IMU - Imuniti Holdings Limited - South African Medical Research Council
IMU
IMU
IMU - Imuniti Holdings Limited - South African Medical Research Council
("MRC")Trials On Imuniti Wellness Pack
IMUNITI HOLDINGS LIMITED
(Incorporated in the Republic of South Africa)
(Registration number 2004/002282/06)
(JSE Code: IMU & ISIN: ZAE000089199)
("Imuniti" or "the Group")
SOUTH AFRICAN MEDICAL RESEARCH COUNCIL ("MRC")TRIALS ON IMUNITI WELLNESS PACK
Further to the SENS announcement made on the 10 June 2009 in connection with
the MRC Trials, the directors are pleased to advise shareholders that the
Group has received the full report from the MRC regarding Phase I of the
clinical trials conducted on the Imuniti Wellness Pack, a Herbal-Nutritional
supplement with putative immune-modulating properties ("the Wellness Pack").
Shareholders are reminded that the Phase 1 trials were in respect of the
possible toxicity of the contents of the Wellness Pack and the MRC conclusion
as set out below should be understood in this context:
"Overall in this study of healthy Study participants, there were no
significant consistent changes in laboratory parameters over the 5 week study
period in the groups receiving IMUNITI at different dosages. Furthermore,
when compared to Study participants taking Placebo, Imuniti was subjectively
well tolerated. No Study participant reported any side-effects. It is now
necessary to carry out a safety and tolerability study in Study participants
infected with the human immunodeficiency virus (HIV) and to determine the
efficacy of IMUNITI as an immune modulating agent".
The directors are furthermore pleased to report that Phase II of the clinical
trials has been approved by the MRC`s Ethics Committee. We quote from the
letter received from the MRC:
"The next study, which is a Phase II placebo controlled efficacy study, to be
conducted in KwaZulu-Natal in the VCT centres has been granted ethical
approval. This study will recruit 100 HIV positive participants per site from
the rural, and semi-urban and an urban VCT site".
Durban
11 November 2009
Designated Advisor
Arcay Moela Sponsors (Proprietary) Limited
(Registration number 2006/033725/07)
Date: 11/11/2009 17:00:55 Produced by the JSE SENS Department.
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