BioDiem Ltd. Agreement with PATH for Prototype Pandemic Influenza Vaccine
Melbourne, Tuesday 1 September 2009: Australian pharmaceutical development company BioDiem Ltd (ASX: BDM) announced that the Institute of Experimental Medicine (IEM), the originator of BioDiem’s Live Attenuated Influenza Vaccine (LAIV) technology, has executed a development and collaboration agreement with PATH to develop a prototype pandemic LAIV for use in developing countries.
The aim of the agreement is to demonstrate that the cold–adapted master virus (A/Leningrad/134/17/57 -H2N2 type) bearing avian or human influenza virus genes from viruses with pandemic potential will be safe and produce an immune response in humans.
The development plan includes the generation of a set of live, attenuated cold–adapted virus vaccines against avian influenza subtypes with potential to cause a pandemic outbreak in humans. Preclinical studies of these vaccine candidates will be performed. Each candidate will be produced under internationally recognised Good Manufacturing Practice conditions for use in Good Laboratory Practice toxicology studies, leading to high quality materials suitable for evaluation of safety and potent immunity in future clinical studies.
Subject to IEM’s achievement of established milestones, PATH will provide financial and technical support to IEM and third party contractors to a maximum of US$3.6 million. Any development plan data will be available for use in developing countries under the World Health Organization’s Global Pandemic Influenza Action Plan to Increase Vaccine Supply.
Professor Larisa Rudenko, a director of BioDiem and head of the Department of Virology at IEM, said “Our technology has the potential to provide a significant defence in the event of an influenza pandemic and we are delighted to be working with PATH."
“We are pleased to be working with the Institute of Experimental Medicine to speed the development of live-attenuated influenza vaccines that can be a safe, low-cost, and highly effective method for enabling real-time response against an influenza pandemic,” said Dr. Rick Bright, scientific director of PATH’s Influenza Vaccine Project. “Our ultimate goal is to develop vaccines that can be accessible and affordable for people in low-resource countries, who may be hit hardest in a pandemic."
About BioDiem Ltd
BioDiem is an ASX listed company, based in Melbourne, with an international focus on finding, adding value to and commercializing world-class research for vaccines, infectious diseases and other therapeutic areas. The company uses a cost-efficient approach to drug development through collaborations with academic centres of excellence, contract research organizations and partnerships with international pharmaceutical companies.
BioDiem’s leading product is the Live Attenuated Influenza Vaccine (LAIV) technology from the Institute of Experimental Medicine in St. Petersburg, Russia. LAIV is a novel intranasal vaccine being developed to prevent infection from endemic and pandemic influenza. It was licensed to Nobilon International B.V., Schering-Plough’s human vaccine business unit, in 2004 and is currently in Phase I clinical trials. BioDiem’s second product is BDM-E, a small synthetic peptide being developed for the treatment of retinal eye diseases. It is currently in pre-clinical testing.
About LAIV Technology
Unlike the more traditional influenza vaccinations which are injectible, the LAIV nasal spray influenza vaccine contains live viruses. However, these are attenuated (weakened) and cannot cause illness. The weakened viruses being cold-adapted, they are designed only to cause infection at the cooler temperatures found within the nose, and not in the lungs or other areas where warmer temperatures exist.
For additional information, please visit www.biodiem.com
About PATH
PATH is an international nonprofit global health organization based in the United States that creates sustainable, culturally relevant solutions, enabling communities worldwide to break longstanding cycles of poor health. By collaborating with diverse public- and private-sector partners, PATH helps provide appropriate health technologies and vital strategies that change the way people think and act. PATH’s work improves global health and well-being.
For more information visit www.path.org/
The aim of the agreement is to demonstrate that the cold–adapted master virus (A/Leningrad/134/17/57 -H2N2 type) bearing avian or human influenza virus genes from viruses with pandemic potential will be safe and produce an immune response in humans.
The development plan includes the generation of a set of live, attenuated cold–adapted virus vaccines against avian influenza subtypes with potential to cause a pandemic outbreak in humans. Preclinical studies of these vaccine candidates will be performed. Each candidate will be produced under internationally recognised Good Manufacturing Practice conditions for use in Good Laboratory Practice toxicology studies, leading to high quality materials suitable for evaluation of safety and potent immunity in future clinical studies.
Subject to IEM’s achievement of established milestones, PATH will provide financial and technical support to IEM and third party contractors to a maximum of US$3.6 million. Any development plan data will be available for use in developing countries under the World Health Organization’s Global Pandemic Influenza Action Plan to Increase Vaccine Supply.
Professor Larisa Rudenko, a director of BioDiem and head of the Department of Virology at IEM, said “Our technology has the potential to provide a significant defence in the event of an influenza pandemic and we are delighted to be working with PATH."
“We are pleased to be working with the Institute of Experimental Medicine to speed the development of live-attenuated influenza vaccines that can be a safe, low-cost, and highly effective method for enabling real-time response against an influenza pandemic,” said Dr. Rick Bright, scientific director of PATH’s Influenza Vaccine Project. “Our ultimate goal is to develop vaccines that can be accessible and affordable for people in low-resource countries, who may be hit hardest in a pandemic."
About BioDiem Ltd
BioDiem is an ASX listed company, based in Melbourne, with an international focus on finding, adding value to and commercializing world-class research for vaccines, infectious diseases and other therapeutic areas. The company uses a cost-efficient approach to drug development through collaborations with academic centres of excellence, contract research organizations and partnerships with international pharmaceutical companies.
BioDiem’s leading product is the Live Attenuated Influenza Vaccine (LAIV) technology from the Institute of Experimental Medicine in St. Petersburg, Russia. LAIV is a novel intranasal vaccine being developed to prevent infection from endemic and pandemic influenza. It was licensed to Nobilon International B.V., Schering-Plough’s human vaccine business unit, in 2004 and is currently in Phase I clinical trials. BioDiem’s second product is BDM-E, a small synthetic peptide being developed for the treatment of retinal eye diseases. It is currently in pre-clinical testing.
About LAIV Technology
Unlike the more traditional influenza vaccinations which are injectible, the LAIV nasal spray influenza vaccine contains live viruses. However, these are attenuated (weakened) and cannot cause illness. The weakened viruses being cold-adapted, they are designed only to cause infection at the cooler temperatures found within the nose, and not in the lungs or other areas where warmer temperatures exist.
For additional information, please visit www.biodiem.com
About PATH
PATH is an international nonprofit global health organization based in the United States that creates sustainable, culturally relevant solutions, enabling communities worldwide to break longstanding cycles of poor health. By collaborating with diverse public- and private-sector partners, PATH helps provide appropriate health technologies and vital strategies that change the way people think and act. PATH’s work improves global health and well-being.
For more information visit www.path.org/