AMES, IA -- (Marketwired) -- 05/06/13 -- NewLink Genetics Corporation (NASDAQ: NLNK), a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapies to improve treatment options for patients with cancer, today reported consolidated financial results for the first quarter of 2013.
"We are looking forward to completing patient accrual for our IMPRESS trial of algenpantucel-L for surgically resected pancreatic cancer. It was also encouraging to see additional clinical trials of both our HyperAcute and IDO product candidates advancing this past quarter," commented Dr. Charles Link, Chairman and Chief Executive Officer of NewLink. "In addition, NewLink presented preclinical results for our second IDO pathway inhibitor drug candidate, NLG919, at the American Association for Cancer Research annual meeting. Based on these data, we plan to initiate a clinical trial with NLG919 later this year, further expanding our clinical development programs."
First Quarter and Recent Accomplishments
•Demonstrated significant progress towards completing enrollment in our IMPRESS (Immunotherapy for Pancreatic Resectable cancer Survival Study) Phase 3 trial with algenpantucel-L for patients with surgically resected pancreatic cancer. The primary endpoint for this open label, randomized, multi-centered, 722 patient trial is overall survival. As determined by Special Protocol Assessment (SPA), the first interim analysis will be conducted when 222 deaths are reported for the study. •Continued patient accrual in our randomized Phase 2B/3 trial comparing tergenpumatucel-L to docetaxel for patients with previously treated non-small cell lung cancer. We expect to add additional sites in the coming months for this trial which has a planned accrual of 240 patients. •Launched a randomized, placebo controlled Phase 2 study for patients with metastatic breast cancer evaluating the combination of docetaxel with NewLink's most advanced small molecule IDO pathway inhibitor, indoximod. This Phase 2 clinical study will enroll up to 120 patients and follows the successful Phase 1b dose-escalation study of indoximod in patients with advanced solid tumors in which a favorable safety profile and promising early signs of activity were observed. •Pre-clinical data on NLG919 demonstrating on target anti-tumor effects and synergy with indoximod were presented at the American Association for Cancer Research annual meeting. Favorable oral bioavailability, pharmacokinetic and pharmacodynamic profiles were also reported. NLG919 is NewLink's second small molecule IDO pathway inhibitor and, based on these data, is expected to enter human clinical trials by the end of this year.
•Appointed Brian Wiley as Vice President Business Development and head of pre-commercialization activities for algenpantucel-L. Mr. Wiley has extensive oncology business development and commercialization experience within the pharmaceutical industry. •Closed Public Offering with aggregate net proceeds of approximately $49.0 million providing NewLink with resources to advance its lead development programs to their next major data points.
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