In the Pipeline

• Delex Therapeutics has dosed the first patients in the company’s Phase II clinical trial of aerosolized liposome encapsulated fentanyl (AeroLEF) in post-surgical patients. The objective of this study is to confirm the analgesic effects of aerosolized liposome encapsulated fentanyl in adult patients experiencing moderate-to-severe pain following arthroscopic anterior cruciate ligament surgery reconstruction.

• Nabi Biopharmaceuticals has announced that the FDA has determined that the company’s investigational product, Staphylococcus aureus Immune Globulin (Human) (Altastaph) for immediate protection against S. aureus infections in neonates, has received a fast-track designation. 

• Kosan Biosciences has announced the start of a Phase Ib clinical trial to evaluate KOS-862 (Epothilone D) as an anticancer therapy in combination with gemcitabine HCl (Gemzar) in patients with advanced solid tumors.

• Transkaryotic Therapies has announced that its clinical trial evaluating iduronate-2-sulfatase (I2S) has completed patient enrollment. I2S is TKT’s investigational enzyme replacement therapy for the treatment of Hunter syndrome (MPS II).

• Inhibitex has begun enrollment in a Phase II clinical trial for Aurexis, a humanized monoclonal antibody being developed as a first-line therapy, in combination with standard of care antibiotics, for S. aureus bloodstream infections in hospitalized patients

• Vion Pharmaceuticals has received fast-track designation from the FDA for VNP40101M (Cloretazine) in relapsed or refractory acute myeloid leukemia.

• Micromet AG has initiated a randomized, open-label, international, Phase II trial to investigate the efficacy and safety of fully human antibody MT201 for the treatment of breast cancer patients who experienced a metastatic relapse.

• Threshold Pharmaceuticals has begun a Phase I clinical trial of 2-deoxy-D-glucose (2-DG). 2-DG selectively targets the slow-growing but highly metastatic cells within the poorly vascularized zones of solid tumors

• Amicus Therapeutics has announced that the FDA has granted orphan-drug status for the company’s first clinical candidate, AT1001, for the treatment of Fabry disease.

• EntreMed has announced that a new formulation of 2-Methoxyestradiol, 2ME2 (Panzem) currently is being evaluated in a Phase I clinical trial. 2-Methoxyestradiol, 2ME2 has been tested in cancer patients as a single agent, as well as in combination with chemotherapeutics.

• NeuroMed Technologies has initiated Phase I clinical testing for its lead drug candidate, NMED-160 (a calcium channel blocker) for chronic pain.

• Panacos Pharmaceuticals has begun a Phase I clinical trial of its small molecule HIV drug candidate PA-457

• Pharmos Corp. has completed patient enrollment in its Phase III study of dexanabinol for the treatment of severe traumatic brain injury.

• Targeted Genetics has initiated a Phase I clinical trial of its product candidate, tgAAC94, in patients with rheumatoid arthritis.

• Genmab A/S announced that HuMax-CD4, an antibody that targets the CD4 receptor on T-lymphocytes, has been designated a fast-track product by the FDA. This designation covers patients with cutaneous T-cell lymphoma who have failed currently available therapy.