The biopharmaceutical company Antisense Pharma announced today that the US-American Food and Drug Administration (FDA) has issued an Investigational New Drug (IND)-authorisation for clinical studies with trabedersen for patients with high-grade glioma. This authorisation entitles the company to include US-American clinics both in the phase III study SAPPHIRE and in further studies. The aim of the international, randomised, active-controlled approval study is to confirm the promising results obtained in previous studies concerning the efficaciousness and safety of the Antisense active ingredient trabedersen on 132 adult patients with recurrent, or refractory high-grade anaplastic astrocytoma (malignant brain tumor, WHO Grade III).
Phase III-Study SAPPHIRE goes to the USA
"For Antisense Pharma, the issuing of the IND is a significant milestone for the clinical development of trabedersen and a precondition for making this therapy available 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 (FDA und EMA) had already assigned trabedersen the status of Orphan-Drug for the treatment of high-grade glioma, which reflects the medical demand in this therapeutic area: According to the estimates of the the American Cancer Society, over 22,000 malignant tumors of the brain and nervous system were diagnosed during 2009 in the USA alone. Despite considerable medical advances, the situation for the treatment of malignant brain tumors (WHO Grad III / IV) is still insufficient: Despite operations, radio and chemotherapy, the tumor recurs in almost all cases and the patients die within a few months.
Trabedersen fulfills a great demand for medical innovation
"Trabedersen could signify a considerable advance in the treatment of malignant brain tumors"said Prof. Rolando Del Maestro, Director of the Division of Neurosurgery at the Montreal Neurological Institute and Hospital and the international head of the SAPPHIRE Study. He continued "The data from the previous studies show that this new, targeted therapy is extremely promising: Patients with recurrent or refractory anaplastic astrocytoma benefited particularly well from treatment with trabedersen and obtained a survival advantage of over 17 months when compared to patients who were treated with standard chemotherapy techniques."
Phase IIb Data already commended in the USA
The great potential of trabedersen has already been honored with a commendation at this year's congress of the American Association for Cancer Research (AACR) in Washington: The abstract of the Phase IIb Study results – the basis for the SAPPHIRE study – was commended as one of the best of the 6,300 abstracts submitted. In addition to this the data received a great deal of attention at the AACR press conference.
"We notice a great deal of interest from the American health professionals for our innovative therapy concept and the SAPPHIRE study when we present the clinical data for trabedersen" explained Dr. Hubert Heinrichs, Chief Medical Officer of Antisense Pharma. He continued, "We are very pleased that, with the approval of the FDA, we are able to meet the great deal of interest for our innovative and effective therapy concept and in this way to be able to start up the US-American sites."