? Apexigen Inc., of Burlingame, Calif., said its partner, 3SBio Inc., of Shenyang, China, filed an investigational new drug application for APX001, also known as SSS07, with the State Food and Drug Administration (SFDA) in China. If approved, the product, indicated for the treatment of autoimmune and inflammatory diseases, will enter clinical trials. APX001/SSS07 is the second antibody discovered through the use of Apexigen's technologies for which an IND has been filed with the SFDA.
? The Drug Development Office at Cancer Research UK plans to launch a Phase I trial of AZD8931 , an experimental candidate from AstraZeneca plc, of London, in advanced esophagogastric cancer. The trial is the second study to open through the Experimental Cancer Medicine Centre Combinations Alliance initiative. The study will examine whether combining AZD8931 with existing chemotherapeutics oxaliplatin and capecitabine is more effective than treatment with chemotherapy alone.
? Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, reported preliminary results from a Phase I dose-ranging study of LX2931, an inhibitor of sphingosine-1-phosphate lyase, in rheumatoid arthritis. The compound was well tolerated at all doses evaluated, with no serious adverse events. Seven of eight patients on LX2931 achieved drug trough levels greater than 60 ng/ml, and six of the eight patients experienced a drop from baseline in the DAS28 score of greater than or equal to 1.2, as did both placebo patients. The company also reported top-line results from its Phase I study of LX7101, an inhibitor of LIM domain kinase 2 (LIMK2), in glaucoma. Sixty-three patients with glaucoma were randomized among two doses of LX7101, each given as an eye drop, or vehicle in a single daily dose during the first week of the study and two daily doses during the second week. LX7101 was well tolerated at all doses evaluated, and statistically significant improvements in measures of intraocular pressure were observed at both dose levels, compared to vehicle.
? Medicago Inc., of Quebec City, and the Infectious Disease Research Institute (IDRI), of Seattle, reported that they have received FDA clearance to initiate a Phase I trial for an H5N1 Avian Influenza VLP vaccine candidate. The trial is focused on evaluating the safety and immunogenicity of the H5N1 vaccine, combined with IDRI's glucopyranosyl lipid A (GLA) adjuvant, which will be administered intramuscularly or intradermally. Each study participant in the trial will receive two doses of a given formulation in order to collect and compare data. The trial will enroll 100 healthy adult volunteers, ages 18 to 49, at three locations in the U.S., and it is anticipated that the study will take 15 months to complete.
? Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, published Phase III results from the AFFIRM trial of enzalutamide (MDV3100) in metastatic castration-resistant prostate cancer patients previously treated with docetaxel-based chemotherapy in the New England Journal of Medicine. The randomized, double-blind, placebo controlled trial measured benefit in overall survival compared to placebo. Men treated with enzalutamide showed a median overall survival of 18.4 months, compared to 13.6 months for the placebo group. The reduction in risk of death was 37 percent. Side effects included fatigue, diarrhea and hot flush. Serious adverse events were lower in the enzalutamide group than in the placebo group. The companies reported top-line data from AFFIRM last year. (See BioWorld Today, Nov. 4, 2011.)
? Nectid Inc., of Princeton, N.J., began U.S. clinical development of agomelatine for autism and pain. The drug is approved in Europe, Australia and several other countries for major depressive disorder. It is believed to resynchronize circadian rhythms and restore sleep cycle. Disorders of circadian rhythm are implicated in a number of disorders including neuropathic pain, fibromyalgia, inflammatory bowel disorder, autism and multiple sclerosis.
? Oculus Innovative Sciences Inc., of Petaluma, Calif., enrolled its first patients in a trial of Microcyn hydrogel for hypertrophic or keloid scars. The double-blind, randomized study in 40 patients will produce top-line data by the middle of 2013. The study will be carried out at four sites in the U.S., and its results will be used to support a 510k application with the FDA.
? Oncolytics Biotech Inc., of Calgary, Alberta, said it completed enrollment in two Phase I cancer trials of Reolysin. An open-label, dose-escalating study in the UK is testing the human reovirus in combination with cyclophosphamide in patients with advanced or metastatic solid tumors, including pancreatic, lung and ovarian cancers that are refractory to standard therapy or for which there is no standard therapy. The second trial, a single-arm dose-escalation study being conducted in the U.S., will evaluate Reolysin in combination with FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy in 21 patients with oxaliplatin refractory, KRAS-mutant colorectal cancer.
? Pluristem Therapeutics Inc., of Haifa, Israel, said it received permission to begin a Phase II trial of its PLX Cells for the treatment of thromboangiitis obliterans (Buerger's disease) from the Indian Ministry of Health. Buerger's disease is highly prevalent in India, particularly among smokers. The trial will be potentially followed by a larger multinational Phase III study in the U.S., Europe and India.
? ThromboGenics NV, of Leuven, Belgium, said data from two Phase III trials showed that a single intravitreal injection of ocriplasmin resolved vitreomacular adhesion, releasing traction and closing macular holes in significantly more patients than placebo. The data were published in Thursday's New England Journal of Medicine. The FDA's Dermatologic and Ophthalmic Drug Advisory Committee gave unanimous support last month for ocriplasmin to treat symptomatic vitreomacular adhesions. No drugs have been approved for the condition in the U.S. (See BioWorld Today, July 27, 2012.)