• Advanced Cell Technology Inc., of Worcester, Mass., said data published in the June 2005 issue of Cloning and Stem Cells demonstrated that cloned blood-forming stem cells are capable of long-term multi-lineage engraftment in an aged large animal model. Other findings show that somatic-cell nuclear transfer can be used to generate histocompatible replacement cells that have an increased regenerative capacity. The research was conducted in collaboration by the company and researchers at the Memorial Sloan-Kettering Cancer Center, the Mayo Clinic and the University of Pennsylvania.

• Alexion Pharmaceuticals Inc., of Cheshire, Conn., said that a study shows that patients with paroxysmal nocturnal hemoglobinuria (PNH), who received eculizumab, maintained statistically significant reductions in red blood cell destruction and blood transfusions. The study was published June 28, 2005, in the online issue of Blood and will run in the Oct. 1, 2005, print issue. If approved for PNH, eculizumab would represent the first approved drug from a new class of anti-inflammatory therapeutics-terminal complement inhibitors, as well as the first drug available specifically for patients suffering from the disease.

• Amgen Inc., of Thousand Oaks, Calif., and partner Wyeth Pharmaceuticals, of Madison, N.J., said Phase III data published in the June 2005 issue of the British Journal of Dermatology demonstrate that Enbrel (etanercept) provided psoriasis patients with more rapid improvement and a better response rate at 12 weeks when the highest dose (50 mg twice weekly) was used, compared to a continuous 25-mg twice-weekly dose. Results showed that when the dose was reduced by half at week 12 in the 50-mg group, efficacy was sustained for most patients for the remainder of the 24-week trial.

• Aradigm Corp., of Hayward, Calif., reported positive results from a self-injection study in which healthy na ve users successfully administered sumatriptan via the company's needle-free Intraject system, achieving bioequivalent blood plasma levels to a marketed subcutaneous needle-injected product. The trial is part of Aradigm's effort to develop and launch a needle-free injectable triptan for the treatment of migraine and cluster headaches.

• Cenix BioScience GmbH, of Dresden, Germany, and the Instituto de Medicina Molecular in Lisbon, Portugal, initiated a collaboration to identify human genes required for the malaria infection process, using systematic genome-scale RNAi screening. Financial terms were not disclosed.

• CiVentiChem LLC, of Research Triangle Park, N.C., entered a research and development collaboration with Tranzyme Pharma Inc., also of Research Triangle Park, a company developing mechanism-based therapeutics for the treatment of gastrointestinal disorders. CiVentiChem will provide research services in the areas of medicinal chemistry, custom compound synthesis and process development. CiVentiChem also will provide services to Tranzyme through its subsidiary, Indus Biosciences, of Hyderabad, India.

• Conforma Therapeutics Corp., of San Diego, and Sumitomo Pharmaceuticals Ltd., of Osaka, Japan, reached a licensing agreement for Amrubicin HCl, a third-generation, totally synthetic anthracycline cancer drug. Conforma has obtained exclusive rights, including sublicensing rights, to develop and market Amrubicin in North America and Europe. Amrubicin is approved and marketed in Japan for small-cell and non-small-cell lung cancer. Sumitomo will manufacture the product for worldwide distribution. Financial terms of the agreement were not disclosed.

• EntreMed Inc., of Rockville, Md., said Duke University Medical Center received a grant from the Susan G. Komen Breast Cancer Foundation to study EntreMed's lead compound, 2ME2 (2-methoxyestradiol, or Panzem) in metastatic breast cancer. EntreMed will supply the compound for basic, translational and clinical studies using it in combination with chemotherapeutic agents to determine the effect of 2ME2 on chemotherapy-resistant tumors.

• Eporgen Venture Spa, of Turin, Italy, said it is providing the bulk of private capital for six start-up companies as result of a joint project called Discovery, carried out with Bioindustry Park Canavese SpA. Investments totaled €3 million in private capital and €2.7 million in public money for the new companies - BioNucleon, Biopaint, Eicosamed, Narvalus, Spider Biotech and Target Heart. They are based in the Bioincubator facility, which was created by the Bioindustry Park, and Eporgen holds between 60 percent and 76 percent of each company.

• Keryx Biopharmaceuticals Inc., of New York, initiated a Phase III and Phase IV clinical program with KRX-101 (oral sulodexide gelcap) in diabetic nephropathy. The Phase III study is designed to enroll 1,000 patients and compare 200 mg daily of KRX-101 vs. placebo in patients with persistent microalbuminuria. The Phase IV portion is designed to enroll about 2,200 patients and will compare 200 mg daily of KRX-101 in patients with persistent macroalbuminuria or overt nephropathy. Keryx reached agreement with the FDA earlier this year on a special protocol assessment for the pivotal program. (See BioWorld Today, March 17, 2005.)

• KeyNeurotek AG, of Magdeburg, Germany, a developer of drugs for degenerative disorders of the central nervous system, closed an exclusive license agreement with Bayer Healthcare AG, of Leverkusen, Germany. KeyNeurotek will proceed with the further clinical development and marketing of Bayer's compound Bay 38-7271 for traumatic brain injury.

• MannKind Corp., of Valencia, Calif., initiated patient enrollment in the pivotal Phase III trial of inhaled Technosphere Insulin in the U.S. The open-label, randomized, prospective study will evaluate the pulmonary safety of TI in patients with Type I and Type II diabetes. That is the second Phase III trial of inhaled Technosphere Insulin following the beginning of MannKind's initial Phase III efficacy study in Europe in late 2004.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., named Deborah Dunsire, head of Novartis Pharmaceuticals Corp.'s North American oncology operations, president and CEO of Millennium. Dunsire also will be elected to the company's board and will succeed Mark Levin, co-founder since the company's inception. She will assume her duties by Aug. 1.

• Pozen Inc., of Chapel Hill, N.C., said the FDA set Aug. 4 as the date for its meeting with the Peripheral and Central Nervous System Drugs Advisory Committee, which is expected to review the potential occurrence of tardive dyskinesia, an involuntary neurological movement disorder, with the use of Pozen's migraine treatment, MT 100. The drug received a not-approvable letter a year ago after failing to show superiority over naproxen for sustained pain relief. The FDA also raised issues related to the risk of tardive dyskinesia. (See BioWorld Today, June 2, 2004.)

• PTC Therapeutics Inc., of South Plainfield, N.J., said complete Phase I and II data reported at the European Cystic Fibrosis Conference in Crete confirmed that PTC124 is generally well tolerated and achieves target plasma concentrations that have been associated with activity in preclinical models. Also, to demonstrate specificity of the oral drug's effects, additional tests revealed no evidence of undesirable, nonspecific read-through of normal stop codons.

• Xechem International Inc., of New Brunswick, N.J., completed the sale of the majority of its interest in CepTor Corp., of Hunt Valley, Md., in a transaction with CepTor that resulted in cash proceeds to Xechem of $2.3 million. Xechem is engaged in the research, development and production of niche generic and proprietary drugs from natural sources.

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