Gliomark

New Diagnostics for Gliomas

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  • Work packages
  • Clinical evaluation
  • Participating companies
  • Literature
Tab 1
GLIOMARK is segmented into 10 work packages. WP1 contains all regulatory support for preparation/conduct of clinical phases II and III (pivotal validation study), including clinical trial application. WP2-4 cover the phase II, with all preparatory work including training of trial site staff and qualification of all trial sites (WP2), trial conduct (WP3) and analysis (WP4). WP5-7 contain the phase III validation study, with preparatory work including training of trial site staff and qualification of all trial sites (WP5), conduct (WP6) and analysis with subsequent publication (WP7). WP8 comprises establishment of a GMP process and GMP manufacturing. Furthermore, distinct work packages are dedicated to management & administration (WP9), as well as to communication & commercialization (WP10).

The concept of this project was based on the innovative research work by Dr. Andreas Fotopoulos (Professor of Nuclear Medicine, University of Ioannina and University Hospital of Ioannina) and his group over the last decade.
Tab 2
Within the project, 2 clinical studies will be performed. In a phase II study the evaluation of technical and diagnostic performance will be conducted. We foresee this to be implemented in several sites across Europe. Data will be used to decide on optimum L/N cut-off value to be used in phase III study.

Subsequently, a pivotal phase III validation study will be conducted which is blinded, controlled, multi-centered and randomized across Europe. This study serves as the pivotal study for application for EU marketing authorization with EU orphan designation. The relationship between TTF uptake as biomarker for BBB permeability and differential glioma diagnosis, as well as between TTF uptake and histologic glioma grading/aggressiveness will be formally proven.
Tab 3
  • ProActina SA
  • ConsulTech GmbH
Tab 1
Stacks Image 2010
proACTINA SA is a privately owned Small-Medium Enterprise (SME), founded in 2006 as a Contract Research Organization, in Athens-Greece. Currently the company is active in Life Sciences projects with main focus the development of novel diagnostic tools for gliomas (brain tumors). In addition, the company cooperates with Universities and Research Institutes throughout Europe, in the frames of collaborative research programs funded by either national or European sources (see here).

ProACTINA is the main business and innovation driver and will lead all commercialization activities. It has the know-how of manufacturing the diagnostic product to be used in the clinical validation. Furthermore, it retains all rights to the clinical know-how generated so far and will oversee the clinical program.

Tab 2
Stacks Image 2013
ConsulTech (www.consultech.de) is a consulting company founded in 1992. Since then, it has been consulting companies and research institutions in the life-sciences sector in financing their R&D projects. ConsulTech unites expertise from the pharmaceutical industry and biotechnology start-ups with many years of experience in financial and general strategic consulting and in the identification of suitable financing options including venture capital, business angels and public funding.

Furthermore, ConsulTech assist companies of all sizes active in the fields of biotechnology, pharmaceutical development, medical technology and environmental technology by providing a one-stop-access to a network of experts in all areas of pharmaceutical and diagnostic development termed CONELIS (www.conelis.org).

ConsulTech’s tasks in GLIOMARK include financial grant management specifically regarding subcontract management and various activities relating to the implementing the clinical program. Furthermore, ConsulTech will lead the dissemination activities.
Tab 4
Publications relevant to GLIOMARK project have been authored by Prof. A. Fotopoulos who is lead clinical investigator in this project:
 
1. The value of 99mTc-tetrofosmin brain SPECT in predicting survival in patients with glioblastoma multiforme. George A Alexiou, Spyridon Tsiouris, Athanasios P Kyritsis, George Fotakopoulos, Anna Goussia, Spyridon Voulgaris, Andreas D Fotopoulos Journal of Nuclear Medicine 11/2010; 51(12):1923-6. · 5.77 Impact Factor

2. Metabolic Imaging of Brain Tumor by 99mTc-Tetrofosmin Scintitomography (book chapter). Spyridon Tsiouris, George Alexiou, Athanasios Papadopoulos and Andreas Fotopoulos In: “Diagnostic Techniques and Surgical Management of BrainTumors”, Edited by: Ana Lucia Abujamra, ISBN 978-953-307-589-1, Publisher: InTech, Publication date: September 2011

3. Evaluation of brain tumor recurrence by 99mTc-tetrofosmin SPECT: a prospective pilot study. G.A. Alexiou, A.D. Fotopoulos, A. Papadopoulos, A.P. Kyritsis, K.S. Polyzoidis, S. Tsiouris. Ann Nucl Med 21 (2007) 293-298. 1.507 Impact factor

4. Comparison of diffusion tensor, dynamic susceptibility contrast MRI and 99mTc-Tetrofosmin brain SPECT for the detection of recurrent high-grade glioma. Alexiou GA, Zikou A, Tsiouris S, Goussia A, Kosta P, Papadopoulos A, Voulgaris S, Tsekeris P, Kyritsis AP, Fotopoulos AD, Argyropoulou MI. Magn Reson Imaging. 2014 Sep;32(7):854-9. 2.02 Impact factor

5. Characterization of intracranial space-occupying lesions by 99mTc-Tetrofosmin SPECT. A.D. Fotopoulos, A.P. Kyritsis, S. Tsiouris, J. Al-Boucharali, A. Papadopoulos, S. Voulgaris, G.A. Alexiou. J Neurooncol 101 (2011) 83-89. 2.79 Impact factor


A flyer with some general information about all aspects of the project is ready for download
here.