• Abraxis BioScience Inc., of Los Angeles, reported that Abraxane (nanoparticle albumin-bound paclitaxel) showed promising results in a Phase I/II study in advanced pancreatic cancer when used in combination with gemcitabine. The study showed that, in 44 patients treated with Abraxane plus gemcitabine, the median overall survival time was 12.2 months, double the survival time compared to historical controls of gemcitabine alone. Data also showed that combination treatment resulted in a confirmed overall response rate in 50 percent of treated patients and a disease control rate of 68 percent.

• Cell Therapeutics Inc., of Seattle, entered an agreement with the North Central Cancer Treatment Group to conduct a Phase II study of pixantrone in patients with HER2-negative breast cancer who have tumor progression after at least two, but not more than three, prior chemotherapy regimens. The proposed trial design is to test two different dosing schedules, either 108 mg/m2 every three weeks or 85 mg/m2 weekly for three weeks with a one-week break. Goals include finding the best dose for further development in a Phase III trial against standard second- or third-line treatment.

• Celsion Corp., of Columbia, Md., said the data monitoring committee for the Phase III study of ThermoDox in primary liver cancer recommended continuation of the trial after reviewing data from 294 patients. The trial is expected to enroll a total of 600 patients and is being conducted under a special protocol assessment, with a primary endpoint of progression-free survival. ThermoDox is a heat-activated liposomal encapsulation of doxorubicin.

• Chimerix Inc., of Research Triangle Park, N.C., started a Phase I study of CMX157, a lipid conjugate of the nucleotide tenofovir (marketed as Viread by Gilead Sciences Inc.) with in vitro activity against both tenofovir-sensitive and tenofovir-resistant HIV. The dose-escalating study is designed to test safety, tolerability and pharmacokinetics in healthy volunteers receiving a single dose of CMX157, a standard dose of Viread or placebo.

• Fibrocell Science Inc., of Exton, Pa., started a small histology study of azficel-T, an autologous cell therapy under FDA review for moderate to severe nasolabial fold wrinkles. The study has a target enrollment of about 20 subjects from the completed and statistically significant Phase III studies and will evaluate tissue treated with azficel-T as compared to tissue treated with sterile saline. The additional histological data were requested in the agency's Dec. 21, 2009, complete response letter for azficel-T.

• Repligen Corp., of Waltham, Mass., filed an investigational new drug application for a Phase I study of RG2833, a selective histone deacetylase 3 inhibitor aimed at treating Friedreich's ataxia. The trial will enroll up to 40 healthy volunteers.

• Rexahn Pharmaceuticals Inc., of Rockville, Md., said it will start a Phase IIb trial of Zoraxel, a dual enhancer of serotonin and dopamine, in erectile dysfunction. The 12-week study is expected to enroll about 225 subjects, ages 18 to 65, and will include the International Index of Erectile Function, Sexual Encounter Profile survey and quality of life study endpoints. Rexahn anticipates starting the trial in the second half of this year, with preliminary data available in 2011.