proACTINA SA, on behalf of the GLIOMARK consortium, is delighted to announce that the Gliomark1 Phase II clinical study has been successfully completed.
Gliomark1: Phase II exploratory study assessing the technical performance of 99mTc-tetrofosmin for the differentiation of tumour recurrence vs. radiation-necrosis in patients with high grade brain tumours following initial treatment (EudraCT No.: 2015-005573-21, ClinicalTrials.gov ID: NCT02971319).
Sponsor: ProACTINA SA
The study, conducted in 6 large glioma centers in Europe, met all end-points, regarding both technical and diagnostic performance of 99mTc-tetrofosmin, and sets a strong basis for the design of a successful phase III confirmatory study.
The sponsor wishes to thank all the Principal Investigators and their dedicated teams, as well as our highly experienced team of Medical Advisors for their impactful contribution and commitment to bringing the study to its successful completion.
Dr Alex Strongilos, CEO of proACTINA, stated that “the successful completion of the phase II study is a major advancement towards the completion of this ambitious project and it constitutes a very strong foundation for the upcoming Phase III study”.
Dr Daniel Schubart, Managing Director of ConsulTech, stated that “We have now reached a very important milestone of the GLIOMARK project and we are very enthusiastic about this significant achievement”.
Further information is available at www.gliomark.eu
Gliomark1 Phase II clinical study was part of GLIOMARK project, which receives funding from the European Union´s Horizon 2020 Research and Innovation, SME Instrument Phase II programme (GA No. 673737).
proACTINA SA, a research-driven and innovation-focused Small-Medium Enterprise in Athens-Greece, today announced that European Commission (EC) has granted Orphan Designation for tetrofosmin for the diagnosis of glioma, following a positive opinion by European Medicines Agency (EMA). The Decision was published in the Community Register of Orphan Medicinal Products and the product has received EU orphan designation number: EU/3/16/1764
For the full press release see: Orphan designation press release
Our project has been published in National Documentation Center’s bi-monthly newsletter for research and Innovation. Please find this publication here.