Boehringer Ingelheim has extended research funding for another year in its Alzheimer's disease collaboration with
Ablynx. In January 2007 the companies entered into a $265 million worldwide research and licensing agreement to discover and develop new therapies for Alzheimer's disease using Ablynx's Nanobodies, a class of therapeutic proteins. The agreement included a joint research program with Ablynx scientists.
BI will be responsible for the development, manufacture and commercialization of any products resulting from the collaboration. As part of the collaboration, Ablynx received an upfront fee and will receive development and commercial milestones as well as undisclosed royalties based on net sales.
Dr. Edwin Moses, chief executive officer and chairman of Ablynx, commented, "We are very pleased with the progress that has been made in our joint Alzheimer's disease program with BI. We look forward to continue working together with BI in this medical area which urgently requires an innovative approach."
Bayer HealthCare Pharmaceuticals and
Onyx Pharmaceuticals began enrolling patients in the STORM (Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma) trial. The randomized, double-blind, placebo-controlled Phase III study is evaluating Nexavar (sorafenib) tablets as adjuvant treatment for patients with hepatocellular carcinoma (HCC), or primary liver cancer.
"Nexavar is the only systemic therapy with proven efficacy and tolerability in HCC across multiple patient populations," said Dimitris Voliotis, M.D., vice president, Nexavar Clinical Development, Bayer HealthCare Pharmaceuticals. "Liver cancer is the third largest global cancer killer worldwide and there is a significant need for new therapies that can be used at all stages in the course of the disease to delay disease progression and prolong life."
In addition, the FDA has completed a SPA for the STORM trial. An SPA is a written agreement on the design and size of a trial intended to form the basis for a new drug application.
The trial is expected to enroll approximately 1,100 patients and will include patients who have received surgical resection or local ablation. The study will look at whether oral Nexavar delays the time to recurrence and increases overall survival. The primary endpoint of the study is recurrence free survival. Secondary endpoints include overall survival, time to recurrence, patient-reported outcomes, plasma biomarkers, safety and tolerability.
Lex Jansen has been appointed senior consultant, Clinical Data Strategies,
Octagon Research Solutions. In his new role, Mr. Jansen will serve as a consultant on Clinical Data Interchange Standard Consortium (CDISC) Study Data Tabulation Model (SDTM) implementations for pharma and biopharma organizations. Mr. Jansen will offer guidance on the use of data integration technologies and best practices to convert electronic clinical data into CDISC SDTM compliant format.
Mr. Jansen has nearly 20 years of professional experience in the pharmaceutical industry. Prior to joining Octagon, he was the senior director, Clinical Information Systems at TAKE Solutions where he consulted with clients to help them with their CDISC SDTM implementations and designed a SAS toolset to support SDTM implementations. He also spent 16 years at Organon where he was responsible for the global biometrics SAS infrastructure and served as technical lead for the CDISC Implementation Team, project lead and technical lead for Organon’s CDISC SDTM Late Stage Conversion Project and a core member of the SDTM-based data warehouse project. He is a member of the CDISC, Operational Data Model (ODM) team and a member of the editorial board of the journal, Pharmaceutical Programming.
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