Alpha-Beta's Betafectin, Disappointing Ph III Data

Alpha-Beta Technology's shares plunged 43% to $6.32 on the day thecompany disclosed disappointing preliminary data from a Phase III study of its carbohydrate drug Betafectin (PGG-glucan).

Although the data demonstrate a significant reduction in the number of serious infections in patients undergoing non-colorectal gastrointestinal surgeries, including surgeries of the stomach, pancreas, small bowel and liver, in a second defined stratum, patients undergoing colorectal surgeries, including surgeries of the colon and rectum, there was no difference in the incidence of serious infections between the placebo and the two Betafectin arms (0.5mg/kg and 1.0mg/kg). In the non-colorectal group, 36% of the placebo group experienced serious infections after surgery compared with 22% of both Betafectin groups. In patients undergoing colorectal surgeries, however, 14% in both the treatment arms and the placebo group experienced serious infections. Furthermore, in the overall study, 21% of the placebo group suffered serious post-surgical infections, versus 17% in both the Betafectin-treated groups. This result did not achieve statistical significance.

Betafectin did not fare much better on secondary endpoints. The mean number of infections per patients was 0.39 in the placebo group, 0.27 in the 0.5mg/kg Betafectin group and 0.23 in the 1.0mg/kg Betafectin group. The mean length of stay was 14.3 days, 12.4 days and 14.6 days, respectively, while mortality by day 30 was 9%, 5% and 8% in each respective group.