• Alchemia Ltd., of Sydney, Australia, reported positive efficacy data from its HyCAMP Phase II trial for patients with metastatic colorectal cancer. The trial tested HyCAMP, its proprietary formulation of the anticancer drug irinotecan, against irinotecan alone. Data examined to date showed that patients on HyCAMP were able to receive more doses (a median of six cycles of therapy compared to two for irinotecan along), and median progression-free survival for HyCAMP patients was 5.2 months, compared to 2.4 months for the Irinotecan arm. The primary safety endpoint - comparison of the incidence of late grade 3 or 4 diarrhea in both arms - was not met due to lower than expected incidence of diarrhea in the control arm. The company said it plans to meet with the FDA to discuss proceeding to a pivotal phase III study more quickly than anticipated.

• Iomai Corp., of Gaithersburg, Md., said results of a Phase II dose-ranging trial showed its vaccine against enterotoxigenic E. Coli (ETEC), or travelers' diarrhea, produced positive results even at the lowest dose tested. The dose-ranging trial was designed to measure levels of an antibody, IgG, that is associated with protection against ETEC. Four doses - 7.5 mcg, 22.5 mcg, 37.5 mcg and 50 mcg - and a placebo patch were tested, and antibody levels were checked at 21 and 42 days. The results showed that nearly all patients in the four dosing groups responded to the vaccine, with even the lowest dose of the vaccine evoking a response in more than 95 percent of patients. Iomai's ETEC vaccine uses "heat labile" toxin, or LT, produced by E. coli, to induce an immune response against the bacteria, and LT also functions as a potent adjuvant in the company's influenza patch programs. Full results are expected to be available in May.

• Novagali Pharma, of Evry, France, said the FDA has approved its investigational new drug application to conduct a pivotal Phase III clinical trial of its ocular product Nova22007. Nova22007 is a cyclosporine A ophthalmic product for patients suffering from moderate to severe dry eye syndrome. Nova22007 is a proprietary cationic emulsion enabling an optimal penetration of cyclosporine A in tissues of the eye surface. The FDA has agreed that Novagali can proceed directly into pivotal Phase III clinical trials in the U.S. in patients with moderate to severe dry eye syndrome.

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