Lakewood-Amedex to speed up development of its broad spectrum anti-influenza product into clinical studies

Lakewood-Amedex Inc., (L-A), the anti-infectives biopharmaceutical company developing a unique portfolio of anti-bacterial and anti-viral products including NuBiotics, a novel family of synthetic anti-bacterial compounds, and anti-viral products against hepatitis, HIV and influenza, announced today that it is accelerating development of its broad spectrum anti-influenza product into clinical studies.

Lakewood-Amedex's nRNA product works by selectively silencing targeted genes in the viral genome. The company is building on the previously successful animal model study where mice infected with H1N1 type A influenza virus were given two doses of the L-A nRNA product and all survived while control and placebo dosed mice all died within six days. In addition L-A previously published a study demonstrating the effectiveness of its technology against the lethal H5N1 "bird flu" influenza virus in which a single intra-nasal dose of the company's nRNA product protected 100% of the infected chickens while placebo treated chickens all died within seven days.

Steve Parkinson, L-A's President and Chief Executive Officer, commented, "We had intended to develop our broadly applicable influ-RNA product to treat seasonal flu and as an emergency stockpile product in the event of a further outbreak of avian influenza, but due to the escalating global H1N1 pandemic and now the report of this virus having been isolated from turkeys in Chile, we feel it is critical to have a product that can target multiple strains of influenza and is useable year after year."

Mr. Parkinson explained that the L-A product does not work like a vaccine that stimulates the human host immune system to produce antibodies targeted at the specific viral strain composing the vaccine. Instead the nRNA product contains several short oligonucleotide sequences that are mirror images to unique sites on the viral mRNA from the viral replicative genes. When the nRNA comes into contact with its specific target, it hybridizes with the viral mRNA locking this mRNA up and preventing production of vital viral replicative proteins. Deprived of these, the virus is unable to multiply itself and rendered unable to spread and infect other cells.

Paul DiTullio, chief scientist for Lakewood-Amedex said, "We are essentially shutting the virus down in the infected person. By targeting the highly conserved replicative genes we have a product that should be useable for years even if the virus mutates. We are also hitting several genetic sites and the chances of them all mutating in the same season is minimal. Even if the H1N1 strain does undergo recombination with the deadly H5N1 strain our product will still shut it down." DiTullio added, "That is the limitation with vaccines. They stimulate antibody production in the host against the surface antigens of the virus but unfortunately it is the surface antigens that mutate most of the time requiring a new vaccine to be developed. Our product works independently of surface antigen mutation."

Mr. Parkinson commented, "The Company intends to complete its pre-clinical data package and enter human clinical trials as quickly as possible. We are talking to government agencies and potential partners and hope soon to have a universal anti-influenza product as an alternative to seasonal vaccines."