• Cardiome Pharma Corp., of Vancouver, British Columbia, said partner Merck & Co. Inc., of Whitehouse Station, N.J., recently completed an additional multiple rising-dose Phase I study to explore higher doses of oral vernakalant, and data showed the drug was well tolerated. An additional Phase I trial assessing oral vernakalant when dosed for a more extended time period at higher exposure is set to start later this year. Data from both trials will be used to design a Phase II program, expected to start in late 2012. Oral vernakalant is in development for atrial fibrillation. Merck gained rights to the compound in a potential $800 million deal in 2009. (See BioWorld Today, April 14, 2009.)

• Galena Biopharma Inc., of Lake Oswego, Ore., reported that data from Phase II clinical trials of its NeuVax vaccine showed that it may provide a meaningful clinical benefit in patients with less aggressive forms of breast cancer, and potentially keep them free of their disease. Results were presented at the 26th Annual Meeting of the Society for the Immunotherapy of Cancer in North Bethesda, Md.

• Hutchison MediPharma Ltd., of London, a subsidiary of Chi-Med, announced the start of the first-in-human Phase I trial of Epitinib (HMPL-813), an orally active small molecule inhibitor targeting the epidermal growth factor receptor designed to achieve broad antitumor activity. The company said the first patient was dosed on Oct. 31.

• Jennerex, Inc., of San Francisco, initiated the Phase IIb TRAVERSE trial evaluating the use of JX-594 to treat patients with advanced liver cancer, also known as hepatocellular carcinoma (HCC), who failed prior therapy with sorafenib (Nexavar), the only approved drug for advanced HCC.

• RegeneRx Biopharmaceuticals Inc., of Rockville, Md., reported data from its 72-week Phase II study showing that RGN-259, its sterile, preservative-free eye drop, met statistical significance after a challenge-controlled adverse environment in the reduction from baseline in central corneal fluorescein staining compared to placebo at the 24-hour recovery period (p = 0.0075) and in the reduction from baseline in exacerbation of superior corneal fluorescein staining in the chamber as compared to placebo (p = 0.0210). The drug also reduced the exacerbation of ocular discomfort at day 28 during a 75-minute challenge in a controlled adverse environment compared to placebo (p = 0.0244). The study, however, failed to meet the two primary outcome measures, defined as statistically significant sign and symptom improvements. Shares of Regenerx (OTCBB:RGRX) fell 9 cents, or 30. 1 percent, to close Friday at 20 cents.

• Rexahn Pharmaceuticals Inc., of Rockville, Md., reported results from a Phase IIb trial showing that Serdaxin in major depressive disorder did not demonstrate efficacy compared to placebo over an eight-week treatment period, as measured by the Montgomery-Asberg Depression Rating Scale. All groups showed an approximate 14-point improvement in the protocol of the defined primary endpoint, and all groups had a substantial number of patients showing meaningful clinical improvement from baseline. The study tested 0.5 mg and 5 mg doses of Serdaxin. Rexahn said the firm plans to evaluate the Serdaxin clinical programs and possible paths forward. Shares of the company (AMEX:RNN) fell 34 cents, or 33 percent, to close Friday at 69 cents.

• Santarus Inc., of San Diego, and Pharming Group NV, of Leiden, the Netherlands, said a retrospective analysis of integrated efficacy data from hereditary angioedema (HAE) patients undergoing treatment with Rhucin (recombinant human C1 inhibitor) for acute HAE attacks showed that median time to primary endpoint of onset of symptom relief was 60 minutes and median time to minimal symptoms was 240 minutes. Abdominal attacks had the fastest onset of relief (36 minutes), followed by urogenital (56 minutes), oro-facial-pharyngeal-laryngeal (65 minutes) and peripheral attacks (84 minutes). Those and other data were presented at the American College of Allergy, Asthma & Immunology meeting in Boston.

• Vivus Inc., of Mountain View, Calif., announced that results from the 56-week EQUIP study of investigational drug Qnexa in 1,267 severely obese patients in 91 U.S. sites showed an average weight loss of 14.4 percent of initial body weight among those who completed the study at the top dose. In addition, the company said, severely obese patients had improvements in blood pressure, glucose, triglycerides and cholesterol. The company said the results suggest that Qnexa has the potential to effectively treat severely obese patients without surgery. Results were published in Obesity. (See BioWorld Today, Sept. 16, 2011.)