Drug Criteria & Outcomes
• MedImmune has initiated two Phase II clinical trials for Vitaxin, a development-stage monoclonal antibody. In one trial, the company is evaluating the anti-tumor activity and safety of Vitaxin in patients with metastatic melanoma (skin cancer). In the second trial, MedImmune is studying the effect Vitaxin has on disease activity and the progression of structural joint damage in patients with rheumatoid arthritis (RA). Vitaxin targets the alpha-v-beta-3 integrin.
• Rigel Pharmaceuticals has initiated a multidose safety trial of R112, an experimental drug to treat allergic rhinitis.
• Eximias Pharmaceutical Corp. has initiated a Phase I/II combination trial of nolatrexed dihydrochloride (Thymitaq) with docetaxel (Taxotere), made by Aventis Pharma S.A. The trial will evaluate the safety and efficacy of nolatrexed dihydrochloride plus docetaxel used in combination in cancer patients with advanced solid tumors who have failed prior therapy.
• Sucampo Pharmaceuticals has begun a multicenter, Phase IIa safety and efficacy study for the treatment of cystic fibrosis with its proprietary agent SPI-8811.
• Genmab A/S has initiated a Phase I/II trial using HuMax-EGFr to treat patients suffering from head and neck cancer.
• Idun Pharmaceuticals has announced that the FDA has granted Orphan Drug designation for the use of IDN-6556 to treat patients undergoing liver transplantation and other solid organ transplantations. IDN-6556 is a drug intended to protect hepatocytes from excessive programmed cell death.
• Human Genome Sciences has activated clinical sites and begun to screen patients for randomization and treatment in a Phase II clinical trial of LymphoStat-B (a human monoclonal antibody to B-lymphocyte stimulator), for the treatment of systemic lupus erythematosus.
• GPC Biotech AG has announced that the first patient has been dosed in the satraplatin Phase III registrational trial. The multicenter, global, randomized study has been named SPARC (Satraplatin and Prednisone Against Refractory Cancer) and is evaluating satraplatin plus prednisone vs. prednisone alone as a second-line chemotherapy regimen for treating patients with hormone-refractory prostate cancer.
• The Immune Response Corp. has initiated a Phase II clinical study designed to evaluate the use of Remune, an immune-based therapeutic vaccine, for treatment of HIV-infected patients who have not been treated previously with antiretroviral drugs.
• Abbott Laboratories has expanded its immunology clinical trials program to include an additional Phase III study evaluating the potential of adalimumab (Humira) in Crohn’s disease.
• Nabi Biopharmaceuticals has begun its confirmatory Phase III clinical trial with S. aureus polysaccharide conjugate vaccine (StaphVax). The trial, being conducted with three leading dialysis providers, will encompass approximately 3,000 end-stage renal disease patients on hemodialysis in approximately 200 sites across the United States.
• ArQule has initiated the first human clinical trial with CO-501, a novel investigational small-molecule anti-cancer drug.
• Salmedix has initiated a Phase II/III clinical development program for bendamustine (SDX-105), an anti-cancer agent currently marketed in Germany. The first study in the program, which is designed to support registration of SDX-105 for the treatment of non-Hodgkin’s lymphoma (NHL) in the United States and Canada, is a Phase II trial in patients with relapsed NHL.
• Pharmos Corp. has announced the FDA has granted fast track designation for dexanabinol for treatment of severe traumatic brain injury.
• Abbott Laboratories has announced the expansion of its immunology clinical trials program to include an additional Phase III study evaluating the potential of adalimumab (Humira) in psoriatic arthritis.
• IntraBiotics Pharmaceuticals has enrolled the first patients in a pivotal clinical trial of its lead product, iseganan, in patients receiving mechanical ventilation to reduce the risk of pneumonia.
• Vicuron Pharmaceuticals has initiated a Phase III clinical trial to evaluate the safety and efficacy of the company’s semisynthetic glycopeptide antibiotic, dalbavancin, vs. vancomycin, one of the current standards of care for the treatment of skin and soft-tissue infections.
• Indun Pharmaceuticals has initiated a Phase II clinical trial of IDN-6556 in patients undergoing liver transplantation. IDN-6556 is designed to protect liver cells from excessive programmed cell death, also known as apoptosis.
• Peptimmune has initiated a multicenter Phase I clinical trial to test the safety of PI-0824 in patients with pemphigus vulgaris (PV). PI-0824 is a synthetic novel peptide being developed as immunotherapy for the treatment of PV and is the only investigational therapy in development for treatment of the disease.
• Millennium Pharmaceuticals has initiated a Phase I/II multiple ascending-dose clinical trial of MLN2704 in patients with metastatic androgen-independent prostate cancer. MLN2704 is designed to deliver the maytansinoid chemotherapeutic agent, DM1, directly to prostate cancer cells through a targeted monoclonal antibody vehicle that binds specifically to the prostate-specific membrane antigen.
• Tanox has announced that the FDA has granted fast-track status to TNX-355 for the treatment of patients with human immunodeficiency virus 1 infection who have failed or are failing antiretroviral therapy.
• Pharma has announced that the FDA has granted orphan drug designation to its lead product candidate SAHA, an inhibitor of histone deacetylase, for the treatment of multiple myeloma.
• Millennium Pharmaceuticals has initiated a multicenter Phase II clinical trial of MLN1202 in approximately 30 patients with rheumatoid arthritis. MLN1202, a novel humanized monoclonal antibody, is specifically designed to block the MCP-1/CCR2 chemokine pathway.
• Guilford Pharmaceuticals has completed patient enrollment for a Phase II clinical trial of its novel neuroimmunophilin ligand, GPI 1485, for the treatment of Parkinson’s disease.
• Corus Pharma has initiated a Phase II study of aztreonam formulated for inhalation (Corus 1020) in cystic fibrosis patients to evaluate efficacy, safety, and tolerability.
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