Molecular Insight Pharmaceuticals, Inc. Initiates Azedra(TM) Phase 1 Clinical Trial for Treatment of Neuroendocrine Cancer; Orphan Drug Targeted Radiotherapeutic Candidate Also Receives Fast Track Status.CAMBRIDGE, Mass. -- Molecular Insight Pharmaceuticals announced today that it has initiated a Phase 1 clinical trial phase 1 clinical trial Phase 1 study. See Phase study. for its lead oncology candidate, Azedra(TM) (Ultratrace(TM) iobenguane I 131, formerly known as Ultratrace MIBG MIBG Metaiodobenzylguanidine ) for the treatment of neuroendocrine tumors such as carcinoid carcinoid /car·ci·noid/ (kahr´si-noid) a yellow circumscribed tumor arising from enterochromaffin cells, usually in the gastrointestinal tract; the term is sometimes used to refer specifically to the gastrointestinal tumor , pheochromocytoma Pheochromocytoma Definition Pheochromocytoma is a tumor of special cells (called chromaffin cells), most often found in the middle of the adrenal gland. and neuroblastoma Neuroblastoma Definition Neuroblastoma is a type of cancer that usually originates either in the tissues of the adrenal gland or in the ganglia of the abdomen or in the ganglia of the nervous system. . The company also announced that the U.S. Food and Drug Adminstration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) granted Fast Track status to Azedra. As previously announced, the compound was recently granted Orphan Drug status by the FDA. The Phase 1 dosimetry dosimetry /do·sim·e·try/ (do-sim´e-tre) scientific determination of amount, rate, and distribution of radiation emitted from a source of ionizing radiation, in biological d. trial is designed to evaluate the safety, tolerability and distribution of Azedra in adult patients with one of two forms of neuroendocrine neuroendocrine /neu·ro·en·do·crine/ (-en´do-krin) pertaining to neural and endocrine influence, and particularly to the interaction between the nervous and endocrine systems. neu·ro·en·do·crine adj. cancer - either carcinoid or pheochromocytoma. Azedra recognizes unique molecular targets expressed by certain neuroendocrine cancers which enable the drug to be accumulated in the tumor. Azedra, developed using Molecular Insight's proprietary Ultratrace technology, is designed to maximize the delivery of radiolabeled MIBG molecules to targeted neuroendocrine tumors to effectively enable safe and effective diagnosis and treatment while minimizing the amount of non-radioactive MIBG molecules that are delivered to the patient. The study is being conducted at Duke University, Durham, NC, and is planned to include a limited number of adult patients for either pheochromocytoma or carcinoid. A trial for the treatment of neuroblastoma, a cancer that primarily affects children, is also planned, pending preliminary assessment of the safety and distribution of Azedra in adults and input from the FDA. The Fast Track program, established under the FDA Modernization Act of 1997, provides for expedited regulatory review for investigational drugs demonstrating the potential to address unmet medical needs for the treatment of serious or life-threatening conditions. Under the program, FDA will facilitate and expedite the development and review of Molecular Insight's application for the approval of the product. About Molecular Insight Pharmaceuticals, Inc. Molecular Insight Pharmaceuticals is a biopharmaceutical company focused on the research, development and commercialization of innovative molecular imaging pharmaceuticals and targeted radiotherapeutics. The company's product candidates target markets with significant unmet needs in cardiology, oncology, and neurology. Molecular Insight's lead cardiology product candidate, Zemiva(TM) (iodofiltic acid I 123) is in development as a molecular imaging pharmaceutical for the diagnosis of insufficient blood flow to the heart, or cardiac ischemia. The company's second lead product candidate, Azedra, is in development for the diagnosis and treatment of neuroendocrine tumors. Molecular Insight Pharmaceuticals is based in Cambridge, Massachusetts. The company's website is: www.molecularinsight.com. |
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