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First-in-man study demonstrates the therapeutic effect of RNAi gene silencing in cancer treatment
Date:2/11/2013

any Alnylam, scientists have developed a lipid nanoparticle approach that can deliver two of these molecules targeted against the genes encoding two key proteins involved in the development of cancer cells (VEGF and KSP). This system takes the form of a novel drug (ALN-VSP) made up of RNAi molecules and lipid nanoparticles (LNPs).

The new paper, published in the journal Cancer Discovery, presents the results of a Phase I clinical trial, involving 41 patients with advanced cancer that had metastasised to the liver. These patients were treated with the new drug twice a week with intravenous doses of between 0.01-1.5 mg/kg.

The trial found that not only was the drug safely administered, but also presented good evidence for clinical utility. In 11 of the 37 patients, the disease either did not progress or stabilized after six months of treatment. In some cases of patients with metastasis to the liver or abdominal lymph glands, there was a complete regression of metastasis. (It should be noted that the liver typically responds better to treatment due to its excellent capacity to absorb these molecules.)

The research team performed a pharmacodynamics analysis to determine the impact of the drug on the tumours by taking biopsy samples from the patients before and after the drug was administered. This revealed the presence of the RNAi constructs in the samples, thus showing that the structurally modified molecules reached the tumour and were effective.

Having previously tested the drug on animals, this first-in-man clinical test has demonstrated that an efficient formula has been developed to transport and deliver RNAi with clinically promising results. The results will have to be confirmed and extended in additional clinical studies.

The importance of clinical research

This study, which also involved other international research centres including the Dana-Farber Cancer Institute (Boston) and the Memorial
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Contact: Amanda Wren
awren@vhio.net
34-695-207-886
Vall dHebron Institute of Oncology
Source:Eurekalert

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