• Alba Therapeutics Corp., of Baltimore, disclosed encouraging preliminary results from its Phase IIa trial of AT-1001 in 86 patients with celiac disease. The trial was designed to evaluate the safety, tolerability and efficacy of multiple doses of AT-1001 during a two-week gluten challenge. It said dose-dependent responses were seen in intestinal permeability, and that drug patients had improved symptoms and outcomes. A Phase IIb clinical study in planned for the third quarter.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., discontinued treatment of all enrolled patients in the 40-mg cohort of its Phase II dose-finding study of incyclinide for the treatment of acne. The company last week said it suspended enrollment of new patients in that cohort pending investigation of apparent significant phototoxicity in one patient. Subsequently, another case was seen. No adverse events were seen at lower doses. The company is evaluating options for continuing development of incyclinide in acne at lower doses, and is continuing the Phase II dose-finding trial of incyclinide for the treatment of rosacea.

• Genaera Corp., of Plymouth Meeting, Pa., said it began enrolling subjects in the first human study of trodusquemine (MSI-1436), an appetite suppressant designed to selectively inhibit protein tyrosine phosphatase 1B for treating obesity. The Phase I study will enroll healthy overweight and obese volunteers to assess safety and pharmacokinetics. Genaera also will look for evidence supporting preclinical observations that trodusquemine induces appetite suppression and weight loss while normalizing glucose metabolism and insulin sensitivity.

• IR BioSciences Holdings Inc., of Scottsdale, Ariz., reported positive preliminary data from its influenza vaccine adjuvant study being performed in conjunction with GenPhar Inc., of Mount Pleasant, Calif. Studies entailed vaccination with pieces of influenza viruses. Specifics on the study were not disclosed.

• Isotechnika Inc., of Edmonton, Alberta, said monitors reviewed data from 116 patients in its Phase IIb de novo kidney transplant trial of the immunosuppressive drug ISA247. To date, it said, very good kidney function was observed in all ISA247 dosing groups. Within the first month post-transplant, kidney function showed improvement across all ISA247 dosing groups similar to that observed in the tacrolimus group. The product also showed reduced side effects vs. tacrolimus. The trial will include 332 patients.

• Medicure Inc., of Winnipeg, Manitoba, said trial monitors recommended continuation of its Phase III MEND-CABG II trial. The double-blind, randomized, placebo-controlled trial is evaluating the cardioprotective drug MC-1 in up to 3,000 patients undergoing coronary artery bypass graft surgery. The primary efficacy endpoint is the reduction in the composite of cardiovascular death and nonfatal myocardial infarction. Enrollment is expected to be completed by November. (See BioWorld Today, Nov. 20, 2006.)

• Nymox Pharmaceutical Corp., of Harsbrouck, N.J., announced positive results from a long-term outcome study of NX-1207 for benign prostatic hyperplasia data from two Phase I/II studies that began in 2003. Overall, patients treated with NX-1207 showed a mean improvement of 8.6 points in the primary outcome endpoint of AUA Symptom Score value 42 months after NX-1207 treatment, vs. the 3.5 to 5 points reported in published studies of currently approved BPH drugs. The product has been tested in Phase II trials.

• Pacgen Biopharmaceuticals Corp., of Vancouver, British Columbia, said its Phase I/II study of PAC-113 showed it was generally safe, well tolerated and active in the treatment of oral Candida infection, with clinical cure rates comparable to the current standard of care. The study in immunocompromised patients and patients with salivary dysfunction showed 37 percent of PAC-113 patients were assessed as clinically cured at day 14 compared to 36 percent of Nystatin patients. Complete or partial responses were seen in 95 percent of PAC-113 patients and 87 percent of Nystatin patients. The company plans to initiate a Phase IIb trial to optimize dosing and formulation.