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• Novartis has submitted an application to the Food and Drug Administration (FDA), seeking marketing authorization for zoledronic acid for injection (Zometa) in the treatment of bone metastases associated with a broad range of tumor types. These include prostate and lung cancer, for which no bisphosphonate therapy currently is approved, as well as breast cancer and multiple myeloma. Zometa is a new generation intravenous bisphosphonate that received FDA approval on Aug. 20 for the treatment of hypercalcemia of malignancy (HCM). Novartis has received marketing clearances for Zometa in the treatment of HCM in more than 30 countries.
• Repligen Corp. announced that the FDA has granted fast-track designation for secretin for the treatment of pediatric autism. In April, Repligen completed a Phase II clinical trial that evaluated three doses of secretin or a placebo in 126 children, 3-6 years of age, with moderate-to-severe symptoms of autism and reported gastrointestinal symptoms.
• NeoTherapeutics has added four additional clinical trial locations to its Neotrofin Phase II Parkinson’s disease trial. New participants include Memorial Hospital of Rhode Island (Providence), Rush Presbyterian-St. Luke’s Medical Center (Chicago), The Parkinson’s Institute (Sunnyvale, CA), and Oregon Health & Science University (Portland). Ten patients currently are receiving either Neotrofin or placebo, including seven patients at the Parkinson’s and Movement Disorder Institute at Long Beach (CA) Memorial Hospital. Patients in this trial will receive doses of Neotrofin escalating from 250 mg to 1,000 mg twice per day for 12 weeks.
• AstraZeneca has initiated a clinical trial to examine the ability of the beta-blocker metoprolol succinate (TOPROL-XL) extended-release tablets to reverse the cardiac remodeling associated with left ventricular (LV) systolic dysfunction. REVERT (Reversal of Ventricular Remodeling with TOPROL-XL) will involve some 300 patients diagnosed with asymptomatic heart failure (NYHA Class I) who have a reduced ejection fraction of less than 40%. The study will be conducted at 45 centers across the United States. TOPROL-XL recently was approved by the FDA for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive or cardiomyopathic etiology.
• OraPharma has started a Phase I clinical trial of OC-1012 for the prevention of mucositis, following the FDA’s recent clearance of the Investigational New Drug (IND) application for this agent. In the double-blind, placebo- controlled trial, OC-1012 will be administered to patients undergoing bone marrow transplants at the University of Washington, Fred Hutchinson Cancer Research Center.
• Ribozyme Pharmaceuticals Inc. (RPI) has started a new Phase I clinical trial relating to the safety and pharmacokinetics of its compound HERZYME, an anti-Human Epidermal growth factor Receptor type 2 (HER2) ribozyme being developed through RPI’s collaboration with Elan Corp. (Medizyme Pharmaceuticals Ltd.). Elan and RPI plan to develop HERZYME for treatment of breast and ovarian cancer in conjunction with Elan’s proprietary MEDIPAD Drug Delivery system.
• Adolor Corp. has dosed the first group of normal volunteers in a Phase I clinical trial of ADL 10-0116, an orally available peripherally restricted kappa opioid receptor agonist designed to relieve inflammatory pain associated with acute and chronic inflammatory diseases, such as rheumatoid arthritis. This Phase I study will assess the compound’s safety. ADL 10-0116 is the second in a series of kappa agonists that Adolor is evaluating in clinical trials.
• Keryx Biopharmaceuticals announced that the FDA has designated its compound, sulodexide (KRX- 101) for the treatment of diabetic nephropathy, as a fast-track product. The company is discussing with the FDA preparations to initiate a Phase III study.
• Cubist Pharmaceuticals has completed patient enrollment in the first of two Phase III trials investigating the safety and efficacy of daptomycin for injection (Cidecin) in the treatment of community-acquired pneumonia requiring hospitalization. This first study (CAP1), which is an international, randomized, prospective, double-blind study, has 729 enrolled patients.
• Immunex Corp. and Wyeth-Ayerst Laboratories will sponsor a 10,000-patient rheumatoid arthritis study. The Rheumatoid Arthritis DMARD Intervention and Utilization Study (RADIUS) is designed to gain more comprehensive knowledge regarding current treatment for the disease.
• RxKinetix has initiated a Phase IB trial with its first lead drug candidate, RK-0202, in treatment of oral mucositis. The study, which is being conducted under its collaboration with Elan Corp., will enroll a small number of patients at two major U.S. transplant centers and is designed to assess the safety and tolerability of the compound and finalize the formulation.
• MedImmune has begun dosing rheumatoid arthritis patients with the antibody Vitaxin in a Phase I clinical trial. The randomized, double-blind, placebo-controlled, dose-escalation trial will be conducted at eight U.S. and Canadian sites.
• Pharmacyclics has completed patient enrollment in a Phase II clinical trial to evaluate its lead investigational product, motexafin gadolinium (Xcytrin) for the potential treatment of glioblasoma mulltiforme (GBM). Twenty-four newly diagnosed GBM patients were enrolled at eight leading medical centers in this single-arm study designed to evaluate the safety and pharmacokinetics of a six-week treatment course of Xcytrin combined with a standard six-week course of radiation therapy.
• Neurobiological Technologies announced that Forest Laboratories is conducting a second large-scale, multicenter, double-blind, placebo-controlled trial to assess the safety and efficacy of Memantine in the treatment of diabetic neuropathy.
• Tanox has opened enrollment in a Phase I clinical trial of a monoclonal antibody TNX-355 (formerly known as Hu5A8) being developed for a new approach to the treatment of HIV. The dose-escalation study will evaluate the safety and tolerability of single intravenous infusions of TNX-355 in patients infected with HIV who have failed two courses of a highly active anti-retroviral therapy (HAART).