LONDON, December 8, 2010 /PRNewswire/ --
- Safety and Immunogenicity in Humans Established
SEEK, a leading UK privately-owned drug-discovery group, today presented data on the successful conclusion of a Phase I safety and tolerability study for its investigational Universal Influenza Vaccine, FLU-v, at the World Influenza Congress in Amsterdam (7-9 December).
The results showed that the vaccine was well tolerated and had no significant identifiable safety issues. Clear evidence of immunogenicity (provoking an immune response) across a wide range of the human population was also demonstrated, consistent with results seen in pre-clinical studies.
FLU-v is the first of a new class of breakthrough T cell vaccines that are anticipated to be effective against the highly-mutagenic influenza virus, and has been developed to provide a single vaccination which is effective against all strains of influenza virus, including pandemic strains.
Gregory Stoloff, Chief Executive Officer, comments: "This Phase I data validates our predictive model in humans, which to date had only been validated in other species. Importantly, the data is consistent with the immune response seen in other species - that showed protection against many strains of flu - and we therefore eagerly await the data from the Phase II study, which will provide information on safety, efficacy and cross-protection against a number of strains of flu."
A Phase II study to examine the safety, tolerability and protective efficacy of FLU-v in an influenza challenge has also been completed with data expected early 2011.
Using a novel predictive technique, SEEK has successfully identified small proteins (which can be synthetically manufactured) to which the immune system will react, in regions of the influenza flu virus that have not changed over 60 years (in either human or animal strains), and developed a vaccine to target them. By targeting these reactive small proteins that are in ever-present or "conserved" regions of the virus, the vaccine is intended to provide long-term protection against the threat of emerging strains, eliminating the need for an annual vaccination.
About the trial
The randomised trial was conducted in 48 participants, aged between 18 and 40, and consisted of giving a single low or high dose of the vaccine - either 250 or 500 micrograms - with or without adjuvant, or placebo, with or without adjuvant, followed by an observation period of 21 days. The results showed that at 21 days, a single dose of adjuvanted FLU-v induced an antigen specific T cell response (250micrograms, p=0.006, 500micrograms p=0.003) compared to placebo. FLU-v without adjuvant did not induce a specific T cell or B cell response.
No significant difficulties or increased local pain levels were associated with administration of FLU-v.
The need for FLU-v: a universal influenza vaccine
Unlike traditional vaccines which are grown in highly-specialised facilities, and whose production is limited by egg supply and the process of growing a vaccine, FLU-v can be quickly and easily manufactured in chemical plants. This allows the vaccine to be made and administered in large quantities prior to a pandemic outbreak, enabling a large proportion of the global population to be protected.
Major mutations in the antigen components of the virus can result in global pandemics, such as the outbreak of "Spanish flu" in 1918-1919, "Asian influenza" in 1957, "Hong Kong influenza" in 1968 and the H1N1 pandemic in 2010. There is also current concern about the potential transmission of an avian A (H5N1) strain to humans. However, even minor genetic changes require the annual reformulation of currently-used vaccines and re-inoculating at-risk individuals. There is therefore a significant need for a flu vaccine that will be protective against a range of strains of the virus and which can confer long term immunity. FLU-v is designed to protect against both type A and B viruses, as well as antigenic drift within each virus type.
Influenza is a common human disease that spreads around the world in seasonal epidemics and affects 5 to 15% of the population annually. These epidemics are thought to result in between three and five million cases of severe illness and between 250,000 and 500,000 deaths every year. The current viruses causing this disease are divided into two groups, A and B, and these can be further subdivided by their surface antigen components.
Founded in 2004, SEEK - previously known as PepTcell - is privately-owned and funded, with headquarters in London, UK. Using a pioneering scientific and commercially-driven approach, SEEK aims to create breakthrough medicines which address major diseases in order to radically improve human health. SEEK's strategy is to take promising molecules through the challenging stages of discovery to late-stage human proof-of-principle and then to seek partners to take the molecules through the final stages of development and ultimately commercialisation. SEEK's current product-development areas are vaccines, inflammation/autoimmune diseases, transplantation tolerance induction, respiratory diseases, cancer and diabetes/obesity.
For further information about SEEK please visit http://www.seekacure.com.
1. Data presented at the World Influenza Congress (Europe), Amsterdam, 8th December 2010. Flu-v 001: A single centre, randomised, double blind, Phase I study of the safety, tolerability and immunogenicity of a single S/C dose of FLU-v, a novel universal influenza vaccine candidate.
2. Flu-v 002: A randomised double-blind, placebo controlled, Phase Ib study in 28 volunteers to evaluate the safety, tolerability and protective efficacy of a single subcutaneous dose of the influenza vaccine candidate FLU-v in an influenza challenge model.