• Immtech Pharmaceuticals Inc., of New York, initiated a Phase IIb trial of the oral agent pafuramidine maleate to treat patients with uncomplicated malaria caused by Plasmodium falciparum. The primary objective is to establish a dose to be studied as monotherapy in a subsequent Phase III trial. The trial also will explore the treatment efficacy of the combination of pafuramidine and artesunate. Immtech separately is conducting a Phase II trial of pafuramidine for malaria prevention. The new trial will evaluate one or two doses over three days. Further details on the trial were not disclosed.
• Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia, said partner Helicon Therapeutics Inc., of New York, reported unfavorable efficacy data from a Phase IIa trial of the IPL455,903 (HT-0712) in age-associated memory impairment. The randomized, placebo-controlled study demonstrated safety and tolerability, but did not demonstrate significant positive effects on memory and learning. The PDE-4 inhibitor did not show efficacy or signal on quantitative EEG, Inflazyme said. It said it requested data and reports from Helicon so it can assess and interpret the outcome independently. Inflazyme's stock (TSE:IZP) fell C2 cents Monday, or 17.7 percent, to close at C7 cents.
• Threshold Pharmaceuticals Inc., of Redwood City, Calif., initiated patient enrollment in a Phase II trial evaluating the efficacy and safety of glufosfamide in patients with previously treated, advanced soft-tissue sarcoma, which includes cancers of cartilage, fat, muscle, blood vessels or other connective or supportive tissue. The primary endpoint of the 22-patient, open-label trial is objective response rates. Secondary endpoints include duration of response, progression-free survival, overall survival and various safety parameters. Threshold earlier this year moved the compound into separate Phase II trials in patients with advanced ovarian and small-cell-lung cancers. Also this year, Threshold reported the product failed to produce a statistically significant improvement in overall survival vs. best supportive care in a Phase III trial in 303 patients with metastatic pancreatic cancer who had relapsed after chemotherapy. Threshold's stock (NASDAQ:THLD) gained 22 cents Monday, or 13.8 percent, to close at $1.82. (See BioWorld Today, Feb. 28, 2007.)