• Cardium Therapeutics Inc., of San Diego, and Molecular Medicine BioServices Inc., of Carlsbad, Calif., signed a manufacturing agreement covering the production of Cardium's lead product candidate, Generx, a DNA-based cardiovascular-directed growth factor therapeutic for late-stage clinical development. Financial terms were not disclosed.

• CepTor Corp., of Hunt Valley, Md., said the Office of Orphan Products Development of the FDA granted orphan drug designation for Myodur for both Duchenne's and Becker muscular dystrophies. CepTor's primary efforts are now focused on moving Myodur into Phase I/II trials for Duchenne's muscular dystrophy.

• DOR BioPharma Inc., of Miami, completed the second development milestone for its ricin vaccine, RiVax, under the Challenge Grant awarded in September 2004 by the National Institutes of Health in Bethesda, Md. The company completed the development of a process for large-scale manufacture of the key vaccine ingredient, which consists of a modified ricin toxin subunit protein, and achieved supplementary characterization and formulation objectives.

• EntreMed Inc., of Rockville, Md., started a single-arm, open-label Phase II study with MKC-1 that will be conducted at 15 centers in the U.S. and will enroll patients with advanced or metastatic breast cancer who have failed conventional therapies. MKC-1 is an orally active, small-molecule cell-cycle inhibitor.

• Genaera Corp., of Plymouth Meeting, Pa., said its board named John Armstrong CEO and president. In October, Armstrong was appointed interim CEO and president to begin Jan. 1, 2006. He previously served as CEO of Mills Biopharmaceuticals, a subsidiary of Oklahoma City-based UroCor Inc., and as vice president of business development at UroCor. Genaera has four products in development to treat eye, cancer and respiratory disorders.

• Generex Biotechnology Corp., of Toronto, said interim results of an ongoing trial designed to assess peptide vaccine AE37 in breast cancer patients show that the three patients receiving 100 mg of the vaccine developed peptide-specific responses, as measured by reactivity of their T cells to AE37. That response was observed more quickly in the 500-mg dose group, which showed a proliferative T-cell response 2.7 to 5.7 times the highest levels seen in the 100-mg group. Results also showed the vaccine to be safe and well tolerated. AE37, a second-generation peptide vaccine designed to stimulate an immune response against tumors expressing the HER-2/neu oncogene, is being developed by Generex's wholly owned subsidiary, Antigen Express.

• ImQuest Pharmaceuticals Inc., of Frederick, Md., and Samjin Pharmaceutical Co. Ltd., of Seoul, Korea, formed a strategic drug development alliance. ImQuest will provide preclinical and clinical drug development support for therapeutic small molecules discovered by Samjin. Financial terms were not disclosed.

• Kosan Biosciences Inc., of Hayward, Calif., started a Phase I multicenter trial of an oral formulation of KOS-1022, a second-generation heat-shock protein 90 inhibitor. It is the first-reported Hsp90 inhibitor to be administered orally to patients with cancer, the company said. Intravenous KOS-1022 is in a Phase I trial in patients with hematologic malignancies, as well as multiple Phase I studies sponsored by the National Cancer Institute in patients with advanced solid tumors.

• MorphoSys AG, of Munich, Germany, said its partner, Basel, Switzerland-based F. Hoffmann-La Roche Ltd. filed to begin a European Phase I trial with a HuCAL-derived antibody for treating Alzheimer's disease. The antibody is designed to target abnormal buildups of amyloid beta protein in cerebral tissue. The filing triggered an undisclosed clinical milestone payment from Roche to MorphoSys.

• Nobex Corp., of Research Triangle Park, N.C., said a schedule was approved by the Delaware Bankruptcy Court for conducting an auction of the company's assets. The auction is set for noon on March 16, with the court to approve the highest or best bid on March 20, 2006. Selected assets available for purchase include IN-105, an oral insulin for Type II diabetes; BN-054, a oral B-type natriuretic peptide for cardiovascular disease; and Oratonin, an oral calcitonin in Phase I development for osteoporosis.

• Sangamo BioSciences Inc., of Richmond, Calif., said preclinical efficacy data were published demonstrating the potential use of zinc finger DNA-binding protein transcription factors as a new class of human therapeutics to treat severe late-stage peripheral artery disease. The study, reported in the current issue of the FASEB Journal, was designed to test the efficacy of a ZFP TF engineered to activate the vascular endothelial growth factor gene in a preclinical model of critical limb ischemia (CLI). The strength of the data was an important factor in the company's decision to move the ZFP therapeutic into a human trial in CLI.

• SRI International, of Menlo Park, Calif., and the University of California at San Francisco, received a five-year, $10 million grant from the National Institutes of Health for the Pharmacogenetics of Nicotine Addiction Treatment program.

• Xechem International Inc., of New Brunswick, N.J., said it has closed the $4.2 million settlement of its antitrust lawsuit against New York-based Bristol-Myers Squibb Co. and the net proceeds have been received by Xechem. The lawsuit, filed in federal district court in Chicago in 2003, centered on allegations that Bristol-Myers had engaged in anticompetitive practices relating to Xechem's efforts to manufacture and bring to market the drug paclitaxel, a generic equivalent of Bristol's cancer drug, Taxol. The pharmaceutical company did not admit to any wrongdoing as part of the settlement.

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