• Biodel Inc., of Danbury, Conn., initiated a Phase II trial of its recombinant insulin-based ultra-rapid-acting mealtime insulin candidate, BIOD-123. The study is designed to assess the clinical impact of the absorption profile of BIOD-123 relative to currently marketed mealtime insulin analogues. In April, Biodel reported positive top-line results from a Phase I study of BIOD-123, demonstrating the formulation had more rapid absorption than Humalog (insulin lispro, Eli Lilly and Co.), with comparable injection-site tolerability. The open-label Phase II study is enrolling 130 patients with Type I diabetes, randomized to BIOD-123 or insulin lispro at mealtime over 18 weeks. The primary endpoint compares changes in HbA1c, while secondary endpoints compare postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes. The company expects to report top-line safety and efficacy data in the third quarter of 2013.

• BioDelivery Sciences International Inc., of Raleigh, N.C., reported a positive outcome of its pharmacokinetic study for BEMA buprenorphine/naloxone (BNX), which is being developed for the potential treatment of opioid dependence. Based on that study, the company anticipates that it will file a new drug application in the second quarter of 2013.

• DUSA Pharmaceuticals Inc., of Wilmington, Mass., said results of an investigational study on Levulan Kerastick for the treatment of minimally to moderately thick actinic keratoses (AKs) on the upper extremities showed a statistically significant lesion reduction and complete clearance of actinic keratoses of the extremities (hands and arms). The study enrolled 70 subjects, with half of the subjects receiving Levulan and half receiving vehicle with three-hour incubation. Since both arms of each subject were treated, there were 140 treatment areas. At 12 weeks following photodynamic therapy (PDT), the subjects that were treated with Levulan plus occlusion demonstrated an 89 percent (p < 0.0001) AK lesion clearance rate as compared to a 70 percent (p < 0.0001) clearance rate for those treated without occlusion after up to two PDT treatments; subjects receiving vehicle plus occlusion and vehicle alone demonstrated 17 percent and 6 percent lesion clearance rates, respectively.

• Edison Pharmaceuticals Inc., of Mountain View, Calif., reported positive results from a completed Phase IIa study on EPI-743 in children with Leigh syndrome, an inherited lethal, progressive, predominately pediatric neuromuscular disorder for which there are no approved treatments. Ten children with seven differing subtypes of Leigh syndrome, ranging in age from 1 to 13 years, were treated with EPI-743. All 10 children exhibited reversal of disease progression as measured by four different disease-relevant metrics. The clinical response was durable over 180 days. No significant safety events were observed.

• Emmaus Medical Inc., of Torrance, Calif., said a Phase III trial of L-Glutamine for sickle cell disease is near its target enrollment of 225 patients, with 190 enrolled. The company also submitted an interim analysis of a subset of data by an independent committee to the FDA. Final data are expected to be complete in 2013.

• Generex Biotechnology Corp., of Worcester, Mass., reported early results from a Phase II study of its AE37 vaccine in patients with HER2 low-expressing and triple-negative breast cancer, which showed an overall reduction of 42 percent in the risk of relapse in all patients in the study who received the vaccine, and a 66 percent reduction in the risk of relapse for patients with low expression of the HER2 oncoprotein who were classified as having triple-negative breast cancer. The immunotherapeutic candidate is being developed by Generex's Antigen Express Inc. subsidiary, which is proceeding with plans for a pivotal Phase III trial.

• Glenmark Pharmaceuticals SA, of Mumbai, India, said a Phase II trial of GBR 500, for severe ulcerative colitis, has begun. The trial will enroll 84 patients who will receive GBR 500 or placebo over a period of several weeks. Glenmark's partner, Paris-based Sanofi SA, has licensed all rights to the drug and is carrying out clinical development.

• Oncolytics Biotech Inc., of Calgary, Alberta, reported preliminary results from a Phase II trial of Reolysin plus carboplatin and paclitaxel in patients with squamous cell carcinoma of the lung. The primary objective of the trial was assessment of antitumor effect of the therapy, and the secondary objectives were progression-free survival and overall survival, as well as proportion of patients disease free at six months, and safety and tolerability. The trial met its endpoint. Five out of 15 patients had a partial response, and eight more had stable disease. The disease control rate was 87 percent. The company said it will proceed to the second stage of the study.

• Pearl Therapeutics Inc., of Redwood City, Calif., said it completed a Phase IIb dose-ranging study in which six doses of the long-acting muscarinic antagonist glycopyrrolate, ranging from 18 mcg to 600 nanograms twice-daily, were delivered via metered-dose inhaler to patients with moderate to severe chronic obstructive pulmonary disease. Results identified doses believed to be the lowest effective and optimal doses, and those data supported progression of the drug in combination with twice-daily formoterol fumarate, the long-acting beta agonist component of Pearl's fixed-dose bronchodilator combination PT003 toward a Phase III program.

• Prolor Biotech Inc., of Nes-Ziona, Israel, said Phase II data presented at the Annual Congress of the European NeuroEndocrine Association in Vienna, Austria, affirmed that a single weekly injection of its long-acting human growth hormone, hGH-CTP, in growth hormone-deficient adults has the potential to replace seven consecutive daily injections of currently marketed human growth hormone and at a much lower cumulative dose. An exploratory part of the study also demonstrated the potential for a twice-monthly injection regimen. The product had a good safety and tolerability profile, with no unexpected adverse events.

• Repros Therapeutics Inc., of The Woodlands, Texas, updated its pivotal Phase III studies of Androxal, stating that it randomized the first subjects in ZA-301 , the first of two pivotal trials, while the second Phase III study, ZA-302, is set to start enrollment following completion of recruitment in ZA-301. Repros said it believes results from the first study could be available as early as the second quarter of 2013, and its current cash level should be sufficient to complete the necessary studies for submission of a new drug application for Androxal in secondary hypogonadism.

• Senesco Technologies Inc., of Bridgewater, N.J., said the first patient was enrolled and dosing has begun in the second cohort of its study testing SNS01-T in multiple myeloma. The open-label study is dosing patients twice-weekly for six weeks, followed by an observation period. The first group received 0.0125 mg/kg via intravenous infusion. The planned dose levels for the second, third and fourth groups are 0.05 mg/kg, 0.2 mg/kg and 0.375 mg/kg, respectively. The primary objective is to evaluate safety and tolerability, though the effect of SNS01-T on tumor response and time to relapse or progression also will be assessed. SNS01-T is designed to selectively trigger apoptosis in B-cell cancers.

• Zealand Pharma A/S, of Copenhagen, Denmark, said it dosed the first patient in a Phase I study of ZP2929, a dual-acting glucagon/GLP-1 peptide agonist, in development for treating patients with Type II diabetes and/or patients with obesity. The study will test safety and tolerability of single ascending daily doses of the drug in healthy subjects. The start of Phase I triggered an undisclosed milestone payment from Boehringer Ingelheim GmbH, of Ingelheim, Germany, which licensed rights to the product in a 2011 global collaboration. (See BioWorld Today, June 17, 2011.)