Agenix remains on course to apply for Hepatitis B drug clinical trials in China

[Guest guest]

http://www.proactiveinvestors.com.au/companies/news/16976/agenix-remains-on-cour\

se-to-apply-for-hepatitis-b-drug-clinical-trials-in-china-16976.html

Agenix remains on course to apply for Hepatitis B drug clinical trials in China

Wednesday, June 08, 2011

Agenix (ASX: AGX) has confirmed the company remains on track to submit a formal

application to begin clinical trials in China for its lead Hepatitis B drug, AGX

1009.

The company plans to file a formal application with China’s State Food and Drug

Administration in the second quarter of 2012, and anticipates approval to begin

Phase I human studies in late 2012.

Agenix, a China–focussed drug development and diagnostic company, confirmed the

drugs status following a series of meetings in Australia with senior

representatives of Agenix’s joint venture partner, the Beijing–based Institute

of Medicinal Biotechnology (IMB) of the Chinese Academy of Medical Sciences.

The patents for AGX–1009 run until 2026 and the company plans to make the drug

available as a once–daily treatment.

AGX–1009 belongs to a new class of drugs that work by blocking an enzyme the

hepatitis virus requires to replicate.

AGX–1009 is a so called a ‘prodrug’ in the same class as Tenofovir, marketed by

GlaxoKline (NYSE: GSK, LON: GSK) in Asia as Viread® and which gained

approval in the US in 2008.

Viread®, or tenofovir disoproxil fumarate, is a prescription medicine used to

treat chronic Hepatitis B virus in adults.

The drug has already passed a number of early development hurdles and has been

found to have a low toxicity profile, as well as not inhibiting the group of

enzymes that process drugs in the liver.

The meetings in Australia with senior representatives of China’s IMB, led by

Professor Jiang Jian–Dong, focussed on key pharmacology, toxicology, chemical

composition, manufacturing methods and clinical trial protocol data submissions

for AGX–1009

Weston, chief executive officer of Agenix, said “together we believe

[with IMB] we have the opportunity to significantly improve the health and

quality of life for millions of people by commercialising promising new drug

candidates quickly and at a fraction of the cost it would take in the US or

Europe.”

The drug has received support by the Chinese Government’s State Special Funds

for important newly developed drugs.

[Guest guest]

http://www.proactiveinvestors.com.au/companies/news/16976/agenix-remains-on-cour\

se-to-apply-for-hepatitis-b-drug-clinical-trials-in-china-16976.html

Agenix remains on course to apply for Hepatitis B drug clinical trials in China

Wednesday, June 08, 2011

Agenix (ASX: AGX) has confirmed the company remains on track to submit a formal

application to begin clinical trials in China for its lead Hepatitis B drug, AGX

1009.

The company plans to file a formal application with China’s State Food and Drug

Administration in the second quarter of 2012, and anticipates approval to begin

Phase I human studies in late 2012.

Agenix, a China–focussed drug development and diagnostic company, confirmed the

drugs status following a series of meetings in Australia with senior

representatives of Agenix’s joint venture partner, the Beijing–based Institute

of Medicinal Biotechnology (IMB) of the Chinese Academy of Medical Sciences.

The patents for AGX–1009 run until 2026 and the company plans to make the drug

available as a once–daily treatment.

AGX–1009 belongs to a new class of drugs that work by blocking an enzyme the

hepatitis virus requires to replicate.

AGX–1009 is a so called a ‘prodrug’ in the same class as Tenofovir, marketed by

GlaxoKline (NYSE: GSK, LON: GSK) in Asia as Viread® and which gained

approval in the US in 2008.

Viread®, or tenofovir disoproxil fumarate, is a prescription medicine used to

treat chronic Hepatitis B virus in adults.

The drug has already passed a number of early development hurdles and has been

found to have a low toxicity profile, as well as not inhibiting the group of

enzymes that process drugs in the liver.

The meetings in Australia with senior representatives of China’s IMB, led by

Professor Jiang Jian–Dong, focussed on key pharmacology, toxicology, chemical

composition, manufacturing methods and clinical trial protocol data submissions

for AGX–1009

Weston, chief executive officer of Agenix, said “together we believe

[with IMB] we have the opportunity to significantly improve the health and

quality of life for millions of people by commercialising promising new drug

candidates quickly and at a fraction of the cost it would take in the US or

Europe.”

The drug has received support by the Chinese Government’s State Special Funds

for important newly developed drugs.

[Guest guest]

http://www.proactiveinvestors.com.au/companies/news/16976/agenix-remains-on-cour\

se-to-apply-for-hepatitis-b-drug-clinical-trials-in-china-16976.html

Agenix remains on course to apply for Hepatitis B drug clinical trials in China

Wednesday, June 08, 2011

Agenix (ASX: AGX) has confirmed the company remains on track to submit a formal

application to begin clinical trials in China for its lead Hepatitis B drug, AGX

1009.

The company plans to file a formal application with China’s State Food and Drug

Administration in the second quarter of 2012, and anticipates approval to begin

Phase I human studies in late 2012.

Agenix, a China–focussed drug development and diagnostic company, confirmed the

drugs status following a series of meetings in Australia with senior

representatives of Agenix’s joint venture partner, the Beijing–based Institute

of Medicinal Biotechnology (IMB) of the Chinese Academy of Medical Sciences.

The patents for AGX–1009 run until 2026 and the company plans to make the drug

available as a once–daily treatment.

AGX–1009 belongs to a new class of drugs that work by blocking an enzyme the

hepatitis virus requires to replicate.

AGX–1009 is a so called a ‘prodrug’ in the same class as Tenofovir, marketed by

GlaxoKline (NYSE: GSK, LON: GSK) in Asia as Viread® and which gained

approval in the US in 2008.

Viread®, or tenofovir disoproxil fumarate, is a prescription medicine used to

treat chronic Hepatitis B virus in adults.

The drug has already passed a number of early development hurdles and has been

found to have a low toxicity profile, as well as not inhibiting the group of

enzymes that process drugs in the liver.

The meetings in Australia with senior representatives of China’s IMB, led by

Professor Jiang Jian–Dong, focussed on key pharmacology, toxicology, chemical

composition, manufacturing methods and clinical trial protocol data submissions

for AGX–1009

Weston, chief executive officer of Agenix, said “together we believe

[with IMB] we have the opportunity to significantly improve the health and

quality of life for millions of people by commercialising promising new drug

candidates quickly and at a fraction of the cost it would take in the US or

Europe.”

The drug has received support by the Chinese Government’s State Special Funds

for important newly developed drugs.

[Guest guest]

http://www.proactiveinvestors.com.au/companies/news/16976/agenix-remains-on-cour\

se-to-apply-for-hepatitis-b-drug-clinical-trials-in-china-16976.html

Agenix remains on course to apply for Hepatitis B drug clinical trials in China

Wednesday, June 08, 2011

Agenix (ASX: AGX) has confirmed the company remains on track to submit a formal

application to begin clinical trials in China for its lead Hepatitis B drug, AGX

1009.

The company plans to file a formal application with China’s State Food and Drug

Administration in the second quarter of 2012, and anticipates approval to begin

Phase I human studies in late 2012.

Agenix, a China–focussed drug development and diagnostic company, confirmed the

drugs status following a series of meetings in Australia with senior

representatives of Agenix’s joint venture partner, the Beijing–based Institute

of Medicinal Biotechnology (IMB) of the Chinese Academy of Medical Sciences.

The patents for AGX–1009 run until 2026 and the company plans to make the drug

available as a once–daily treatment.

AGX–1009 belongs to a new class of drugs that work by blocking an enzyme the

hepatitis virus requires to replicate.

AGX–1009 is a so called a ‘prodrug’ in the same class as Tenofovir, marketed by

GlaxoKline (NYSE: GSK, LON: GSK) in Asia as Viread® and which gained

approval in the US in 2008.

Viread®, or tenofovir disoproxil fumarate, is a prescription medicine used to

treat chronic Hepatitis B virus in adults.

The drug has already passed a number of early development hurdles and has been

found to have a low toxicity profile, as well as not inhibiting the group of

enzymes that process drugs in the liver.

The meetings in Australia with senior representatives of China’s IMB, led by

Professor Jiang Jian–Dong, focussed on key pharmacology, toxicology, chemical

composition, manufacturing methods and clinical trial protocol data submissions

for AGX–1009

Weston, chief executive officer of Agenix, said “together we believe

[with IMB] we have the opportunity to significantly improve the health and

quality of life for millions of people by commercialising promising new drug

candidates quickly and at a fraction of the cost it would take in the US or

Europe.”

The drug has received support by the Chinese Government’s State Special Funds

for important newly developed drugs.