• Convergence Pharmaceuticals Ltd., of Cambridge, UK, started a Phase II proof-of-concept study with CNV2197944, a calcium channel blocker designed to selectively inhibit highly active Cav2.2 channels, in pain associated with diabetic peripheral neuropathy (DPN). The trial is a two-period, two-treatment crossover study to compare the efficacy and safety of a dose regime versus placebo in patients with DPN. The primary endpoint of the trial is the effect of repeat oral dosing of CNV2197944 on the pain experienced in DPN, as measured by the Pain Intensity Numeric Rating Scale (PI-NRS), after three weeks, compared to baseline. The company is developing the molecule on behalf of its sister company Calchan Ltd., and results from the study are expected in the second half of 2014.

• Cytokinetics Inc., of South San Francisco, offered an update on the conduct of BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS). The trial is designed to enroll up to 500 patients with ALS. To date, more than 450 patients have been enrolled in the study. Cytokinetics was recently informed by its data management vendor that a programming error in the electronic data capture system controlling study drug assignment caused 58 patients initially randomized to and treated with tirasemtiv to receive placebo instead at a certain study visit and for the remainder of the study. No patients randomized to placebo were dispensed incorrect treatment. Cytokinetics and all clinical trial site personnel remain blinded to the specific patients affected by the error. Since the error was detected, the company has taken steps to ensure no further incorrect study drug assignments have occurred and the programming error in the electronic data capture system controlling study drug assignment has been corrected. The company's stock (NASDAQ:CYTK) closed Monday at $13.42, up 61 cents. (See BioWorld Today, June 26, 2013.)

• DBV Technologies, of Bagneux, France, completed enrollment in its global Phase IIb trial, VIPES (Viaskin Peanut's Efficacy and Safety), a 12-month treatment study with Viaskin Peanut. VIPES started in August 2012 and is being conducted in Europe (France, the Netherlands and Poland) and in North America with a total of 22 investigators, who collectively screened and randomized 315 and 221 peanut-allergic subjects respectively. VIPES' patient population includes 113 chidren (6-11), 73 adolescents (12-17) and 35 adults (18-55). DBV anticipates reporting 12-month topline data during the second half of 2014. The FDA has granted fast-track status to the therapy.

• Erytech Pharma SA, of Lyon, France, said it has made a fast start with its Phase IIb study in acute myeloid leukemia (AML), which is evaluating efficacy and tolerability of Graspa in the treatment of newly diagnosed AML patients, older than 65, unfit for intensive chemotherapy. All 21 French investigation sites have been authorized to participate in the study and 10 percent of the targeted 123 patients have been enrolled in the study. The company estimated that at the current pace full patient recruitment should be completed before the end of 2014. In February, the European Medicines Agency granted Graspa orphan drug status for the treatment of AML.

• Genmab A/S, of Copenhagen, Denmark, said collaborator Glaxosmithkline plc, of London, will start a new Phase III study of ofatumumab given subcutaneously to treat pemphigus vulgaris, a rare autoimmune disorder of the skin. The study is double blinded and will include about 136 patients with active pemphigus vulgaris who have achieved disease control on a stable dose of steroids prior to randomization. Patients in the study will be randomized equally into one of two arms. Patients will receive either ofatumumab (60 mg) or placebo every 12 weeks for a total of five doses over which time a scheduled gradual steroid reduction will be undertaken. Patients will then be followed for at least 12 weeks longer. The study objectives are to establish efficacy and safety, based on disease remission. (See BioWorld Today, Aug. 19, 2009.)

• Pergamum AB, of Stockholm, Sweden, a portfolio company of Karolinska Development AB, said the primary safety and tolerability endpoint was met in a randomized Phase I/II trial of LL-37 for treatment of venous leg ulcers. The data also showed that patients treated with LL-37 had a statistically significant improved healing rate compared with placebo. In a double-blind multicenter study, 34 patients with venous leg ulcers received either placebo or one of three different doses of LL-37. Top-line results from the trial showed that patients treated with LL-37 for one month experienced an improved healing rate compared to placebo for the two lower doses. Initial analysis showed that the average healing rate in patients receiving 0.5 mg/ml or 1.6 mg/ml was three to six times higher than in the placebo group and this difference was statistically significant.

• La Jolla Pharmaceutical Co., of San Diego, said an online publication of the Journal of the American Society of Nephrology on June 13, 2013, confirmed data La Jolla released on May 29. The data from La Jolla showed a statistically significant inverse correlation between galectin-3 and estimated glomerular filtration rate in the Phase I study of GCS-100 in chronic kidney disease.

• Novavax Inc., of Rockville, Md., began enrolling a Phase I trial with its monovalent virus-like particle vaccine candidate for the prevention of disease due to A/Anhui/1/13-like A(H7N9) avian influenza viruses (A(H7N9) vaccine). The randomized, observer-blinded, placebo-controlled trial will enroll up to 280 eligible adults. Each subject will be randomized into one of seven treatment groups, including placebo, or varying doses of the A(H7N9) vaccine, with or without an adjuvant. Each subject will receive two identical intramuscular doses at day zero and day 21 and undergo study follow-up for approximately one year after the second dose. All subjects will be evaluated for safety and immunogenicity.

• Oramed Pharmaceuticals Inc., of Jerusalem, said the first patient has been enrolled in a Phase IIa trial of ORMD-0801, an orally ingestible insulin capsule, for patients with Type II diabetes. The trial is designed to assess the safety of the product.