Drug Criteria & Outcomes: In The Pipeline
• Amylin Pharmaceuticals has begun a Phase III trial of synthetic exendin-4 (AC2993). 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 metformin alone.
• GPC Biotech AG has announced that the FDA has granted Orphan Drug Designation for its Phase II clinical compound Bryostatin-1 in combination with Taxol for the treatment of esophageal cancer.
• Genmab A/S has received permission from the FDA to begin a Phase III study with HuMax(TM)-CD4 to treat patients with active rheumatoid arthritis (RA) who have failed to respond to treatment with methotrexate and TNF-alpha blocking agents.
• Elan Corporation, plc has enrolled and dosed the first patients in their multicenter Phase III clinical trials of natalizumab (Antegren) in multiple sclerosis.
• Transgene has begun a Phase II clinical trial of its immunotherapeutic MVA-HPV-IL2 vaccine candidate for the treatment of vulvar intra-epithelial neoplasia (VIN3). The trial will be conducted in France and will include up to 30 women with VIN3.
• Antex Biologics has begun a Phase I human clinical trial for the second component of its combination ACTIVAX vaccine to prevent travelers’ diseases caused by the consumption of contaminated food and water. The trial, to be carried out at the Johns Hopkins University Vaccine Testing Unit in Baltimore, is designed to test the safety and immunogenicity of a vaccine against Shigella sonnei infection.
• AtheroGenics has begun a Phase IIb clinical trial, the Canadian Antioxidant Restenosis Trial-2 (CART-2), of its proprietary v-protectant drug, AGI-1067, for the treatment of restenosis and atherosclerosis.
• Neurocrine Biosciences and Taisho Pharmaceutical Co., Ltd. have initiated the first Phase IIb clinical trial of NBI-6024, a therapeutic vaccine, in approximately 400 adult and adolescent patients with new onset Type 1 diabetes. A second Phase IIb trial is planned to begin during 2002.
• BioCryst Pharmaceuticals has announced that patient enrollment has begun in a Phase III trial with once-a-day orally administered peramivir (RWJ-270201), BioCryst’s influenza neuraminidase inhibitor. The objective of the trial is to assess the efficacy and safety of peramivir for the treatment of acute influenza A and influenza B infections in otherwise healthy adults.
• Emisphere Technologies has announced that enrollment for the PROTECT Trial has been completed. The PROTECT Trial is investigating an oral heparin solution formulation for the prevention of deep vein thrombosis (DVT) following total hip replacement surgery.
• Versicor began a Phase III clinical trial with the novel investigational agent, anidulafungin, in an additional indication: the treatment of invasive aspergillosis. Alexion Pharmaceuticals has commenced enrollment in the Phase III clinical trial of pexelizumab in patients undergoing coronary artery bypass graft surgery with cardiopulmonary bypass.
• Human Genome Sciences has announced that the FDA has approved its Investigational New Drug application to begin clinical trials of Albuleukin, a novel recombinant human protein, for treatment of certain types of cancer.
• Life Medical Sciences has received approval from the FDA to conduct a multi-center, feasibility clinical trial on its REPEL-CV bioresorbable adhesion barrier. REPEL-CV is designed to reduce the formation of adhesions on the surface of the heart after open heart surgery.
• InterMune has received Fast Track Designation from the FDA for Interferon gamma-1b (Actimmune) injection for the treatment of idiopathic pulmonary fibrosis, a debilitating and usually fatal disease for which there is no effective therapy.
• Millennium Pharmaceuticals has begun multiple Phase I clinical trials of MLN341 (formerly LDP-341, PS-341), in combination with docetaxel (Taxotere) for Injection Concentrate, Aventis Pharmaceuticals’ chemotherapy agent used in the treatment of some breast and lung cancers.
• AstraZeneca filed a supplemental New Drug Application with the FDA for its oral, once-daily hormonal medication bicalutamide (Casodex) for the treatment of early-stage non-metastatic prostate cancer.
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