• Argos Therapeutics Inc., of Durham, N.C., reported updated results from its Phase II study of AGS-003, an Arcelis immunotherapy, in combination with Sutent (sunitinib, Pfizer Inc.), showing that treatment prolonged survival in patients with unfavorable-risk metastatic renal cell carcinoma. Results from the 21-patient study indicated multiple partial responses were observed with the combination regimen. Eleven of 15 (73 percent) patients with serial immune assessments demonstrated increases in their CD28-positive memory T cells, and those immune responses correlated directly with prolonged survival. Median progression-free survival was 11.2 months and estimated Kaplan-Meier median overall survival was 29.3 months, based on follow-up through January 2012. Data were presented at the ASCO Genitourinary Cancers Symposium in San Francisco. Argos said it plans to initiate the Phase III ADAPT study based on those results.

• Chimerix Inc., of Research Triangle Park, N.C., reported Phase II data showing CMX001 produced a statistically significant benefit vs. placebo in preventing cytomegalovirus (CMV) viremia and/or CMV disease 13 weeks post-hematopoietic stem cell transplant. Patients receiving the broad-spectrum lipid-antiviral conjugate showed a reduction in CMV viremia (CMV > 200 copies/mL) or disease compared to patients in the placebo arm (p = 0.001). Results also showed that three different doses of CMX001 demonstrated statistically significant reductions in the proportion of patients with CMV viremia greater or equal to 1 ,000 copies/mL at any time during treatment when compared to placebo (p = 0.002, p < 0.001 and p < 0.001, respectively). The study enrolled 230 patients.

• Neurelis Inc., of San Diego, said the FDA cleared the investigational new drug application for NRL-1, an intranasal diazepam formulation, to begin clinical trials in acute breakthrough seizures. Delivered through a commercially available nasal sprayer, NRL-1 is being developed to manage patients who require intermittent use of diazepam to control bouts of acute repetitive seizure activity outside the hospital setting.

• Orexigen Therapeutics Inc., of San Diego, said it agreed with the FDA on a special protocol assessment for the Contrave (naltrexone HCl/bupropion HCl) cardiovascular outcomes trial. The study, which will enroll about 10,000 patients, is aimed to resolve issues raised in last year's complete response letter for the obesity candidate. The objective of the study is to demonstrate that Contrave does not unacceptably increase the risk of major adverse cardiovascular events (MACE). Orexigen plans to start the study in the second quarter. An interim analysis and new drug application resubmission is planned once about 87 MACE events have occurred, which is anticipated to be less than two years from the start of the study. Orexigen raised $90 million in a public offering in December 2011 to help fund the outcomes study. The company's stock (NASDAQ:OREX) gained 45 cents, or 16.3 percent, to close Monday at $3.21. (See BioWorld Today, Feb. 2, 2011, Sept. 22, 2011, and Dec. 16, 2011.)

• Remedy Pharmaceuticals Inc., of New York, reported preliminary Phase II data for RP-1127, an NCCa-ATP channel inhibitor, in severe stroke. The open-label GAMES-Pilot data indicated major swelling occurred in 12.5 percent of the treated group compared to 88 percent in the historical group. No significant hemorrhages were found in treated patients, compared to 30 percent in the historical group. Follow-up magnetic resonance imaging on patients treated with RP-1127 indicated an absence of midline shift and ventricle compression, preservation of sulci and preservation of white matter. The data were presented at the 2012 International Stroke Conference in New Orleans.

• Ziopharm Oncology Inc., of New York, said the FDA accepted its investigational new drug application for the oral dosing of Zymafos (palifosfamide, ZIO-201), a DNA cross-linker candidate that is being tested intravenously in a Phase III study in metastatic soft-tissue sarcoma and set to start another Phase III trial in small-cell lung cancer. The oral formulation is aimed at expanding Zymafos' development options, including the possibility of treating pediatric cancer patients and allowing outpatient treatment.