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Safety of VIRxSYS Gene Therapy
Apr 28, 2006

Is VIRxSYS safe? I have been accepted into a study, but have some concerns about the study. It was brought to my attention that over half of the patients that received this in France died of cancer. In addition, the informed consent docs don't provide a lot of information as it relates to additional animal studies since a mouse developed Leukemia.

I went off of T-20 in December and was advised there wouldn't be any benefit based on Genotyping. I went off of 3TC in November due to a neurological problem. I have failed my current regimen and need to do something promptly.

Response from Dr. Daar

VirXSYS is in relatively early stages of development. The strategy is to modify the patient's own CD4 cells with gene therapy that would protect a subset of the individuals CD4 cells from HIV infection. Previously reported Phase I trials included five individuals and it was stated that based upon these results it would be moving forward into so called phase II studies which may provide additional insight into safety and effectiveness. I am not aware of any further data reported from these trials or the safety concerns you had raised about cancer in patients treated in France.

It is important to know that all clinical research is carefully reviewed for safety during all stages of development. If the company were performing studies abroad, any new data, good or bad, would need to be provided as part of the informed consent process to all future study subjects. I recommend you speak to the investigator about your concerns and s/he will be able to communicate with the company directly and provide you the most up to date information on animal and human studies. Also be aware that while participation in clinical research is essential to move the field forward, research is done for a reason, i.e. we do not know the answers. When they tell you that they can not assure you that any direct benefit will be derived by you as a result of your participation in the trial, believe it. That doesn't mean you should consider this or other studies, just that you need to be a fully informed participant in the process.

If you feel an urgent need to modify your therapy you should sit down with your provider and discuss what options are currently available. This would include using approved treatments, those available through so called "expanded access" programs and clinical trials. There are more options now than ever.

Best, Eric


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