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Fluorescent tumours in the clinic

15.12.2011

Munich/Groningen/Penzberg – For ten years, the application of image-guided surgery with tumour-specific fluorescent dyes has been limited to animal studies, because no one could predict safety or bio­distribution of such targeted dyes in patients. Now for the first time, a Dutch-German team of researchers has found a way to convince regulatory authorities that their fluorochromes are safe and can be tested on human subjects. In November, the team got the go-ahead for a Phase I study in breast cancer patients with the fluorochrome IR dye 800 CW (LI-COR Bioscience) coupled to the antibody drug Avastin (Roche).
“Our advantage is that we already have a lot of clinical data about the safety and biodistribution of the cancer therapeutic Avastin, which binds to VEGF produced by cancer cells,” said Werner Scheuer from Pharma Research & Early Development at Roche (Penzberg), who developed the anti­body-flurochrome conjugates in cooperation with Vasilis Ntziachristos (TU Munich) and Go van Dam (Medical College Groningen). In the November issue of the Journal of Nuclear Medicine (52(11): 1778-1785), the authors provided evidence that their cancer imaging agent behaves in animals as Avastin does in humans. For proving safety in humans, they will use microdoses of the dye – 100 times lower than the lowest dose in which the cancer drug shows an effect. “We want to statistically prove that breast cancer patients benefit from image-guided surgery with targeted fluorochromes,” explains Ntziachristos. He has developed a camera system that can identify the tumour margins with seven times better resolution than a surgeon can with the naked eye. A pipeline of antibody-fluorochrome conjugates is already being tested in animals.

Politics / Law

06.03.2012

London – The European Medicines Agency (EMA) calls it “the biggest change to the legal framework since the establishment of the Agency in 1995.” This year, the EU drug regulators are preparing new so-called pharmacovigilance...

Clinical Trial

06.03.2012

Norway’s Algeta ASA (Oslo) has updated its Phase III survival analysis of Alpharadin in patients with castration-resistant prostate cancer and bone metastases. The analysis showed an increase of 3.6 months in median overall...

Clinical Trial

06.03.2012

Genticel S.A. (Toulouse) has completed enrolment in its Phase Ib study of a lyophilised version of the world’s very first therapeutic vaccine ProCervix, which inhibits infection with the cancer-causing Human Papilloma Virus. The...

Clinical Trial

06.03.2012

The share value of French specialist for cardiometabolic diseases Genfit S.A. (Loos/Lille) took a jump after the company announced its candidate drug GFT505 had met all efficacy endpoints in a pilot Phase II study involving 22...

Clinical Trial

06.03.2012

The US Food and Drug Administration (FDA) has granted a Biologics License Application (BLA) to the HER2 dimerisation inhibitor pertuzumab developed by Roche (Basel) for previously untreated HER2­-positive metastatic breast...

Politics / Law

06.03.2012

A For years, the world’s major patent offices – including the EPO, USPTO and JPO – have been collaborating in the Patent Prosecution Highway (PPH) programme. Under the PPH, an applicant whose claims have been allowed in one...

BioFunding

06.03.2012

Berlin/Dublin – Two EU initiatives are seeking to better predict response to cancer treatments. Researchers from the a6m RESPONSIFY Project will develop biomarker-based breast cancer prognosis tests that could be used to predict...

BioFunding

06.03.2012

Bremen/Brussels – European researchers kicked-off the MicroB3 (Bio­diversity, Bioinformatics, Biotechnology) project in February. Thanks to a a9m EU fund, the 32 groups involved will create a unique bioinformatic resource that...

BioFunding

06.03.2012

A Brussels – The European Commission is boosting its investments and policy activities to foster sustainability. “Europe needs to make the transition to a post-petroleum economy,” said Máire Geoghegan-Quinn in Brussels. In...

Politics / Law

06.03.2012

Brussels – In February, I heard of a slightly mad and very worrying trend in decisions handed down by the Court of Justice of the European Union (CJEU) with regard to IP issues handed up from the national level for clarification....

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