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December 13, 2013
08:40 EDTMACKMerrimack announces clinical data from Phase 1 study of MM-302
Merrimack Pharmaceuticals announced Phase 1 clinical trial results for MM-302, a novel HER2-targeted liposomal doxorubicin for the treatment of advanced HER2-positive breast cancer. Primary objectives for the trial are to assess the safety of MM-302 as a monotherapy and in combination with trastuzumab, as well as to determine the Phase 2 dose for MM-302. Anthracyclines, particularly doxorubicin, have been an effective component of breast cancer treatment for decades, though their use is ultimately limited by cardiac toxicity. These cardiotoxic effects limit the use of traditional anthracyclines in combination with targeted therapies, such as trastuzumab, for treatment of HER2-positive breast cancer. MM-302 is specifically designed to address this issue by delivering doxorubicin to tumor cells overexpressing HER2, while minimizing uptake into normal cells, including those of the heart. In this ongoing Phase 1 study, patients treated with MM-302 showed no signs of clinical decline in cardiac function. The most common adverse events were fatigue, nausea and decreased appetite; the rates of these events were consistent across MM-302 as a monotherapy and in combination with trastuzumab. Results from the trial also showed that patients treated with MM-302 as a monotherapy at doses of 30, 40 and 50 mg/m2 had an estimated progression free survival of 5.6 and a clinical benefit response rate of 37%. Of note, 5 of 9 patients who had not been previously treated with anthracyclines had a PFS of greater than 9 months.
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April 8, 2014
08:08 EDTMACKMerrimack says ferumoxytol well tolerated in diagnostic imaging study
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