• Anacor Pharmaceuticals Inc., of Palo Alto, Calif., in partnership with the Drugs for Neglected Diseases initiative (DNDi), began a Phase I trial of SCYX-7158 in human African trypanosomiasis, or sleeping sickness. The trial is randomized, double-blind and placebo-controlled, and it will assess safety, tolerability, pharmacokinetics and pharmacodynamics of the drug in up to 120 healthy volunteers. DNDi plans to advance it to Phase II trials in subSaharan Africa.

• Dynavax Technologies Corp., of Berkeley, Calif., said results of an early Phase III study showed Heplisav was well tolerated and demonstrated superior and more durable seroprotection earlier than the licensed comparator hepatitis B vaccine. The study, which compared Heplisav with Engerix-B (GlaxoSmithKline plc) in 412 patients, showed that the seroprotection rate at one month after the second dose was 97 percent in the Heplisav group vs. 24 percent in the Engerix-B group (p < 0.0001). At one month after the third dose, the seroprotection rates were 100 percent for Heplisav, compared to 73 percent for Engerix-B (p < 0.0001). At one year after the first dose, rates were 100 percent for Heplisav and 69 percent for Engerix-B (p < 0.0001). Data were published in in Vaccine. Dynavax said it plans to submit a biologics license application for Heplisav in May for use in adults, 18 to 70.

• Inovio Pharmaceuticals Inc., of Blue Bell, Pa., said it achieved strong T-cell immune responses in a Phase I study of Pennvax-B, its product for treating the HIV subtype prevalent in North America and Europe. All 12 HIV-positive patients completed the four-dose vaccination regimen, and there were no adverse events or vaccine-related Grade 3 or Grade 4 adverse events noted. The interim results were presented at the Vaccine World Summit 2012 meeting in Hyderabad, India.

• Intercell AG, of Vienna, Austria, said it started a pivotal Phase II/III trial of its Pseudomonas aeruginosa vaccine, following an exploratory Phase II study in which lower all-cause mortality rates were observed in the vaccine groups compared to controls. The study will enroll a total of 800 ventilated intensive-care patients who will be vaccinated twice with either Intercell's vaccine candidate or placebo at a seven-day interval in addition to the standard of care. The primary objective is to compare all-cause mortality rates at day 28 after first vaccination between the two study groups, while secondary objectives will compare infection-related mortality rates and P. aeruginosa infection rates and will investigate the vaccine's immunogenicity, safety and tolerability. A futility analysis is planned after about 400 patients have been enrolled, and the first interim data are expected in mid-2013. The P. aeruginosa program is part of Intercell's collaboration with Basel, Switzerland-based Novartis AG, and both companies will share the trial costs. (See BioWorld Today, July 5, 2007.)

• Medivir AB, of Huddinge, Sweden, said protease inhibitor TMC435, developed by New Brunswick, N.J.-based Johnson & Johnson unit Janssen Pharmaceuticals, started patient dosing in a Phase III trial testing the drug against Incivek (telaprevir, Vertex Pharmaceuticals Inc.), each in combination with pegylated interferon alpha-2a and ribavirin, in hepatitis C virus (HCV) genotype-1-infected patients who were null or partial responders to prior interferon/ribavirin therapy. The study is targeted to enroll 744 patients, and the primary endpoint is sustained virological response at 12 weeks (SVR12). Medivir also started a second Phase III trial, designed as an open-label, single-arm study, to test TMC435 in combination with interferon/ribavirin in 100 treatment-naïve or treatment-experienced HCV genotype-4-infected patients. The primary endpoint of that study is SVR12.

• Nuvilex Inc., of Silver Spring, Md., said data from an early clinical trial in pancreatic cancer indicated that its Cell-in-a-Box technology, acquired from SG Austria, of Singapore, might have an effect on downstream micro metastatic disease. Cell-in-a-Box technology capsules, when used in combination with cytochrome P450-expressing cells, can be placed at the tumor site so that the cells inside the capsule can convert the chemotherapeutic drug ifosfamide. When the patient is subsequently injected with ifosfamide, the encapsulated cells are designed to transform the prodrug into its active form, which kills the pancreatic cancer cells.

• PX'Therapeutics SA, of Grenoble, France, launched a Phase I trial of its prophylactic HIV vaccine. The randomized, observer-blinded trial will evaluate safety and immunogenicity of nasal-prime and intramuscular boost immunization with EN41-FPA2 HIV vaccine in healthy female volunteers. It is funded by the European Union's Seventh Research Framework Programme. The vaccine, based on HIV envelope protein, is designed to create neutralizing antibodies that block entry of HIV into cells at mucosal sites and in blood.

• Rexahn Pharmaceuticals Inc., of Rockville, Md., said it enrolled the first subject in its exploratory Phase I study of RX-3117, a nucleoside compound aimed at inhibiting DNA methyltransferases and DNA synthesis, in cancer. The study is designed to assess the oral bioavailability of the drug in humans. Enrollment will continue through the first half of 2012, with preliminary data expected in the second half of this year.