Kowa meldt veiligheid van phosphodiesterase 3 remmer K-134 op AHA 2011
ArrayKowa Company, Ltd., meldt dat de resultaten van twee Fase 2-onderzoeken en een niet-klinisch onderzoek van K-134 worden gepresenteerd bij wijze van mondelinge en posterpresentatie op de American Heart Association Scientific Sessions 2011 (AHA 2011), die plaatsvinden van 12 t/m 16 november in Orlando. K-134 wordt momenteel ontwikkeld in de VS en Japan als therapie voor perifere slagaderziekte.
K-134 is een nieuwe, selectieve remmer van phosphodiesterase (PDE) activiteit (type 3A/3B) met een anti-bloedplaatjeseffect, en zal naar verwachting de loopfunctie verbeteren bij patienten met claudicatio intermittens, ook bekend als syndroom van Charcot. Op basis van de resultaten van deze Fase 2-onderzoeken zal Kowa zijn klinische ontwikkelingsprogramma voortzetten en een Fase 2b-onderzoek in Japan beginnen met het oogmerk tot het verkrijgen van marktautorisatie voor deze nieuwe therapeutische optie.
Engelstalig bericht:
Kowa Announces the Efficacy and Safety of a Novel Phosphodiesterase 3 Inhibitor K-134 for the Treatment of Intermittent Claudication in AHA 2011
Kowa Company, Ltd., (Headquarters: Nagoya, Japan, President & CEO: Yoshihiro Miwa, “Kowa”) today announced that the results of two Phase 2 studies and a non-clinical study of K-134, will be presented as an oral presentation and posters at the American Heart Association Scientific Sessions 2011 (AHA 2011) from Nov. 12-16 in Orlando, Florida, US. K-134 is currently being developed in the United States (US) and Japan as a therapeutic agent for peripheral arterial disease.
K-134 is a novel selective inhibitor of phosphodiesterase (PDE) activity (type 3A/3B) that has anti-platelet effects, and is anticipated to improve walking performance in patients with intermittent claudication (IC).
Based on the results of these Phase 2 studies, Kowa will continue its clinical development program and will initiate a Phase 2b study in Japan with the aim of achieving marketing authorization for this new therapeutic option for the treatment of IC. Presentations accepted by AHA 2011 are as follows:
- Phase 2 clinical study in the US: Clinical Effects of the Phosphodiesterase Inhibitor K-134 in Peripheral Artery Disease and Claudication (Oral Presentation, program No. 9800; Nov 14, 11:30-11:45)
- Phase 2a clinical study in Japan: The Novel Phosphodiesterase 3 Inhibitor K-134 Improves Walking Performance in Japanese Patients with Intermittent Claudication (Poster Presentation, poster No. 14430; Nov 13, 9:30-11:00)
- Non-clinical study: Phosphodiesterase 3 Inhibitor Prevents Thrombotic Diseases Without Affecting Hemostatic Function (Poster Presentation, poster No. 8694; Nov 13, 9:30-11:00)
Kowa has made arterial and lifestyle disease R&D priorities, and is endeavoring to develop and explore innovative medicines. In addition, Kowa focuses on three major activities: drug discovery, innovative formulation discovery, and the development of neo generics, and actively engages in R&D activities to satisfy unmet medical needs.
Kowa Company, Ltd.
Kazuhiro Kachi, +81-3-3279-7392 (Japanese inquiries only)
Fax: +81-3-3279-7250
or
Kowa Research Institute, Inc.
Gary Gordon, +1-919-433-1607 (English Only)
Senior Vice President, Operations
or
Kowa Research Europe, Ltd.
Kowa Pharmaceutical Europe Co. Ltd.
Rod Coombs, +44-118-922-9013 (English Only)
Commercial Director EU and MENA