• GenSpera Inc., of San Antonio, Texas, said the FDA cleared the firm to start a Phase II trial of lead compound G-202 in prostate cancer patients who have failed prior hormonal therapy. The trial is expected to recruit up to 40 patients with chemotherapy-naïve, metastatic castrate-resistant prostate cancer. GenSpera's platform combines plant-derived cytotoxin thapsigargin with a prodrug delivery system designed to release the drug only within the tumor.

• Lixte Biotechnology Holdings Inc., of East Setauket, N.Y., said the FDA cleared the firm for a Phase I trial of cancer compound LB-100. The company also said it raised $2.5 million to initiate the trial and continue drug discovery research through an offering to holders of warrants for exercising their rights in cash.

• Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., reported results from a new study of long-term treatment outcomes for men who had received a single injection of NX-1207 2.5 mg for treatment of benign prostatic hyperplasia, with analysis showing a statistically significant greater number of men in the treatment group reporting positive treatment outcomes, compared to men who received placebo. The combined statistical analysis of blinded data showed that NX-1207 had a lasting benefit in terms of positive treatment outcomes that was superior to placebo (p = 0.02). Nymox is conducting two pivotal trials and said both are nearing enrollment completion.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., reported results from a Phase I viral kinetic study of nucleotide analogue ALS-2200 in hepatitis C virus (HCV), with data showing a 4.54 log10 reduction in HCV RNA in people with genotype 1 chronic HCV who were new to treatment, after seven days of dosing with 200 mg of ALS-2200 once daily. The drug also was well tolerated, with no patients discontinuing due to adverse events. Based on those data, Vertex plans to begin Phase II studies this year, testing 12-week all-oral regimens, including ALS-2200, in HCV genotype 1 patients.