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April 17, 2014
10:21 EDTGALTGalectin Therapeutics announces first patient dosed in GR-MD-02 trial
Galectin Therapeutics announced that the first patient in cohort 2 of its Phase 1 clinical trial of GR-MD-02 in patients with NASH with advanced fibrosis has been successfully dosed with 4 mg/kg, which is double the dose given in cohort 1. Cohort 2, as with all phases of the clinical trial, was initiated in full compliance with the rules, regulations, and specific conditions set forth by the U.S. Food and Drug Administration for this Phase 1 clinical trial. The second cohort follows highly successful results from the first cohort showing that 2 mg/kg was safe and very well tolerated, and that GR-MD-02 treatment resulted in significant improvement in multiple biomarkers of fibrosis and liver inflammation in patients with NASH with advanced fibrosis. The remaining patients in cohort 2 are expected to be enrolled over the next few weeks and we anticipate reporting the results of cohort 2 around the end of July.
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July 30, 2014
11:14 EDTGALTHigh option volume stocks
High option volume stocks: EXAM ASML EWY TQNT NFX RFMD RATE BPI GALT ZLTQ
09:24 EDTGALTGalectin Therapeutics comments on reactions to GR-MD-02 phase 1 results
Galectin Therapeutics commented on market and social media reactions to the announced results of cohort 2 of its phase 1 clinical trial in patients with NASH with advanced fibrosis. The company stated, "While the results of the clinical trial were positive, the market reacted negatively to this report. We believe the reaction was fueled in part by certain commentary on social media sites and the Internet and we strongly disagree with these interpretations of our data". "There is a large amount of scientific literature showing galectin-3 is a critical protein in fibrosis". "Certain commentators on social media labeled the second cohort results, 'a flop.' This is simply not accurate. The primary endpoints for the phase 1 trial have always been safety and pharmacokinetics and have been successfully met for each cohort completed." "While the phase 1 trial is still ongoing, we deem the phase 1 clinical trial a success up to this point." "Exploratory biomarkers were included to aid in the design of a phase 2 program that will be focused on showing efficacy, and for this they are serving their purpose." "We are not dependent on biomarker data for a phase 2 clinical trial". "The development program for GR-MD-02 for NASH with advanced fibrosis remains on track". "Upon completion of the third cohort, which has already infused two patients, we will initiate a phase 2 clinical trial program to definitively evaluate the therapeutic potential of this promising therapy using a standard endpoint of liver biopsy to assess efficacy".
July 29, 2014
12:13 EDTGALTOn The Fly: Midday Wrap
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11:37 EDTGALTHigh option volume stocks
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10:39 EDTGALTGalectin drug showed no difference from placebo, The Street reports
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08:42 EDTGALTGalectin Therapeutics drops after posting Phase I GT-020 slides
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July 28, 2014
12:59 EDTGALTGalectin Therapeutics volatility up into Cohort 2 Phase 1 clinical trial results
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12:44 EDTGALTGalectin pays for misleading press releases, The Street's Feuerstein says
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11:00 EDTGALTHigh option volume stocks:
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July 25, 2014
08:55 EDTGALTGalectin Therapeutics to host conference call
Conference call to discuss the Cohort 2 Phase 1 clinical trial results will be held on July 29 at 8:30 am. Webcast Link
July 22, 2014
10:46 EDTGALTHigh option volume stocks: SBAC KS EDU PII GALT EJ AXL TSEM HLF BCOR
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08:44 EDTGALTGalectin Therapeutics announces first patient dosed in GR-MD-02 Phase 1B trial
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