• Active Biotech AB, of Lund Sweden, and Teva Pharmaceutical Industries Ltd., of Jerusalem, reported a 36-week double-blind, multinational active extension study evaluating two doses of laquinimod, an investigational, once-daily oral immunomodulator, demonstrated a sustained positive benefit-risk profile in patients with relapsing remitting multiple sclerosis. Laquinimod reduced Gd-enhancing T1 lesions, while maintaining a good safety profile. The findings were published online in Multiple Sclerosis.

• AstraZeneca plc, of London, and Bristol-Myers Squibb Co., of New York, reported results from a randomized, double blind Phase III clinical study demonstrating that the addition of the investigational drug dapagliflozin to existing therapy with glimepiride, a sulphonylurea, produced significant reductions of HbA1c levels, less than 7 percent, in adults with Type II diabetes vs. glimepiride alone. The study also demonstrated that dapagliflozin plus glimepiride achieved reductions in the secondary efficacy endpoints of change in total body weight, oral glucose tolerance test and fasting plasma glucose levels from baseline at week 24 compared with glimepiride plus placebo.

• Celldex Therapeutics Inc., of Needham, Mass., said the first patient has been treated in a randomized, multicenter, controlled Phase IIb study of CDX-011 (glembatumumab vedotin), an antibody drug conjugate, in patients with glycoprotein NMB-expressing advanced, refractory breast cancer.

• Hybrigenics SA, of Paris, reported results of a Phase IIa study showed that the maximum tolerated dose of daily oral inecalcitol, an orally active agonist targeting the vitamin D receptor, was 4 mg per day, in combination with Taxotere chemotherapy in hormone-refractory prostate cancer patients. The response rate to combination treatment reached 85 percent, based on prostate-specific antigen decline within three months. Hybrigenics plans to proceed to a clinical efficacy Phase IIb study in the same therapeutic indication. It also is considering other diseases, such as hormone-dependent prostate cancer, severe psoriasis or hyperparathyroidism resulting from chronic kidney disease, as additional indications of daily oral inecalcitol.

• IBio Inc., of Newark, Del., said the FDA accepted its investigational new drug application for a vaccine candidate using the firm's iBioLaunch technology platform. The primary endpoint of the study will be safety, with immunogenicity data also collected.

• Micromet Inc., of Bethesda, Md., initiated a Phase II trial evaluating the efficacy, safety and tolerability of blinatumomab (MT103), a first-in-class BiTE antibody, in 20 adults with relapsed or refractory B-precursor acute lymphoblastic leukemia. Patients will receive blinatumomab daily for 28 days followed by two weeks off therapy over a six-week treatment cycle, for up to five treatment cycles. The primary endpoint of the study is objective response rate, with secondary endpoints of duration of response and overall survival.

• Mundipharma International Corp. Ltd., of Cambridge, UK, and SkyePharma plc, of London, said data presented at the European Respiratory Society congress demonstrated that a new fixed-dose combination therapy of fluticasone propionate, an inhaled corticosteroid, and formoterol fumarate, a long-acting beta2-agonist, is as effective in treating asthma as fluticasone propionate/salmeterol xinafoate, but has a more rapid onset of action, and also was more effective in controlling asthma symptoms than fluticasone propionate alone.

• NasVax Ltd., of Ness Ziona, Israel, has initiated recruitment and dosing in a Phase IIa trial for an oral antiCD3 monoclonal antibody immunotherapy in patients with nonalcoholic steatohepatitis, a serious inflammatory disease of the liver, including those with metabolic syndrome. NasVax is using antiCD3 antibodies from Johnson & Johnson subsidiary Centocor Ortho Biotech LP, of Horsham, Pa., which has the exclusive option for several months after receiving the results of the trial to conduct negotiations for a license or collaboration agreement. No financial terms were disclosed.

• Nycomed GmbH, of Zurich, Switzerland, said a new data post-hoc analysis of a Phase III study showed that the rate of frequent chronic obstructive pulmonary disease exacerbations was consistently lower and the time to exacerbation was significantly longer in patients receiving Daxas (roflumilast) compared with placebo. It also showed the greatest benefit of Daxas was seen in patients with a history of frequent exacerbations of two or more per year. Nycomed and its partner Forest Laboratories Inc., of New York, received a complete response letter from the FDA in May, which requested additional analyses and information, but not an additional study. Forest last week submitted a response to the FDA. (See BioWorld Today, May 21, 2010.)

• ProNAi Therapeutics Inc., of Kalamazoo, Mich., said the first patient has been dosed in an open-label, single-arm Phase I dose-escalation study assessing the safety and tolerability of its PNT2258 in patients with advanced solid tumors, a disease for which no standard therapy exists. Patients will receive an intravenous infusion of PNT2258 once daily for five consecutive days of every 21-day cycle.

• Sanofi-Aventis Group, of Paris, said results from a 12-week, randomized, double-blind, multicenter Phase III study found once-daily lixisenatide, a glucagon-like peptide-1 receptor agonist, significantly reduced the mean change from baseline two-hours postprandial glucose by -4.51 and -5.47 mmol/L in the one-step and two-step titration groups, respectively, with mean decreases in body weight observed in all groups. In addition, lixisenatide once-daily reduced glucose excursion by -3.77 and -4.36 mmol/L in the one-step and two-step titration groups, respectively, with mean decreases in body weight observed in all groups. The results were presented in Stockholm, Sweden, at the annual meeting of the European Association for the Study of Diabetes. Sanofi and its partner, Zealand Pharma AS, of Copenhagen, Denmark, had reported top-line results in April. At the same meeting, Sanofi reported that a pooled analysis using patient-level data from randomized trials demonstrated that adding Lantus (insulin glargine, rDNA injection) to patients with Type II diabetes uncontrolled on oral antidiabetic drug (OAD) therapy was associated with a greater reduction in A1C levels and lower incidence of any hypoglycemia vs. all comparators. A second pooled analysis showed that Type II diabetes patients who used Lantus as a monotherapy or added it to one baseline OAD agent had a greater reduction in A1C with lower risk of hypoglycemia than those taking two OADs, with a most significant reduction when Lantus was added to metformin alone vs. other OADs, such as sulfonylurea alone or sulfonylurea plus metformin. (See BioWorld Today, April 16, 2010.)

• Synthecon Inc., of Houston, signed a distribution agreement with Biomerix Corp., of Fremont, Calif., for three-dimensional cell culture scaffolds developed using Biomerix's biomaterial technology. No financial terms were disclosed.