Cell Therapeutics said Monday it is beginning a Phase III trial of itslead product, a compound designed to reduce infections in thoseundergoing bone marrow transplantations.
The product, lisofylline, will be tested in a randomized, double-blind,placebo-controlled study in 106 patients. The trial will assess thebenefit of lisofylline for patients with advanced malignanciesundergoing allogeneic bone marrow transplantation (BMT) fromgenetically matched siblings.
The primary objectives are the incidence of serious infectionsassociated with neutropenia (low white blood cell counts) caused byhigh-dose chemotherapy during the first 35 days following BMT, andto evaluate the effect on treatment-related mortality at 100 days.
Lee Parker, vice president, investor relations at Seattle-based CellTherapeutics, said another trial is being planned in acutemyelogenous leukemia, but company efforts are geared toward thislead indication.
"We need to focus on getting a product to market and this is a goodopportunity for us," Parker said. "We feel strongly that should thePhase III studies hold up with these two primary endpoints we havean approvable product."
Cell Therapeutics in June postponed a planned initial public offeringbecause of market conditions. Parker said it was postponed with thehope that a recovery in the market will take place this fall.
The company's second product, CT-2584, is in a Phase I trial inEngland in colon cancer patients.
Lisofylline is designed to inhibit phosphatidic acid and reduceoxidative damage. Parker said it could have utility in situations wherecells come under stress from causes such as radiation, chemotherapyand trauma.
"Modulating this stress pathway will be beneficial in preventing theproblems associated with chemotherapy and other problems," Parkersaid.
Parker said earlier studies of lisofylline perhaps missed the markwhen primary endpoints of white blood cell counts were assigned.Secondary endpoints in those studies _ such as those involvinginfections and mortality rates _ were met, he said.
It is expected to take about a year to enroll the 106 patients, Parkersaid. The study will run another 100 days after the last patient istreated. n
-- Jim Shrine
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