By Karen Pihl-Carey

Cangene Corp. terminated a Phase III trial of Leucotropin in the U.S. due to slow patient recruitment and new data presented at a recent conference.

Presentations at the 1999 meeting of the American Society of Clinical Oncology suggested the use of high-dose chemotherapy and stem-cell transplantation may not be clinically superior to standard-dose regimens in certain breast cancer patients. As a result, referring practices changed to an extent that it will be difficult to recruit sufficient patients and complete the trial on a timely basis, the company said. The trial was supposed to enroll 258 patients.

"We were just having a hard time recruiting patients and there was changing data that came out," said John Langstaff, Cangene's president and CEO. "I guess one of the problems in the U.S. in general and in the biotech industry is the availability of patients for clinical trials."

Langstaff said Cangene was at a disadvantage as well because Leucotropin is a sort of "me-too" drug, a version of a granulocyte macrophage-colony stimulating factor (GM-CSF), which is already on the market. Leucotropin, if it reaches the market, would compete as a generic drug would. GM-CSF is a protein that stimulates the formation of mature white blood cells.

Langstaff said the termination is disappointing, but that the company has developed a revised clinical strategy in the U.S. for the drug and is talking with experts on where to go next.

"We have some other trials going on in Canada and Great Britain right now, and we're looking at the best strategy for going after the American market, too," he told BioWorld Today. "The trick of it is to get patients in as early as possible."

Leucotropin entered the Phase III trial in the U.S. in December 1997. The trial was expected to take 18 months to complete, Langstaff said.

The drug also is in two other Phase III studies in Canada. The first trial is for use following bone marrow transplantation, and the other trial, which started in August, is for white blood cell recovery following chemotherapy. (See BioWorld Today, Aug. 24, 1999.)

Patient recruitment in the trial, started in August, is going well, the company said, and it should be completed by the end of 2000. The trial is expected to enroll about 100 patients with lymphoma who have had chemotherapy. Cangene expects to expand the trial to sites in the UK.

Cangene's stock (TSE:CNJ) closed Thursday at C$4.75, down C15 cents.