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Sarepta Therapeutics, Inc. Message Board

  • zzzdq zzzdq May 10, 2001 8:31 AM Flag

    AVI to present Avicine results at ASCO

    Thursday May 10, 6:32 am Eastern Time
    Press Release
    AVI BioPharma Scientists To Present Encouraging Phase II Avicine Results at ASCO
    PORTLAND, Ore.--(BW HealthWire)--May 10, 2001--AVI BioPharma, Inc. (Nasdaq:AVII - news; Nasdaq:AVIIW - news, AVIIZ - news) announced today that its therapeutic cancer vaccine, Avicine(TM), will be the topic of a presentation at the annual meeting of the American Society of Clinical Oncology (ASCO), May 12-15, in San Francisco.

    The study, titled ``Active Specific Immunotherapy with a (beta)-hCG Peptide Vaccine in Patients with Pancreatic Cancer'', will be presented by David H. Mason, Jr., M.D., AVI's Senior Vice President of Clinical Development and Regulatory Affairs. Overall, the data from the Phase II clinical study provided support for previous observations that Avicine is an effective cancer-fighting agent. The study also showed that patients treated with the vaccine experienced no significant side effects.

    The study was designed to evaluate the safety and efficacy of Avicine alone vs. in combination with Eli Lilly & Co.'s (NYSE:LLY - news) chemotherapy drug, gemcitabine (Gemzar(TM)) in a randomized trial of 55 patients conducted at seven centers nationwide. Patient accrual was completed in November 2000 and as of May 2, 2001, sixteen of the patients were still alive and participating in the study.

    ``While patient tracking is still ongoing, the results are very encouraging. Our initial data suggest that Avicine is as effective as traditional chemotherapy, but without the devastating side effects associated with that treatment,'' said Dr. Mason. ``We are particularly pleased to report that 16 surviving patients have far exceeded the median survival time reported for Gemzar. This bodes well for potential long term benefits to patients on Avicine immunotherapy.''

    Dr. Mason added, ``This is the first randomized study to report the impact of chemotherapy on antibody response to vaccination. Based on the data analyzed to date, Gemzar may have a negative influence on the immune response to cancer vaccine therapy.''

    Overall, these findings provide support for AVI's ongoing Phase III pivotal trial of Avicine for first-line treatment of colorectal cancer.

    Avicine is a therapeutic cancer vaccine which elicits a highly specific immune response to human chorionic gonadoptropin (hCG), a cancer-associated oncofetal protein. The vaccine blocks hCG's function, which is to facilitate tumor growth, angiogenesis, invasion and immunosuppression. The most common side effects of Avicine are mild reactions at the site of injection. Six completed clinical trials have shown that it is considerably less toxic than traditional chemotherapy.

    ASCO attracts 25,000 oncologists and other health care professionals who come to exchange ideas and hear about the latest breakthroughs in cancer research, treatment and prevention. This year the annual conference is being held in San Francisco. More information about ASCO is available at: http//www.asco.org.

    AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: cancer immunotherapy and gene-targeted drugs. Its lead clinical agent, AVICINE(TM), a therapeutic cancer vaccine, has completed enrollment in a Phase II trial in pancreatic cancer and is in a Phase III pivotal trial in colorectal cancer. The first application of its NEUGENE compounds, Resten-NG, is designed to treat cancer, cardiovascular restenosis and other cell proliferation disorders by inhibiting the production of a cellular transcription factor, the oncogene c-myc. It is currently in Phase II trials for restenosis. More information about AVI is available on the Company's website at http://www.avibio.com.

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    • WASHINGTON (AP) - Congressional approval of a compromise 2002 budget will let Senate Republicans start to write a tax-cutting bill and give them and President Bush a huge advantage in pushing it through the chamber. The evenly divided Senate was poised to vote final approval of the $1.95 trillion budget today. With defections expected by two moderate Republicans, pivotal support was expected to be supplied by a handful of centrist Democrats

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