In the Pipeline
• Xcyte Therapies has initiated a Phase I/II clinical trial evaluating the use of its Xcellerated T Cells in patients with hormone-refractory prostate cancer.
• Protein Design Labs has initiated a Phase II clinical study to evaluate its humanized antibody visilizumab (Nuvion) in patients with steroid-resistant, acute graft-versus-host disease, a potentially fatal complication of hematopoietic cell transplantation.
• Versicor has started a Phase II clinical trial with dalbavancin for the treatment of catheter-related bloodstream infections. Dalbavancin is being developed as the first once-weekly treatment for Staphylococcal (Staph) and other serious Gram-positive hospital infections.
• Amylin Pharmaceuticals has initiated the third of three planned Phase III trials of AC2993 (synthetic exendin-4), a compound being studied as a potential treatment for people with Type 2 diabetes. This study will evaluate the ability of AC2993 to improve glucose control in people with Type 2 diabetes who currently are not achieving target blood glucose levels with a combination of metformin and sulfonylureas.
• Isis Pharmaceuticals has initiated a Phase II clinical trial of ISIS 104838, an antisense inhibitor of tumor necrosis factor-alpha (TNF-alpha), in rheumatoid arthritis.
• Keryx Biopharmaceuticals has begun initial dosing of patients in the Phase II clinical trial of the investigational drug candidate sulodexide (KRX-101) for the treatment of Human Immuno-deficiency Virus Associated Nephropathy (HIVAN) in AIDS patients.
• Atrix Laboratories has commenced Phase II clinical trials for a proprietary formulation of a low-dose oral interferon-alpha product for the treatment of oral warts caused by human papilloma virus (HPV) in HIV-infected patients.
• HepaSense, Ltd., a joint venture of Isis Pharmaceuticals and Elan Corporation has initiated a Phase II clinical trial of ISIS 14803 in patients with chronic hepatitis C virus infections.
• Coley Pharmaceutical Group has initiated a multi-center, Phase I clinical study of its lead product candidate, CpG 7909, in combination with Rituxan, an approved monoclonal antibody product. This dose escalation study will assess the safety and tolerability of CpG 7909 in combination with Rituxan in patients with relapsed or refractory non-Hodgkin’s lymphoma.
• Xcyte Therapies has initiated a Phase I/II clinical trial evaluating the use of its Xcellerated T Cells in patients with hormone-refractory prostate cancer.
• Pharmaceuticals has announced that enrollment has begun in a third Phase III clinical trial of INS365 Ophthalmic for dry eye.
• The Sydney Melanoma Unit of The University of Sydney’s Sydney Cancer Centre plans to proceed with a Phase III study of the Delcath drug delivery system for inoperable cancer in the liver, pending approval of the hospital’s Institutional Ethics committee.
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