• CoTherix Inc., of South San Francisco, started a Phase III trial of Ventavis (iloprost) Inhalation Solution in combination with sildenafil citrate. The trial will evaluate the safety and efficacy of the combination treatment in pulmonary arterial hypertension. It also will include an arm to explore the efficacy of less frequent Ventavis dosing. The trial, called VISION (Ventavis Inhalation with Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension), involves 180 patients who will be randomized to one of three treatment groups for 16 weeks. The primary clinical endpoint is an increase in the distance walked in six minutes.

• Generex Biotechnology Corp., of Toronto, reported positive preliminary results of a six-month clinical trial of Oral-lyn, the company’s oral insulin spray product, in juvenile patients with Type I diabetes mellitus. The objective of the study is to document the effects of replacing the lunchtime dose of subcutaneously injected regular insulin with Oral-lyn. Investigators concluded that during the first two and a half months, replacement of regular insulin with Oral-lyn was associated with overall adequate glycemic control and similar fructosamine and glycosylated hemoglobin concentrations.

• Genmab A/S, of Copenhagen, Denmark, said 77 percent of patients who received two doses of HuMax-CD20 in a Phase I/II dose-escalation study to treat active rheumatoid arthritis obtained ACR20. Even on an intent-to-treat basis, which included six patients who did not receive both doses, 63 percent obtained ACR20. None of the seven placebo patients achieved ACR20. The study included 39 patients who had previously failed at least one disease modifying anti-rheumatic drug. In August, the study was expanded into a Phase II trial, which will include 200 additional patients.

• MGI Pharma Inc., of Minneapolis, said the March edition of The European Journal of Neurosurgery, Acta Neurochirurgica, published 56-month follow-up data showing that Gliadel Wafer provided a durable long-term survival benefit for patients with high-grade malignant glioma. The product is approved by the FDA to treat patients with newly diagnosed high-grade malignant glioma as an adjunct to surgery and radiation. It also is indicated to treat recurrent glioblastoma multiforme in addition to surgery. The data showed that patients treated with Gliadel Wafer in combination with radiation therapy had a significant survival advantage at three years compared with placebo (9.2 percent vs. 1.7 percent; p=0.01).

• Santarus Inc., of San Diego, said clinical results indicated Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension provided physicians with an option for treating patients in need of nighttime gastric acid control. The study evaluated Zegerid, Nexium (esomeprazole magnesium) and Prevacid (lansoprazole) in reducing the occurrence of nocturnal acid breakthrough (NAB) when given to patients with nocturnal symptoms of gastroesophageal reflux disease on an empty stomach at bedtime. Of the 49 patients who completed the study, 61 percent experienced NAB while treated with Zegerid, compared to 92 percent who experienced it while being treated with either Nexium or Prevacid.

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