Wed, May 11, 8:31 AM
- Galectin Therapeutics (NASDAQ:GALT) completes enrollment in its Phase 2 clinical trial, NASH-FX, assessing lead product candidate GR-MD-02 in patients with non-alcoholic steatohepatitis (NASH) with advanced (stage 3) fibrosis. The single-site study is being conducted at the San Antonio Military Medical Center in Texas. Top-line results should be available by late September, as previously planned.
- The 30 subjects in NASH-FX were split into two equal arms to receive either 8 mg/kg of GR-MD-02 or placebo every other week for 16 weeks (nine total doses). The primary endpoint is the mean change in liver fibrosis as measured by multi-parametric magnetic resonance imaging (LiverMultiScan) developed by UK-based Perspectum Diagnostics.
- GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a protein that plays a key role in the pathogenesis of fatty liver disease and fibrosis. Another mid-stage NASH study, NASH-CX, started in July 2015 with top-line data expected in Q4 2017. It is also being evaluated for the treatment of psoriasis.
- Shares are up 16% premarket on light volume.
- Previously: Galectin's mid-stage study of GR-MD-02 in NASH with advanced fibrosis underway (Sept. 16, 2015)
- Previously: Galectin initiates enrollment in mid-stage trial of GR-MD-02 in NASH (July 1, 2015)
Wed, Apr. 6, 1:45 PM
- Gilead Sciences' (GILD +2%) acquisition of Nimbus Therapeutics for as much as $1.2B appears to have investors in a lather over other developers of therapies to treat nonalcoholic steatohepatitis (NASH), especially Galmed Pharmaceuticals (GLMD +38.3%).
- NASH-related tickers: (MNOV +0.4%)(RGLS +4.8%)(ICPT +4.4%)(CNAT +10.9%)(VBLT +3%)(GALT +2%)(TBRA -0.1%)(OTCPK:ISLT)(SHPG +7.2%)(RPTP +3.6%)(OTCPK:GNFTF -0.9%)(CANF +11.8%)
- Read now NASH Drugs: A Comprehensive Review Of Current Clinical Trials
Nov. 20, 2015, 12:47 PM
Aug. 13, 2015, 9:19 AM
Aug. 13, 2015, 8:40 AM
- The USPTO issues a Notice of Allowance to Galectin Therapeutics (NASDAQ:GALT) for its patent application number 13/726,900 titled, "Galactose-pronged polysaccharides in a formulation for antifibrotic therapies." The patent, when issued, will extend the coverage of the company's pectin-derived compounds to include treatment of chronic kidney disease associated with the development of fibrosis, established kidney fibrosis, chronic lung disease associated with the development of fibrosis and established lung fibrosis.
- Update: shares are up 22% premarket on higher-than-normal volume.
Jun. 11, 2015, 12:45 PM
Jun. 10, 2015, 12:53 PM
Jan. 7, 2015, 12:45 PM
Jan. 7, 2015, 9:20 AM
Jan. 7, 2015, 8:50 AM
- Thinly-traded nano cap Galectin Therapeutics (NASDAQ:GALT) is up 49% premarket on robust volume in response to its report of results from a 30-patient Phase 1 study of GR-MD-02 in patients with nonalcoholic steatohepatitis (NASH).
- The principal objective of the trial was to assess the safety, tolerability and pharmacokinetics of GR-MD-02 but investigators also noted a potential therapeutic effect on fibrosis as measured by a serum biomarker (FibroTest) and liver stiffness (FibroScan). Patients in cohort 3 who received 8 mg/kg GR-MD-02 showed a statistically significant reduction in FibroTest score versus placebo in one of the cohorts.
- Fibrotest is a composite score of six blood tests that correlate to the extent of liver fibrosis.
- NASH represents the next big potential payoff for drug firms after HCV.
- Previously: Galectin NASH treatment meets primary endpoint in Phase 1 (Nov. 10, 2014)
- NASH-associated tickers: (NASDAQ:GILD) (NASDAQ:SHPG) (NASDAQ:LJPC) (NASDAQ:CNAT) (NASDAQ:ICPT) (NASDAQ:RPTP)
Jul. 30, 2014, 12:46 PM
Jul. 30, 2014, 9:09 AM
Jul. 29, 2014, 12:47 PM
Jul. 29, 2014, 9:25 AM
- Shares of Galectin Therapeutics (NASDAQ:GALT) crater 46% premarket on robust volume in response to the company's webcast this morning. It was presenting data for its galactin inhibitor, GR-MD-02, as a treatment for fatty liver disease (NASH). Apparently, Slide 20 shows data that it has no effect on Galectin 3.
Jul. 29, 2014, 9:08 AM
Jul. 25, 2014, 12:45 PM
Galectin Therapeutics, Inc. operates as a biotechnology company, which engages in drug research and development to create new therapies for fibrotic disease and cancer. Its drug candidates are based on the method of targeting galectin proteins, which are key mediators of biologic and pathologic... More
Industry: Drugs - Generic
Country: United States
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