Press release

NUTRICIA PRESS RELEASE: BITE/HIV TRIAL
September 14th 2009
Nutricia Advanced Medical Nutrition announces positive outcomes in a trial targeting the immune system in HIV patients
Nutricia's novel nutritional concept shows significant reduction in CD4+ T cell decline over 52 weeks

San Francisco, USA. Nutricia Advanced Medical Nutrition has announced the results of a clinical trial targeting immunity in HIV patients with a specific nutritional concept, NR100157. Following 52 weeks of treatment, patients using NR100157 experienced a significantly reduced decline in their CD4+ T cell count in comparison to a control group. The results of the trial will be presented to the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) today, by Professor Pedro Cahn, former chair of the International AIDS Society.
HIV affects 34 million people worldwide today with more than 2.5 million new infections every year. Slowing the progression of the disease mainly depends on maintaining patients’s immunity levels. CD4 count is an indicator of the strength of the individual’s immune system and has become the gold standard in tracking HIV disease progression and decline in immune response. It has also become one of the standard reference measures in pharmaceutical treatments for HIV-1 positive adults.
In extensive pre-clinical development and testing, Nutricia scientists designed nutritional concept NR100157 to target the immune system and the barrier function of the gut. In 2007, they began an international multi-centre, double-blind controlled clinical trial to investigate the impact of the concept on the health of several hundred HIV positive patients not yet on antiretroviral therapy.

At the mid-point of the trial, a planned interim analysis reviewed full data for 340 patients. The analysis demonstrated a clear difference in CD4 count between two trial groups after 52 weeks. For the study group taking NR100157, the CD4 count remained significantly higher than for a control group. The trial has now been halted, and Nutricia intends to publish the outcomes, following appropriate peer review.
Flemming Morgan, President of Nutricia Advanced Medical Nutrition, comments: "These results are very encouraging, and the evidence is now building that medical nutrition may be able to make a difference in the lives of patients not only in HIV, but across a broad spectrum of immune-related conditions. The trial outcomes mark another important step forward for our research teams at Nutricia, who have already demonstrated the efficacy of a nutrition-based approach to disease management in areas such as respiratory disease, diabetes, epilepsy and Alzheimer’s."
Based on recommendations from the independent board monitoring the trial, Nutricia is now preparing an accelerated development path for this novel nutritional concept, including further refinement of the intended product and an ambitious timetable for follow-up clinical research and development.

Notes to Editors
More about the Trial
This international, multicentre, controlled double-blind clinical trial began recruiting patients in January 2007. At the half-way stage in 2008, a planned interim analysis was performed on full trial data from the first 340 patients. At this stage, these data clearly demonstrated a significant difference in the trial’s primary end point of CD4+ T-cell count between the two trial arms.
For the study group taking NR100157 (n=168) the CD4 count remained higher than for the control group (n=172), with a difference at 52 weeks of 40 cells in favour of the NR100157 arm (control group -68 cells, active group -28 cells, p=0.03). With no clinical safety concerns to patients seen in the data, the trial was therefore stopped early and the results de-blinded.
The study was conducted in eight countries: Australia, Argentina, Brazil, Italy, The Netherlands, Thailand, USA and UK.
The nutritional concept NR100157 has been designed specifically to address the specific challenges that HIV infection causes to gut integrity, including significant disruption in the normal gut barrier function, local gut inflammation and immune activation.

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