ROCKVILLE, Md., Aug. 22 Human Genome Sciences,Inc. (Nasdaq: HGSI) today announced that it has completed the enrollment andinitial dosing of patients in a randomized Phase 2 trial of HGS-ETR1(mapatumumab) in combination with the chemotherapy agents paclitaxel andcarboplatin as first-line therapy in advanced non-small cell lung cancer(NSCLC).
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"There is an urgent medical need for effective treatment options for non-small cell lung cancer because current treatment strategies have only aminimal impact on survival," said Joachim von Pawel, M.D., a principalinvestigator in the study from the Asklepios Fachkliniken Munchen-Gauting,Germany. "The majority of patients who are newly diagnosed with non-smallcell lung cancer have locally advanced or metastatic disease that is currentlyincurable. We look forward to evaluating the potential of mapatumumab pluschemotherapy to offer a new approach to the first-line treatment of thisdeadly disease."
The NSCLC trial is a randomized, multi-center, open-label Phase 2 study toevaluate the efficacy and safety of HGS-ETR1 in combination with carboplatinand paclitaxel as first-line therapy in the treatment of advanced non-smallcell lung cancer (Stage IIIB or IV). 111 patients have been randomly assignedto one of three treatment groups and treated with either the two-agentcombination of carboplatin and paclitaxel or the three-agent combination ofcarboplatin, paclitaxel, and HGS-ETR1 at either 10 mg/kg or 30 mg/kg. HGSannounced the initiation of the NSCLC trial In December 2007.
"A growing body of preclinical data suggests that combining HGS-ETR1 withchemotherapy agents could be an effective approach to the treatment of anumber of malignancies, including non-small cell lung cancer," said GillesGallant, B. Pharm., Ph.D., Vice President, Clinical Research - Oncology, HGS."HGS-ETR1 is the most advanced of any product in development that targets theTRAIL apoptotic pathway. The NSCLC study is one of three ongoing HGS trialsdesigned to evaluate combinations of HGS-ETR1 with chemotherapeutic agents forthe treatment of specific cancers."
About the HGS-ETR1 Proof-of-Concept Trials
The HGS-ETR1 proof-of-concept phase includes three randomized trials toevaluate its potential in combination with chemotherapy for the treatment ofspecific cancers:
-- Randomization and initial dosing of patients in the NSCLC study havenow been completed.
-- In July 2008, HGS initiated dosing in the safety lead-in to arandomized Phase 2 trial of HGS-ETR1 in combination with Nexavar (sorafenib)in patients with advanced hepatocellular cancer, which accounts for 80-90% ofall liver cancers.
-- The Company expects to have initial data available in the third quarterof 2008 from a randomized Phase 2 trial of HGS-ETR1 in combination withVelcade (bortezomib) in advanced multiple myeloma. Patients in the multiplemyeloma study will continue on treatment until the progression of disease.
These three trials, taken together, will support a decision on whether toadvance HGS-ETR1 to Phase 3 development. It also is possible that asufficiently positive result from any one of the trials could lead to a Phase3 decision for that specific indication.
About Non-Small Cell Lung Cancer
Non-small cell lung cancer accounts for approximately 75-80% of all lungcancers. It is estimated that more than 170,000 new cases and more than160,000 deaths occur annually in the United States alone. It is currently theleading cause of cancer death in the U.S. in both men and women.
HGS-ETR1 (mapatumumab) is an agonistic human monoclonal antibody thatdirectly induces cancer-cell death by specifically binding to and activatingthe protein known as TRAIL receptor 1. Using genomic techniques, HGSoriginally identifie