Vacc-C5 to be prepared for phase I/II clinical trial

Nutri Pharma ASA's wholly owned subsidiary Bionor Immuno AS, has today announced that it will take the therapeutic and potentially preventative HIV-vaccine candidate Vacc-C5 towards phase I/II clinical trial

Oslo, Norway | March 14, 2010 | Based on encouraging results from pre-clinical research, Nutri Pharma ASA's wholly owned subsidiary Bionor Immuno AS, has today announced that it will take the therapeutic and potentially preventative HIV-vaccine candidate Vacc-C5 towards phase I/II clinical trial.

- Research results to date indicate that Vacc-C5 may induce a protective antibody response in HIV patients similar to that found in patients with a very slow or non-progressing disease. This naturally very slow or non-progressing HIV infection observed in a small minority of patients has been the subject of academic interest for years and our discovery of these antibodies in such
patients could lead to a significant shift in the approach to treating HIV. The results have been presented to the company's Clinical Advisory Board with very encouraging feedback, says Birger Sørensen, CEO of Bionor Immuno.

Vacc-C5

The main trigger behind the disease progression from HIV to AIDS is the hyper-activation of the immune system. This hyper-activation overwhelms and gradually causes a collapse in the immune system, leading to the AIDS stage of the disease.

From research on blood donated by patients with a very slow or non-progressing HIV disease, the company has succeeded in identifying a specific part of the virus, C5, which is believed to induce hyper-activation of the immune system. Antibodies to this specific part are likely to be protective and cause a slow disease progression. Using its unique technology, the company has developed the vaccine candidate Vacc-C5, that is designed to induce a similar antibody response to the one discovered in patients with naturally very slow disease progression. Vacc-C5 has passed pre-clinical research tests showing that it has
the potential to induce the desired antibodies.

The antibodies induced by Vacc-C5 are expected to be beneficial at all stages of HIV disease and produce a dual effect; i) slowing down or halting the disease progression and ii) significantly reducing the production of virus. It is believed that the combination of Vacc-C5 together with Vacc-4x, the company's most advanced vaccine candidate (currently in phase II placebo controlled international multicenter trial with 135 patients enrolled; results expected in October 2010), could form a potent preventative HIV vaccine.

Clinical trial program going forward

As part of the preparations for a Phase I/II clinical trial to be initiated in 2011, the company will carry out routine toxicity tests, to ensure the safety of the Vacc-C5 components. The toxicology program is planned to be completed by Q2, 2011.
Following the decision to move Vacc-C5 forward towards clinical testing, the company has placed an order with Bachem for the production of pharmaceutical-grade vaccine components to be used in the upcoming trial.

The HIV-market

In 2008 the UN estimated 33.4 million people are living with HIV globally, of which 2.14 million have access to highly effective treatment. The latter have access to antiretroviral therapy at a cost of between USD 12-15,000 per annum, per patient. Datamonitor estimates the value of antiretroviral sales in the seven major markets (France, Germany, Italy, Japan, Spain, UK and USA) at USD 11.7 billion. The antiretroviral therapy must be administered at precise intervals during the day and often causes adverse side effects.

SOURCE: Nutripharma

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