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first good news will probably be this month

  1. 978 Posts.

    This news will pmost robably be the application for the phase 111 trails in Europe this month - January, followed by the news in February (or maybe even this month) of the first patient to be treated as part of the phase 11b trials in USA/AUSTRALIA:

    below is the relevant extract from biotech news posted by Boiler on 22/12/09:

    Nick Evans Tuesday, 22 December 2009

    Prima Biomed intends to file an application to kick off a Phase 3 trial of CVac in Europe EARLY IN THE NEW YEAR.

    Rogers told BTN the company was still sorting out potential manufacturing facilities, but he hoped to file for regulatory approval of the trial early next year and to begin recruiting patients by September 2010.

    also in extract:

    Prima: US trials ready to go

    PRIMA Biomed says its US Phase 2b trial of ovarian cancer treatment CVac is almost ready to begin recruiting, after the company received ethics approval from its trial sites last week on 14/12/09.

    Prima director Martin Rogers told BTN yesterday the company's clinical investigators had already begun screening patients for the trial. That screening process was expected to take up to eight weeks for each patient, with the first patients expected to begin treatment by February 2010.

    Rogers said there had already been strong interest from potential participants in the US and Prima expected to have a strong idea of how quickly the trial was recruiting by March next year.

    The company is considering opening additional trial sites in the US and Australia to meet its goal of completing recruitment to the 60-patient trial by late next year.

    Prima Biomed has completed the transfer of its manufacturing technology to US contract manufacturer Progenitor Cell Therapy the same company that conducted the manufacturing for Dendreons trials of therapeutic cancer vaccine Provenge.

    Rogers said the company had largely completed the design and research of immunological and potency assays for CVac, which would be used to ensure consistency of treatment for patients in the trial.

    While the company's scientists are happy with the progress on the development of assays for use in the manufacturing process, they are not likely to be fully validated until September next year.

    A validated assay will speed CVacs path to market, according to Rogers, as it will simplify the Chemistry and Manufacturing Control section of Primas marketing application to the US Food and Drug Administration.

    Difficulties in developing acceptable potency assays was one of the problems faced by Dendreon in having Provenge approved by the FDA, and Rogers says Prima is determined to make sure its own processes are of the highest possible quality.

    end of extract

    all looking very postive!


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