Medivir Announces an Interferon-Free Phase II Combination Trial With TMC435 and daclatasvir to Commence Shortly

Informations

• Publié par: medivir
• Nombre de lectures: 20
• Langue: English

Extrait

Medivir Announces an Interferon-Free Phase II

Combination Trial With TMC435 and daclatasvir

to Commence Shortly

PR Newswire

STOCKHOLM, Sweden, June 29, 2012

STOCKHOLM, Sweden

,

June 29, 2012

/PRNewswire/ --

The phase II interferon-free combination study with TMC435 and daclatasvir will

evaluate treatment-naïve or previous null responder patients with HCV genotype

1a and 1b

The study will include approx. 180 patients and will evaluate a combination of

TMC435 and daclatasvir, with or without Ribavirin, in four different cohorts for 12

or 24 weeks of treatment

Medivir AB (OMX:MVIR), the research-based pharmaceutical company focused

on the development of high-value treatments for infectious diseases,

announces that a phase II combination study with the investigational compound

TMC435 and Bristol-Myers Squibb's investigational compound daclatasvir will

start in July. This study is part of the clinical collaboration agreement between

Janssen R&D Ireland and Bristol-Myers Squibb Company (NYSE:BMY) announced

on

2 December 2011

and on

18 April 2012

.

TMC435 and daclatasvir (BMS-790052)

TMC435, a once daily potent NS3/4A protease inhibitor (PI) in phase III clinical

development for the treatment of chronic genotype-1 hepatitis C virus (HCV)

infection, will be investigated in an interferon free phase II trial in combination

with Bristol-Myers Squibb´s investigational NS5A replication complex inhibitor,

daclatasvir (BMS-790052), also in phase III development.

The purpose of this study is to assess the efficacy and safety of TMC435 and

daclatasvir in combination with or without Ribavirin in chronic genotype-1

hepatitis C infected patients who are treatment-naive or null responders to

previous Peginterferon alfa/Ribavirin therapy.

Study design

In this open label phase II study the potential to achieve sustained viral

response (SVR), 12 (SVR

12

) and 24 (SVR

24

) weeks post treatment in treatment-

naïve and null responder patients infected with HCV genotype 1a and 1b will be

evaluated. Patients with advanced liver disease (F3/F4) will be allowed up to

approx. 35% of the total treated population.

Cohort one and two will include patients with genotype 1b where TMC435 and

daclatasvir will be dosed with or without Ribavirin for 12 weeks with a 36 weeks

follow-up or for 24 weeks with a 24 weeks follow-up.

Cohort three and four will include patients with genotype 1a where TMC435,

daclatasvir and Ribavirin will be dosed for 12 or 24 weeks with a 24 weeks post

treatment follow-up.

For additional information from these recently updated studies, please see

http://www.clinicaltrials.gov

About Hepatitis C

Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause

of chronic liver disease and liver transplants. The World Health Organization

estimates that nearly 180 million people worldwide, or approximately 3% of the

world's population, are infected with hepatitis C virus (HCV). The CDC has

reported that almost three million people in

the United States

are chronically

infected with HCV.

About Medivir

Medivir is an emerging research-based pharmaceutical company focused on

the development of high-value treatments for infectious diseases. Medivir has

world class expertise in polymerase and protease drug targets and drug

development which has resulted in a strong infectious disease R&D portfolio.

The Company's key pipeline asset is TMC435, a novel protease inhibitor in

phase III clinical development for hepatitis C that is being developed in

collaboration with Janssen Pharmaceuticals.

In

June 2011

, Medivir acquired the specialty pharmaceutical company

BioPhausia to ensure timely commercialisation of TMC435 in the Nordic

markets, once approved.

Medivir's first product, the unique cold sore product Xerese

®

/Xerclear

®

, is

launched in collaboration with GlaxoSmithKline to be sold OTC under the brand

name ZoviDou in

Europe

,

Japan

and

Russia

.

For more information about Medivir, please visit the Company's

website:http://www.medivir.com

For more information about Medivir, please contact:

Medivir

Rein Piir, EVP Corporate Affairs & IR

Mobile: [phone]

M:Communications

Europe

: Mary-Jane Elliott, Amber Bielecka, Hollie Vile

[e-mail]

[phone]