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NICE Upholds GlaxoSmithKline Appeal For Advanced Breast Cancer Treatment, Tyverb(R)(lapatinib)
The National Institute for Health and Clinical Excellence (NICE) announced that, following GlaxoSmithKline"s (GSK) appeal, it will reconsider the submission for Tyverb (lapatinib), a treatment for an aggressive form of advanced breast cancer (ErbB2-positive).1 GSK is pleased that NICE"s appeal panel agreed that the draft negative guidance should be reviewed, providing fresh hope for up to 2,000 women in the UK who could benefit from this effective treatment on the NHS.

Use Of Lenalidomide In Patients With Multiple Myeloma Having Already Received At Least Two Previous Therapies Approved By NICE, UK
A review of the NICE decision on the approval of lenalidomide is published in a special report Online First and in the July edition of The Lancet Oncology. About 2,000 multiple myeloma sufferers in the UK could benefit from the drug and improve their life expectancy pending a decision by The UK National Institute for Health and Clinical Excellence (NICE). Patients who have received two or more previous therapies could receive lenalidomide, and the cost of cycles beyond the twenty-sixth cycle of treatment would be met by the drug manufacturer.
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Health Protection 2009 Conference - Programme Announced
The Health Protection Agency (HPA) has announced an innovative and wide-ranging programme for the Health Protection 2009 conference, which is taking place at Warwick University from 14th to 16th September.
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Inovio Biomedical, National Microbiology Laboratory, And University Of Pennsylvania To Evaluate Candidate DNA Vaccines Against "Swine" Influenza A

Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, announced today it has established a new collaboration with the National Microbiology Laboratory of the Public Health Agency of Canada and the University of Pennsylvania to further evaluate Inovio DNA vaccine candidates against swine influenza A (H1N1) virus. As a part of its universal influenza vaccine program, Inovio has designed and manufactured consensus DNA vaccines for H1N1 influenza strains. These consensus vaccines, delivered using Inovio"s proprietary electroporation technology, have the potential to provide protection against a broad scope of existing as well as currently unknown, unmatched influenza strains that could emerge -- one of the perpetual challenges in trying to protect against influenza. The purpose of this collaboration is to test these vaccine candidates against pandemic and seasonal influenza strains in animal models and will include testing against a recently identified swine H1N1 strain. The World Health Organization"s (WHO) upgrade on June 11, 2009, of the "swine flu" to a full pandemic status acknowledged the detection of the virus in 74 countries. This first declaration of a global pandemic since 1968 reflected more the rate and ease of spread rather than virulence of the virus. Significantly, by early June scientists had characterized over 60 different gene sequences of the swine influenza A (H1N1) virus amongst the first 259 samples isolated from humans. The rapid spread and evolution of this virus highlights the great potential risk should a more virulent strain of the virus emerge. While strain-specific vaccines may provide some protective immunity against a known influenza strain, they do not resolve the fundamental challenge to protecting against influenza, which is the virus" constant evolution beyond the protective capabilities of strain-specific vaccines. Unfortunately, even the relatively short period of six to nine months to launch a new strain-specific vaccine could allow a more virulent influenza strain to rapidly spread and potentially wreak significant havoc. "We believe a consensus vaccine approach is imperative and look forward to continuing our collaborative evaluation of Inovio"s novel DNA vaccines with their ability to provide protection against evolving, unmatched influenza strains," said Dr. David B. Weiner, Professor, Dept. of Pathology & Laboratory Medicine, University of Pennsylvania and Chairman of Inovio"s Scientific Advisory Board. Dr. J. Joseph Kim, Inovio"s CEO, stated, "The current swine flu outbreak highlights the fact that the world cannot rely solely on the `catch-up" strategy of influenza vaccine design. We need vaccines that provide at least some broad protective capability against evolving seasonal influenza strains and those with pandemic potential. We have already achieved significant validating data in large animal models regarding the ability of Inovio"s consensus vaccines to protect against unmatched strains of different influenza sub-types and look forward to the data resulting from this collaboration of vaccine experts." Work completed by Dr. Gary Kobinger, Head, Vector Design and Immunotherapy, Special Pathogens, National Microbiology Laboratory, Public Health Agency of Canada, and his colleagues recently resulted in the characterization of several currently-circulating clinical isolates of the swine-like H1N1 virus. Inovio, the National Microbiology Laboratory of the Public Health Agency of Canada, and the University of Pennsylvania have previously collaborated and published on studies involving Inovio"s consensus DNA vaccines. In a study of Inovio"s VGX-3400, ferrets vaccinated with this H5N1 avian flu vaccine candidate, when challenged with the unmatched "bird flu" A/Vietnam/1203/04 strain, showed 100% protection. In another study, mice immunized with an Inovio H1N1 consensus DNA vaccine were then challenged with a lethal dose of the unmatched H1N1 virus that caused the 1918 Spanish flu, which killed over 40 million people. All the immunized mice survived the challenge (100% protection) to the end of the experiment and displayed significant protection from infection-associated morbidity. All the control mice died by day 8 after being challenged with the virus. Inovio"s influenza vaccine constructs were designed using the company"s novel SynCon™ technology, which facilitates the design of DNA-based vaccines capable of protecting against unmatched sub-types and strains of pathogens. Inovio scientists have created DNA vaccine candidates broadly targeting the H1N1, H2N2, H3N2, and H5N1 influenza sub-types, which make up the majority of seasonal and pandemic influenza. By formulating combinations of these individual component vaccines, Inovio can employ this designer approach to rapidly develop universal influenza vaccines potentially capable of targeting multiple influenza sub-types and able to protect against evolving strains of the virus. Inovio Biomedical Corporation


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