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COSMO: Positive results of first parts of Phase II / Blu-colonscopy

20-06-2011. Cosmo Pharmaceuticals S.p.A. today announced that a live transmission of a colonoscopy on a patient that had taken a Methylene Blue MMX® tablet for the better diagnosis of polyps, dysplastic lesions and adenomas in the colon, took place in front of approximately 500 specialists from around the world present at the International Meeting for Advanced Gastroenterology Endoscopy at Humanitas Hospital in Milano/Italy. Separately Prof Repici of Humanitas Hospital, who is conducting the phase II dose ranging trial testing the colon staining efficacy of single increasing oral doses of Methylene Blue MMX modified release tablets, gave a preliminary analysis of the results from the first 40 patients that have been treated so far.  
 
Prof. Repici said, “The preliminary results of the phase II dose ranging study convincingly demonstrate Methylene blue-MMX®tablet’s ability to stain the entire colon and thus vastly increase the possibility of detecting small polyps, dysplastic lesions and adenomas. It is of utmost importance to detect these small polyps, lesions and adenomas as early as possible before they turn into cancer, also considering that every colon cancer patient costs between USD 35’000 and USD 85’000 per year. The results that have been achieved in my study point out that Methylene blue-MMX®could become the diagnostic of choice for every screening colonoscopy.”
 
The Methylene blue-MMX®tablet is an oral colon-release formulation in form of coated tablets, containing methylene blue. The tablets are formulated using Cosmo’s patented multimatrix technology (MMX®) that allows the delivery of the active ingredient directly inside the colon. With this technology, the maximum local bioavailability of the active ingredient is achieved and, consequently, the biological effect is optimized. Patents have been filed and are pending.
 
Provepharm SAS, France is the manufacturer of Proveblue™, the methylene blue powder used in Methylene blue-MMX® tablets. The active ingredient in the powder is manufactured in compliance with European Pharmacopoeia. Unlike other manufacturers the powder obtained at Provepharm reaches a purity grade of 99%. Cosmo and Provepharm have entered into an exclusive licensing agreement.
 
The phase II dose ranging study that is being conducted by Prof A. Repici at the Istituto Clinico Humanitas in Rozzano/Italy is designed to treat approximately 100 patients undergoing colonoscopy with single increasing oral doses of Methylene Blue MMX modified release tablets with the intention of testing the colon staining efficacy. It is scheduled to be completed in the second half of the year.

 

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Provepharm: Synthetic Scheme for Methylene Blue

by B2Bioworld Editor* 

Source: US0291943, 26-11-09

 

 

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