Sanochemia Pharmazeutika AG, Vienna, quoted in the Prime Segment of the Frankfurt Stock Exchange, today announced that Avigen, its US partner in the development of the substance tolperisone, has successfully completed two important clinical trials as part of its clinical development programme to establish drug safety:
A drug interaction study involving the parallel administration of tolperisone and metabolic inhibitors in healthy volunteers demonstrated good tolerance to tolperisone when administered in combination with other drugs while also resulting in no significant serious adverse events (AV650-019).
A clinical trial in thirty healthy volunteers established that there were no differences between tolperisone and an administered placebo in terms of reaction times and the results from a battery of cognitive tests (AV650-012). These findings provide the first experimental evidence that tolperisone, in contrast to other drugs used in the same indication area, does not have sedative effects when used in controlled therapeutic dosages.
Evidence of drug safety is a key marketing argument and a means of differentiating tolperisone from competitor products in the same indication.
A further clinical trial in patients with spinal cord injuries has been initiated in the United States (AV650-014). Drug safety associated with tolperisone treatment is to be tested in a total of 100 patients over a period of 28 days in order to provide the first US results of the efficacy of tolperisone in this patient group.
Tolperisone has already been approved in Germany for use in the treatment of muscle spasms associated with neural conditions. Sanochemia is currently working in conjunction with Avigen to meet the preconditions for marketing authorisation in the US market.
Press Conference in Vienna
Sanochemia will be holding a press conference tomorrow, Friday 24.8.2007, on the status of its on-going development projects, the establishment of Countervail Corp., and the latest research results for galantamine and the marketing and business development opportunities these present.
Date: 24 August 2007 - 10:00 Location: Marriott Hotel, Room: Palais Sachsen Coburg III, Parkring 12 A, 1010 Vienna
Earlier publication of quarterly results
Due to its participation at the 5th Small-Cap Conference in Frankfurt on 27 August 2007, Sanochemia has elected to bring forward the publication of its third-quarter results to Friday 24 August. The full quarterly report (1.10.2006 – 30.6.2007) will, however, still be published on Monday as originally announced.
For further information please contact:
Margarita Hoch
Investor Relations Tel.: + 43 / 1 / 3191456 - 335 Mobile: + 43 (0) 664 / 21 38 152
mailto: m.hoch(at)sanochemia.at
www.sanochemia.at
Sanochemia Partner Avigen, Inc. reports successful completion of two key clinical trials in the development...
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