MASSY, FRANCE--(Marketwire - January 05, 2012) -
First clinical trial in Human is expected beginning 2012.
Quantum Genomics (NYSE Euronext Paris ticker MLQGC) announced today the approval from the "Comité de Protection des Personnes (Ile de France VIII)" for the first clinical trial in human of its leading compound QGC001.
QGC001 is the first of a new class of drugs that aim to treat high blood pressure (HBP) - also called hypertension. The application of this First-in-Human clinical trial has been submitted to the French Agency for Safety of Health Products (AFSSAPS).
This clinical trial will be a single ascending oral dose, double-blind and placebo-controlled Phase I study. It will aim at assessing the overall safety, tolerability and pharmacokinetics of QGC001 in healthy volunteers.
An exploratory study conducted in parallel, in partnership with the « Centre d'Investigations Cliniques 9201/APHP-INSERM of the Hôpital Européen Georges Pompidou (Paris, France) and thanks to the financial support from the French National Agency for Research (ANR), will aim at identifying relevant biomarkers to support the next coming phases of the clinical development.
"This approval from the "Comité de Protection des Personnes" is a major step in the development of QGC001 which reinforces the very good preclinical results, says Lionel Segard, President and CEO of Quantum Genomics. QGC001 is a breakthrough innovation that will bring hope to patients with a specific profile, especially those who are usually not properly treated for their hypertension despite several drugs and/or suffer from important side effects.
Quantum Genomics is looking forward to starting the clinical trials in the first half of 2012, as soon as we get the approval from AFSSAPS."
About the "Comité de Protection des Personnes"
The approval from the "Comité de Protection des Personnes" relates to the ethical aspects of the study protocol and the documents proposed to get volunteers' agreement. This is one of the two authorisations that are requested to allow the company to start a clinical trial; the second one comes from AFSSAPS.
About QGC001
The objective of QGC001 is to offer a therapeutic alternative for the treatment of High Blood Pressure. The unique mechanism of action of QGC001 (selective inhibition of brain aminopeptidase A) makes it a promising drug for the treatment of hypertensive patients with Low Renin High Vasopressin profile (LRHV), whose blood pressure is usually poorly controlled.
Hypertension (high blood pressure) affects an estimated 1 billion people worldwide.
Despite several effective proven treatments, high blood pressure has proven difficult to control in 30 to 60% of hypertensive patients (49% in France, X Girerd et al. 2008).
In addition, overall incidence of resistant hypertension to at least three antihypertensive drugs (including a diuretic) is estimated( )to be 15% of the hypertensive population.
Low Renin and High Vasopressin profile (LRHV) is a common condition that characterizes nearly 30% of all hypertensive patients that have reduced response to ACE inhibitors, angiotensin receptor blockers (ARBs), renin inhibitors and beta-blockers.
About Quantum Genomics.
QGC is a biotechnology company seeking to develop new therapies in areas where an unmet medical need exists. QGC is presently focused on the treatment of hypertension.
It will co-develop those products with academic teams and will set up strategic alliances and commercial partnerships with larger company in order to make it to market.
The company is headquartered in Massy France under the leadership of Lionel Ségard, supported by a management team of experienced people, including Fabrice Balavoine (VP Research & Development) and Michel Lepers (VP Business Development).
For more information go to www.quantum-genomics.com
Press release January 5 2012: http://hugin.info/146217/R/1575381/490669.pdf
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Source: Quantum Genomics via Thomson Reuters ONE
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