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Antisense Pharma receives FDA IND authorisation for clinical studies with trabedersen for high-grade glioma The biopharmaceutical company Antisense Pharma announced today that the US-American Food and Drug Administration has issued an Investigational New Drug -authorisation for clinical studies with trabedersen for patients with high-grade glioma. This authorisation entitles the business to include US-American clinics both in the phase III study SAPPHIRE and in additional studies. The purpose of the international, randomised, active-controlled approval study is to verify the promising results obtained in previous studies regarding the efficaciousness and security of the Antisense active component trabedersen on 132 adult patients with recurrent, or refractory high-grade anaplastic astrocytoma . Phase III-Study SAPPHIRE goes to the united states ‘For Antisense Pharma, the issuing of the IND is normally a substantial milestone for the medical development of trabedersen and a precondition to make this therapy open to patients with brain tumors in the United States’ said Dr. Karl-Hermann Schlingensiepen, Chief Executive Officer of Antisense Pharma GmbH. In 2002 both the American and the European health authorities had already assigned trabedersen the status of Orphan-Medication for the treatment of high-grade glioma, which reflects the medical demand in this therapeutic area: Based on the estimates of the the American Cancers Society, over 22,000 malignant tumors of the brain and nervous system were diagnosed during 2009 in the USA alone. Despite significant medical advances, the situation for the treating malignant brain tumors continues to be insufficient: Despite operations, radio and chemotherapy, the tumor recurs in almost all full cases and the patients die within a couple of months. Related StoriesCornell biomedical engineers develop 'super natural killer cells' to destroy malignancy cells in lymph nodesMeat-rich diet may boost kidney malignancy riskFDA grants accelerated acceptance for Tagrisso to take care of individuals with advanced NSCLCTrabedersen fulfills an excellent demand for medical technology ‘Trabedersen could signify a considerable advance in the treatment of malignant brain tumors’stated Prof. Rolando Del Maestro, Director of the Division of Neurosurgery at the Montreal Neurological Institute and Medical center and the international head of the SAPPHIRE Study. In addition to this the data received a lot of attention at the AACR press conference. ‘We notice a great deal of curiosity from the American medical researchers for our innovative therapy concept and the SAPPHIRE study when we present the clinical data for trabedersen’ described Dr. Hubert Heinrichs, Chief Medical Officer of Antisense Pharma. He continuing, ‘We are very pleased that, with the acceptance of the FDA, we are able to meet the lot of interest for our innovative and effective therapy concept and in this way to be able to set up the US-American sites. 16, the amount of antiviral prescriptions dispensed at retail pharmacies was 36 percent greater than the prior week. Over 502,000 prescriptions were filled for Tamiflu in the entire week ending Oct. 16, up 37 percent from just over 367,000 the week before. 16. Antiviral prescriptions have increased each week since the week ending Aug. 21. At 510,110, the quantity of antiviral prescriptions last week is 88 percent greater than at the highest point last season, during the full week ending May 1, when it reached 271,169.

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