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positive result virax hiv grug

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    Announcement to ASX (135)
    16 October 2003

    IMPORTANT POSITIVE RESULT FOR VIRAX HIV DRUG
    • Positive trial result to bring on next stage of HIV drug development
    • Exciting boost for Virax Co-X-Gene™ technology platform

    Melbourne, Australia - October 16, 2003 - Virax Holdings Ltd (ASX: VHL) announced today that the latest clinical trial of its immune-based therapy VIR201 for the treatment of HIV, has returned positive results.

    Virax CEO Dr David Beames said, "We have a very promising material result in the first stage of our assessment of the effectiveness of VIR201. It builds strongly on the safety profile which was established through the Phase I trial, the results of which were announced earlier this year."

    These results arise from the measurement of the study participants' HIV levels (viral load). Currently, this accepted clinical measurement is the only direct means of determining a drug's effectiveness.

    "VIR201 performed better than placebo in controlling HIV-infected patients' viral load," said Professor David Cooper AO, Director of the Australian National Centre for HIV Epidemiology and Clinical Research (NCHECR). "An aim of this pilot study was to see whether VIR201 has the potential to be a therapy that can control the virus. Control or suppression of the HIV virus is the critical factor in the treatment of HIV/AIDS."
    "This latest data provides a promising preliminary indication which merits further development," Professor Cooper said.

    "An effective immune-based therapy could enable patients to reduce their reliance on other HIV drugs (highly active anti-retroviral therapy or HAART). HAART drugs, not withstanding their expense, impact on patients' quality of life due to serious side-effects, and the need for strict adherence," Professor Cooper said.

    Medical scientists around the world agree that there is a demonstrable need for an alternative to HAART.
    In the double-blind placebo-controlled Phase Ma Extension Study, co-ordinated by the NCHECR, participants in the earlier Phase I safety trial of VIR201 received a booster of their trial medication and then ceased taking HAART.

    "The Phase I safety trial results announced early this year did not provide any guidance on VIR201's effectiveness. This extension trial result does provide guidance, and unquestionably it is in the right direction," Dr Beames said.

    "Based on the strength of this result, Virax is moving to the next stage of clinical testing of VIR201 in larger trials," he said.

    "The result also represents a critical, clinical milestone for Virax's Co-X-Gene™ technology. VIR201 is the first Virax product based on this platform to enter clinical trials and this result supports our earlier decision to expand our portfolio into other therapeutic areas."

    Virax and its collaborators at the Royal Adelaide Hospital are about to start pre-clinical testing of a prostate cancer treatment based on Co-X-Gene™ technology.

    Similar studies are also due to start shortly on a hepatitis B treatment, which Virax is working on with the New York Blood Center.

    Virax Holdings Limited ABN 56 006569106 Suite 220 89 High Street Kew Vic 3101 Telephone +61 (0) 3 9854 6230 Facsimile+61 (0) 3 9853 5134
 
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