size of this trial is in line with expectations," he added, and the trial is expected to take 16 to 20 months. "A trial start is positive news because it re-starts the developmental timeline clock for the trial," he wrote.

The advancement of Velcade follows positive results from a Phase II trial, also conducted in patients with multiple myeloma. Those results, presented at the American Society of Clinical Oncology meeting in May, showed that 77 percent of patients experienced stabilization of the disease or a reduction in their (M) protein levels, after receiving the drug for up to 24 weeks.

Velcade also is being studied in other clinical trials, including two ongoing Phase I trials, one in conjunction with Gemzar and another in conjunction with Camptosar. The studies are of patients with advanced solid tumors including pancreatic, lung and colorectal cancer. Preliminary results of those trials showed that Velcade was well tolerated and showed early signs of antitumor activity. Those early results also were presented at ASCO in May.

In January, Millennium initiated a Phase I trial of Velcade in combination with Taxotere (docetaxel) concentrate for injection.

Millennium's stock (NASDAQ:MLNM) fell 54 cents Wednesday to close at $10.85.