• Addex Pharmaceuticals SA, of Geneva, said a Phase IIa proof-of-concept trial of ADX10059, its lead compound, met its primary endpoint in gastroesophageal reflux disease, and also showed statistically significant improvements in many of the secondary measures, including clinical GERD symptoms. The study enrolled 24 patients, who received placebo on day 1 and ADX10059 half an hour before each of three meals on day 2. The primary endpoint, the percentage of time that esophageal pH was greater than 4 during the 24-hour period, was statistically significantly increased during ADX10059 treatment, and results also showed that the duration of acid reflux episodes was significantly reduced throughout the same period. Also, night time reflux was significantly reduced by ADX10059. A selective mGIuR5 negative allosteric modulator, ADX10059, also is in clinical development in migraine and anxiety.

• Advaxis Inc., of North Brunswick, N.J., completed enrollment and dosing of the third cohort of patients diagnosed with advanced, recurrent or progressive cervical cancer in its Phase I/II trial of Lovaxin C, a modified Listeria-based live vaccine. An independent safety panel has found that the product is safe, even in end-stage cancer patients, and dose-escalation is ongoing. The primary endpoint of the work is to establish a maximal safe dose of Lovaxin C. The product is in development to treat women who have developed cervical cancer as a result of human papillomavirus infection.

• Dyax Corp., of Cambridge, Mass., started patient treatment in its Phase III confirmatory study of DX-88 (ecallantide), a recombinant, plasma kallikrein inhibitor, in acute attacks of hereditary angioedema. The EDEMA4 trial will be used to further support the validity of patient-reported outcome methodology used in the successfully completed Phase EDEMA3 Phase III trial, as reported earlier this month, and to confirm the product's efficacy and safety. Dyax also is starting a Phase II trial of DX-88 for the prevention and blood loss that occurs during on-pump cardiothoracic surgery. Pending successful results of the confirmatory trial, the company anticipates gaining approval of DX-88 in late 2008. (See BioWorld Today, April 16, 2007.)

• GTx Inc., of Memphis, Tenn., said data from a Phase II trial of Ostarine revealed that insulin and glucose levels were reduced and insulin resistance was improved among subjects receiving the 3 mg dose compared to baseline. Observations were even more pronounced among a subset of prediabetic subjects. The trial involved 60 elderly men and 60 postmenopausal women, excluding patients with diabetes or obesity. Subjects receiving 3 mg of Ostarine had, on average, an 11 percent decline in fasting blood glucose, a 17.6 percent reduction in insulin levels and a 26.8 percent reduction in insulin resistance when compared to their baseline measurements. GTx plans to begin a Phase IIb trial testing Ostarine in chronic kidney disease muscle wasting later this year.

• Living Cell Technologies Ltd., of Melbourne, Australia, received authorization from the New Zealand regulator to advance its DiabeCell program into a Phase I/II trial in diabetes. That approval enables the company to apply for Regional Ethics Committee consideration, which is the step before formal approval to start the clinical trial. LCT anticipates testing the product in eight long-standing Type I diabetics in the trial, which is expected to take about 12 months, and then moving into a larger pivotal study. DiabeCell is a porcine islet cell product for the treatment of insulin-dependent diabetes.

• Merrimack Pharmaceuticals Inc., of Cambridge, Mass., initiated a Phase II study to evaluate MM-093, an immunomodulator, in rheumatoid arthritis. The study will enroll about 90 to 100 patients with moderate to severe RA despite stable doses of methotrexate, with the objective of examining safety and efficacy of 60 mg of MM-093 per week or placebo for 12 weeks, with an additional follow-up of four weeks. Patients also will be assessed for changes in the signs and symptoms of their disease using standard clinical outcome measurements for RA, such as ACR20 and DAS28 scores. MM-093, Merrimack's lead product, is a recombinant version of human alpha-fetaprotein.

• Neurotech Pharmaceuticals Inc., of Lincoln, R.I., started enrollment in Phase II/III trials of NT-501, its lead Encapsulated Cell Technology (ECT) product, in visual loss associated with retinitis pigmentosa. The trials are part of the RENOIR series, with one study including patients with an earlier stage of the disease and the other involving later-stage disease patients. NT-501 is an intraocular, polymer implant containing human retinal epithelial cells genetically modified to secrete ciliary neurotrophic factor continuously into the back of the eye for sustained periods of time.

• Pharmacopeia Drug Discovery Inc., of Princeton, N.J., said partner Schering-Plough Corp., of Kenilworth, N.J., selected a compound from the companies' collaboration to advance into preclinical development. That selection triggered a $1 million milestone payment to Pharmacopeia. Under the collaboration agreement, which was extended in the fall, Schering-Plough is solely responsible for further development and commercialization of candidates, while Pharmacopeia stands to receive milestone payments, plus royalties on any product sales.

• SCOLR Pharma Inc., of Bellevue, Wash., reported two additional positive pharmacokinetics trials of its extended-release ibuprofen OTC product candidate, showing that subjects in both trials had ibuprofen blood levels believed to be required for regulatory approval. Based on those results, the company is preparing to advance its formulation to commercialization and expects to submit a new drug application in the second half of 2008.

• YM BioSciences Inc., of Mississauga, Ontario, received approval from Japanese regulators for its investigational new drug application to begin a Phase I trial of nimotuzumab, a humanized monoclonal antibody that targets the epidermal growth factor receptor in solid tumors. The trial will enroll a maximum of 20 patients with various solid tumors, and the primary endpoint will be required to show safety in the Japanese population. Nimotuzumab, which is approved in India, China, Cuba, Argentina and Columbia in nasopharyngeal and/or head and neck cancer, is licensed in Japan to Daiichi Sankyo Co. Ltd., of Tokyo, which agreed, in a 2006 deal, to pay YM milestone payments and a margin on any product sales. (See BioWorld Today, Aug. 1, 2006.)