• Advaxis Inc., of Princeton, N.J., said dosing began in a 67-subject Phase II trial evaluating Advaxis' ADXS-HPV construct for advanced cervical cancer. The study is sponsored by the Gynecologic Oncology Group, with the majority of funding from the National Cancer Institute. The trial is in a population similar to a 110-patient study Advaxis is conducting in India. Both studies will assess safety and efficacy in cervical cancer patients who have not responded to conventional cytotoxic treatment and whose cancer has metastasized. Enrollment in India is about 80 percent complete.

• Intercell AG, of Vienna, and Statens Serum Institut, of Copenhagen, reported the start of the first Phase II study in their collaboration to develop tuberculosis (TB) vaccines. The randomized, double-blind trial will evaluate the immunogenicity and safety of two doses of H1IC, a combination of Statens' Ag85B-ESAT-6 and Intercell's IC31, in HIV-positive subjects in South Africa and Tanzania. The study, funded by the European and Developing Countries Clinical Trials Partnership, is being conducted in collaboration with several groups, including the South African TB Vaccine Initiative. First results are expected in 2013, and a second Phase II trial is being planned to assess the safety and immunogenicity of the vaccine candidate in healthy adolescents.

• Pharmos Corp., of Iselin, N.J., said the first U.S. patients have been dosed with its levotofisopam (S-tofisopam) in a Phase IIa proof-of-concept trial in hyperuricemia and gout. In two Phase I studies, completed by Vela Pharmaceuticals, which merged with Pharmos in 2006, levotofisopam was generally well tolerated and was associated with a large, rapid reduction in serum uric acid values. Once the proof-of-concept trial is completed, Pharmos plans to seek a partner to further develop levotofisopam.

• Vical Inc., of San Diego, reported that results from the completed Phase II proof-of-concept trial of its TransVax, a cytomegalovirus DNA vaccine, were published in the online issue of The Lancet Infectious Diseases. The occurrence and duration of cytomegalovirus viraemia episodes were significantly reduced when cytomegalovirus-seropositive patients received up to four doses of the vaccine. Vical's partner, Astellas Pharma Inc., of Tokyo, is preparing to move TransVax into a multinational Phase III trial to control cytomegalovirus reactivation in hematopoietic stem cell transplant recipients, plus a Phase II trial in solid organ transplant recipients. (See BioWorld Today, July 18, 2011, and Jan. 9, 2012.)