• Advaxis Inc., of North Brunswick, N.J., reported that results of a first-in-man trial of the firm's live Listeria vaccine Lovaxin C showed that the vaccine was safe to administer intravenously, the pattern of adverse responses observed were consistent with immune stimulation and a dosage ceiling was determined for the population tested. Lovaxin C is being developed as an immunotherapy for patients with cancers that result from human papilloma virus, including cervical cancer and head and neck cancer. The Phase I/II trial included 15 patients in three dosage groups with 30 minute 250 ml infusions of Lovaxin C at three-week intervals. Patients were observed for a total of 111 days. All patients had either advanced, recurrent or progressive cervical cancer, and with the exception of two women, all patients were stage IVb (end stage). Every patient experienced a flu-like syndrome in the three to 12 hours after dosing comprised of fever, chills, nausea and occasional vomiting, which is consistent with immune stimulation.

• Arpida Ltd., of Rinach/Basel, Switzerland, presented several posters containing clinical data on its late-stage investigational antibiotic iclaprim at the annual meeting of the Infectious Diseases Society of America in San Diego. That included data describing iclaprim's efficacy in the first of two pivotal Phase III trials in complicated skin and skin structure infections (ASSIST-1). The results showed that iclaprim exhibited high clinical cure rates and achieved its prespecified primary endpoint of noninferiority to linezolid.

• Basilea Pharmaceutica Ltd., of Basel, Switzerland, said that the ceftobiprole Phase III top-line study results in hospital-acquired pneumonia (HAP) met the primary endpoint of noninferiority vs. combination therapy of ceftazidime plus linezolid. The study compared clinical outcomes following the treatment with either ceftobiprole monotherapy or combination therapy of ceftazidime plus linezolid in patients with HAP including a subgroup of patients with microbiologically and clinically more complex ventilator-associated pneumonia (VAP). Overall, 69 percent of the clinically evaluable (CE) patients were cured with ceftobiprole compared to 72 percent treated with combination therapy. The study met the noninferiority criteria in both CE and intent-to-treat populations. In the CE patient population excluding VAP clinical cure rates were 77 percent for ceftobiprole and 76 percent for combination therapy. Cure rates in the smaller VAP patient subset (about 25 percent of patients enrolled) were lower for ceftobiprole treated patients and noninferiority could not be established. Ceftobiprole currently is under review by regulatory authorities in the U.S., Europe and Canada for the treatment of complicated skin and skin structure infections.

• Biothera, of Eagan, Minn., has initiated enrollment of patients in a Phase Ib/IIa trial to evaluate the safety and efficacy of Imprime PGG and Erbitux in patients with metastatic colorectal cancer. Imprime PGG is a biological response modifier that enhances specific innate immune cell responses without inducing pro-inflammatory cytokines. Mouse models have demonstrated that combining Imprime PGG and anti-tumor monoclonal antibodies significantly reduces tumor size and increases survival compared with antibody therapy alone. Goals of the trial are to assess the safety and efficacy of various Imprime PGG dose levels in metastatic colorectal cancer. The company plans to follow the study with a double-blind, placebo-controlled Phase IIb trial in a larger patient population.

• DeCODE genetics, of Reykjavik, Iceland, said it has started enrolling patients for its Phase IIa clinical trial for DG051, the company's leukotriene A4 hydrolase inhibitor being developed to prevent heart attacks. Results of a Phase I trial showed that DG051 significantly reduced the production of leukotriene B4 (LTB4), a pro-inflammatory molecule identified as a key factor in modulating risk of heart attack, in a dose-dependent manner. The Phase IIa is a randomized, double-blind, placebo- controlled trial that will examine the impact of DG051 on the production of LTB4 as well as the compound's pharmacokinetic and safety and tolerability profiles in heart patients.

• Johnson & Johnson Pharmaceutical Research & Development, of Raritan, N.J., and partner Basilea Pharmaceutica Ltd., of Basel, Switzerland, said results from a Phase III trial showed that investigational antibiotic ceftobiprole was found to clinically cure 86 percent of patients with diabetic foot infections, including some infections that were caused by methicillin-resistant Staphylococcus aureus. Data showed that 500 mg of ceftobiprole administered intravenously every eight hours demonstrated an 86.2 percent cure rate compared to an 81.8 percent cure rate seen with the combination of 1 gram of vancomycin administered intravenously every 12 hours plus 1 gram of ceftazidime administered intravenously every eight hours. The data were presented at the annual Infectious Disease Society of America meeting in San Diego.

• Living Cell Technologies Ltd., of Melbourne, Australia, released positive preliminary results for its Phase I/IIa clinical trial of DiabeCell porcine islet cell implant for the treatment of Type I diabetes. Six insulin-dependent patients are to be administered the lowest clinically effective dose and then given additional treatments to achieve additional clinical benefit. Thus far two patients have been treated and a monitor reported both appear to be well and have shown no adverse effects. Each achieved much greater than the 25 percent minimum target reduction in daily insulin requirements at the three-month and one-month follow-ups.

• Metabasis Therapeutics Inc., of San Diego, presented positive data at the annual meeting of the American Thyroid Association in New York on MB07811, its liver-targeted, beta-subtype-selective thyroid hormone receptor agonist product candidate for treating hyperlipidemia. One presentation provided data demonstrating that in the animal models studied, MB07811 led to similar reductions in cholesterol and triglyceride levels, but with an improved therapeutic index as compared to the natural ligand, T3, or a prototype non-liver-targeted TR beta-selective agonist (KB-141). The second presentation provided data demonstrating significant total plasma cholesterol reduction when MB07811 was administered in combination with atorvastatin (Lipitor) in various animal models as compared to monotherapy. MB07811 is currently being studied in a Phase 1b multiple dose clinical trial.

• Xanthus Pharmaceuticals Inc., of Cambridge, Mass., has initiated patient dosing in a pivotal Phase III trial with Xanafide (amonafide malate) for the treatment of patients with secondary acute myeloid leukemia. The trial is an open-label, randomized, active control, multi-center study of Xanafide in combination with cytarabine compared to daunorubicin in combination with cytarabine as initial remission induction therapy for patients with sAML. Xanthus plans to enroll approximately 350 patients. The primary endpoint is the rate of complete remission. (See BioWorld Today, June 13, 2007.)