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FDA lifts hold on RXi’s cancer drug, NeuVax

The US FDA has lifted its clinical hold on RXi Pharmaceuticals’ cancer drug, NeuVax, enabling phase III trials to commence

The US Food and Drug Administration (FDA) has lifted the clinical hold on RXi Pharmaceuticals' cancer drug, NeuVax. This means phase III trials are likely to commence in the first half of 2012.

NeuVax works through stimulating cytotoxic T cells, which, while not harming healthy cells, seek and terminate Human Epidermal Growth Factor Receptor 2 (HER2) antigens.

The HER2 gene produces a protein, which occurs in certain breast cancers and, if the gene is altered or duplicated, it can overproduce, leading to the buildup of the protein, stimulating cancer cell growth.

The target for NeuVax is the 50 per cent of HER2 positive patients who, through current standard care, achieve remission but have no available HER2 treatment in order to maintain their disease-free status.

The drug is taken once a month for six months followed by booster injections once every six months.

RXi Pharmaceuticals had to meet all of the FDA's requirements before the hold was lifted. In order to remain on schedule for the drug's trial start date, a clinical trial material manufacturing plan has been put in place.

13th September 2011

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