NORCROSS, Ga., Jan. 07, 2016 (GLOBE NEWSWIRE) — Galectin Therapeutics, Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announces that the year-in-review post “2015-2016, Progress and Possibilities” is now available on the company’s website in the CEO Perspectives section here. Following is the text of the post.
2015-2016, PROGRESS AND POSSIBILITIES FOR GALECTIN THERAPEUTICS
The many accomplishments at Galectin Therapeutics during 2015 ranged from incremental progress touching every aspect of our business to significant advancements with GR-MD-02. Such advancements include positive Phase 1 data that led to the initialization of three Phase 2 trials in 2015 to evaluate GR-MD-02, our lead compound, in patients with non-alcoholic steatohepatitis (NASH) with advanced fibrosis and cirrhosis, and in patients with plaque psoriasis in a proof-of-concept study.
Importantly, this progress forms the basis for numerous milestones expected in 2016 and the coming years including clinical progress, intellectual property fortification, further engagement with the investment community and ongoing outreach to educate our shareholders about our work to develop new therapies, the regulatory environment in which we operate and our target markets.
The CEO Perspectives blog was introduced last year. Authored by CEO and CMO Peter G. Traber, M.D., the blog is designed to provide scientific and technical information largely regarding our work with GR-MD-02 in layman’s language. Much of our progress and accomplishments during 2015 were chronicled in the 14 blog postings.
We were delighted that in the final days of 2015 a U.S. District Court dismissed both the federal securities class-action lawsuit and the shareholder derivative actions lawsuit filed in the summer of 2014 against Galectin and certain officers, directors and a shareholder, which had cast an inappropriate cloud over our many achievements in 2015. The Court entered final judgments of dismissals in both actions based on the Court’s finding that any further amendment of the complaints would be futile (i.e., dismissed with prejudice). Plaintiffs have the right to appeal the Court’s dismissals within 30 days. Based on the Federal Court’s rulings, Galectin is seeking dismissal of a duplicative shareholder derivative action in Nevada, which was filed after the federal actions. See press release here.
Our Clinical Programs
NASH with advanced liver fibrosis
Development of GR-MD-02 for the treatment of NASH with advanced fibrosis and cirrhosis continues to be the primary focus of our company. We completed a successful Phase 1 clinical trial and announced final data in January 2015. The Phase 1 trial demonstrated that GR-MD-02 is safe, with potential for therapeutic effect on fibrosis in NASH patients with advanced fibrosis. We found no serious adverse events and no treatment-emergent adverse events related to our drug. Furthermore, GR-MD-02 was found to be safe and well tolerated in each of the three dose-escalating cohorts of patients, who were suffering from NASH with advanced fibrosis.
These findings alone define the study as a success, but we gained additional valuable information. We found that the FibroTest® score, a composite biomarker of five different blood tests that has been correlated with the extent of liver fibrosis, was significantly reduced by GR-MD-02 treatment in the third dosing cohort of 8 mg/kg. In addition, we found that some patients in this cohort also showed a decrease in liver stiffness, which has a direct correlation with fibrosis. More information is available here.
In addition to the Phase 1 trial in NASH patients with advanced fibrosis, we reported the results of a drug-drug interaction study with GR-MD-02 and midazolam, a common sedative, which showed that in healthy volunteers there was no unfavorable interaction between the two compounds. Because many patients with chronic diseases may take other medications on an ongoing or intermittent basis, this finding is important to the commercial potential of GR-MD-02 and to the patient population that is eligible to participate in our Phase 2 program. More information is available here.
The information gleaned from the Phase 1 studies formed the basis for our Phase 2 program, which consists of two studies, one in NASH patients with advanced fibrosis (the NASH-FX trial) and the other in NASH patients with cirrhosis (the NASH-CX trial). We submitted our protocol to the U.S. Food and Drug Administration (FDA) for the cirrhosis study in the first quarter, engaged our contract research organization and began screening patients at the end of June.
This study is a multicenter, randomized, placebo-controlled, double-blind, parallel-group Phase 2 trial to evaluate the safety and efficacy of GR-MD-02 for the treatment of liver fibrosis and resultant portal hypertension (HVPG) in patients with NASH cirrhosis. A total of 156 patients at approximately 50 sites in the U.S. will be randomized to receive either 2 mg/kg of GR-MD-02, 8 mg/kg of GR-MD-02 or placebo, with 52 patients in each arm. The primary endpoint is a reduction in HVPG. Patients will receive a total of 26 infusions every other week for one year, at which time they will be evaluated for change in HVPG compared with placebo. HVPG will be correlated with secondary endpoints of fibrosis on liver biopsy, as well as with measurement of liver stiffness via FibroScan® and assessment of liver metabolism (13C-methacetin breath test, Exalenz), which are non-invasive measures of the liver that may be used in future studies. More information is available at www.clinicaltrials.gov and here.
We are pleased with the pace of the NASH-CX study and we remain on track with enrolling the trial by the end of August 2016 and our plans to provide data readout in at the end of 2017, as we have previously indicated.
In September 2015 we initiated a 30-patient study with GR-MD-02 in NASH patients with advanced fibrosis, with 15 patients receiving 8 mg/kg of GR-MD-02 and 15 patients receiving placebo every other week for 16 weeks. This study will evaluate the safety and efficacy of GR-MD-02 on liver fibrosis using multi-parametric magnetic resonance imaging (LiverMultiScan®, Perspectum Diagnostics) as the primary endpoint and liver stiffness as assessed by magnetic resonance-elastography and FibroScan as secondary endpoints. Enrollment of this study is also proceeding as planned, with top-line data expected around the end of the third quarter of 2016. More information is available here.
As we have previously reported, one of the patients participating in our Phase 1 NASH study was a long-term psoriasis sufferer, and this patient’s psoriasis cleared as the study progressed, and remained cleared for many months following the conclusion of the study. With an established theoretical pathway for how inhibition of galectin-3 might affect psoriasis, in September 2015 we began an open-label, 10-patient Phase 2a pilot study in patients with moderate-to-severe plaque psoriasis. We expect data readout from this study late in the third quarter of 2016. More information and background on this study is available here.
We continued to support independent research with GR-MD-02 in combination with two commercial melanoma drugs, as preclinical research has shown our compound enhances the efficacy of immune checkpoint inhibitor therapies, a