• 3-V Biosciences Inc., of Menlo Park, Calif., started a Phase I study of TVB-2640 in patients with advanced solid tumors. TVB-2640 is an oral, fatty acid synthase (FASN) inhibitor being evaluated for the treatment of solid tumors. FASN is an enzyme responsible for the synthesis of palmitic acid and has a key role in tumor metabolism, lipid signaling and tumor cell survival, the company said.

• Arca Biopharma Inc., of Westminster, Colo., said its investigational new drug application for atrial fibrillation drug Gencaro was accepted by the FDA. Arca plans to evaluate Gencaro, a beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in a Phase IIb/III study, dubbed GENETIC-AF, expected to begin enrolling patients in the first quarter of 2014. Arca said it has identified common genetic variations that it contended predict individual patient response to Gencaro and will only enroll subjects with the genetic variant of the beta-1 cardiac receptor that responds most favorably.

• Bioalliance Pharma SA, of Paris, was authorized to begin a Phase III trial (Relive) of Livatag in hepatocellular carcinoma in the U.S. and Germany. Bioalliance is also enlarging the German study upon authorization granted by BfArM, the German health agency. The trial will enroll 400 patients who have failed or been intolerant to sorafenib. The endpoint of the trial will be survival. Twenty centers have opened and more than 80 patients have been enrolled. The international expansion was necessary to meet recruitment timeline objectives, which call for an end of recruitment in 2015 and preliminary results in 2016.

• Chemocentryx Inc., of Mountain View, Calif., disclosed positive top-line data from the first two steps of a Phase II trial with CCX168, an inhibitor targeting the chemoattractant receptor known as C5aR, in anti-neutrophil cytoplasmic antibody-associated renal vasculitis (AARV), a serious autoimmune disease causing inflammation of the smaller blood vessels. Data demonstrated that CCX168 appears to be safe, well tolerated and successful in allowing reduction and elimination of high-dose corticosteroids, part of standard of care for AARV patients, without compromising efficacy or safety during a 12-week treatment period. There were no unexpected serious adverse events.

• Galapagos NV, of Mechelen, Belgium, said its GLPG1205, a first-in-class molecule for inflammatory disorders, yielded positive Phase I data. The aim of the study was to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral single and multiple ascending doses of GLPG1205, which proved safe and well-tolerated over a wide dose range in healthy volunteers. A Phase IIa study is planned in inflammatory bowel disease.

• Idera Pharmaceuticals Inc., of Cambridge, Mass., said enrollment is open for a Phase I/II trial of IMO-8400, a Toll-like receptor 7, 8 and 9 antagonist, in patients with Waldenström’s macroglobulinemia, following acceptance of its investigational new drug application by the FDA. The objectives of the trial are to evaluate the compound’s safety, tolerability and potential clinical activity.

• Lightlake Therapeutics Inc., of London, disclosed the initial findings of its clinical trial with the National Institute on Drug Abuse, part of the National Institutes of Health, which support Lightlake’s intranasal delivery of naloxone as a promising innovative treatment for opioid overdose. Initial data from the study showed that Lightlake’s naloxone nasal spray potentially can be delivered into the bloodstream at least as quickly as the injection process currently used by hospitals, first responders and others treating opioid overdoses.

• Oncomed Pharmaceuticals Inc., of Redwood City, Calif., began a Phase Ib trial of vantictumab in combination with nab-paclitaxel (Abraxane, Celgene Corp.) and gemcitabine for pancreatic cancer. The trial is a dose-escalation study evaluating safety of the combination regimen and recommended phase II dose. Secondary objectives include pharmacokinetics and pharmacodynamics. The trial is the third of three Phase Ib trials for vantictumab initiated in 2013 in partnership with Bayer AG, of Leverkusen, Germany. Oncomed stock (NASDAQ:OMED) gained $1.95, to close at $29.65.

• Rxi Pharmaceuticals Corp., of Westborough, Mass., reported additional results from a Phase I study of RXI-109, which is in development for scars. Study subjects received small skin incisions in the abdomen and received three intradermal doses of RXI-109 over a two-week period. The study included four cohorts of three healthy volunteers each, and a fifth cohort was added at the highest dose, to test delaying treatment for two weeks. Over the initial two week period, there was a 50 percent reduction of CTGF mRNA expression compared to placebo. In the fifth cohort, no additional benefit of delaying treatment was seen on mRNA reduction. Delay of dosing resulted in fewer local skin effects for both the placebo and active groups.

• Senesco Technologies Inc., of Bridgewater, N.J., completed the third cohort of its Phase Ib/IIa trial of SNS01-T for multiple myeloma and lymphoma. It has also received approval from its data review committee to proceed to the fourth cohort, which will enroll six patients. The data review committee concluded that SNS01-T was safe and well tolerated at a dose of 0.2 mg/kg. There were no drug-related serious adverse events or dose-limiting toxicities observed. Cohort 4 patients will receive 0.375 mg/kg of SNS01-T.

• Ultragenyx Pharmaceutical Inc., of Novato, Calif., dosed its first patient in a Phase I/II study of recombinant human beta-glucuronidase (rhGUS, UX003) for MPS-7, a rare autosomal recessive lysosomal storage disorder in which the enzyme beta glucuronidsase is deficient. The Phase I/II trial will assess safety and efficacy of rhGUS over 12 weeks, followed by a dose-exploration and long-term extension phase. It will enroll five patients between 5 and 30 years to receive rhGUS every other week intravenously. Interim data are expected in 2014.

• Xenetic Biosciences plc, of London, began a Phase I/II trial of Myeloxen, a vaccine candidate for multiple sclerosis. The open-label study will enroll 26 subjects in three phases, including a cohort of six healthy volunteers, one of 10 patients for dose-escalation and a final cohort of 10 patients dosed at the dose levels determined in part 2. All six healthy vounteers have begun dosing. Patients with relapsing, remitting and secondary progressive multiple sclerosis will be enrolled for parts 2 and 3. The endpoints of the trial will be safety and tolerability, with secondary objectives of surrogate efficacy and mechanism of action.