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Cancer gene therapy news backgrounder: New ideas fuel next generation gene therapy research

some size that had a very efficient transfer into cells," says Charles Lu, M.D., an assistant professor in the Department of Thoracic/Head and Neck Medical Oncology and co-investigator.

The liposomes carry a new payload as well. They encase, like shrink wrap, a normal p53 gene as well as a second gene, FUS1, which is frequently altered or missing early in the development of many solid tumors.

So far, six patients with metastatic lung cancer have been tested with the therapy in a phase I trial headed by Lu. In all, 30 patients are expected to be enrolled. The trial is a "dose escalation" study, which looks for side effects as doses of the drug are increased. "So far, there have been no significant safety issues," says Lu.

The study is the first to test liposome therapy in treating human cancer, according to Lu. "No one before has tried intravenous injections using liposomes to replace genes that are lost or defective. This non-viral aspect is very different in gene therapy. It may offer major benefits because liposomes are non-infectious. They are inert; there are no infection risks to use bubbles of fat.

"If successful - and that is a very big if - liposomes may prove to be a way to deliver gene therapy systemically, potentially treating metastatic disease in multiple cancer sites," says Lu.

What isn't known yet, however, is how often normal cells will absorb the drug and what effect that will cause. Preclinical study seems to show that tumor cells preferentially take up the bubbles - and researchers are pleased with that finding, although they don't know why it happens - but healthy cells can also sop up the new genes. "It may not have too much of an effect on normal cells because they already have these beneficial genes, but we just don't know yet," says Lu.

While Lu describes himself as "very cautious; it's just a proof of a concept right now," he also says he is "excited, because it took so much to get to where we
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Contact: Nancy Jensen
nwjensen@mdanderson.org
713-792-0655
University of Texas M. D. Anderson Cancer Center
5-May-2004


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