• Albireo AB, of Gothenburg, Sweden, reported top-line results from a Phase IIb study showing a clinically meaningful and statistically significant improvement for patients with chronic idiopathic constipation treated with A3309, an IBAT (ileal bile acid transporter) inhibitor, compared to placebo. The primary efficacy endpoint, defined as change from baseline in spontaneous bowel movements (SBMs), showed a dose-dependent increase and significant results were obtained for the two highest dose levels. In addition, the secondary endpoints of effects of SBM and complete SBM frequencies also were dose-dependent and statistically significant. The study enrolled 190 patients.

• Archimedes Pharma Ltd., of Reading, UK, said results from its 403-patient multicenter, open-label Phase III study demonstrated that its fentanyl pectin nasal spray (FPNS) was acceptable and generally well tolerated in patients with breakthrough cancer pain. The most frequently reported adverse events included dizziness, vomiting, constipation and somnolence. Nasal tolerability of FPNS over the long term was demonstrated as good with no significant nasal adverse events. About 94 percent of breakthrough cancer pain episodes were successfully treated by a single dose of FPNS and did not require additional rescue medication within 60 minutes of treatment. More than 90 percent of patients required no increase in their dose of FPNS, once titration was achieved.

• Biothera, of Eagan, Minn., reported that a combination of its Imprime PGG and Erbitux (cetuximab, Eli Lilly and Co.) doubled the overall response rates for second- and third-line metastatic colorectal cancer patients in a Phase Ib/IIa trial. Those results were presented at the European Society for Medical Oncology meeting in Milan, Italy.

• Cel-Sci Corp., of Vienna, Va., was cleared to begin enrolling patients in Taiwan in its Phase III trial testing Multikine in first-line head and neck cancer. The Taiwan centers will be funded by partner Orient Europharma Co. Ltd., of Taiwan.

• Helix BioPharma Corp., of Aurora, Ontario, plans to conduct a Phase I study of L-DOS47 in U.S. patients with refractory solid tumors and a Phase I/II study in patients with Stage III/IV non-small-cell lung cancer in Poland. The firm recently completed its definitive GLP, rodent and primate, repeat-dose toxicology studies with the drug, showing a good safety profile.

• Threshold Pharmaceuticals Inc., of Redwood City, Calif., said interim results from a Phase I/II trial in various solid tumors related to its hypoxia-activated prodrug showed that, of patients with advanced or metastatic pancreatic cancer receiving 340 mg/m2 of TH-302, one had a complete response, five had partial responses, 14 had stable disease and one patient had progressive disease. Those and other data were presented at the European Society for Medical Oncology meeting in Milan, Italy.

• Titan Pharmaceuticals Inc., of South San Francisco, said data from its Phase III trial of Probuphine showed that patients receiving the implant had significantly less illicit opioid use, experienced fewer symptoms of withdrawal and craving, stayed in treatment longer and had greater overall improvement when compared to placebo patients over the course of the 24-week study. Patients receiving Probuphine had a mean percentage of urine samples that tested negative for illicit opioids across the full 24 weeks of 36.6 percent vs. 22.4 percent in the placebo arm. Those results were published in the Journal of the American Medical Association. Top-line data from the trial were reported in 2008. (See BioWorld Today, July 29, 2008.)