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SEEK Awarded FP7 Grant to Fund Phase IIb Trial of Universal Flu Immunotherapeutic


10/15/2013 9:42:52 AM

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London, UK, 15 October 2013: SEEK, a privately-owned UK pharmaceutical group, announces that it has been awarded a prestigious European Union Framework Programme 7 (FP7) grant to advance the development of its universal flu immunotherapeutic, FLU-v. It also announced the appointment of Steven Powell, who will be responsible for the commercialisation of the group’s immunotherapeutic products, including vaccines, anti-virals and monoclonal antibodies in the area of Flu, HIV, Hep B and C, TB, Malaria and Chagas disease.

SEEK's role in the pan-European consortium, that has been awarded an FP7 grant of EUR5.3 million, is to carry out a Phase IIb clinical trial on its immunotherapeutic FLU-v.

SEEK’s immunotherapeutic targets regions of the flu virus that is found on all influenza strains, including pandemic strains. This means that people can be given the medicine at the start of every flu season, even before the strain for that year is known, and even if that strain turns out to be a pandemic strain. The medicine will reduce the severity and duration of the flu and people may not even know they have had the flu. Unlike other such immunotherapeutics, this medicine can be taken before the individual contracts the flu. To date it has shown no associated side effects.

It has become increasingly clear that boosting a person’s T cells to the non-mutating regions of flu strains greatly reduces the severity of the disease. Recent data published by Southampton University[1] and Imperial College[2] supports this position.

Commenting on today’s announcement, Gregory Stoloff, CEO of SEEK Group said: “This FP7 funding provides external validation of our efforts and makes the prospect of bringing this medicine to market a reality. It is a much needed medicine that could finally break the stress and pressures placed on the health communities and governments in dealing with pandemic and annual flu.”

“We are delighted that Steven has joined SEEK to accelerate the development of our immunotherapeutic programmes.” Steven Powell has over 25 years’ experience in the pharmaceutical and biotechnology industry. He was previously Chief Executive Officer of Plethora Solutions Holdings PLC and provides advisory services to Gilda Healthcare Partners B.V. He has non-executive roles in other entities within the industry. He started his career in research at GlaxoSmithKline as a Development Scientist and subsequently held senior management positions with pharmaceutical and biotechnology companies. Dr Powell graduated in Microbiology from the University of Wales and was awarded a PhD from the University of Aberdeen.

About the Phase IIb trial

A randomised double-blind placebo Phase IIb trial will consist of 1600 volunteers split between 4 groups. Volunteers will be male and females aged between 18 and 60 years of age. There will be 4-5 centers across Europe. Volunteers will receive two treatments 21 days apart prior to the start of the flu season. The primary endpoint of the trial is to measure reduced rates of infection and severity of infection over two flu seasons.

SEEK’s Universal Flu immunotherapeutic should be available for fast track approval status and hence could be available, if approved by the regulators, over the next 3 years.

About Flu

Flu 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 3 and 5 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.

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-inoculation of at-risk individuals.

[1] Southampton University, UK. Preexisting influenza-specific CD4+ T cells correlate with disease protection against influenza challenge in humans. Nature Medicine (2012)

2 Imperial College London, London, UK. Cellular immune correlates of protection against symptomatic pandemic influenza. Nature Medicine (2013)

For more information please contact:

Gregory Stoloff, CEO, SEEK Tel +44 (0)20 7153 6570

Hume Brophy

Mary Clark / Hollie Vile / Supriya Mathur Tel +44 (0)20 3440 5654

seek@humebrophy.com

About SEEK

Founded in 2004, SEEK (previously known as PepTcell) is privately-owned and funded, with headquarters in London, UK. SEEK brings safe and low costs medicines to the patients as quickly as possible. It does this by modifying existing medicines to improve their efficacy within current label, dose and regime, by changing the indication but keeping the dose and dosing regime the same or by creating a new medicine when the previous options are unavailable.

Additional information about SEEK is available on the Company’s website located at www.seekacure.com

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