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Trial restarts with replacement material
January 9, 2012
By: Gil Roth
President, Pharma & Biopharma Outsourcing Association
PledPharma has restarted recruitment on a clinical trial of mangafodipir in treatment outcomes during angioplasty. The trial had been suspended last year because of a lack of clinical trial material, but the company recently gained approval from the Swedish Medical Products Agency for new CTM supplied by Recipharm. Maria Lundberg, general manager of Recipharm Pharmaceutical Development AB, commented, “We are pleased to contribute to the continuation of this important clinical trial. After being contacted by PledPharma, both companies worked very hard together to get the clinical trial material approved as fast as possible. We are well used to working with tight deadlines and we were very happy with the result that was achieved.” Jacques Näsström, chief executive officer of PledPharma, remarked, “The restart of the MANAMI study could not have been achieved without a new supply of mangafodipir, and we are satisfied with the collaboration with Recipharm to ensure this. Already we have seen promising results when mangafodipir has been used in conjunction with angioplasty, as it enables a greater reduction in the size of the infarction, for patients suffering myocardial infarction.” PledPharma plans to have two Phase II studies ongoing next year, and is in the final stages of preparatory work ahead of its Phase IIb study in colorectal cancer patients.
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