Almac Announce World’s Largest Gene Expression Study To Develop Prognostic Test for Early Non Small Cell Lung Cancer

July 31, 2008

CRAIGAVON, NORTHERN IRELAND– (31 July 08) – Almac Diagnostic Services has today announced details of a global multi-center collaborative lung cancer study with leading research organizations in the USA, Canada, Asia and Europe which according to Professor Paul Harkin has the “potential to benefit many thousands of patients worldwide”.  The study is led by Dr Dean Fennell, Cancer Research UK Clinician Scientist and Senior Lecturer in Thoracic Medical Oncology at Queen’s University Belfast. The study, managed in partnership with Almac Diagnostic Services will utilize over 1,500 non-small cell lung cancer (NSCLC) tumor samples from 15 research centers.

The aim of the study is to generate a gene expression signature that will allow clinicians to stratify patients with early NSCLC (Stages I and II) into those who will relapse after surgery and those who will have disease free survival with surgery alone. This gene signature will form the basis of a clinical test to identify patients at high risk of lung cancer recurrence after surgery and who may therefore benefit from adjuvant treatment.

The study will utilize Almac’s unique Cancer DSA™ technology; a proprietary microarray platform designed to measure gene expression in archived FFPE (formalin fixed paraffin embedded) tissue. This microarray platform identifies tens of thousands of transcripts that are specific to lung cancer and not available on conventional commercial arrays.

The use of FFPE tissue samples will enable Almac to retrospectively generate and validate this powerful prognostic test.  This has clear clinical utility, as frozen tissue is not routinely collected during surgery.

To date most prognostic gene expression signatures have been developed using relatively small numbers of samples. The benefit of being able to access large numbers of archive samples retrospectively is the ability to identify molecular sub types which are likely to influence patient’s prognosis.

Professor Paul Harkin President and Managing Director of Almac Diagnostic Services explained: “This is the largest transcriptional study of its type and has the potential to benefit many thousands of patients worldwide. Our microarray technology means we can now access a wide range of genetic material, previously not available through commercial array analysis, in order to validate prognostic tests. This fits in with Almac’s vision to be the global leader in the provision of translational genomic based solutions for the advancement of patient care”.

Dr. Dean A. Fennell, the Academic Lead on the study from the Center for Cancer Research and Cell Biology at Queen’s added: “Lung cancer is a global health burden and it accounts for around 30% of cancer deaths in the USA and Europe. Prognosis following diagnosis of NSCLC, the most common form of the disease in 80% of patients, remains abysmal with an overall 5-year survival of only 10-15%, a figure which has not changed in decades. However one fifth of patients have early stage NSCLC that is potentially curable following surgery which results in 5-year survival rate of 40-82%, depending on the tumor size and the degree of local invasion. “While it is now accepted that the use of adjuvant chemotherapy reduces the risk of recurrence in a minority of patients no routinely used molecular test exists to select those patients at a high risk of recurrence. This large scale gene expression study will generate the first such test capable of identifying patients with high risk NSCLC. It is anticipated that submission to International regulatory bodies for approval will occur by 2010 to enable its routine implementation in the clinic.” he added.

Professor Giorgio Scagliotti, University of Turin, Department of Clinical and Biological Sciences and leading world expert on Lung Cancer said:

“Potentially this study will generate data easily applicable to clinical practice and will hopefully lead to a much better treatment optimzation for our patients”

Contact:

Michael Sloan

Almac Diagnostic Services

T: + 44 (0) 2838 337575

diagnostics@almacgroup.com

www.almacgroup.com/diagnostics

Brendan Mulgrew

Stakeholder Communications

T: + 44 (0) 2890 339949

NOTES TO EDITOR:

About Almac Diagnostic Services:

Almac Diagnostic Services provides translational genomic based solutions for pharma, biotech and academic customers. Almac specializes in working with fresh and FFPE tissue for generation of predictive and prognostic tests, drug development, target identification and companion diagnostics.

About Almac Group:

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/Web/EDC), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company has over 2,000 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. For more information about the Almac Group, please visit www.almacgroup.com.

About Cancer DSA™ Technology:

Almac has developed a range of Cancer DSA™ research tools to facilitate the provision of solutions for the oncology market. The Cancer DSA ™ research tools are the first high-density transcriptome based microarrays which focus on the transcriptome of a particular disease. They contain the most comprehensive information available for the disease under investigation on a single array and enable the obtaining of robust data from FFPE and FF sample, while delivering additional information on the disease setting.

The following DSA™ research tools are now available: Lung DSA™, Ovarian DSA™, Colorectal DSA ™, Breast DSA™ & Prostate DSA™.

About the study:

Collaborators in the study include Queen’s University Belfast, University of Turin, St. James Hospital, Dublin University of Texas MD Anderson Cancer Center, Royal Brompton and Harefield Hospital London and Saccomanno Research Institute at St. Mary’s Hospital & Medical Center, Grand Junction, Colorado and Guy’s & St Thomas NHS Foundation Trust.

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