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• NeoOncoRx will begin a Phase II study of its anticancer compound Neoquin in the United Kingdom by year-end. The principal investigator for the study will be Roger M. Philips, MD, of the Cancer Research Unit at the University of Bradford in England. A peer-reviewed article on the potential for Neoquin in treating bladder cancer, authored by Dr. Philips, has been accepted for publication by the British Journal of Cancer and is expected to be published soon.
• Texas Biotechnology Corp. has announced that the FDA has issued an approvable letter for a supplemental New Drug Application (sNDA) for Argatroban. This sNDA further expands the treatable patient population to include patients who have or who are at risk of developing thrombosis associated with heparin-induced thrombocytopenia (HIT) and are undergoing percutaneous coronary intervention (PCI). The sNDA defines dosing guidelines for the use of Argatrogan during PCI in such patients.
• Researchers at New York University (NYU) Medical Center have begun a trial to study the efficacy of an investigational oral treatment OGT-918 (Vevesca) for Type 1 Gaucher disease. The study is being conducted in the Gaucher clinic at NYU.
OGT-918 works by inhibiting the production of the lipids associated with the disease. It has been studied in a total of 80 patients, both in combination with ERT and as monotherapy. Oxford GlycoSciences Plc, the developer of the drug, will submit the study data to the FDA for marketing approval this year. The drug has received "fast track" status from the FDA to expedite its review.
• BTG has started a Phase I clinical study to test AQ4N, a new drug designed to increase the effectiveness of several widely used anticancer drugs, as well as radiotherapy. This study should provide a foundation for further trials of the efficacy of AQ4N in a range of tumor types when given with radiotherapy or with cancer chemotherapeutics. The main objectives of the trial are: to establish the maximum tolerated dose of AQ4N either given alone intravenously or in combination with radiotherapy; to determine the toxicity profile of AQ4N and identify the dose-limiting toxicity; and to establish a safe dose for Phase II evaluation.
• Immunex Corp. has filed a fourth supplemental biologics license application (sBLA) with the FDA for etanercept (Enbrel). The filing requests approval for reducing signs and symptoms of psoriatic arthritis, including use with or without methotrexate. It will be the first product ever reviewed by the FDA to treat this disease.
• Immunex Corp. has filed an investigational new drug application (IND) with the FDA to begin Phase 1 clinical studies with Interleukin-1 (IL-1) Receptor Type II to assess tolerability. Phase 1 studies will be initiated in patients with rheumatoid arthritis. Single- and multiple-dosing schedules will be evaluated. Results of the studies are expected mid-2002.
• Ribozyme Pharmaceuticals and Chiron Corp. have announced treatment of the first patient in a Phase II clinical trial evaluating the safety and efficacy of the ribozyme anti-angiogenic drug Angiozyme in patients with metastatic colorectal cancer. This study of Angiozyme in combination with standard therapy is the second Phase II clinical trial that is investigating the clinical activity of Angiozyme in metastatic solid tumors.
• Metabolex has begun treating subjects with its lead investigational drug, MBX-102, in a Phase I human clinical trial for patients with diabetes.
• Medinox has begun a Phase I/IIa clinical trial, designed to evaluate the safety, tolerability, and preliminary efficacy of NOX-100 in sepsis patients. The trial is being conducted at Stanford University and at the University of Pittsburgh Medical Center and will take about one year to complete.
• OSI Pharmaceuticals has initiated a Phase III clinical trial evaluating the use of OSI-774 (Tarceva) in combination with carboplatin (Paraplatin) and paclitaxel (Taxol) for non-small cell lung cancer (NSCLC). The multi-center, 1,000-patient study is one of two randomized, controlled Phase III trials in NSCLC to be conducted by the OSI/Genentech/Roche alliance that will assess the value of adding Tarceva to two of the most commonly used front-line combination chemotherapy regimens for NSCLC. The study has improvement in duration of patient survival as the primary endpoint.