• Cephalon Inc., of Frazer, Pa., reported data from a Phase IV trial of Nuvigil (armodafinil) in patients experiencing excessive sleepiness associated with shift-work disorder, showing a statistically significant difference in improvement in overall clinical condition related to late-shift sleepiness in the Nuvigil group compared to placebo. The drug was approved in 2007. (See BioWorld Today, April 3, 2007.)

• Emergent BioSolutions Inc., of Rockville, Md., started a Phase Ib/II study of TRU-016, a CD37-directed small modular immunopharmaceutical protein therapeutic, in chronic lymphocytic leukemia (CLL). The study is designed to enroll up to 114 bendamustine-naïve patients with a confirmed diagnosis of relapsed CLL and who have failed up to three previous treatments. The Phase Ib portion will determine a safe and tolerable dose of the drug in combination with bendamustine (marketed as Treanda by Cephalon Inc.), while the Phase II portion will evaluate TRU-016's safety and efficacy in combination with bendamustine vs. bendamustine alone, with a primary endpoint of overall response rate. TRU-016 is partnered with Abbott, Ill.-based Abbott.

• Generex Biotechnology Corp., of Worcester, Mass., and wholly owned subsidiary Antigen Express Inc. amended the clinical study agreement with the Henry M. Jackson Foundation for the Advancement of Military Medicine in regard to an ongoing Phase II trial of AE37, an immunotherapeutic vaccine for breast cancer. The amendment calls for increasing the number of patients enrolled in the study from 190 to 330 and modifying the inclusion criteria to ensure good representation of patient populations being considered for the upcoming Phase III trial.

• Immune Network Ltd., of Vancouver, British Columbia, said newly acquired business Immunitor Inc. published interim Phase IIb data showing that V5 was safe, ameliorated the symptoms of tuberculosis and improved the quality of life. Efficacy after just one month was observed, including in multidrug-resistant TB patients, with a conversion rate of sputum smear of 78.3 percent in the treatment group vs. 0 percent in the placebo group. Those data were detailed in the Journal of Immune Based Therapies and Vaccines.

• Resverlogix Corp., of Calgary, Alberta, said lead drug RVX-208, an ApoA-I production drug, showed positive effects on a marker of cognitive function and Alzheimer's disease, plasma amyloid beta 40. Data were analyzed from a stable coronary artery disease population in the company's 299-patient ASSERT trial.

• Rexahn Pharmaceuticals Inc., of Rockville, Md., enrolled the first patient in its Phase IIb trial of Serdaxin in major depressive disorder. The study will recruit up to 300 patients to test the oral, extended-release tablet. Preliminary data are expected in late 2011.