Kronova Bolest: Antibiotikom do potpunog izlečenja?
Posted: 18 Jun 2012, 12:02
Rezultati kliničkih ipitivanja su svakako ohrabrujući (Preuzeto sa http://www.redhillbio.com/product-pipeline/rhb-104/).
RHB-104
RHB-104 is a proprietary antibiotics drug combination for Mycobacterium avium paratuberculosis (MAP) infection in Crohn’s disease.*
RHB-104 was acquired from Sydney-based Giaconda [ASX: GIA] in August 2010.
RHB-104 will be indicated for treatment of MAP infection in Crohn’s patients, suspected as the underlying cause for Crohn’s disease symptoms. There is currently no available treatment for MAP infection in Crohn’s disease, and no other effective cure for Crohn’s disease. Current standard of care includes 5-ASA agents, corticosteroids, immunomodulating drugs (e.g. Methotrexate) and anti-TNFα (e.g. Remicade, Centocor (J&J)). However, standard care leaves an unmet medical need for a long lasting treatment with low side-effects. RHB-104 holds promise for providing long term remission with reduced side-effects allowing affected patients to lead normal lives. RHB-104 demonstrated promising results in phase II and phase IIIa trials in Australia and has an IND status in the US.
RedHill is currently preparing for two parallel placebo-controlled, double-blind clinical trials with RHB-104 – a Phase II/III trial in North America and a European Phase III trial.
RedHill further acquired an exclusive license from the University of Central Florida Research Foundation, Inc. to a patent-protected diagnostic test for the detection of the MAP bacterium.
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*Selected references:
1- Greenstein. R.J. Is Crohn’s disease caused by a mycobacterium? Comparisons with leprosy, tuberculosis, and Johne’s disease. THE LANCET Infectious Diseases 2003, Vol 3, PP 507-514.
2- Behr. A. M.; Kapur. V. The evidence for Mycobacterium paratuberculosis in Crohn’s disease. Current Opinion in Gastroenterology. 2008, 24, PP 17–21.
3-Borody T.J.; Leis. S.; Warren. E.F.; Surace. R. Treatment of severe Crohn’s disease using antimycobacterial triple therapy–approaching a cure? Digestive and Liver Disease 2002, Vol 34, 1, PP 29-38.
4-Taylor, J. H. Treatment with drugs active against Mycobacterium avium subspecies paratuberculosis can heal Crohn’s disease: more evidence for a neglected Public Health tragedy. Digestive and Liver Disease. 2002, 34, PP 9-12.
5- Borody. T.J.; Bilkey. S.; Wettstein. A. R.; Leis. S.; Pang. G.; Tye. S.; Anti-mycobacterial therapy in Crohn’s disease heals mucosa with longitudinal scars
Digestive and Liver Disease. 2007, Vol 39, 5, PP 438-44.
6- Chamberlin. W.; Ghobrial. G.; Chehtane. M.; Naser. S. A. Successful Treatment of a Crohn’s Disease Patient Infected with Bacteremic Mycobacterium Paratuberculosis. American Journal of Gastroenterol. 2007, 102, PP 689-691.
7-Chamberlin. W.; Borody.T.; Naser. S. MAP-associated Crohn’s Disease: MAP, Koch’s postulates, causality and Crohn’s Disease. Digestive and Liver Disease. 2007, 39, PP 792-794.
8- Kirkwood. C.D.; Wagner. J.; Boniface. K.; Vaughan. J.; Michalski. W. P.; Catto-Smith. A. J.; Cameron. Don .J.S.; Bishop. R. F.Mycobacterium avium subspecies paratuberculosis in children with early-onset Crohn’s disease. Inflammatory Bowel Diseases. 2009, Vol 15, 11, PP 1643-1655.
RHB-104
RHB-104 is a proprietary antibiotics drug combination for Mycobacterium avium paratuberculosis (MAP) infection in Crohn’s disease.*
RHB-104 was acquired from Sydney-based Giaconda [ASX: GIA] in August 2010.
RHB-104 will be indicated for treatment of MAP infection in Crohn’s patients, suspected as the underlying cause for Crohn’s disease symptoms. There is currently no available treatment for MAP infection in Crohn’s disease, and no other effective cure for Crohn’s disease. Current standard of care includes 5-ASA agents, corticosteroids, immunomodulating drugs (e.g. Methotrexate) and anti-TNFα (e.g. Remicade, Centocor (J&J)). However, standard care leaves an unmet medical need for a long lasting treatment with low side-effects. RHB-104 holds promise for providing long term remission with reduced side-effects allowing affected patients to lead normal lives. RHB-104 demonstrated promising results in phase II and phase IIIa trials in Australia and has an IND status in the US.
RedHill is currently preparing for two parallel placebo-controlled, double-blind clinical trials with RHB-104 – a Phase II/III trial in North America and a European Phase III trial.
RedHill further acquired an exclusive license from the University of Central Florida Research Foundation, Inc. to a patent-protected diagnostic test for the detection of the MAP bacterium.
h
*Selected references:
1- Greenstein. R.J. Is Crohn’s disease caused by a mycobacterium? Comparisons with leprosy, tuberculosis, and Johne’s disease. THE LANCET Infectious Diseases 2003, Vol 3, PP 507-514.
2- Behr. A. M.; Kapur. V. The evidence for Mycobacterium paratuberculosis in Crohn’s disease. Current Opinion in Gastroenterology. 2008, 24, PP 17–21.
3-Borody T.J.; Leis. S.; Warren. E.F.; Surace. R. Treatment of severe Crohn’s disease using antimycobacterial triple therapy–approaching a cure? Digestive and Liver Disease 2002, Vol 34, 1, PP 29-38.
4-Taylor, J. H. Treatment with drugs active against Mycobacterium avium subspecies paratuberculosis can heal Crohn’s disease: more evidence for a neglected Public Health tragedy. Digestive and Liver Disease. 2002, 34, PP 9-12.
5- Borody. T.J.; Bilkey. S.; Wettstein. A. R.; Leis. S.; Pang. G.; Tye. S.; Anti-mycobacterial therapy in Crohn’s disease heals mucosa with longitudinal scars
Digestive and Liver Disease. 2007, Vol 39, 5, PP 438-44.
6- Chamberlin. W.; Ghobrial. G.; Chehtane. M.; Naser. S. A. Successful Treatment of a Crohn’s Disease Patient Infected with Bacteremic Mycobacterium Paratuberculosis. American Journal of Gastroenterol. 2007, 102, PP 689-691.
7-Chamberlin. W.; Borody.T.; Naser. S. MAP-associated Crohn’s Disease: MAP, Koch’s postulates, causality and Crohn’s Disease. Digestive and Liver Disease. 2007, 39, PP 792-794.
8- Kirkwood. C.D.; Wagner. J.; Boniface. K.; Vaughan. J.; Michalski. W. P.; Catto-Smith. A. J.; Cameron. Don .J.S.; Bishop. R. F.Mycobacterium avium subspecies paratuberculosis in children with early-onset Crohn’s disease. Inflammatory Bowel Diseases. 2009, Vol 15, 11, PP 1643-1655.