• Concert Pharmaceuticals Inc., of Lexington, Mass., has initiated a Phase I study in healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of CTP-347, a deuterium-containing serotonin modulator created by Concert researchers. Concert intends to evaluate CTP-347 as a nonhormonal treatment for vasomotor symptoms (hot flashes) in patients with increased risk of adverse effects due to, or contraindicated to using, hormone therapy, as well as in the larger menopausal population. Results of the Phase I study are expected to be available in the first half of 2009. CTP-347 is Concert's first compound to advance into clinical trials.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, presented positive interim data from its ongoing Phase I/II trial with its investigational oral drug candidate Triolex (HE3286) in obese insulin resistant subjects at the 6th World Congress on Insulin Resistance Syndrome in Los Angeles. The additional data demonstrated that Triolex is safe and well tolerated to date, and that it significantly improved insulin sensitivity and lowered fasting blood glucose and insulin levels in obese insulin resistant subjects treated orally with 5 mg or 10 mg of the compound administered twice daily for 28 days, as compared to placebo-treated subjects.

• ImClone Systems Inc., of New York, has started patient enrollment in its disease-directed randomized Phase II trial of IMC-A12, its fully human, IgG1 anti-insulin-like growth factor-1 receptor monoclonal antibody, in women with advanced breast cancer. The primary objective of the randomized study is to evaluate the efficacy of both IMC-A12 alone and IMC-A12 combined with the last anti-estrogen therapy to which the patient's cancer became refractory. The study also will characterize the safety of IMC-A12 given alone and combined with anti-estrogen therapy. IMC-A12 will be administered on an every-two-week schedule.

• Neurobiological Technologies Inc., of Emeryville, Calif., said previously found excess symptomatic intracranial hemorrhage in an earlier European trial of ancrod (Viprinex) for the treatment of acute ischemic stroke may be minimized with avoidance of prolonged low levels of fibrinogen and use of common blood pressure entry criteria. The data from the retrospective analysis were presented at the 6th World Stroke Conference in Vienna, Austria. Using the revised dosing regimen, NTI currently is conducting two Phase III trials of Viprinex to investigate whether ancrod, a fibrinogen (the primary component of blood clotting) reducing agent, can safely and effectively reduce disability following an acute ischemic stroke.

• Novo Nordisk Inc., of Princeton, N.J., said data from a 52-week Phase III study (LEAD 3) its liraglutide, a once-daily analogue of human glucagon-like peptide-1, were published online in The Lancet. The data demonstrated that the drug, when taken alone, produced statistically significant and sustained improvements in blood sugar control in patients with early Type II diabetes, as compared with glimepiride, a widely used oral antidiabetic drug. Treatment with liraglutide also led to weight loss, reduced systolic blood pressure and lowered rates of hypoglycemia after 52 weeks of treatment.

• Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., reported Phase II data showing that men treated with NX-1207 had statistically significant improvement in symptoms associated with benign prostatic hyperplasia three months after a single treatment, with no reported serious drug-related side effects. In two Phase II trials, the aggregated mean improvement in the primary endpoint of BPH Symptom Score for 2.5 mg NX-1207 was 10.3 points, representing a 44 percent improvement. Those data were presented at the North Center Section of the American Urological Association meeting in Chicago.

• pSivida Corp., of Watertown, Mass., said the data safety monitoring board has recommended the two pivotal Phase III trials continue under the current protocol without change. The trial is studying the use of Medidur FA for the treatment of diabetic macular edema and is being conducted by licensing partner, Alimera Sciences Inc., of Alpharetta, Ga. Medidur, a tiny injectable insert to deliver fluocinolone acetonide to the retina, will be marketed under the name Iluvien.

• Sepracor Inc., of Marlborough, Mass., presented Phase III studies of eslicarbazepine acetate, a novel once-daily anti-epileptic agent, at the 8th European Congress of Epileptology in Berlin. The data demonstrated that the drug, in combination with other anti-epileptic agents, significantly reduced the frequency of partial seizures in patients with refractory partial epilepsy. It also significantly improved patient quality of life, reduced depressive symptoms and demonstrated sustained reduction in partial seizure frequency during a one-year, open-label period. A new drug application submission to the FDA is targeted for the end of 2008 or early 2009.