• Celsion Corp., of Columbia, Md., said results from a Phase I liver cancer study of ThermoDox in combination with radiofrequency ablation treating patients with primary and metastatic liver cancer showed the dose of 50 mg/m2 is both safe and tolerable for use in a Phase III study. Data were presented at International Hepato-Pancreato-Biliary Association conference in Mumbai, India.

• Inhibiton Therapeutics Inc., of Centennial, Colo., said testing has shown that its ICA-1 compound demonstrated more exacting specificity of protein kinase C-iota and not of proteins that are closely related to PKC-iota. Research has shown that the ICA-1 compound has been effective in laboratory in vitro testing in various cancer cell lines. Specifically, it demonstrated that inhibition of the enzyme protein kinase C-iota is a promising means to prevent and treat certain cancers through development of a targeted therapy.

• OrthoLogic Corp., of Tempe, Ariz., has begun dosing for its AZX100 Phase I clinical trial in dermal/hypertrophic scarring. The study will evaluate the safety and tolerability of escalating doses of AZX100 in healthy adult males. The primary objective is to evaluate the initial safety and tolerability of AZX100 in healthy adult subjects. AZX100 is a synthetic preclinical 24-amino acid peptide, one of a new class of compounds in the field of smooth muscle relaxation and fibrosis.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., reported further information related to infusion reactions and deaths in its Phase III trials of Puricase (pegloticase) in treatment-failure gout patients, showing that 18 patients, rather than the 19 previously reported, in the Puricase arm experienced an infusion reaction termed serious or severe. Of the seven patients previously reported to have severe infusion reactions, five of those had a serious infusion reaction that also was characterized as "severe" in an overlapping manner. Savient also said that of the two patients who died after the completion of the study, one was in the treatment group and one was in the placebo group. Katherine Xu, an analyst with Credit Suisse Securities LLC, wrote in a research note that the safety data "appear to be slightly better than previously reported," and said that, overall, Puricase "offers a compelling benefit/risk ratio in this treatment-failure gout population." The company posted positive results from the two Phase III studies in December and said it planned to file a biologics license application this year. Puricase is a pegylated recombinant mammalian urate oxidase. (See BioWorld Today, Dec. 14, 2007.)