Human Genome says trials of HGS-ETR1 with chemo show promise in fighting advanced solid tumors

By E. Janene Geiss

Philadelphia, Nov. 17 - Human Genome Sciences, Inc. said Thursday that the results of two ongoing phase 1b clinical trials demonstrate that HGS-ETR1 in combination with chemotherapy agents was well tolerated and could be administered safely and repetitively in patients with advanced solid tumors.

Partial response was observed in a number of patients in each of the studies and the findings support further evaluation, officials said in a company news release.

Twenty patients in an ongoing open-label, dose-escalation trial conducted in the United States had previously received multiple cancer treatments, including chemotherapy, radiotherapy and surgery, officials said.

Three dose cohorts received HGS-ETR1 in combination with paclitaxel and carboplatin intravenously every 21 days with escalating doses. The primary objective was to evaluate safety and tolerability of escalating doses of HGS-ETR1 with chemotherapy agents. Secondary objectives were pharmacokinetic analysis and tumor response, officials said.

Results to date showed the combination was well tolerated. Tumor response in patients is being evaluated, but four patients have had partial response to the treatment. Stable disease was observed in 10 patients, officials said.

Another similar, open-label study in the Netherlands enrolled 16 patients who received HGS-ETR1 with gemcitabine and cisplatin.

Results showed the combination was well tolerated. Partial response was observed in five patients. Stable disease was observed in nine patients, officials said.

The findings were presented Thursday in poster sessions at the AACR-NCI-EORTC International Conference on Molecular Therapeutics in Philadelphia.

"Both the combination of HGS-ETR1 with paclitaxel and carboplatin, and the combination of HGS-ETR1 with gemcitabine and carboplatin were well tolerated and could be administered safely at the doses and schedules evaluated. Partial response was observed in a number of patients in each of these studies. The maximum tolerated dose was not reached in either trial. Further phase 2 studies of both combinations appear to be warranted," Roger B. Cohen, director of phase 1 clinical trials program at Fox Chase Cancer Center in Philadelphia said in the news release.

Human Genome is a Rockville, Md., biopharmaceutical company focused on novel protein and antibody drugs.

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