Human Genome says two phase 1 studies show HGS-ETR2 stabilized disease of some refractory cancer patients

By E. Janene Geiss

Philadelphia, Nov. 17 - Human Genome Sciences said Thursday that results of two phase 1 clinical trials show that HGS-ETR2 is well tolerated and can be administered safely and repetitively in patients with advanced solid tumors.

The findings support further evaluation in phase 2 trials, officials said in a company news release.

Thirty-seven patients in the United Kingdom were enrolled in the open-label, dose-escalation trial and had previously received multiple cancer treatments including chemotherapy, immunotherapy, radiotherapy, hormone therapy and/or surgery. Six cohorts received HGS-ERT2 intravenously in a 21-day schedule, officials said.

Results showed that the treatment was well tolerated with minimal toxicity at doses up to 10 mg and could be administered every 21 days. Dose-limiting toxicity was defined at 20 mg.

The study's primary purpose was to evaluate the safety and tolerability of escalating doses in patients with relapsed or refractory solid tumors. Pharmacokinetics and tumor response also were evaluated, officials said.

Thirty-one patients in the United States enrolled in another open-label, dose-escalation trial also previously received multiple cancer treatments. Five cohorts received HGS-ERT2 intravenously in a 14-day schedule.

Results showed that HGS-ETR2 was well tolerated with minimal toxicity at doses up to 10 mg and could safely be administered intravenously every 14 days.

The primary objective was to evaluate the safety and tolerability of escalating doses in patients with advanced solid malignancies. Secondary objectives were to evaluate the pharmacokinetics and tumor response.

One patient experienced a dose-limiting toxicity at the 10-mg dose that was determined to be possibly related to HGS-ETR2 and also possibly related to a nutritional supplement the patient was taking, officials said.

The pharmacokinetics were found to be linear up to 10 mg.

Stable disease was observed in 10 of these heavily pre-treated and refractory patients, officials said.

"In both studies for which data were presented, stable disease was observed in a number of these heavily pretreated and refractory patients. Phase 2 trials of HGS-ETR2 are warranted to evaluate its potential for use in the treatment of specific cancers," Anthony W. Tolcher, director of clinical research at the Institute for Drug Development of the Cancer Therapy and Research Center, and clinical professor, department of Medicine/Oncology, University of Texas Health

Sciences Center in San Antonio, Texas, said in the news release.

The findings, along with another poster of preclinical studies assessing HGS-ETR2 alone and combined with chemotherapeutic agents in non-small cell lung cancer, were presented at the AACR-NCI-EORTC International Conference on Molecular Therapeutics in Philadelphia.

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

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