Start Of Phase III Trial On The Anti-influenza Drug CS-8958

Main Category: Flu / Cold / SARS
Also Included In: Clinical Trials / Drug Trials;  Pediatrics / Children's Health
Article Date: 17 Nov 2008 - 1:00 PST

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Daiichi Sankyo Co., Ltd. (TYO:4568) today announced that its anti-influenza drug, CS-8958, has started! it's pivotal Phase III trial for adults and Phase II/III trial for paediatrics.

CS-8958, a long-acting neuraminidase inhibitor (LANI), was discovered by Daiichi Sankyo and is co-owned with Biota Holdings Limited. CS-8958 is an inhaled formulation for influenza treatment and it is expected that single administration of CS-8958 will be efficacious for the treatment of influenza.

CS-8958 shows efficacy against H5N1 avian influenza virus as well as influenza A and B viruses in preclinical tests.

The Phase III clinical trial for adults is designed to test the efficacy and safety of CS-8958 in several hundred adult patients per group who have confirmed, naturally acquired influenza A or B. The trial uses symptom resolution and fever as its end points after a single inhaled dose. In this double-blind non-inferiority study, it is expected to confirm that single inhalation of CS-8958 is equally effective to 75 mg of oseltamivir administered orally twice dai! ly for 5 consecutive days. Also, the safety of CS-8958 will be assessed in this study.

This study was named MARVEL (Multinational Asian Clinical Research for Influenza Virus Extermination on LANI) study, and is being conducted as multinational clinical study in Asia (Japan, Taiwan, Hong Kong, and Korea).

In the Phase II/III for pediatrics, the efficacy of symptom resolution and fever with the same dose regimens as adults will be confirmed.

About BIOTA HOLDINGS LIMITED

Biota is a leading anti-infective drug development company based in Melbourne Australia, with key expertise in respiratory diseases, particularly influenza. Biota developed the first-in-class neuraminidase inhibitor, zanamivir, subsequently marketed by GlaxoSmithKline as Relenza.

Biota research breakthroughs have included a series of candidate drugs aimed at treatment of respiratory syncytial virus (RSV) disease, licensed to MedImmune Inc. and novel nucle! oside analogues designed to treat hepatitis C virus (HCV) infe! ctions, licensed to Boehringer Ingelheim. Biota has clinical trials underway with its lead compound for human rhinovirus (HRV) infection in patients with compromised respiration or immune systems. In addition, Biota has a key partnership with Daiichi-Sankyo for the development of second generation influenza antivirals. Inverness Medical markets Biota's co-developed OIA FLU influenza diagnostics. http://www.daiichisankyo.com

Relenza(tm) is a registered trademark of the GlaxoSmithKline group of companies. BioStar(R) OIA(R) FLU and BioStar(R) OIA(R) FLU A/B are registered trademarks of Inverness Medical.

http://www.biota.com.au

About Daiichi-Sankyo Company Limited

Daiichi Sankyo Company, Limited was established in 2005 through the merger of two leading Japanese pharmaceutical companies. This integration created a more robust organization that allows for continuous development of novel drugs that enrich the quality of life for patients around the world.

Daiichi-Sankyo Company Limited