Georgia Cancer Specialists Conducting Phase I Clinical Trial of a Novel Cancer Drug

Thursday, December 22nd, 2005

Drug Compound Given to Humans for First Time Ever

Georgia Cancer Specialists (GCS), the largest private oncology/hematology practice in the Southeast, recently began testing a new experimental drug that has been found to block genes that prevent cancerous cells from dying. The first patient ever to receive this drug, which is administered in a pill form, was treated on January 31, 2005, at the GCS Northside office, located on the campus of Northside Hospital.

The experimental drug, AT-101, comes from the gossypol class and has been found to block the bcl-2 and bcl-x oncogenes, two genes that are highly expressed on a variety of tumor types. Oncogenes are cancer-causing genes that prevent cancerous cells from dying. Blocking such genes leads to cancer cell death (apoptosis) and is one way of specifically targeting tumors.

This Phase I trial will test the safety, tolerability, and pharmacokinetic properties (the process by which the drug is absorbed, distributed, metabolized, and eliminated by the body) of AT-101.

Dr. Mansoor Saleh, Director of Clinical Research for GCS, said, “We are excited about this experimental compound and hope this trial will shed light on some critical properties of AT-101 when administered to patients with cancer.”

The study is a Phase I, open label, multi-center, dose escalation study with the primary objective being to characterize the safety, and determine the maximum tolerated dose, of AT-101 when administered to patients with advanced cancer.

The GCS Northside office in Atlanta is the only center in the region that will be conducting this trial. Also participating in the trial are the University of Alabama-Birmingham and the Mayo Clinic in Minnesota.

James Gilmore, Research Operations Director for GCS, said, “Phase I trials are only the first testing stop for a new drug, and are generally only conducted at major academic centers. We are very proud to be able to offer this trial in the community setting here at GCS.”

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