Darien, Conn., Dec 14, 2010 —Life Science Pharmaceuticals (LSP) announced today a milestone related to monoclonal-antibody (mAb) 806 licensed to Abbott. A Phase 1 trial with ABT-806, a humanized version of mAb 806 that selectively targets the epidermal growth factor receptor (EGFR), has been initiated by Abbott in the U.S. The trial will assess the safety and pharmacokinetics of ABT-806 in patients with advanced solid tumors likely or known to express EGFR. A clinical study of the chimeric predecessor mAb, ch806, published in PNAS, suggested an ability to target and bind to EGFR expressing tumors selectively, with essentially no targeting of normal tissues. Preclinical data show that ABT-806 may be effective in treating multiple tumor types.
“We are hopeful that ABT-806 will confirm the preclinical studies performed by Abbott and the Ludwig Institute in humans. We look forward to further expanding our knowledge of mAb 806 with this trial” noted James Fiore, CEO of LSP.
Phase 1 Study Design
The primary goals of this phase 1 trial are to assess the safety and pharmacokinetics of ABT-806 and to determine the recommended dosing for future clinical trials. The trial will enroll up to 30 patients with advanced solid tumors likely or known to express EGFR, either wild-type or mutant, in addition to other standard eligibility criteria. Secondary endpoints will include an assessment of efficacy in different tumor types. A number of biomarker studies related to ABT-806 are also ongoing.
Information about clinical sites and contact information can be accessed at www.clinicaltrials.gov
About Life Science Pharmaceuticals
Life Science Pharmaceuticals, Inc. (LSP) is a biopharmaceutical company dedicated to developing drugs for cancer and other serious diseases. LSP entered into a strategic collaboration to develop mAb 806 and other cancer therapeutics developed by Lloyd J. Old and the dedicated scientists at the Ludwig Institute for Cancer Research in 2006. An LSP monoclonal antibody targeting melanoma is currently in clinical development and several additional mAb’s are in pre-clinical development.
LSP and its independently controlled affiliate, Extended Delivery Pharmaceuticals continually seek to acquire novel, early-stage product candidates for pre-clinical and clinical development.
LSP news releases and other information are available on the company’s Web site at www.investinlife.com
Contact – James Fiore
President & CEO