By Frances Bishopp

Alpha-Beta Technology Inc.'s stock plummeted 43 percent Monday on news its Phase III study of Betafectin PGG glucan, a non-antibiotic infection-fighting glucose polymer, did not achieve overall statistical significance in its primary endpoint, a reduction in the incidence of patients who developed serious infections 30 days after surgery.

Alpha-Beta's stock (NASDAQ:ABTI) closed Monday at $6.125, down $4.688.

Betafectin, which is being studied for the prevention of serious infections in patients at high risk for post-operative infections, did achieve statistical significance in one of the two stratums in the study: non-colorectal gastrointestinal surgeries (gastric, biliary, pancreatic and small bowel procedures), which represented one third (391) of the patients in the trial.

In this area, the study found a 39 percent reduction of serious post-operative infection vs. placebo. In this group, 36 percent of the placebo patients suffered serious post-surgical infections compared with 22 percent of the Betafectin-treated patients. Also, favorable trends were observed in all of the secondary endpoints.

Patients in the other stratum, however — colorectal patients undergoing colon resections, large bowel surgery and colorectal cancer — experienced no difference in the incidence of serious infections between the placebo and Betafectin. This stratum comprised two thirds (786) of the patients in the trial.

In the overall study, 21 percent of the placebo patients suffered serious post-surgical infections compared with 17 percent of the Betafectin-treated patients, results which did not achieve statistical significance in the primary endpoint.

Despite results, Spiros Jamas, president and CEO of Alpha-Beta, told BioWorld Today he still considers the trial to be a "partial success."

Jamas said the 20 percent or so reduction in serious infections between placebo and the Betafectin-treated groups was a trend driven entirely by the effects of the drug in the non-colorectal group.

Jamas said Alpha-Beta plans to meet with the FDA to review results in detail and push for filing a product license application based on results of the non-colorectal stratum.

The randomized clinical study was conducted at 40 centers in the U.S. and included 1,177 patients who received either 0.5 mg/kg of Betafectin, 1.0 mg/kg of Betafectin, or placebo. All the patients had received a standard regimen of antibiotics prior to surgery.

Jamas said there is a strong possibility the company will run another confirmatory trial, with approximately 250 to 300 patients, using the lower dose of Betafectin. "This trial could be run in parallel with a filing, or we may have to do a trial first," Jamas added.

Betafectin, the Worcester, Mass.-based company's lead product, is a carbohydrate that acts by priming the microbicidal activities of neutrophils and monocytes. Unlike other immumodulatory compounds, including unmodified beta-glucans, Betafectin does not stimulate the production of biochemical mediators, such as interleukin-1 and tumor necrosis factor, which cause undesirable inflammatory side effects.

The Phase III results led Peter Drake, an analyst with Vector Securities International Inc., of Deerfield, Ill., to downgrade the rating of the Alpha-Beta stock on the premise the stock would be under pressure Monday and "would take some time to recover."

Alpha-Beta, which owns all rights to Betafectin, raised $42 million in a secondary offering in March 1996.

As of June 30, 1997, Alpha-Beta had approximately $25 million in cash. *