By Randall Osborne
Bolstered by encouraging results in one stratum of the Phase III study of its lead product, Alpha-Beta Technology Inc. plans to begin by year's end a confirmatory Phase III clinical trial of Betafectin PGG glucan for preventing serious infections after surgery.
Alpha-Beta, of Worcester, Mass., took a hit in August when results of its Phase III study of Betafectin failed to reach overall statistical significance. Two-thirds of the patients (786) in the trial experienced no difference between the drug and a placebo in the incidence of serious infection. When the news broke, Alpha-Beta's stock plummeted 43 percent. (See BioWorld Today, Aug. 5, 1997, p. 1.)
However, one-third of the patients (391) in the study did achieve statistical significance. These were patients who had undergone non-colorectal gastrointestinal surgeries (gastric, biliary, pancreatic and small-bowel procedures).
"We're confident that we have a product here [that can reach the marketplace]," said Davidson Easson, vice president and chief operating officer for Alpha-Beta. In September, Alpha-Beta restructured to reduce operating costs to focus on Betafectin and cut its work force, laying off 60 people. (See BioWorld Today, Sept. 22, 1997, p. 1.)
Betafectin is a carbohydrate that acts by priming microbicidal activities of neutrophils and monocytes, without stimulating biochemical mediators such as interleukin-1 and tumor necrosis factor, which cause inflammatory side effects.
In the overall study, 21 percent of patients suffered serious post-surgical infections, compared with 17 percent of patients treated with Betafectin. In the non-colorectal gastrointestinal segment, 36 percent suffered serious post-surgical infections, compared with 22 percent of Betafectin-treated subjects.
Encouraging trends were evident in the secondary endpoints, which included number of infections, number of days in the hospital, and number of days on antibiotics.
FDA Helped Design Phase III Trial
Company officials have agreed with the FDA on the design of the confirmatory study, which will be a double- blind, placebo-controlled study of about 600 non-colorectal surgery patients at 30 sites. The study is expected to be completed within 18 months, and an interim analysis will be performed when 50 percent of the patients are enrolled, probably near the end of next year, Easson said.
"The [original] study was prospectively stratified into colorectal and non-colorectal groups, and we did not have an agreement to analyze them independently," Eason said. "We intend to essentially duplicate the non-colorectal stratum."
Betafectin's failure with colorectal patients may have been due to the larger infectious invasion in such surgeries — more than the drug could overcome, Easson said.
"In the colorectal patients, when you're exposed to infection, you get exposed to a very high inoculum of infecting organism," he said. "The major risk is from spillage from the intestine."
Alpha-Beta also has an antifungal research program to discover direct inhibitors of fungal cell wall synthesis. In May 1997, Alpha-Beta bought MycoTox Inc. for $3 million and merged the Denver-based company's antifungal research, drug-screening and in vitro fungal diagnostics with Alpha-Beta's program. (See BioWorld Today, May 9, 1997, p. 1.)
Alpha-Beta's stock (NASDAQ:ABTI) closed Tuesday at $2.687, up $0.062. *