Genetic Engineering & Biotechnology News

SEP1 2013

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Translational Medicine thracycline, taxane, or capecitabine treatments will participate in the trial. The primary endpoint of the study is overall survival and secondary endpoints include progression-free survival, objective tumor response rates, clinical beneft rate, duration of response, PK data, safety profles, quality-oflife measurements, and pharmacoeconomic implications. The study is also evaluating specifc biomarker data to assess correlation with objective tumor response rates, progression-free survival, overall survival, and selected toxicities. > OncoGenex Pharmaceuticals initiated Spruce™, an investigator-sponsored, randomized, double-blind, placebo-controlled Phase II trial evaluating OGX-427, a heat shock protein 27 (Hsp27) inhibitor, in patients with previously untreated advanced nonsquamous non-small-cell lung cancer (NSCLC). Spruce will randomize approximately 155 patients with nonsquamous NSCLC to receive either OGX-427 plus carboplatin and pemetrexed therapy or placebo plus carboplatin and pemetrexed therapy. Patients may also continue maintenance therapy with pemetrexed and/or OGX-427/placebo until disease progression or unacceptable toxicity. The primary objective of the trial is progression-free survival, with additional analyses to evaluate tumor response rates, overall survival, safety, tolerability, and the efect of therapy on Hsp27 levels. > Eli Lilly completed SQUIRE, a Phase III trial, and reported that it met its primary endpoint. the study found that patients with stage IV metastatic squamous non-small cell lung cancer (NSCLC) experienced increased overall survival when administered necitumumab (IMC-11F8) in combination with gemcitabine and cisplatin as a frst-line treatment, as compared to chemotherapy alone. SQUIRE enrolled 1,093 patients—age greater than or equal to 18 years—with histologically or cytologically confrmed, stage IV squamous NSCLC, who had received no prior therapy for metastatic disease. Patients were randomized to receive frst-line necitumumab plus chemotherapy consisting of gemcitabine and cisplatin in study Arm A, or gemcitabine-cisplatin chemotherapy alone in study Arm B. Patients underwent radiographic assessment of disease status—computed tomography or magnetic resonance imaging—every six weeks (+/- 3 days), until radiographic documentation of progressive disease (PD). Chemotherapy continued for a maximum of six cycles in each arm and patients in Arm A continued to receive necitumumab until there was radiographic documentation of PD, toxicity requiring cessation, or withdrawal of consent. The most common adverse events occurring more frequently in patients on the necitumumab arm were rash and hypomagnesemia. Serious, but less frequent, adverse Send your Clinical Trials to sbhutta@GENengnews.com events occurring more often on the necitumumab arm included thromboembolism. Rheumatoid Arthritis > Isis Pharmaceuticals reported that rheumatoid arthritis (RA) patients treated with ISIS-CRPRx achieved rapid, dose-dependent mean reductions of up to 67% in C-reactive protein (CRP) in a Phase II study. Patients treated with ISIS-CRPRx showed im- provements in signs and symptoms of RA. The study is randomized, placebo-controlled, multiple-dose in patients with RA who had chronically elevated CRP. In the trial, 51 patients received 100 mg, 200 mg, or 400 mg dose of ISIS-CRPRx or placebo for 12 weeks. Patients treated with ISIS-CRPRx achieved substantial, dose-dependent reductions in CRP early in treatment that were prolonged through the treatment process. Patients also experienced improvements in the signs and symptoms of RA, as measured by ACR20 and ACR50 scores. According to the company, these improvements correlated with reductions in CRP, but were not sufciently greater than improvements observed in the placebo groups, which demonstrated a higher than expected response in both symptom score and CRP reduction. n Scan the code with your mobile device to go directly to SLAS2014.org Short Courses: January 18 - 19 Conference: January 20 - 22 Exhibition: January 19 - 21 Why Participate in SLAS2014, the Third Annual SLAS Conference and Exhibition? Keynote Presenters Eric J. Topol, M.D. Because it's where more than 5,000 of the best laboratory science and technology minds from across the globe come together to learn, explore and share the latest know-how and innovaton in laboratory technology. Join your colleagues—innovative scientists, engineers, researchers and technologists from academic, government and commercial laboratories—at SLAS2014 and directly beneft from 130 outstanding podium presentatons comprising 30 unique scientfc sessions, hundreds of posters and new and emerging technologies from 300+ exhibitors from around the world. Partcipatng at SLAS2014 is an invaluable investment that pays signifcant dividends towards your personal and organizatonal goals, as well as your professional success. Register now at SLAS2014.org SLAS2014 Scientifc Program Crosses a Diversity of Industries and Interests • • • • Drug Discovery and Development Informatcs Clinical Diagnostcs Technology Transfer • Laboratory Instrumentaton • Synthetc Chemistry • Healthcare Jad Abumrad Co-host and Creator, Radiolab Robert Krulwich Co-host, Radiolab Dates to Remember Tony B. Academic Travel Award Poster Submissions Due: Monday, September 16, 2013 Poster Abstract Submissions: Due: Monday, October 28, 2013 (Deadline for inclusion in Student Poster Competton and to be included in the Final Program) SLAS 2014 Educational Tracks • Assay Development and Screening • Automaton and High Throughput Technologies • Bioanalytcal Techniques Director, Scripps Translatonal Science Insttute Chief Academic Ofcer, Scripps Health Professor of Genomics, The Scripps Research Insttute • • • • Diagnostcs and Biomarkers Drug Target Biology Informatcs Micro/Nano Technologies Monday, January 6, 2014 (Final Deadline; Not included in Final Program) SLAS Member Early Bird Registraton Deadline: Due: Thursday, October 31, 2013 Premier Sponsor: Genetic Engineering & Biotechnology News | GENengnews.com | September 1, 2013 | 53

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