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 Marqibo® (vincristine sulfate injection, OPTISOME™) - A Novel Targeted Anti-Cancer Compound for Non-Hodgkin's Lymphoma and Acute Lymphoblastic Leukemia. We acquired our rights to Marqibo from Inex Pharmaceuticals Corporation in May 2006. Marqibo has been evaluated in 13 clinical trials with over 600 patients, including Phase II clinical trials in patients with NHL and ALL. Based on the results from these studies, we plan to conduct a Phase II, open-label trial in relapsed adult ALL. We also plan to conduct a Phase III first line clinical trial in adults with ALL as a primary registrational trial. This Phase III randomized, multicenter trial will compare Marqibo to vincristine in the induction, consolidation, and maintenance phases of treatment in elderly patients with ALL We plan to conduct this study in collaboration with three major oncology cooperative groups. Pending finalization of the protocol by the cooperative groups, we plan to initiate this study in 2007. Alocrest™ (vinorelbine tartrate injection, OPTISOME™) - A Novel Targeted Anti-Cancer Compound for Breast and Lung Cancer. In August 2006, we initiated a Phase I clinical trial to assess the safety, tolerability and preliminary efficacy of Alocrest in patients with advanced solid tumors, including non-small cell lung and breast cancers. The trial is being conducted at the Cancer Therapy and Research Center in San Antonio, Texas and at McGill University in Montreal. Brakiva™ (topotecan hydrochloride injection, OPTISOME™)- A Novel Targeted Anti-Cancer Compound for Small-Cell Lung Cancer and Ovarian Cancer. Following completion of preclinical development, we expect to file an investigational new drug application, or IND, and to initiate clinical trials in 2007. Kyrbax™ (Menadione) - A Topical Compound for Skin Rashes Associated with EGFR Inhibitors. We acquired the rights to Menadione in October 2006 pursuant to a license agreement with the Albert Einstein School of Medicine. We expect to complete formulation of Menadione by the end of 2007 and to file an IND in 2008. For further information on our product pipeline and/or business development inquiries please contact the Business Development Department. |
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