• AVAX Technologies Inc., of Philadelphia, reached a special protocol assessment agreement with the FDA to begin a pivotal Phase III trial of M-Vax, its AC Vaccine technology for metastatic melanoma. The double-blind registration study will enroll up to 387 patients with Stage IV melanoma and assign them in a 2:1 ratio to M-Vax or placebo. The M-Vax arm will consist of an initial dose of M-Vax (autologous DNP-modified tumor cells) followed by cyclophosphamide and then six weekly doses of M-Vax administered with bacillus of calmette and guerin. Following vaccine administration, patients will receive a specific schedule of low dose IL-2. Patients in the control group will receive identical treatment save for placebo. The study's primary endpoints are best overall antitumor response rate and the percentage of patients surviving at least two years. An interim analysis of best overall response rate (complete and partial) will be performed when half the patients have completed assessment of their best antitumor response. Secondary endpoints include overall survival time, response duration, percentage complete and partial responses, progression-free survival and treatment-related adverse events.

• Discovery Laboratories Inc., of Warrington, Pa., disclosed positive data from the Phase II trial with Surfaxin (lucinactant) in bronchopulmonary dysplasia. The trial enrolled 136 premature infants who got either Surfaxin standard dose (175 mg/kg), Surfaxin low dose (90 mg/kg), or sham air as a control. The trial was designed as an estimation study to evaluate the safety and potential efficacy of Surfaxin in infants at risk for BPD, and was not powered to determine statistically significant differences in outcomes. The standard dose is the same as Discovery administered in its successful Phase III trials in respiratory distress syndrome. In the BPD trial, infants showed a positive acute pharmacological response to Surfaxin therapy, as evidenced by a reduction in supplemental oxygen and ventilatory support, and a lower incidence of death or BPD in patients receiving the standard dose compared with controls (57.8 percent and 65.9 percent, respectively), as well as other benefits. Discovery's stock (NASDAQ:DSCO) closed Thursday at $2.64, up 51 cents, or 23.9 percent

• Manhattan Pharmaceuticals Inc., of New York, expanded its oral Oleoyl-estrone (OE) obesity program to include a new Phase IIa trial in morbidly obese male subjects. The double-blind, parallel group study will include about 24 subjects with a body mass index of 40 to 55 and randomize them into three treatment groups to evaluate the safety and efficacy of 10 mg or 30 mg of oral OE compared to placebo given once daily for 30 days.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., received regulatory approval to begin a new clinical trial of its lead tumor necrosis therapy agent, Cotara, in India. The trial is designed to test the drug's safety and efficacy in up to 40 patients with glioblastoma who have experienced their first relapse. Cotara already is being studied in a U.S. glioblastoma trial.