Alpha-Beta Technology Inc. is incorporating FDA suggestions intoits protocol for a Phase III trial of Betafectin PGG-glucan, andexpects shortly to begin the pivotal study for the prevention ofhospital-acquired infections.
The trial of the Worcester, Mass., company's lead product has beenanticipated since April 29, when Alpha-Beta presented positivePhase II trial results, which were questioned at the annual meeting ofthe Surgical Infection Society in Toronto. And on the followingMonday, May 2, when company officials said they were delaying thepivotal trial, Alpha-Beta stock dropped 42 percent, or $9, to $12.50per share.
"We stepped back and made sure we had a manufacturing processwe could take forward into Phase III, and into launch," said PaulBleicher, vice president of clinical affairs for Alpha-Beta. "Wealtered the process to optimize yield and purity."
Alpha-Beta also completed a study in healthy volunteers ofBetafectin produced through the new manufacturing process. Then itsent its suggested Phase III protocol to the FDA.
"We have found the FDA review to be very positive, veryconstructive," Bleicher told BioWorld. "They raised issues we agreewith and will incorporate into the trial. We have every expectationwe will be able to start the trial very soon."
Betafectin is a mutated derivative of the cell walls of yeast. Itattaches to the specific beta-glucan receptor on the surface of whiteblood cell macrophages (neutrophils and monocytes), enhancing theability of white blood cells to respond to pathogens.
The drug, a carbohydrate polymer, is used as an adjunct toantibiotics, the standard treatment for hospital-acquired infections.Even with antibiotics, 30 to 40 percent of patients undergoing opengastrointestinal surgeries get infections, Bleicher said.
He said 900-plus patients are expected to be enrolled at about 30sites in the U.S., but those numbers could change depending on thefinal protocol. The trial will have three arms _ .5 mg/kg, 1 mg/kgand placebo. Patients will receive an intravenous infusion ofBetafectin before surgery, after surgery and at days two and four.There also is a 30-day follow-up period.
"The FDA has helped us identify infections which are serious, so theendpoint will be the incidence of those serious infections," Bleichersaid. Secondary endpoints include hospital length of stay, intensivecare unit (ICU) stay and antibiotic usage.
Betafectin reduced infections and ICU and hospital stay in smallerPhase II studies.
In one study of 13 placebo subjects, five sustained 22 infectiousepisodes, requiring an average of 3.3 days in intensive care. Five of17 Betafectin subjects had eight infections, which were less severethan those in the placebo group, and averaged 0.1 days in ICU.Betafectin patients spent an average of 12 days in the hospital aftersurgery while those who were given placebos spent 17 days.
Bleicher said it should take about a year after the trial approval toenroll patients.
Alpha-Beta's stock, hit hard after the trial delay announcement inMay, gained 20 percent, or $1.75, to $10.50 in trading Thursday,after the company's news that it is incorporating FDA comments intoits protocol. The stock (NASDAQ:ABTI) fell $1.25 Tuesday, closingat $9.50. n
-- Jim Shrine
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