Drug Criteria & Outcomes: In the Pipeline
Drug Criteria & Outcomes: In the Pipeline
• Protarga is proceeding with two separate Phase III clinical studies of its new cancer drug, DHA-paclitaxel (Taxoprexin Injection), for the treatment of metastatic melanoma and pancreatic cancer.
• QLT has announced that the Food and Drug Administration (FDA) has granted fast track review status to tariquidar (XR 9576) for the treatment of multi-drug resistance in first-line treatment of non-small cell lung cancer patients.
• Icagen has received notification from the FDA that ICA-17043, currently in Phase II clinical trials for the treatment of sickle cell anemia, has received fast track designation.
• Cell Therapeutics has initiated its polyglutamate paclitaxel (Xyotax) Phase III non-small cell lung cancer trial at 20 centers in the United States and anticipates having more than 100 centers initiated by the end of 2002.
• Abbott Laboratories has initiated a study to make its investigational medication, adalimumab (D2E7), available to rheumatoid arthritis patients.
• Vion Pharmaceuticals has initiated a Phase II trial of Triapine, a ribonucleotide reductase inhibitor, as a single agent in patients with recurrent or metastatic squamous cell cancer of the head and neck.
• QLT and Novartis Ophthalmics have started enrolling patients in two Phase III clinical trials using photodynamic therapy with verteporfin (Visudyne) for the treatment of multiple basal cell carcinoma.
• Roche and Trimeris’ New Drug Application for enfuvirtide (Fuzeon, T-20) has been granted priority review status by the FDA. Enfuvirtide is designed for the treatment of HIV-1 in combination with other antiretroviral agents.
• DynPort Vaccine Co. LLC will enter into a Phase I clinical trial consisting for a new, injectable recombinant anthrax vaccine. The vaccine consists of a highly purified protein, protective antigen.
• Genaera Corp. has received regulatory approval from the Irish Medicines Board to begin a Phase II clinical trial for Lomucin, its oral mucoregulator treatment, in people with cystic fibrosis.
• Celgene Corp. has advanced its lead JNK (c-Jun N-terminal Kinase) inhibitor, CC-401, into clinical testing. Following the completion of a Phase I trial, Celgene will evaluate CC-401 as a potential therapy of acute immunological indications.
• ILEX Oncology has launched the first combination therapy clinical trial involving the investigational anticancer agent clofarabine, a second-generation nucleoside analogue. The study is a Phase I/II trial of clofarabine in combination with the chemotherapy drug ara-C (cytarabine) in adults with a spectrum of hematologic malignancies.
• InterMune has completed patient enrollment in a second multi-center global Phase III trial of oritavancin for the treatment of complicated skin and skin structure infections. Oritavancin is InterMune’s second-generation glycopeptide antibiotic to treat gram-positive bacterial infections.
• AEterna Laboratories announced that the FDA has granted orphan-drug status to its lead product, Neovastat, antiangiogenic components extracted from marine cartilage for the treatment of renal cell carcinoma.
• Ribapharm will commence Phase II clinical trials of viramidine in the treatment of chronic hepatitis C by the end of 2002.
• Genta, in collaboration with Aventis, has initiated a new clinical trial that uses its lead anticancer drug, Bcl-2 Antisense (Genasense), in combination with rituximab (Rituxan), in patients with recurrent non-Hodgkin’s lymphoma.
• Corvas International has announced the commencement of a multi-center, Phase II clinical program to investigate the safety and efficacy of its proprietary anticoagulant, recombinant nematode anticoagulant protein c2, in patients with acute coronary syndromes, which include unstable angina and non-ST-segment elevation myocardial infarction.
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