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Examples
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More cases of clinically relevant mucositis were reported in the talactoferrin arm, but the difference was not statistically significant.
unknown title 2011
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The study evaluated the effect of talactoferrin versus placebo in 47 patients with acute myelogenous leukemia AML in preventing neutropenic fever and oral mucositis, which are common side effects of chemotherapies used to treat AML.
unknown title 2011
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Torsten Hombeck, Ph.D., Chief Financial Officer and Spokesperson of the Management Board, said: We had a very productive first half of 2011, highlighted by solid progress with our clinical programs for our oral immunotherapy, talactoferrin.
unknown title 2011
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Even if the results from our later stage trials with talactoferrin, including the ongoing FORTIS-M trial in non-small cell lung cancer, are considered positive, there can be no guarantee that they will be sufficient to gain marketing approval in the United States or any other country, and regulatory authorities may require additional information, data and/or further pre-clinical or clinical studies to support approval.
unknown title 2011
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Additionally, data on talactoferrin were presented at a variety of major medical meetings in the U.S. and Europe.
unknown title 2011
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We were also very pleased to hire several highly experienced executives in key areas as we prepare for a possible regulatory filing for talactoferrin and a potential commercial launch.
unknown title 2011
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The increase in R&D expenses is primarily due to increased patient enrollment in the Phase III FORTIS-M trial with talactoferrin in non-small cell lung cancer NSCLC and preparation for the Phase II/III OASIS trial with talactoferrin in severe sepsis, which was initiated at the end of the second quarter of 2011.
unknown title 2011
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The Company confirmed that management continues to expect top-line data from the FORTIS-M trial evaluating talactoferrin in third-line+ NSCLC in the first half of 2012.
unknown title 2011
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Talactoferrin is currently in Phase III clinical trials in non-small cell lung cancer, and a Phase II/III trial with talactoferrin in severe sepsis is underway.
unknown title 2011
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No increase in mucositis has been reported in other clinical studies with talactoferrin.
unknown title 2011
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