Sydney, Feb 15, 2008 AEST (ABN Newswire) - Medical Therapies Limited (ASX: MTY), today announced that it has completed its 'first-in-human' clinical trial of Cuprindo(tm) to determine its safety, tolerability and systemic absorption characteristics. The Phase 1 trial was conducted using a topical suppository formulation in preparation for a planned efficacy study in proctitis patients.
Interim results from patient diaries indicate that Cuprindo is safe and well tolerated. The trial subjects, healthy volunteers, reported 100% compliance with the dosing protocol which involved application of Cuprindo suppositories twice daily over a seven day period. In addition, post-trial colonoscopy on the subjects uncovered healthy mucosa and no evidence of rectal inflammation or ulceration.
While the trial was not geared to assess Cuprindo's systemic efficacy one subject reported relief in chronic joint pain after Day 4 of the trial. Results of the full biochemical analysis of the trial assays, including information on systemic absorption characteristics of Cuprindo, are expected in the coming weeks.
"The trial has been a success confirming our pre-clinical safety information on Cuprindo and it paves the way for our efficacy study in patients with proctitis," said Dr Stephanie Williams, Chief Scientific Officer of MTY.
Proctitis is a debilitating disease characterised by inflammation and ulceration of the colon, resulting in tiny open sores that can bleed and produce mucus.
Symptoms of the disease include chronic diarrhea, bloody stools and, in severe cases, fecal incontinence.
Current treatments such as corticosteroids and immuno-modulators can cause serious side effects and provide no relief for up to 30% of proctitis patients. A topically applied safe treatment, such as a Cuprindo suppository, could provide a much needed alternative for the 1 in 60 people suffering from the disease.
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Forward-looking statement
This Announcement may contain forward looking statements regarding the Company's business and commercialisation objectives. These statements should be viewed as "at risk" and they are subject to the technical and commercial risks associated with companies engaged in developing pharmaceutical products. Although Medical Therapies may not publish changes to forward looking statements it will release all material information to the market in a timely manner.
Contact
Maria Halasz
CEO and Managing Director
T +61 2 9299 0311
M +61 416 008 413
Dr Stephanie Williams
CSO
T +61 2 9299 0311
M +61 419 677 041
WEB: www.medicaltherapies.com.au or contact:
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