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Novel drugs help solve Gleevec resistance

ove to be safe, and the study can move seamlessly from Phase I into Phase II. "No patient is ever 'stuck' at a lower, potentially ineffective dose," says Giles, who helped design the protocol. "Everyone keeps moving up until we find the best dose that is both safe and active." Doses from 50 milligrams to 1,200 milligrams have been tested so far. "This kind of study is in the best interest of patients because it gives us the power and the numbers to quickly find the dose that can work best," he says.

The study is funded by Novartis, which manufacturers both AMN107 and Gleevec.

Both drugs have "tight" mechanism of action

Gleevec, as well as its two new companions, reduces the activity of an abnormal tyrosine kinase enzyme that leads to uncontrolled cell growth. Both CML and Philadelphia-positive ALL is caused by the swapping of genetic material in bone marrow stem cells between chromosome 9 and 22, producing an abnormality called the Philadelphia chromosome (named for the city from where the first patient in whom it was seen resided).

Specifically, a fusing of a piece of chromosome 9 that contains part of the ABL gene with a piece of chromosome 22 that contains part of the BCR gene forms the new cancer causing gene, BCR-ABL. This oncogene produces a tyrosine kinase that turns on multiple signals that tell the cells to grow and divide in an uncontrolled manner leading to overt leukemia. Gleevec binds to the abnormal enzyme (Bcr-Abl) and shuts down its activity, often leading to the death of the leukemia cell.

AMN107 is up to 30 times more potent than Gleevec because it was designed to more efficiently bind to the enzyme, Giles says. "Through molecular, chemical and crystallography studies, we now know the detailed structure of the enzyme, which allowed the development of the better-fitting drug AMN107," he says. "This both increases the effectiveness of the agent and perhaps reduces the potential of developing resistanc
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Contact: Nancy Jensen
nwjensen@mdanderson.org
713-794-1584
University of Texas M. D. Anderson Cancer Center
5-Dec-2004


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