Professor Sir Chris Evans’ Lab21 launches new commercial companion diagnostic service for HIV tropism in UK

Cambridge, UK, August 31 - Lab21 Limited, the Cambridge, UK-based specialist in personalised medicine is pleased to announce the addition of a new diagnostic test for HIV to its portfolio of companion diagnostic services.
Lab21 will be the first commercial reference laboratory in the UK to provide a companion diagnostic service for the HIV drug, Celsentri, which is marketed by ViiV Healthcare who are currently supporting the provision of this genotypic tropism testing to the UK NHS.
Lab21 will offer the HIV service from its UK operation with immediate effect and will be able to receive samples from all parts of the world. In the longer term the company also plans to offer the test as part of its comprehensive HIV service at its US facility in Greenville, South Carolina.
The HIV diagnostic is a genotypic test which determines the sequence of a specific region of the virus, the V3 loop. This information helps to determine the specific cell type the strain of HIV will infect and replicate. As individual drugs are only effective against specific strains of HIV, this allows clinicians to identify the most effective treatment, improving patient care, and reducing costs
Dr Berwyn Clarke, CSO of Lab21 commented: “This new technology has been developed in the HIV field over the past few years and we have now introduced the protocols into the Lab21 service labs to provide a fully validated, fast turnaround assay. The addition of this service to Lab21’s portfolio means that we can offer a fully comprehensive menu of tests for HIV clinicians to use including viral load and resistance analysis, CD4 counts and serology”.

Professor Sir Chris Evans’ ReNeuron presents new data showing how its stem cells work to repair brain damage. 12/07/10

Guildford, UK, 12 July 2010: ReNeuron Group plc (LSE: RENE.L) today announces important new data regarding the mechanisms of action of its lead CTX stem cell line in pre-clinical models of brain damage. The results of these studies will be presented in two posters1 at the UK National Stem Cell Network Annual Scientific Conference, taking place on 12 – 14 July, 2010 at the University of Nottingham, East Midlands Conference Centre, Nottingham, UK. In one series of studies, the angiogenic potential of the CTX stem cell line was tested, both in vitro and in rodent models of stroke damage. Angiogenesis is a multiple-step process whereby new blood vessels develop from pre-existing vasculature, potentially contributing to the functional recovery of the brain from damage such as that caused by ischaemic stroke. The results of these studies showed that the CTX cells express several trophic and pro-angiogenic factors in culture and also induce endothelial cell markers associated with blood vessel formation in the host at both 72 hours and 7 days post-implantation of the cells into the brain. Taken together, these results suggest that the CTX cells may play a role in promoting the functional recovery of stroke patients through up-regulation of angiogenesis in the region of ischaemic brain damage. In a series of further studies, the CTX cells were seen to inhibit T cell activation. This immunosuppressive activity was in part attributed to the up-regulation of the ligand CD274, a regulator of T cell function. T cells are a type of white blood cell associated with the mediation of immune responses in the body. These results suggest that the CTX cells may act to suppress the inflammatory response associated with brain damage, thereby aiding the natural healing processes in the brain. This anti-inflammatory characteristic opens up a number of exciting new potential applications for the CTX cell line as a cell-based therapy for certain inflammatory diseases both within and beyond the brain. ReNeuron recently announced the commencement of a UK Phase I clinical trial of its lead ReN001 stem cell therapy for disabled stroke patients. The ReN001 therapy represents the initial therapeutic application of the Company’s CTX stem cell line. Due in part to the anti-inflammatory properties of the CTX cells, patients in this clinical trial will not require immunosuppressive drug treatments alongside their cell therapy. Further information concerning the conference can be found at: www.uknscn.org/meetings/meetings10.html.John Sinden, Chief Scientific Officer of ReNeuron, said:“We are excited by the results of these new pre-clinical studies. They build on previously presented research findings regarding the way in which our CTX cell line may effect repair in the brain, and suggest that a number of repair mechanisms may be at work, post-implantation of the cells. These latest findings further illustrate and potentially explain the potency of the CTX cells in assisting the body’s own repair mechanisms in vascular conditions such as stroke and peripheral arterial disease, and suggest the potential utility of the cells to treat a much wider range of inflammatory diseases.”1. Human neural stem cells promote angiogenesis in vitro and in vivo following intracerebral implantation Hicks C, Stevenato L, Richardson S, Stroemer P, Corteling R, Miljan E, Sinden J. Involvement of CD274 in neural stem cell line mediated suppression of T cell activation Corteling R, Stevenato L, Hicks C, Miljan E, Sinden J.

Professor Sir Chris Evans’ Lab21 achieves first product registration in China

Cambridge, UK – 1st June 2010 - Lab21 Limited, the healthcare diagnostics company, is pleased to announce that it has achieved its first product registration in the People’s Republic of China, thereby further extending the number of territories in which its market leading range of diagnostic and blood-banking products are available.
The first Lab21 product registered in China is a TPHA assay used in syphilis screening.
Graham Mullis, Lab21’s CEO, stated: “Lab21 will now supply its TPHA product via its distribution partner into China, one of the currently fastest growing in-vitro diagnostic markets. The Chinese IVD market has a value in the region of US$1.5bn and is the world’s seventh largest, expanding at 15% annually. Our TPHA assay is already the leading syphilis assay in a number of key blood screening markets and we are delighted to make it available in another key region.”
Hayden Jeffreys, Divisional Director for Diagnostic Products at Lab21, added: “We are delighted to be able to expand our product coverage into this geographical region and we anticipate that this will be the first of a number of our products to be registered in the Chinese market, planned over the next 18 months.”

Professor Sir Chris Evans’ Lab21 and Virco partner to offer UK-based HIV-1 genotyping services

Cambridge, UK – 24th May 2010: Lab21 Limited, the Cambridge-based specialist in personalised medicine testing, has announced that it has reached agreement with Virco BVBA to distribute Virco’s virco®TYPE HIV-1 drug-resistance genotyping services for the UK and Ireland.
Lab21 will now provide the genotyping services to the UK and Ireland market directly from its own UK laboratory in Cambridge using Virco protocols whilst virtual phenotyping will continue to be provided by Virco BVBA via Lab21 as a distributor. This new arrangement between Lab21 and Virco followed the acquisition of Delphic Diagnostics by Lab21 in December 2009.
Dr Berwyn Clarke, Chief Scientific Officer at Lab21, commented: “Lab21 was originally founded on the basis of personalised medicine in the antiviral area. We are therefore delighted to be working closely with a partner with a similar background. We plan to expand our antiviral resistance services into other viral systems including HCV and HBV with further service launches in 2010.”
Mike Annable, Divisional Director for Clinical Services at Lab21, added: “We are delighted to be part of this collaboration as it will provide substantial improvements in the efficiency of delivery of resistance analysis to HIV patients in the UK and Ireland. We also hope to explore future technology opportunities with our new partner and others to seek new solutions for HIV and other diseases.”

Professor Sir Chris Evans’ ReNeuron cited as a regenerative medicine leader in UK Government's . 22/03/10

Guildford, UK, 22 March 2010: ReNeuron Group plc (LSE: RENE.L) is pleased to learn that it has been cited as a UK-based world leader in regenerative medicine in a new publication by the UK Government. The “Best of British” publication, produced by the Department for Business Innovation and Skills (BIS), showcases in a series of sector case studies the business sectors in which the UK leads on innovation, enterprise and technology. These are the sectors from which future UK economic growth and jobs are expected to be generated and include life sciences, digital communications and renewable energy, among others. Within life sciences, the case study refers to the importance of regenerative medicine and the UK’s pre-eminence in this field, giving the example of ReNeuron and its recently approved first-in-man clinical trial in the UK with ReN001, the Company’s stem cell therapy for disabled stroke patients. This trial, the world’s first of its kind using expanded neural stem cells in this indication, is due to commence shortly and will be conducted through the NHS system at a leading stroke treatment centre in Glasgow, Scotland.The “Best of British” publication forms part of an update given by the Government regarding its strategy to support the development of key new industries in the UK. The publication is available on the BIS website at www.bis.gov.uk. Michael Hunt, Chief Executive Officer of ReNeuron, said:“We are delighted to learn that the potential of our ground-breaking stem cell programmes has been recognised by the UK Government in this way. We are proud to be pioneering the translation of exciting stem cell science into clinical-stage therapeutics as a UK-based business, in collaboration with a number of leading UK academic institutions, hospitals and commercial organisations.”

Professor Sir Chris Evans’ ReNeuron signs further stem cell manufacturing contracts with Angel Biotechnology for stroke clinical trial. 18/03/

Guildford, UK, 18 March 2010: ReNeuron Group plc (LSE: RENE.L) today announces that it has signed two further clinical-grade stem cell manufacturing contracts with Angel Biotechnology Holdings plc ("Angel"), in support of ReNeuron’s recently approved first-in-man clinical trial with its ReN001 stem cell therapy for stroke patients. Under these contracts, Angel will manufacture further drug substance lots of ReN001 for administration to patients in the trial, along with the provision of manufacturing process validation services. The cost of the drug product manufacture is being met by a recently-awarded grant from the UK Government's Technology Strategy Board, under its Regenerative Medicine Programme.The "PISCES" clinical trial (Pilot Investigation of Stem Cells in Stroke) will take place through the NHS at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board. In this ground-breaking Phase I trial, the world’s first using expanded neural stem cells in this indication, ReNeuron’s ReN001 stem cell therapy will be administered to stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition. The trial is designed primarily to test the safety profile of ReN001 in ischaemic stroke patients at a range of cell doses, but a number of efficacy measures will also be evaluated over the course of the trial.Michael Hunt, Chief Executive Officer of ReNeuron, said:"We are pleased to continue to work with Angel as our chosen contract manufacturing partner for the PISCES clinical trial for ReN001 in stroke. Angel has consistently demonstrated its strong expertise in the field of regulatory-compliant cell manufacture, meeting ReNeuron’s needs for this important first-in-man study."
Notes to editors
About Angel Angel Biotechnology Holdings plc is a biomanufacturing company offering process development services, GMP manufacturing for advanced biologics and regulatory support including preparation of dossiers for regulatory submissions. Angel has a global business supporting biotechnology and pharmaceutical companies worldwide. Angel's principal activity is the manufacture and supply of materials for use in early stage drug development and pre-clinical studies, along with drug product and CMC documentation for Phases I, II and III clinical trials and the manufacture of licensed drugs or vaccines. Angel specialises in the provision of advanced biologics including autologous and allogeneic cell therapy products including stem cells and cellular vaccines, specific purified natural and recombinant proteins and bacteriophage. Angel is managed by a team with wide-ranging experience in biopharmaceutical manufacture, gained in companies such as Glaxo, Johnson and Johnson, Serologicals Inc., PPL Therapeutics and Intercell Ag.Angel was admitted to trading on AIM in November 2005. More information about the company can be found at www.angelbio.com.About ReNeuronReNeuron is a leading, UK-based stem cell business. Its primary objective is the development of stem cell therapies targeting areas of significant unmet or poorly met medical need. ReNeuron has regulatory approval for a Phase I clinical trial in the UK with its lead ReN001 stem cell therapy for disabled stroke patients. Patient recruitment for this trial is expected to commence shortly. The Company is also developing stem cell therapies for a number of other conditions, including peripheral arterial disease and diseases of the retina.ReNeuron has also developed a range of stem cell lines for non-therapeutic applications - its ReNcell products for use in academic and commercial research. The Company’s ReNcellCX and ReNcellVM neural cell lines are marketed worldwide under license by USA-based Millipore Corporation.ReNeuron's shares are traded on the London AIM market under the symbol RENE.L. Further information on ReNeuron and its products can be found at www.reneuron.com.This announcement contains forward-looking statements with respect to the financial condition, results of operations and business achievements/performance of ReNeuron and certain of the plans and objectives of management of ReNeuron with respect thereto. These statements may generally, but not always, be identified by the use of words such as "should", "expects", "estimates", "believes" or similar expressions. This announcement also contains forward-looking statements attributed to certain third parties relating to their estimates regarding the growth of markets and demand for products. By their nature, forward-looking statements involve risk and uncertainty because they reflect ReNeuron's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of factors could cause ReNeuron's actual financial condition, results of operations and business achievements/performance to differ materially from the estimates made or implied in such forward-looking statements and, accordingly, reliance should not be placed on such statements.

Brief Overview Of Excalibur

Excalibur Fund Managers Limited is a venture capital firm specializing in early, mid, and late stage investments. It seeks to invest in medical sciences, biotechnology, and life sciences sector. The firm prefers to invest in companies that bring human medicines or medical devices to the market. It prefers to invest in European companies. The firm prefers to be an active investor and seeks to take a seat on the board of directors of its portfolio companies. It was formerly known as Merlin Biosciences Limited. Excalibur Fund Managers Limited was founded in 1996 and is based in London, United Kingdom with an additional office in Cardiff, United Kingdom.