QUANTUM GENOMICS : First patients recruited for Phase IIa trial of drug candidate QGC001
Quantum Genomics (Alternext - FR0011648971 - ALQGC), a biopharmaceutical company with the mission of developing new therapies for unmet medical needs in the field of cardiovascular diseases, announces it has now recruited the first three patients for its Phase IIa trial of its molecule QGC001.
This first-in-class drug candidate of the new class of therapeutics for the treatment of high blood pressure, in November 2014 obtained the authorisations from ANSM (the French national drug and health products safety agency) and CPP (the French consumer protection agency) to start Phase IIa trials aimed at proving its effectiveness in hypertensive patients.
Four clinical investigation centres named "Centres of Excellence" by the European Society of Hypertension (ESH)
The clinical trials will be conducted on some 30 patients with grade 1 high blood pressure (systolic pressure > 140 and <= 159 mmHg; diastolic pressure > 90 and <= 99 mmHg) or with grade 2 high blood pressure (systolic pressure > 160 mmHg; diastolic pressure > 100 mmHg).
The study involves four clinical investigation centres in France, under the supervision of Prof. Michel Azizi (Clinical Investigation Centre at Georges Pompidou European Hospital, Paris) as part of the CLINAPAI collaborative programme, subsidised by the French National Research Agency (ANR). The four French centres, named "Centres of Excellence" by the European Society of Hypertension (ESH), participating in this clinical trial are:
- the Georges Pompidou European Hospital, Paris;
- the Croix Rousse Hospital, Lyon;
- the Cardiology Hospital - Lille Regional University Hospital Centre;
- the Arthur Gardiner Hospital, Dinard.
It is a randomised double-blind study, with cross-over, to compare the effects of the product QGC001 (500 mg morning and night) with those of a placebo. It also aims to analyse the pharmacodynamic effects of QGC001 on several hormonal biomarkers (measures of concentrations of plasma renin, aldosterone, cortisol, adrenocorticotropin (ACTH), apelin and copeptin, a Vasopressin biomarker, as well as urinary aldosterone and urinary cortisol).
Quantum Genomics' goal is to sign, by the end of 2016, a license agreement or partnership with a manufacturer in the healthcare sector to continue the clinical development of its product QGC001, its registration and commercialisation.
This announcement comes several weeks after Quantum Genomics' highly successful capital increase with its public offering of €12.9 million, aimed in particular at financing this Phase IIa study.
Olivier Madonna, Medical Director of Quantum Genomics, says:
"The implementation in the participating centres and the start of our first Phase IIa study for the treatment of hypertension are taking place in a very satisfactory way. As of today, three patients have already been enrolled. The involvement of the investigators is strong and the recruitment of patients is going on at a pace which is perfectly in line with our plan."
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ABOUT QUANTUM GENOMICS
Quantum Genomics is a biopharmaceutical company with the mission of developing new therapies for unmet medical needs in the field of cardiovascular diseases, especially high blood pressure and heart failure.
Quantum Genomics is developing a new therapeutic approach based on BAPAI (Brain Aminopeptidase A Inhibition). This is the result of more than 20 years of academic research in the laboratories of the Collège de France, INSERM, CNRS and the University of Paris Descartes.
Quantum Genomics is listed on the Alternext market in Paris (ISIN code FR0011648971, Ticker ALQGC).
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