• Dynavax Technologies Corp., of Berkeley, Calif., said Phase II/III data to be reported at this weekend’s American Academy of Allergy, Asthma and Immunology meeting in Miami demonstrated that the ragweed immunotherapeutic Tolamba produced a statistically significant 21 percent reduction in the change from baseline of total nasal symptom scores (p=0.04). That’s better than interim data that showed an 18.8 percent treatment effect (p=0.06). Going forward, the company will conduct an additional safety and efficacy trial to determine whether a more intensive, single-course dosing regimen can elicit an even greater treatment effect than prior regimens. It is expected to start at the beginning of next quarter, to take advantage of this year’s ragweed season.

• Genaera Corp., of Plymouth Meeting, Pa., said data from a 24-week interim analysis of its largest Phase II trial of Evizon (squalamine lactate) showed that a 40-mg dose was safe and well tolerated, and stabilized vision in the majority of subjects. The product is in development for wet age-related macular degeneration. Specific findings showed Evizon improved or stabilized vision in 83 percent of subjects receiving the 40-mg dose, compared to 71 percent of control subjects. The data also provided additional signals of a dose response and support the company’s plans to begin an additional Phase II study to explore doses of up to 160 mg.

• Genta Inc., of Berkeley Heights, N.J., said Phase II findings published in the current issue of The Cancer Journal showed Ganite (gallium nitrate injection) to be effective in hospitalized patients with cancer-related hypercalcemia when compared with Aredia (pamidronate disodium, from Novartis AG). In the double-blind trial, 64 patients were randomized to either drug, and 69 percent of those treated with Ganite achieved normocalcemia compared with 56 percent of Aredia patients. The difference was not statistically significant. Ganite is FDA-approved for symptomatic patients with cancer-related hypercalcemia that is resistant to hydration.

• Keryx Biopharmaceuticals Inc., of New York, began a Phase II program to evaluate KRX-0401 (perifosine) as a treatment for leukemia. The multicenter trial marks the second study to be launched under the company’s corporate-sponsored hematological clinical program, unveiled earlier this year in connection with the initiation of a Phase II study of perifosine for multiple myeloma. The new trial will assess the objective response rate and evaluate the pharmacokinetics and safety and tolerability of perifosine as a single agent in relapsed or refractory acute myeloid leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, high-risk myelodysplastic syndrome and chronic myeloid leukemia in the blastic phase.

• Micromet AG, of Munich, Germany, said data published in a recent issue of Molecular Immunology explained the need for large amounts of antibodies to achieve a therapeutic effect in cancer patients. The results demonstrated that the antibody-dependent cellular cytotoxicity of both adecatumumab (MT201) and Herceptin (trastuzumab, from Genentech Inc.) is strongly inhibited by serum due to nonspecific immunoglobulin G antibodies competing for binding of therapeutic antibodies to the Fc-gamma receptor III (CD16) on natural killer cells. In a physiological environment, the efficacy of therapeutic antibodies therefore may be limited primarily by their recruitment of natural killer cells rather than by their binding affinity to tumor cells.

• Myogen Inc., of Denver, said an abstract describing the effects of ambrisentan in patients with pulmonary arterial hypertension will be presented at the International Conference of the American Thoracic Society held in May in San Diego. It will highlight Phase III data of 192 patients. The data demonstrated that ambrisentan improved exercise capacity, delayed clinical worsening and improved symptoms in patients with PAH. It was well tolerated and not associated with any clinically significant serum aminotransferase abnormalities.

• Novogen Ltd., of Sydney, Australia, said Phase I data demonstrated the anti-inflammatory compound NV-52’s rapid absorption, indicating its potential as an oral therapy. The drug, a synthetic analogue based on the phenolic structure of naturally occurring isoflavones, is being developed for inflammatory bowel disease.

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