BOTHELL, Wash.--()--Alder Biopharmaceuticals, Inc., an emerging antibody therapeutics company, today announced results from a Phase 1 clinical study of the Company’s lead monoclonal antibody therapeutic, ALD518, for treatment of advanced cancer demonstrating the drug to be safe, well-tolerated and to reduce fatigue in patients with advanced cancer. Data were presented during a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, Florida. (ASCO Abstract No. 3025)
“There is a dire need for therapeutic options for cachexia, and we look forward to continued investigation of ALD518 for treatment of cachexia.”
ALD518 is a humanized anti-IL-6 antibody being developed for the treatment of cancer cachexia – unplanned weight loss, weakness, muscle atrophy -- and fatigue. The trial enrolled 9 patients with advanced cancer. Patients were assigned to one of three dose-escalating cohorts and received a single I.V. infusion of ALD518. Results demonstrated no dose-limiting toxicities and no grade 3 /4 toxicities. In addition, ALD518 reversed fatigue and increased hemoglobin and albumin.
“In addition to demonstrating that ALD518 was safe and well tolerated, we were especially pleased to see initial signs of efficacy following a single administration,” said Randall Schatzman, Ph.D., Chief Executive Officer of Alder. “Results from this trial supported the advancement of ALD518 into our Phase 2 trial that is currently enrolling patients with non-small lung cancer.”
“Cachexia, or cancer-related fatigue, has an enormous impact on the quality of life of cancer patients, often affecting their daily lives even more than nausea, fatigue or depression,” said Jeff Smith, MD, Alder’s Chief Medical Officer. “There is a dire need for therapeutic options for cachexia, and we look forward to continued investigation of ALD518 for treatment of cachexia.”
ALD518 is currently being evaluated in a Phase 2 randomized, double blind trial to evaluate multiple I.V. doses of ALD518 compared to placebo in patients with non-small cell lung cancer-related fatigue and cachexia. The trial is designed to evaluate safety as well as time to symptomatic progression. Approximately 124 patients will be enrolled in the trial, which is estimated to complete by the end of 2009.
About Cancer cachexia
Cachexia is one of the most devastating symptoms of cancer, afflicting up to 75 percent of all cancer patients. Cachexia deprives patients of their energy, quality of life and, ultimately, their sense of independence. Most patients afflicted with cancer cachexia have non-small-cell lung cancer or cancers of the gastrointestinal tract (esophagus, stomach, colon and pancreas). The foremost sign of cachexia is drastic weight loss, typically greater than 10% of total body weight.
About Alder Biopharmaceuticals
Alder Biopharmaceuticals, Inc. uniquely identifies, develops, and manufactures novel antibody therapeutics to alleviate human suffering in the autoimmune and inflammatory disease areas. Alder’s management team combines decades of industry experience with a proven track record for identifying and developing novel antibody therapeutics. Today the company is actively engaged in developing its own proprietary therapeutics and enabling partners through the out-licensing of its technologies. Current partners include Schering-Plough, Seattle Genetics, Genmab, and two non-disclosed large pharmaceutical companies. For more information, visit www.alderbio.com.
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