GemacBio announces the successful conclusion of Phase IIa clinical trials for its new molecule designed to treat multiple sclerosis
The new molecule's excellent safety profile is likely to be a key factor in allowing long term treatment of a chronic illness such as MS
BORDEAUX, France, February 1, 2006 - GemacBio, a biopharmaceutical company specialized in the development of innovative molecules for the treatment of chronic central nervous system and auto-immune diseases, announces today the successful conclusion of a Phase IIa clinical trial on patients suffering from multiple sclerosis. Understanding MS as a multifactorial disease lies at the heart of this advance. GemacBio scientists realized they needed to design a molecule that targeted all aspects of MS pathology. To achieve this, they grafted together several molecules occurring in the human body using a patented process. The resulting molecule applies this new approach in acting against a multifactorial pathology through a number of targets. The molecule is active in three areas: anti-inflammatory, immunomodulating, and neuroprotecting.
Compared to existing MS therapies, this molecule has the enormous additional advantage of oral (sub-lingual) administration. This patient-friendly, convenient route of administration allows improvement of the quality of life for patients who hitherto have had to receive frequent injections.
"We are delighted that a number of eminent clinical experts have expressed their support and a high level of interest in these positive Phase IIa results," said Thibault de la Rivière, CEO of GemacBio. "These encouraging results should reassure existing and future investors as we begin the quest for additional financial resources to enable us to carry out Phase IIb studies and move our molecules further in development and closer to the patient."
The Phase IIa trials took place in three sites in France for periods of between six and 18 months on 22 patients suffering from indications of secondary progressive multiple sclerosis. The trials showed 100 per cent tolerance and a very high safety profile for GemacBio's product.
"Our treatment has two major advantages," said Dr Michel Geffard, Chief Scientific Officer at GemacBio. "The first is the absence of side effects due to the product's low toxicity, an essential characteristic for the long term treatment of chronic diseases, and the second is the maximization of the therapeutic effect via the triple anti-inflammatory, immunomodulating and neuroprotecting action of our combinations of therapeutic molecules."
About GemacBio http://www.gemacbio.com GemacBio, Bordeaux, is a biopharmaceutical company specialized in the development of innovative molecules for the treatment of chronic central nervous system and auto-immune disease. The company's initial focus is on multiple sclerosis and amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). It has already validated its technological approach with a first Phase IIa clinical trial on multiple sclerosis. GemacBio's know-how is based on immunochemistry and the vectorization of small molecules to enhance their therapeutic effect. Gemacbio benefits from the presence of a strong multi-disciplinary scientific team combining biology, chemistry and immunology expertise. The company has raised EUR 4M in financing, principally from regional sources in south west France including IRDI (Institut Régional de Développement Industriel de Midi-Pyrenées), SOCRI (Sud-Ouest Capital Risque Innovation) and business angels. -- Heidi Thompson ANDREW LLOYD & ASSOCIATES http://www.ala.com firstname.lastname@example.org
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Andrew Lloyd & Associates Andrew Lloyd/ Heidi Thompson Tel: +44 1273 675100 email@example.com>firstname.lastname@example.org /email@example.com> firstname.lastname@example.org Submitted 2/4/2006 10:13:46 PM