Talecris Biotherapeutics Names Inaugural Talents Grant Recipients.Program Funds Basic and Clinical Research Programs Involving Intravenous Immunoglobulin Therapies RESEARCH TRIANGLE PARK Research Triangle Park, research, business, medical, and educational complex situated in central North Carolina. It has an area of 6,900 acres (2,795 hectares) and is 8 × 2 mi (13 × 3 km) in size. Named for the triangle formed by Duke Univ. , N.C. -- Seven scientific investigators and clinicians from research institutions around the world are the first recipients of the Talents Awards initiated by Talecris Biotherapeutics, Inc. The awarded grants support investigator-initiated trials conceived by researchers and clinicians with an interest in intravenous immunoglobulin (IGIV) therapies. Talents (Talecris New Trials Support) is designed to further advance research that addresses the use of IGIV in antibody replacement as well as immune modulation therapies. Talecris produces and markets Gamunex([R]) (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified), a leading IGIV therapy. The seven 2006 winners represent three countries including the United States, Canada, and the United Kingdom. "When we announced this program in May, we committed $1 million yearly to support external basic science and clinical research projects complementary to our own innovative in-house research," said Alberto Martinez, M.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Talecris Biotherapeutics. "The Talents program is an important source of research funding for the IGIV community, and another opportunity for Talecris to demonstrate our ongoing commitment to further advancing knowledge and insights leading to improved patient outcomes." The inaugural Talent grants will fund a variety of studies ranging from basic cellular mechanisms by which IGIV mediates immune response, to a multicenter clinical registry to establish the efficacy of IGIV in patients with chronic inflammatory demyelinating polyneuropathy Chronic inflammatory demyelinating polyneuropathy (CIDP) is an acquired immune-mediated inflammatory disorder of the peripheral nervous system but often can have central nervous system involvement. The disorder is sometimes called chronic relapsing polyneuropathy. (CIDP) who do not meet normal diagnostic criteria. Investigators receiving this year's Talents grants are: Dr. Regine Mydlarski, University of Calgary, Calgary, Canada: "A randomized double-blind, placebo controlled trial to assess the safety and efficacy of intravenous immunoglobulin in the treatment of pemphigus vulgaris." Dr. Melvin Berger, Children's Research Foundation of Cleveland, Cleveland, Ohio: "Subcutaneous versus intravenous immune globulin intravenous immune globulin A formulation of concentrated antibodies–aka immune globulins, predominantly IgG, prepared by pooling plasma from ±1000 donors, with a broad spectrum of activity against CMV, HAV, HBV, measles, rubella, tetanus, varicella treatment in animal models of neuromuscular disease." Dr. Andreas Goebel, Department of Clinical Neurology, University of Oxford, Oxford, United Kingdom: "Intravenous immunoglobulin in the treatment of primary trigeminal neuralgia refractory to carbamazepine carbamazepine /car·ba·maz·e·pine/ (kahr?bah-maz´e-pen) an anticonvulsant and analgesic used in the treatment of pain associated with trigeminal neuralgia and in epilepsy manifested by certain types of seizures. (IGIV in TN)." Dr. David Scott Saperstein, Phoenix Neurological Associates, Phoenix, Arizona: "Database of immune-mediated neuropathy treatment outcomes." Dr. Frederick Goldman, University of Iowa Hospitals and Clinics The University of Iowa Hospitals and Clinics (UIHC) is a 762-bed public teaching hospital and level 1 trauma center affiliated with the University of Iowa. UIHC is part of University of Iowa Health Care, a partnership between the University of Iowa Roy J. and Lucille A. , Iowa City, Iowa Iowa City is a city in Johnson County, Iowa, United States. It is the principal city of the Iowa City, Iowa Metropolitan Statistical Area which encompasses Johnson and Washington counties. : "Immunomodulatory properties of IGIV in developing immune systems post hematopoietic stem cell Hematopoietic stem cell A cell that can develop into any type of specialized blood cell. Mentioned in: Umbilical Cord Blood Banking transplant." Dr. Mieko Toyoda, Transplant Immunology Laboratory, Cedars-Sinai Medical Center Cedars-Sinai Medical Center is a world-renowned hospital located in Los Angeles, California. History Cedars-Sinai is the result of a merger in 1961 between two major Los Angeles hospitals, Cedars of Lebanon and Mount Sinai Home for the Incurables, with Steve Broidy as , Los Angeles, California: "Development of novel assays to monitor human B-cell responses to alloantigens in patients undergoing desensitization desensitization or hyposensitization Treatment to eliminate allergic reactions (see allergy) by injecting increasing strengths of purified extracts of the substance that causes the reaction. with IVIG IVIG Intravenous immunoglobulin, see there . Relationship to antibody mediated rejection and responses to IVIG therapy." Dr. Vera Bril, University Health Network, University of Toronto Research at the University of Toronto has been responsible for the world's first electronic heart pacemaker, artificial larynx, single-lung transplant, nerve transplant, artificial pancreas, chemical laser, G-suit, the first practical electron microscope, the first cloning of T-cells, , Toronto, Ontario, Canada: "A randomized trial of plasma exchange compared with IVIG in the treatment of Myasthenia Gravis myasthenia gravis (mīəsthē`nēə grä`vĭs), chronic disorder of the muscles characterized by weakness and a tendency to tire easily. ." The Talents Evaluation Committee, comprised of experts in neurology, immunology, and hematology, as well as Talecris scientists, received more than 50 letters of intent in its inaugural year. "We were extremely impressed with the quality of the grant submissions," said Rene McRogers, Deputy Director of Scientific Relations and Communications and Talents Program Chair at Talecris Biotherapeutics. "We look forward to the results that will come from these research projects and the impact they will have to increase our understanding of disease processes and clinical care." Disbursements of grants will begin in early January, 2007. Talecris will begin accepting letters of intent for the 2007 awards in August, 2007. All information about the program, including how to apply, is available on the Talents Web site, www.talecristalents.com. About Gamunex([R]) Gamunex([R]) is a lifesaving IGIV therapy that contains antibodies purified from the donated blood plasma of thousands of people and is used to treat a variety of health problems, both as a means of immune replacement and for modulating the immune system. Gamunex([R]) is indicated as replacement therapy of primary humoral immunodeficiency disease (PI) and as immunomodulatory therapy for idiopathic thrombocytopenic purpura Idiopathic Thrombocytopenic Purpura Definition Idiopathic thrombocytopenic purpura, or ITP, is a bleeding disorder caused by an abnormally low level of platelets in the patient's blood. (ITP). Important Safety Information Gamunex([R]) is contraindicated in individuals with known anaphylactic or severe systemic response to Immune Globulin (Human). Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure acute renal failure Acute kidney failure Nephrology An abrupt decline in renal function, triggered by various processes–eg, sepsis, shock, trauma, kidney stones, drug toxicity-aspirin, lithium, substances of abuse, toxins, iodinated radiocontrast. , osmotic nephrosis nephrosis (nəfrō`səs), kidney disease characterized by lesions of the epithelial lining of the renal tubules, resulting in marked disturbance in the filtration function and the consequent appearance of large amounts of protein (albumin) and death. Patients should be instructed to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath Shortness of Breath Definition Shortness of breath, or dyspnea, is a feeling of difficult or labored breathing that is out of proportion to the patient's level of physical activity. (which may suggest kidney damage) to their physicians. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Gamunex([R])does not contain sucrose. Glycine, a natural amino acid, is used as a stabilizer. There have been reports of noncardiogenic pulmonary edema, rare reports of hemolytic anemia, and very rare reports of aseptic meningitis in patients administered with IGIV. Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. The most common side effects noted during clinical trials included headache, vomiting, fever, nausea, rash, and back pain. As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated. For additional information on Gamunex([R]), please see Full Prescribing Information at www.gamunex.com. About Talecris Biotherapeutics: Inspiration. Dedication. Innovation. Talecris Biotherapeutics is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology pul·mo·nol·o·gy n. The branch of medicine that deals with diseases of the respiratory system. pulmonology The study of the lungs and respiratory function , and hemostasis. Talecris is proudly building upon a 60-year legacy of innovation and a commitment to improving the lives of people who rely on its therapeutic products. With an emphasis on scientific inquiry and technological excellence, Talecris is expanding its current portfolio of products, programs, and services through its own world-class product development organization as well as through strategic initiatives that leverage its strengths with those of its partners. Talecris, which earned revenues exceeding $1 billion through the year ending June 30, 2006, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 3,000 talented people worldwide. To learn more about Talecris and how our employees are making a difference in the lives of patients and the healthcare community, visit www.talecris.com or www.talecrisplasma.com. |
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