By Mary Welch
Cangene Corp. started its third Phase III trial for Leucotropin, a granulocyte macrophage-colony stimulating factor (GM-CSF), this time for white blood cell recovery following chemotherapy.
The first Leucotropin Phase III trial, which is taking place in Canada, is for use following bone marrow transplantation. The second, for the mobilization of peripheral blood stem cells in breast cancer patients, is occurring in the U.S. That trial, which started Dec. 9, 1997, has not yet enrolled the planned 258 patients. There is no completion timetable for either trial.
The new trial, which will take place in Canada, will enroll about 100 patients with lymphoma who have had chemotherapy. The trial should take about 12 months, said Jean Compton, manager of investor relations.
"We started this trial because the first one - for bone marrow transplantation - has slowed down a bit," she said. "There are fewer being performed in this country so patient recruitment and enrollment is a bit behind what we were expecting. It's still proceeding but at a slower pace."
Cangene, of Winnipeg, Manitoba, soon plans to submit a regulatory filing to start a similar trial in the UK, she added.
The new Canadian multicenter trial will be managed by a contract research organization.
Leucotropin is a protein that stimulates the production of certain infection-fighting white blood cells that are often depleted following cancer chemotherapy and some AIDS treatments. A loss of white blood cells often leaves a patient susceptible to infection.
"There are similar GM-CSF products on the market so we would compete similar to a generic drug," Compton said. "We will compete on price and quality."
Separately, Compton said the company's offer to acquire Hyal Pharmaceutical Corp., of Mississauga, Ontario, is "off the table. It is not active at all." (See BioWorld Today, Aug. 5, 1999, p. 1.)
Cangene's stock (TSE:CNJ) closed Monday at C$4.80, down 5 cents.