• Algeta AS, of Oslo, Norway, completed sample size re-estimation of pivotal Alsympca trial, which was pre-planned for the first half of this year. The company said that the sample size re-estimation confirmed that the current plan to recruit 750 patients into the Alsympca trial will meet the original goals for the study. The increase in recruitment for Alsympca is expected to increase the statistical power of the trial to 90 percent thereby further increasing the likelihood of proving the efficacy of Alpharadin.

• Anthera Pharmaceuticals Inc., of Hayward, Calif., announced detailed results from a new biomarker analysis of the FRANCIS study examining the effects of once-daily varespladib vs. placebo as an adjunct treatment to high-dose atorvastatin and standard of care on inflammatory biomarkers known to be predictive of secondary cardiovascular events in patients with a recent acute coronary syndrome. The analysis of diabetic patients demonstrated treatment with varespladib was associated with early and statistically significant improvements in inflammatory markers, including C-reactive protein, low-density lipoprotein-cholesterol and varespladib's target enzyme, sPLA2.

• Aton Pharma Inc., of Lawrenceville, N.J., said results from a multicenter patient registry study of its Lacrisert ophthalmic insert showed that the insert decreased ocular surface disease index in patients with moderate-to-severe dry eye after one month of treatment. The largest decrease in scores was seen in the severe group (29.8 percent decrease, p <. 001). Scores in the moderate group decreased by 18.9 percent (p = 0.016). Improvement in OSDI scores for patients in the study was over and above any improvement patients may have gained from previous dry eye therapies administered before the study. The results were presented at the annual meeting of the Association for Research in Vision and Ophthalmology in Fort Lauderdale, Fla.

• Celator Pharmaceuticals Inc., of Princeton, N.J., reported positive results from its Phase II study of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection vs. conventional cytarabine and daunorubicin (the "7+3" regimen) in patients, 60 to 75 years of age, with untreated acute myeloid leukemia. The primary endpoint, the rate of patients achieving a complete remission with CPX-351 compared to "7+3," achieved statistical significance. In addition, there was a reduction in the 30-day and 60-day mortality with CPX-351 vs. the "7+3" regimen. The multicenter, randomized, open-label trial enrolled a total of 126 patients. Patient follow-up is ongoing, and results will be submitted to a major medical conference in 2010.

• Curis Inc., of Cambridge, Mass., said it has successfully completed enrollment and treatment of the last patient in its Phase I trial of CUDC-101, Curis' first-in-class HDAC, EGFR and HER2 inhibitor. A Phase Ib study is planned at the established maximum-tolerated dose of 275 mg/m2 at various dosing schedules and in select tumor types including gastric, head and neck, breast and liver cancers, to seek additional signals of activity and to help guide future clinical studies. The firm also plans a Phase I/II l trial in non-small-cell lung cancer patients in the second half of this year.

• Noxxon Pharma AG, of Berlin, said it has successfully completed a Phase I trial with Spiegelmer NOX-A12, which is being developed for acute as well as chronic indications in the area of hematological malignancies and/or solid tumors. Final data analysis demonstrated an excellent safety and tolerability up to the highest tested dose of 10.8 mg/kg, the company said. In addition, analysis by flow cytometry revealed a long-lasting and dose-dependent mobilization of WBC and CD34 positive cells. NOX-A12 is scheduled to enter a multiple dose Phase I trial by midyear.

• Omeros Corp., of Seattle, reported additional data from a Phase II trial of OMS103HP, its PharmacoSurgery product candidate for arthroscopy, showing that patients treated with OMS103HP during arthroscopic meniscectomy surgery achieved statistically significant clinical benefits. OMS103HP is an investigational drug product that is added to arthroscopic irrigation solution and is designed to improve postoperative joint function and motion and reduce postoperative pain.

• SARcode Corp., of San Francisco, reported results of a 230-patient Phase II proof-of-concept study evaluating topical SAR 1118 ophthalmic solution in the treatment of aqueous deficient dry eye (keratoconjunctivitis sicca). The results demonstrated clear improvements in both signs and symptoms of dry eye at 12 weeks, the company said. SAR 1118 was well tolerated, with no serious ocular adverse events reported. The results were presented at the Dry Eye Summit meeting in Fort Lauderdale, Fla.