• Barrier Therapeutics Inc., of Princeton, N.J., announced positive results of a safety, dose escalation study with its oral antifungal agent pramiconazole. No clinically relevant changes were seen in any of the 32 healthy volunteers dosed with up to 6 g of pramiconazole given over a five-day period, as compared to placebo. The study measured cardiac parameters, including QT/QTc interval, liver and kidney function, and several other blood chemistry parameters. The total of 6 g administered over five days is 30 times higher than the single weekly dose of 200 mg of pramiconazole that is being used in a Phase IIa study in toenail onychomycosis (nail fungus) currently under way in Europe.

• Brane Discovery Srl, of Gerenzano, Italy, started a Phase I trial of its lead compound, BND-11624, a pyrrolidinone derivative for neuropathic pain associated with indications such as antiviral therapy and osteoarthritis. The study, involving 24 healthy volunteers, already has completed administration of the first dose in all volunteers with excellent tolerability. Brane Discovery plans to perform a second Phase I repeat-dose trial in the first quarter of 2008 and to start a Phase II study in HIV patients by the third quarter of next year.

• Eurand NV, of Milan, Italy, completed gastrointestinal bioavailability study with Zentase (EUR-1008), the company's lead product candidate for the treatment of exocrine pancreatic insufficiency (EPI). The study was conducted in chronic pancreatitis patients in the U.S., and results will be included in Eurand's rolling new drug application for fast-track Zentase, started in June and expected to complete before the end of this year. Zentase is a porcine-derived pancreatic enzyme replacement therapy.

• Inovio Biomedical Corp., of San Diego, said partner Tripep AB, of Uppsala, Sweden, treated the first subject in a Phase I/II trial of ChronVac-C, a DNA vaccine in development for chronic hepatitis C virus infection. The study aims to test ChronVac-C, administered using Inovio's MedPulse DNA Delivery System, in 12 HCV patients. Inovio's advanced electroporation devices are designed to facilitate delivery and expression of DNA vaccines to produce the desired antigens.

• Kinex Pharmaceuticals LLC, of Buffalo, N.Y., started Phase I trials with the Src kinase inhibitor KX2-391 for advanced malignancies that are refractory to conventional therapies. Dosing has begun at Roswell Park Cancer Institute in Buffalo, and will commence in the next several days at M.D. Anderson Cancer Center in Houston. The trial is expected to enroll 50 patients with advanced solid tumors and lymphoma and will evaluate safety, tolerability and pharmacokinetics. Exploratory biomarker studies also will be involved, the company said.

• Naryx Pharma Inc., of Santa Barbara, Calif., completed enrollment of a 180-subject Phase IIb trial of Sybryx (tobramycin solution for nasal inhalation) in chronic sinusitis patients who have undergone previous sinus surgical procedures. Results will be reported in the first quarter of 2008. Sybryx previously was granted fast-track status by the FDA.

• Nventa Biopharmaceuticals Corp., of San Diego, said safety data from its first cohort of patients in a Phase I trial of HspE7 in cervical intraepithelial neoplasia were normal and met the limits prescribed in the trial protocol, according to the safety review committee, which allows the company to progress to the second cohort of patients to receive HspE7 with an escalated dose of adjuvant. The trial is expected to dose up to five cohorts comprising 24 patients. Four of those will receive 500 mcg of HspE7 with varying doses of adjuvant containing Poly-IC, a Toll-like receptor-3 agonist. A fifth cohort of six patients given 1,000 mcg of HspE7 and 2,000 mcg of adjuvant might be added if deemed appropriate based on data from the first four cohorts. HspE7 is a therapeutic vaccine candidate for diseases caused by the human papillomavirus.

• Osiris Therapeutics Inc., of Columbia, Md., disclosed positive one-year interim results in the evaluation of Chondrogen, a preparation of adult stem cells formulated for direct injection into the knee. The one year data showed improvement in joint condition that correlated with a clinically and statistically significant improvement in pain in patients with osteoarthritis who received Chondrogen as compared to those treated with the control, hyaluronic acid. Osiris' stock (NASDAQ:OSIR) closed Tuesday at $11.84, up $1.60, or 16 percent.

• Raven Biotechnologies Inc., of South San Francisco, said it is continuing to enroll new patients in the maximum tolerated dose cohort expansion segment of its Phase I/IIa trial of RAV12 in gastrointestinal tract cancers expressing the RAAG12 antigen. The previous dose-escalation segment involving 33 patients revealed that a fractionated dosing regimen provided an improved safety profile and the expansion segment is designed to provide information to support an upcoming Phase II study in pancreatic cancer. RAV12 is a chimeric monoclonal antibody directed against a primate-specific glycotope, RAAG12, which is widely displayed on the surfaces of tumor cells, particularly those of gastrointestinal origin.

• Sosei Group Corp., of Tokyo, said SD118, which is under development for the treatment of neuropathic pain, has commenced a multiple dose ascending Phase I study, and the initial single ascending dose Phase I study to explore higher doses has been extended. SD118 is being jointly developed with NeuroDiscovery Ltd., of Perth, Australia. SD118 was previously under investigation in Japan for a different indication and now, following re-profiling and evaluation in experimental animal models, has demonstrated its potential as a new oral therapy for neuropathic pain, Sosei said.