• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., reached an agreement with the FDA on a special protocol assessment for its Phase III safety and efficacy trials with the female sexual dysfunction drug LibiGel (transdermal testosterone gel). The company will conduct two double-blind, placebo-controlled trials, each of which will enroll 500 patients for six months of treatment, with a primary endpoint of increasing the number of satisfying sexual events and sexual desire. The first trial already has been initiated and the second will start in early 2008. BioSante also recently initiated a Phase III cardiovascular safety study of LibiGel that will involve 12 months or patient monitoring prior to filing for approval and four years of monitoring after approval.

• Inverseon Inc., of San Francisco, said Phase IIa data published in Pulmonary Pharmacology & Therapeutics showed that eight of 10 asthma patients treated with the beta-blocker nadolol experienced a clinically meaningful, dose-related reduction in airway hyper-responsiveness.

• Myriad Genetics Inc., of Salt Lake City, said results of a Phase I human clinical trial of MPC-0920, an orally available direct thrombin inhibitor, demonstrated significant biological effect on clotting time and a desirable safety profile following oral administration. The trial studied healthy volunteers in a single, escalating-dose format to determine the safety, dose range and pharmacokinetics of the drug. Each cohort of the Phase I trial consisted of eight volunteers, six of whom were given the drug and two the placebo. MPC-0920 was shown to be absorbed with a very close correlation between the plasma concentration of drug in plasma and an effect on blood clotting as measured by an increase in pro-thrombin time. There were no apparent drug-related adverse events during the study. The primary objectives of the Phase I trial were to examine the safety and pharmacokinetics of MPC-0920, and a secondary objective was to study the biological activity of MPC-0920. The study showed that a significant biological activity was present and highly correlated to the observed plasma concentration.

• NPS Pharmaceuticals Inc., of Bedminster, N.J., said it expects to begin a confirmatory Phase III clinical study to evaluate Gattex (teduglutide, recombinant GLP-2) in patients with short bowel syndrome (SBS) who are dependent on parenteral nutrition. The study was recommended by the FDA, the firm said, noting that it is in the process of finalizing the trial's protocol, which will include comments provided to the company by drug regulators. The confirmatory study will be a placebo-controlled, multicenter trial evaluating Gattex vs. placebo in patients with parenteral nutrition-dependent SBS with an initial parenteral nutrition optimization and stabilization period followed by a dosing period of 24 weeks. NPS currently has a 28-week, 65-patient Phase III extension study under way that is evaluating Gattex for patients with parenteral nutrition-dependent SBS. The company in October reported that Gattex failed to meet its primary endpoint in the pivotal Phase III study. (See BioWorld Today, Oct. 12, 2007.)

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said it has started screening patients for a clinical trial designed to evaluate the safety and efficacy of bavituximab, a monoclonal antibody that binds to phosphatidylserine, in combination with chemotherapy in patients with advanced breast cancer. The primary objective of the study is to assess the overall response rate to the combination of bavituximab with docetaxel, a chemotherapy drug commonly used in advanced breast cancer. The multicenter clinical trial is being conducted in the Republic of Georgia. In the trial's two-stage design, up to 15 patients with advanced breast cancer will be enrolled initially. The study will then be expanded up to a total of 46 patients if promising results are observed. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. Patients may continue to receive bavituximab alone after completion of chemotherapy as long as the cancer does not progress and adverse effects are acceptable.

• Pro-Pharmaceuticals Inc., of Newton, Mass., said Phase II study results showed that Davanat, a carbohydrate polymer composed of mannose and galactose, improves median profession-free survival in patients with colorectal cancer. The Phase II trial involved 20 previously heavily treated patients with colorectal cancer, all of whom had at least two previous chemotherapy treatments. The study demonstrated the benefit of combining the Davanat to 5-fluorouracil for patients with colorectal cancer refractory to approved chemotherapies. The median progression-free survival was 8.4 weeks. One patient reported an objective response. Of the serious adverse events reported, only two were determined to be drug related.

• QuatRx Pharmaceuticals, of Ann Arbor, Mich., unveiled the results of two Phase I trials with the lipid lowering drug sobetirome (QRX-431). The data demonstrated that both single and multiple doses of sobetirome were well tolerated and lowered LDL cholesterol levels in healthy volunteers by as much as 22 percent with the single dose and 41 percent with multiple doses. Sobetirome is a selective thyroid hormone receptor beta agonist that may activate reverse cholesterol transport.

• Surface Logix, of Boston, said results of a Phase IIa clinical trial demonstrated that SLx-4090, a nonsystemically available microsomal triglyceride transfer protein inhibitor, caused clinically significant reductions in postprandial triglycerides and LDL cholesterol and was well tolerated. The trial was designed to examine the safety, tolerability, pharmacokinetics and effect on lipid profiles in patients administered repeat oral doses of SLx-4090 either three times daily or once daily for 14 days. The company said it intends to initiate a Phase IIb study of SLx-4090 in dyslipidemia, high cholesterol and triglyceride levels in the bloodstream, in the third quarter of 2008.

• Topigen Pharmaceuticals Inc., of Montreal, initiated a Phase II trial of the inhaled anti-inflammatory, RNA-targeting drug TPI ASM8 in asthma. The European, double-blind, randomized, placebo-controlled, crossover study will evaluate TPI ASM8 once-daily for 14 days.

• Tranzyme Pharma, of Research Triangle Park, N.C., said the FDA cleared its investigational new drug application for TZP-102, a second-generation ghrelin agonist. The company plans to immediately begin a Phase I trial of the drug, which will be developed for mild to moderate gastroparesis and other chronic gastrointestinal motility disorders.

• Viventia Biotech Inc., of Toronto, said it intends to explore strategic alternatives including a possible sale or merger to maximize the value of its antibody pipeline. Viventia also said an interim analysis from a Phase III trial of Proxinium in advanced head and neck cancer demonstrated a 40 percent improvement in median survival in the drug arm. Final data are expected in early 2009. The drug is a humanized antibody fragment conjugated to the cytotoxic protein Pseudomonas exotoxin A.