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Daiichi Sankyo & Biota start Phase III Asian trials for next generation
Relenza product
LANI Phase III clinical trials set for enrolment
Biota Holdings Limited (ASX:BTA) Melbourne, Australia – 17 November 2008 - today
announced that the multiple centres involved in the Phase III clinical trail on
its long acting neuraminidase inhibitor (LANI) CS-8958 are ready to commence
treatment. Patients are expected to enrol into the study progressively
throughout the Asian influenza season.
The Phase III multi centre study will be conducted in Japan, Taiwan, Hong Kong
and Korea involving adult patients who have confirmed, naturally acquired
influenza A or B. The trial will use time to symptom resolution as its primary
end point, after a single inhaled dose of CS-8958. The double blind,
non-inferiority study uses 75 mg of oseltamivir, twice daily for five days as
its control. Safety will be also assessed in the study.
A second Phase II/III paediatric study will also be conducted in Japan on
children of less than nine years of age. This study will use the same primary
end point as the adult study, but a dose of 2 mg/kg of oseltamivir, twice a day
for five days, as the control.
The duration of the studies will depend on the availability of patients for the
trials and the severity of the Asian influenza season.
CS-8958 is a long acting neuraminidase inhibitor, discovered by Daiichi Sankyo
and co-owned with Biota. A total of US$5.6 million of western clinical programs
for CS-8958 have been or are intended to be funded by the US National Institute
of Health. The drug’s profile suggests that a single inhaled dose of CS-8958
should be efficacious for the treatment of influenza and an inhaled dose once a
week, to maintain prophylaxis. Pre-clinical tests have shown CS 8958 to be
effective against influenza A & B virus as well as against the H5N1 avian
influenza virus.
*** Please note below a copy of the Daiichi Sankyo announcement to the Tokyo,
Osaka and Nagoya Stock Exchanges on Monday 17 November.
About LANI’s (Long-Acting Neuraminidase Inhibitors)
Current neuraminidase inhibitors for influenza require daily or more frequent
dosing. The ability to dose patients on a weekly, or even less frequent, basis
offers numerous benefits. Firstly, any stockpile of weekly-dosing drug will last
longer and protect more people, in the case of an influenza pandemic.
Additionally, a weekly dose may improve patient compliance over a more frequent
regime.
About Daiichi Sankyo
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.
Further information, visit
www.daiichisankyo.com
About Biota (ASX:BTA)
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 AstraZeneca
and novel nucleoside analogues designed to treat hepatitis C virus (HCV)
infections, 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 codeveloped OIA FLU
influenza diagnostics.
Relenza™ is a registered trademark of the GlaxoSmithKline group of companies.
BioStar ® OIA® FLU and BioStar ® OIA® FLU A/B are registered trademarks of
Inverness Medical.
Further information available at
www.biota.com.au
For Immediate Release
Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Takashi Shoda, President and Representative Director
(Code no.: 4568, First Section, Tokyo, Osaka and Nagoya Stock Exchanges)
Please address inquiries to Toshiaki Sai, General Manager,
Corporate Communications Department
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com
Start of Phase III Trial on the Anti-influenza Drug CS-8958
Tokyo, November 17, 2008 – Daiichi Sankyo Co., Ltd. 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 daily 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.
Investor / Analyst Enquiries
Biota Holdings Limited
Peter Cook
T: +61 3 9915 3720
Damian Lismore
T: +61 3 9915 3721
European media and investor enquiries
College Hill Life Sciences
Adam Michael / Justine Lamond / Benjamyn Tam
T: +44 (0)20 7866 7857
biota@collegehill.com
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