NEWS PRECOS expands drug discovery models FDA News
FDA approves Genzyme multiple sclerosis treatment
The FDA has approved Genzyme’s AUBAGIO (teriflunomide) as a new once- daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). The drug has shown significant efficacy across key measures of MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI. The FDA approval was based on efficacy data from a Phase 3 clinical trial.
The ongoing AUBAGIO clinical development programme, involving more than 5,000 patients in 36 countries, is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to ten years. The drug is an
immunomodulator with anti- inflammatory properties. Although the exact mechanism of action for AUBAGIO is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS). Marketing applications for the product are under review by the EMA and other regulatory authorities.
Preclinical Oncology Services Limited (PRECOS), a preclinical research and development service provider with a specific focus on oncology, has been awarded a licence to store and research human tissue samples by the Human Tissue Authority (HTA). PRECOS is established in the area of preclinical patient- derived tumour xenograft (PDX) modelling and the new licence enables the company to continue to invest in and expand its cancer model portfolio. The HTA licenses more than 800 organisations that store and use human tissue for purposes including research, patient treatment, post-mortem examination, teaching and public exhibitions. Its continuous licensing system is supported by a new sector-specific compliance monitoring framework involving the collection of regular compliance updates from licensed establishments. The HTA enables the necessary regulatory frameworks to ensure that human tissue is used safely, ethically and with proper consent by those organisations awarded licenses.
PRECOS already has a large and growing collection of PDX models which are designed to be more authentic, offering closer representation to the clinical setting. With increasing focus on subset-specific panels of PDX for targeted therapies, genetic profiling and histological heterogeneity are essential for recapitulating the clinical situation. Retention of the human stroma component in these models provides a more relevant heterogeneous system in which human tumour and stromal cells are in close co-operation within a unique microenvironment, thereby providing the right context to accurately and robustly evaluate the efficacy of a new therapeutic agent.
PRECOS will now be able to quickly and easily access patient tissue directly, allowing for greater access to samples for oncology model development by acquiring tissues for specific projects and research. It also allows the company and its customers greater scope for research opportunities across many cancer types. PRECOS utilises
methodology to retain the stromal
elements of patient tissue which is important for sustaining heterogeneity and proper ligand- receptor interactions in cancer models that can then be used in a proprietary 3D tumour growth assay (TGA).
While the company has a primary focus on lung cancer PDX subsets, the acquisition of the HTA licence will enable PRECOS to invest in other cancer types, including breast and hematopoietic cancers, to create panels of subtype-specific PDX models with clinical information and original patient material for target identification, validation, through to lead optimisation. The HTA licence will also allow PRECOS to collect patient material in addition to tumour tissue, such as blood samples, normal tissue and other bodily fluids which can be used for biomarker assessment and more specific requirements such as assessment of circulating tumour cells. In addition, the company’s customers will now have a broader access to early- stage patient samples for specific studies as and when they are needed.
Iron magnetic particle synthesis with Syrris Asia Flow Chemistry
Syrris has produced a hand-held video demonstrating how the company’s Asia Flow Chemistry system is used in iron magnetic nanoparticle synthesis. For further information see the video on the right and also contact the company as follows: Tel: +44 1763 242555 Email:
info@syrris.com Web:
www.syrris.com
Hovione appoints general manager at TTC Hovione has appointed Dr Mike
Ironside as general manager at the company’s Technology Transfer Center in New Jersey, USA. Dr Ironside was previously with GSK in the UK as well as being with AMRI and, most recently, Anacor Pharmaceuticals, both in the USA, where he held
the position of vice president of chemical manufacture and development.
Dr Ironside brings to Hovione more than 20 years of experience in the development and scale-up of APIs from lead candidate optimisation through to NDA submission and
8 sp2 Inter-Active September/October 2012
commercialisation. He also has extensive experience in the management of scientific and operational teams in biotech and contract research organisation environments. He is a member of the Royal Society of Chemistry in the UK. He trained as an organic chemist at Dundee University and
holds a PhD in organic chemistry. Hovione has also appointed Dr Conrad Winters as director, drug product development. Dr Winters was previously with Merck & Co in the USA and Canada and most recently with Xenon
Pharmaceuticals Inc, where he held the position of senior director of the Compound Properties Group.
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