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Human Genome Sciences Presents New Data Showing Anti-Tumor Activity And Safety Of Trail Receptor Antibodies In Combination With Chemotherapy
Date:10/24/2007

AIL receptors 1 and 2 offer a targeted mechanism of cancer-cell death that can be administered safely in combination with a variety of proven chemotherapies," said Gilles Gallant, B. Pharm., Ph.D., Vice President, Clinical Research - Oncology, HGS. "The data suggest that both pre-treatment and co-treatment with chemotherapy may be effective approaches to the use of TRAIL receptor antibodies for the treatment of cancer."

About the Results of the Phase 1b Trial of HGS-ETR2

In the first reported clinical trial of a TRAIL receptor 2 agonist in combination with chemotherapy, 41 patients with a wide range of solid malignancies received HGS-ETR2 plus a full-dose regimen of chemotherapy (gemcitabine, pemetrexed, doxorubicin or FOLFIRI). Four to seven patients in each chemotherapy cohort received HGS-ETR2 intravenously at doses of either 5 mg/kg or 10 mg/kg.

The results showed that HGS-ETR2 in combination with full-dose chemotherapy was generally safe and well tolerated. Objective responses were reported for two patients (a colorectal cancer patient in the FOLFIRI arm, and a small-cell lung cancer patient in the doxorubicin arm). Stable disease was observed in 22 patients. Overall, the nature and severity of adverse events were consistent with the underlying disease and known safety profile of the chemotherapeutic regimens. The pharmacokinetics of HGS-ETR2 were not influenced by the chemotherapeutic agents, nor did HGS-ETR2 affect the pharmacokinetics of gemcitabine, doxorubicin or irinotecan. Further studies of HGS-ETR2 in combination with chemotherapy are warranted.

"The results of the Phase 1b study of HGS-ETR2 show that it is well tolerated and can be repetitively administered in combination with standard chemotherapy agents in patients with a variety of advanced solid malignances," said Norma Lynn Fox, Ph.D., Senior Director, Clinical Research, HGS. "We were encouraged by the observation of objective responses in two patients and stable disease i
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SOURCE Human Genome Sciences, Inc.
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