• Cytokinetics Inc., of South San Francisco, reported data on two Phase II trials evaluating CK-2017357, the lead candidate in its skeletal muscle contractility program, in patients with amyotrophic lateral sclerosis (ALS) at the American Academy of Neurology annual meeting in New Orleans. The trials evaluated the multi-week safety and tolerability of different doses and dosing schedules of CK-2017357, with and without riluzole (Rilutek, Sanofi SA), the only approved treatment for ALS. Consistent with previous trials, the findings suggested CK-2017357 was safe and well tolerated when dosed with riluzole. The company said the data supported the progression of CK-2017357 into later-stage clinical development. Separately, Cytokinetics reported preclinical data in a poster presentation at the 2012 Experimental Biology Annual Conference in San Diego. The preclinical study was designed to assess the effects of CK-2017357 in treadmill running time, an aerobic fatigue assay, and rotarod running time, an anaerobic fatigue assay. On the treadmill, rats showed improvements of 50 percent in running time compared to controls when administered CK-2017357 at doses of 10 mg/kg and 20 mg/kg (p < 0.01 and p < 0.05, respectively). Investigators also found that rotarod running time at least doubled following the administration of CK-2017357 at doses of 1 mg/kg and 3 mg/kg (p < 0.05 and p < 0.01, respectively) while the administration of potential control anti-fatiguing treatments did not improve performance in the test.

• CytRx Corp., of Los Angeles, began a Phase II trial of INNO-2006 for pancreatic ductual adenocarcinomas. The open-label trial will enroll up to 27 patients to receive IV INNO-206 once every three weeks for eight cycles. The trial will assess objective tumor response, with secondary endpoints of complete and partial response, stable disease at four months and progression-free survival.

• Forest Laboratories Inc., of New York, reported positive top-line results from a Phase III trial of levomilnacipran for major depressive disorder. Patients who received the drug had significantly reduced depression symptoms compared to placebo as early as week one. Results from an additional Phase III trial are anticipated within the next few months.

• Genprex Inc., of Austin, Texas, reported that a paper was published in PLoS One describing Phase I results from a trial of Oncoprex (TUSC2) nanoparticles) in advanced lung cancer. The trial in 23 patients showed the drug halted tumor growth in five patients. Biopsies before and after treatment showed a 10 percent to 25 percent increase in TUSC2 protein following treatment. The trial showed that a functioning tumor suppressor gene can be delivered intravenously to human cancer cells using a nanoparticle vector.

• Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said the safety monitoring committee for its three Phase III U.S. trials of NX-1207 in benign prostatic hyperplasia indicated no significant safety concerns at its most recent meeting. Patient recruitment and trial activities for the studies – NX02-0017, NX02-0018 and NX02-0020 – are nearing completion at more than 80 sites. The company plans a symposium and panel discussion on NX-1207 at the 2012 Annual Meeting of the American Urological Association in Atlanta next month, when investigators will present an overview of the compound and the trial results to date.

• Omthera Pharmaceuticals Inc., of Princeton, N.J., reported that in a Phase III (EVOLVE) trial of Epanova, for very high triglycerides, there was highly statistically significant reduction of triglycerides in all dose groups, with median decreases of about 26 percent in the 2 g cohort, and 31 percent in the 4 g cohort. The drug was also safe and well tolerated. Epanova is a formulation of the free fatty acid forms of eicosapentaenoic acid and docosahexaenoic acid.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, reported interim data from a trial of Copaxone (glatiramer acetate injection) for relapsing-remitting multiple sclerosis. The study evaluated spasticity in patients transitioned to Copaxone from interferon-beta. Interim results from 52 out of 110 subjects showed significant reduction in muscle stiffness, pain and discomfort, and reduction of the effect of spasticity on walking and activities of daily living. There were also improvements in total spasticity scores. The data were presented at the 64th Annual Meeting of the American Academy of Neurology in New Orleans.

• Upsher-Smith Laboratories Inc., of Maple Grove, Minn., presented posters characterizing the pharmacokinetic profile of USL255, its once-daily, extended-release topiramate formulation, at the American Academy of Neurology annual meeting in New Orleans. One poster showed equivalent exposure between USL255 and equal doses of immediate-release (IR) topiramate at steady state, a second poster confirmed switching between formulations did not affect steady-state plasma concentrations and a third poster showed USL255 demonstrated linear dose proportionality. The presentations included data demonstrating USL255 administered once daily provided an improved PK profile compared to twice-daily IR topiramate.