scottish pain conférence 14/10/2009

16:00 Development of novel NSAIDs and COX-2 inhibitors in the post-Vioxx era
• What have we learned about GI and cardiovascular risk?
• What strategies are being employed to improve GI and cardiovascular safety?
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Example #1: Naproxcinod, a nitric-oxide donating analog of naproxen
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Example #2: CG100649, a dual inhibitor of COX-2 and carbonic anhydrase
• Are regulatory hurdles manageable in the USA and Europe?


http://www.scottish-biomedical.com/upload/file/main/6th_Annual_Pain_Management_(2009).pdf

En clair ça donne ça..

16:00 Développement de nouveaux AINS et inhibiteurs de la COX-2 dans l'ère post-Vioxx
• Qu'avons-nous appris sur la GI et le risque cardiovasculaire?
• Quelles sont les stratégies utilisées pour améliorer la GI et de l'innocuité cardiovasculaire?
--
Exemple 1: Naproxcinod, un don d'oxyde nitrique du naproxène analogique
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Exemple # 2: CG100649, un double inhibiteur de la COX-2 et de l'anhydrase carbonique
• Êtes-gérable obstacles réglementaires aux Etats-Unis et l'Europe?

Merci Vinsse,
C'est William K. Schmidt, Vice President, Clinical Development de CrystalGenomics qui va développer le sujet en mettant en avant son produit en Phase IIa.
NicOx n'interviendra pas. Bien dommage qu'ils ne soient pas présent pour défendre leur (notre !) beefsteak, le Naproxcinod !

Next Generation NSAID de Crystalgenomics

Indications: Osteoarthritis, rheumatoid arthritis, CNS diseases (e.g. Alzheimer’s, Huntington’s, etc), and colon cancer.

Current status: Phase IIa Clinical Trial in EU has been completed and further development plans are ongoing.

Characteristics:
CG100649 is a next generation NSAID which inhibits COX-2 in the
inflammatory joint, but not in the cardiovascular and gastrointestinal systems. Thus, CG100649 is highly efficacious in the control of inflammation and pain without showing typical side effects of other NSAIDs have shown. Such tissue specific inhibition has been demonstrated in the preclinical and clinical studies. Recently, a phase IIa clinical trial in EU has been completed showing the superiority of CG100649 in efficacy over placebo. There were no withdrawals due to lack of efficacy. There were no drug-related serious adverse events, and no indication of a negative effect on heart function, ECG profiles or blood pressure. Moreover, no evidence of gastrointestinal bleeding was found during the study.

Plan: Further Clinical Development through Partnering.