( SYDNEY Australia 24 April 2007. Giacon...)FDA approves MyocondaR IND for MAP in Crohn's Disease,Health

SYDNEY, Australia 24 April 2007. Giaconda Ltd (ASX: GIA) today announced that the US Food and Drug Administration (FDA) has approved the Company's Investigational New Drug application (IND) for the clinical development of MyocondaR to treat patients with Crohn's Disease infected with Mycobacterium avium spp paratuberculosis (MAP).

The Company understands that its lead product, MyocondaR, is the first therapy to be submitted to the FDA for this indication. There are no anti-MAP therapies approved for use in Crohn's Disease.

MAP is considered as the most likely infectious cause of Crohn's Disease. Current treatments on the market are indicated for symptomatic treatment of the disease. On the basis of clinical experience, Giaconda believes that by treating and controlling the underlying MAP infection, MyocondaR will offer a valuable therapy to patients who do not respond to currently available therapies. Current research indicates that between 40 - 50% of Crohn's patients are MAP positive.

Patients can be diagnosed with MAP infection using a blood test. The IND approval allows the Company to commence the next clinical trial of MyocondaR in the USA. The Company is continuing preparations for the multi-centre, double blind, placebo controlled, Phase II/III trial. Before the trial commences the Company will conduct pharmacokinetics investigations, test the drug manufacturing for the trial and make ethics submissions to the various clinical trial centres. It is anticipated that the trial will commence by the end of 2007.

Since the previous Phase III trial, which was undertaken prior to Giaconda acquiring MyocondaR, an alternative development program, substantially different from its predecessor, has been undertaken based on further understanding of the mechanism of action of MyocondaR. This has resulted in a new product based on the original research. The Phase II/III trial is necessary due to the changes in the drug form
'"/>




Page: 1 2 3 4
Related medicine technology :

1. FDA approves IND on Lead Product M6G
2. ChemoCentryx Presents Positive Phase 2 Clinical Data for Traficet-EN in Crohns Disease at the Digestive Disease Week 2007 Conference
3. Enzo Biochem Individualized Oral Immune Regulation Therapy May Be Effective Approach to Treating Crohns Disease
4. UCB Presents Long-Term CImzia Data in Crohns Disease
5. New Analysis of Data Shows Treatment With Abbotts Humira (Adalimumab) Significantly Reduced Disease-Related Hospitalization for Patients with Crohns Disease
6. Appendicitis: Evolving Tools to Diagnose a Classic Disease
7. Non-Invasive Diagnostic Tests for Celiac Disease
8. Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease
9. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
10. Samaritans Alzheimers Drug Caprospinol Suggests Brain May be Able to Heal From Alzheimers Disease
11. BusinessWeek Article Highlights Promising Breakthrough Treatment for Advanced Coronary Artery Disease