• Biothera, of Eagan, Minn., initiated a Phase I/II trial of Imprime PGG in combination with G-CSF for mobilization of bone marrow stem cells into the peripheral blood in normal human subjects. The study's objective is to determine whether that combination is better than G-CSF alone for enhancing stem cell mobilization. Biothera anticipates completing the enrollment of 56 subjects by the end of the year.

• Dyax Corp., of Cambridge, Mass., completed the double-blind portion of its pivotal Phase III trial, EDEMA3, for DX-88 (ecallantide) in hereditary angioedema. The company also reported that the FDA broadened the fast-track designation for the drug to include all types of acute HAE attacks. The Phase III study enrolled 72 patients and is designed to determine the efficacy of the 30-mg subcutaneous dose of DX-88. Following the double-blind phase, patients will continue treatment in a repeat-dosing phase. DX-88 is partnered with Cambridge, Mass.-based Genzyme Corp.

• Immtech Pharmaceuticals Inc., of New York, said the FDA granted orphan drug status for Pafuramidine (DB289) for pneumocystis jiroveci pneumonia, an opportunistic infection in HIV/AIDS and other immunosuppressed patients. Orphan designation provides financial and regulatory benefits, and could guarantee seven years of marketing exclusivity if Pafuramidine is approved. The drug is in Phase III trials.

• Repligen Corp., of Waltham, Mass., said the FDA granted orphan drug designation to RG1068, synthetic human secretin, for use with magnetic resonance imaging of the pancreas. Orphan drug status would qualify the product for seven years of marketing exclusivity if it's approved. Repligen is in a Phase II/III trial of RG1068 as an agent to improve the detection of structural abnormalities of the pancreatic ducts during MRI imaging, as well as a Phase I study to assess the use of secretin for functional imaging of the pancreas.

• Sosei Group Corp., of Tokyo, said AD 452 failed to meet its primary or secondary endpoints in a Phase IIb trial in rheumatoid arthritis. As a result, Sosei decided to discontinue development of AD 452 in RA and to remove the compound from its priority pipeline. Results of the 308-patient trial, which evaluated the once-daily administration of the drug vs. placebo for a 12-week treatment period, showed that 40 percent of the top dose group of AD 452 achieved ACR20 compared to 32 percent in the placebo with methotrexate background group, missing statistical significant. The compound continued to demonstrate a good safety profile.

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