Almac and Lilly UK have entered into a partnership to develop a companion diagnostic for ALIMTA, with cisplatin, as a combination therapy for non-squamous non-small cell lung cancer.
The study focuses on evaluating Thymidylate Synthase (TS) as a predictive marker of response to Alimta in combination with cisplatin. A number of parallel exploratory analyses will be performed as alternative strategies to identify further potentially novel predictive biomarkers of response to the combination therapy. These include global gene expression profiling from FFPE tumour samples using the Almac Diagnostics Lung Cancer DSA™ research tool.
Paul Harkin, president of Almac Diagnostics, explains;
“Almac is focussed on enabling personalised medicine. Our core expertise is in the discovery and validation of both prognostic and predictive biomarkers. We have a specific expertise in the development of biomarkers from FFPE tissue and are very happy to announce this partnership with Lilly.”
The project will involve a multi-centre, single arm Phase II study that will recruit patients diagnosed at stage IIIB/IV. Almac’s technical team will perform global gene expression profiling, microRNA profiling, SNP genotyping, qPCR validation as well as data analysis and project management of the study. The final endpoint will be the development of a companion diagnostic test that will select patients likely to benefit from treatment with ALIMTA.
Almac Diagnostics Lung Cancer DSA™ research tool
This high density array has been developed through a combination of in-house sequencing and data mining to create the unique information content. It is the first microarray based on the transcriptome of an individual disease and so will maximise the data selected from the specific disease setting allowing Lilly to obtain significantly more reliable and relevant gene expression information that would not be available on a generic array.
About Almac Diagnostics
Almac Diagnostics is a personalised medicine company providing translational genomic based solutions for pharma, biotech and academic customers. Almac specialises in working with fresh and formalin fixed paraffin embedded (FFPE) tissue for generation of predictive and prognostic tests, drug development, target identification and companion diagnostics.
Almac is a financially stable, privately owned organisation with over 30 years experience, it provides integrated development solutions to over 600 customers worldwide including all the world leaders in the pharmaceutical and biotechnology sectors. Their services include R&D, translational genomic services; API manufacture; formulation development; clinical trial supply and technology (IVRS/IWRS/ePRO) and commercial-scale manufacture.
The company has over 2,500 employees and is headquartered in Craigavon, Northern Ireland, where it was awarded “Business of the Year 2009”. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $112m North American Headquarters in PA started in July 08 and will be completed in 2010.