Clinical Trial

Genfit goes towards proof-of-concept

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 non-diabetic patients with insulin resistance and abdominal obesity (NCT 01271777). Following eight weeks of treatment with the PPAR a and d-modulator, patients’ insulin sensitivity in the liver had improved by 37%. Furthermore, markers for liver dysfunction like gGT, ALAT or ASAT were lowered, as well as those for inflammation such as fibrinogen or hapto­globin. Finally, plasma lipid para­meters improved, according to the company. Genfit aims to establish the oral compound as a treatment for NALFD (non-alcoholic fatty liver disease), which affects at least 80% of diabetic patients, and NASH (non-alcoholic steato­hepatitis), which affects 20-50% of them. Results from long-term tests in rats and monkeys suggest the compound does not provoke the severe side effects of other oral PPARg diabetes drugs. Unlike glitazones or glitazars, GFT505 did not induce cardiac hypertrophy, mortality, weight gain or edema after six months of treatment.

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 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....

Politics / Law

06.03.2012

The human race is at war with another species, and has been for thousands of years. Each of us in Europe swats dead dozens of the enemy every summer, and in the tropics they kill thousands of people with infectious diseases...

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