By Kim Coghill
Phase III clinical trials for a drug designed to reduce the incidence of life-threatening bacterial and fungal bloodstream infections related to the use of catheters were initiated Wednesday by Vancouver-based Micrologix Biotech Inc.
Micrologix started its 18-month clinical trials in the United States for MBI 226, its novel lead antimicrobial drug product, according to David Friedland, Micrologix's director of clinical development.
The FDA has awarded the drug fast-track status and the company expects approval within the next two and a half years.
"We are very positive about this drug and we think the study will progress well," Friedland said. "Following the Phase III study we expect to file a new drug application within three months and we are confident the FDA will grant us priority review as part of the fast-track status."
In the Phase III trials, MBI 226 will be compared to the current standard of care in randomized, blinded, multicenter studies. The study is designed to prove that MBI 226 (a topical treatment), administered at central venous catheter (CVC) insertion sites, reduces or eliminates bacterial and fungal colonization of the catheters and prevents subsequent bloodstream infections, Friedland said.
The pivotal study has two parts, both involving about 1,500 patients at 12 clinical sites across the U.S., Friedland said. Each should be completed independently in 12 months.
The trial involves applying the topical treatment upon the first CVC and each time the dressing is changed. Patients will be followed up to 28 days.
"In Phase I, MBI 226 reduced the number of microorganisms growing on the skin of healthy people by 99.9 percent and the incidence of catheter colonization to zero," Friedman said.
The majority of CVC-related bloodstream infections occur when bacteria and fungi that colonize the patient's skin around the catheter insertion site migrate down the catheter tract to colonize the implanted portion of the device. The microorganisms cause "blood poisoning."
Because of positive results of Phase I, the FDA required only a safety study in Phase II, which proved MBI 226 is safe and well tolerated.
CVCs are devices used by physicians to deliver therapeutic and nutritional agents, sample blood and monitor a patient's status. Generally they are inserted through the chest wall into a major vein, such as the jugular vein.
Each year in the United States, in excess of 5 million CVCs are sold and it is estimated that catheter-related bloodstream infections develop in 250,000 to 400,000 patients, resulting in 50,000 deaths.
Friedland said Micrologix's goal is to reduce the infection rate by 30 percent worldwide. Micrologix may begin seeking approval in foreign markets prior to FDA approval.