• Bionor Pharma ASA, of Oslo, Norway, reported a statistically significant reduction in viral load of HIV virus at the end of its Phase IIb study testing its therapeutic HIV vaccine candidate, Vacc-4x. Although the study did not meet the primary endpoints, findings from the additional analysis discovered that treatment difference with regard to viral load was statistically significant both within the study period and when compared to the viral load prior to starting antiretroviral therapy. Due to the findings, the firm reversed its earlier decision to stop development of Vacc-4x and will work to position the product as a potentially viable HIV vaccine.

• Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., in collaboration with the National Institute on Drug Abuse and the Veterans Administration Cooperative Studies Program, initiated a registration-directed Phase IIb trial of CPP-109, a version of vigabatrin, in patients with cocaine addiction. The study will enroll about 200 patients who will be treated with CPP-109 or placebo for a period of nine weeks, with an additional four weeks of follow-up. The primary endpoint is to demonstrate that a larger proportion of treated subjects will be cocaine-abstinent during their last two weeks of treatment. Data are expected in the second quarter of 2012. It is anticipated the company's collaborators will provide substantial resources for the trial, with Catalyst contributing about $2.8 million of the estimated $10 million cost.

• Circassia Ltd., of Oxford, UK, reported Phase II results showing that its T-cell vaccine for house dust mite allergy met safety and efficacy endpoints, with the optimal treatment regimen achieving a major reduction in patients' reactions to house dust mite allergens. Patients received four standardized doses of ToleroMune T-cell vaccine over a number of weeks and, during the study, investigators administered a challenge dose of house dust mite allergen to the volunteers' skin and eyes. Results showed that the optimal treatment regimen reduced each of the allergic reactions, achieving a therapeutic effect 32 percent to 87 percent greater than placebo.

• Cytochroma Inc., of Markham, Ontario, reported Phase I/II data showing that CTAP101, a capsule designed to treat vitamin D insufficiency, given at 900 mcg, achieved gradual increases of 25D3 to target, but also reduced intact parathyroid hormone at 24 hours by a mean of 19 percent from baseline. Those and other data were presented at the American Society of Nephrology meeting in Denver.

• Intercell AG, of Vienna, Austria, said top-line results from a Phase II trial of V710, a vaccine designed to prevent Staphylococcus aureus infections, showed that immunogenicity data suggested that V710 can elicit a sustained immune response in a relatively immunocompromised patient population. Safety evaluations demonstrated overall that the drug was well tolerated when administered as a single- or multiple-dose regimen at any dosage group studied. The 201-patient trial was conducted by partner Merck & Co. Inc., of Whitehouse Station, N.J.

• Medivir AB, of Huddinge, Sweden, said top-line, 24-week interim data from the Phase IIb ASPIRE study of TMC435 in treatment-experienced hepatitis C virus patients showed that patients treated with TMC435 and standard of care demonstrated high response rates and antiviral efficacy in all patient groups up to and including week four, 12 and 24. In the relapser group, 81 percent, 92 percent and 94 percent of patients taking TMC435 and Peg-IFN and ribavirin achieved undetectable HCV RNA levels at week four, week 12 and week 24, respectively. For the partial responder group, 62 percent, 84 percent and 86 percent achieved undetectable HCV RNA levels at week four, week 12 and week 24, respectively. TMC435 is a hepatitis C protease inhibitor in joint development with Tibotec Pharmaceuticals Ltd., a unit of New Brunswick, N.J.-based Johnson & Johnson.

• Oncolytics Biotech Inc., of Calgary, Alberta, said the Children's Oncology Group intends to start a Phase I trial of Reolysin in combination with cyclophosphamide in pediatric patients with relapsed or refractory solid tumors. The study will test Reolysin in patients, ages 3 to 21, who will receive intravenous administrations of the oncolytic virus-based candidate on days one through five of each 28-day treatment cycle. Some patients also will receive oral cyclophosphamide on days one through 21. The primary objectives include estimating maximum tolerated dose and defining and describing toxicities.

• Sangamo BioSciences Inc., of Richmond, Calif., said Phase II data demonstrated that SB-509, a zinc finger protein transcriptional activator of the VEGF-A gene, was well tolerated in subjects with amyotrophic lateral sclerosis and that 40 percent of SB-509-treated patients had delayed deterioration of toe and ankle muscle strength as measured by manual muscle testing, compared to 23 percent of baseline-matched historical controls. Data were presented at the Society of Neuroscience meeting in San Diego.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said Phase II data published in The New England Journal of Medicine showed that cystic fibrosis patients treated with VX-770 showed improvements in lung function and markers of disease. The trial enrolled 39 patients with cystic fibrosis who have the G551D mutation in the CFTR gene. VX-770, a CFGR potentiator, is designed to increase the function of defective CFTR proteins. It was discovered as part of a collaboration with Cystic Fibrosis Foundation Therapeutics Inc.

• YM BioSciences Inc., of Mississauga, Ontario, said its Phase I/II trial for oral JAK1/JAK2 inhibitor CYT387 in patients with myelofibrosis was expanded to five sites. Subject to regulatory approval, the study will be expanded from 120 to 140 patients to add a 20-patient cohort to be dosed twice-daily at 150 mg per dose. CYT387 has orphan drug status in myelofibrosis.