The post Results from the NASH-FX Study Underscore the Importance of Completing the NASH-CX Clinical Trial for Patients with NASH Cirrhosis appeared first on NASH & Liver Fibrosis | Galectin Therapeutics.
]]>The NASH-FX study was designed as a pilot study at a single site, involving only four months of treatment with GR-MD-02. This pilot study evolved from the results of a Phase 1 study in NASH patients with advanced fibrosis that had suggested FibroScan® measurements improved in three patients with just four doses of the study drug. The full report of this Phase 1 study will be published in the next few weeks in the peer-reviewed scientific journal, Alimentary Pharmacology and Therapeutics.
While most experts feel that liver fibrosis trials should have treatment phases for at least a year in duration, the results from the earlier Phase 1 NASH study provided a rationale for studying a larger group of patients with shorter therapy and exploring non-invasive technologies for assessing liver disease and fibrosis with a goal of using these technologies in later trials.
I want to give you a few details on the design of the NASH-FX study. The primary endpoint of NASH-FX was the LiverMultiScan (LMS), an approved magnetic resonance imaging test developed by Perspectum Diagnostics to assist in the diagnosis of liver disease. In NASH, the LMS is reported to measure the amount of fibrosis and inflammation. The LMS has low variability between scans in the same individual, and we used this low variability to calculate the number of patients we would need for the study to show a statistically significance difference between treatment groups with a power of 80%. In other words, the study was designed to have an 80% chance of showing a statistically significant difference in a 30 patient study, with 15 placebo and 15 GR-MD-02 patients. The power of the actual study, calculated after completion, was almost exactly an 80% chance to show an approximately 10% difference in LMS between placebo and treated groups. Therefore, the study design was adequate for the primary endpoint.
In contrast to LMS, the study was not powered for the secondary endpoints of liver stiffness, FibroScan and magnetic resonance elastography (MRE). The study would have required between 3 to 5 times as many patients to have an adequate power to show a difference with these tests. This is because the variability of these tests for repeated measurements is considerably greater than LMS.
However, we did not know before we conducted the study, nor did anyone else know, whether LMS correlated with the liver stiffness measurements of FibroScan and MRE. The NASH-FX study showed that there was poor correlation. Therefore, one cannot conclude that because there was no difference in LMS, that there would not be a difference in stiffness measurements, which have been shown in liver biopsy studies to correlate with fibrosis.
Although there was no apparent improvement in the three non-invasive tests for assessment of liver fibrosis in the four-month NASH-FX study, Dr. Stephen Harrison, a leading investigator in NASH and liver disease and the principal investigator of the NASH-FX study has pointed out that the inhibition of galectin-3 with GR-MD-02 remains promising for the treatment of NASH fibrosis. Dr. Harrison was especially encouraged that GR-MD-02 has demonstrated an improved clinical effect in moderate-to-severe psoriasis, suggesting the compound has activity in a human disease that can occur in association with NASH.
It remains critical that we complete the longer therapy NASH-CX clinical trial that has a much larger group of patients with NASH cirrhosis.
The NASH-CX trial is a one-year of treatment, multi-center trial in patients with NASH cirrhosis that is being conducted at 36 outstanding liver centers in the United States. The endpoints of the NASH-CX trial include invasive tests that are well-validated measures of liver disease severity. The primary endpoint is the change from baseline in the hepatic venous pressure gradient (HVPG), which measures the blood pressure in the liver and is well correlated with the clinical outcomes of patients.
Liver biopsy is an important secondary endpoint in the NASH-CX trial, which evaluates the stage of liver fibrosis and the amount of collagen, the primary component of fibrotic tissue. Finally, there are also non-invasive tests as secondary endpoints, including FibroScan and the 13C-methacetin breath test, which measures the metabolic function of the liver. These are important to correlate with the invasive tests because they may be useful in future trials and in management of patients.
I am pleased to report additional information on the status of this most important clinical trial as of October 10, 2016:
The safety and tolerance of GR-MD-02 in all of the trials is most encouraging and supports our commitment to pursue the lead indication of NASH cirrhosis. In the NASH-FX study, GR-MD-02 was found to be safe and well-tolerated among the patient population with no serious adverse events related to the study medication. Over all of the clinical trials, including the patients in the NASH-CX trial, more than 1600 doses of GR-MD-02 have been administered without serious adverse effects related to the drug. This highlights the superior safety profile of the therapy in a patient population with advanced-stage disease, which is buttressed by the biological activity demonstrated in patients with moderate to severe plaque psoriasis.
Dr. Harrison, one of the two co-lead investigators in the NASH-CX trial, stated his belief that the inhibition of galectin-3 with GR-MD-02 remains a promising treatment for NASH fibrosis and that it is important to complete the NASH-CX trial.
Dr. Naga Chalasani, the other co-lead principal investigator of the NASH-CX trial, provided his assessment, stating:
“The results from the NASH-FX trial do not diminish the significance of the NASH-CX trial. Along with the safety and tolerability profile observed in the NASH-FX trial, the different patient population, much larger enrollment, rigorous study design and longer duration of therapy offer compelling rationale to complete the NASH-CX trial.”
As a company, Galectin Therapeutics’ attention has always been focused on completing the NASH-CX clinical trial and reporting results in a timely fashion.
With an outstanding safety profile, inhibition of galectin-3 with GR-MD-02 remains a potential treatment of NASH cirrhosis. Additionally, the longer therapy for one year, and endpoints that may serve as a surrogate for outcomes for registration trials in this patient population, provides us encouragement about our continuation of NASH-CX clinical trial.
These “CEO Perspectives” are a regular feature of our communication activities and may contain forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including whether GR-MD-02 may be effective in the treatment of NASH. These statements relate to future events and use words such as “may,” “might,” “could,” “expect” and others. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.
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]]>The post A Brief Overview of Non-Invasive Testing in Liver Fibrosis appeared first on NASH & Liver Fibrosis | Galectin Therapeutics.
]]>I wrote recently about why we rely on liver biopsies for the diagnosis of NASH and liver fibrosis and the need for alternative, non-invasive tests that enable us to diagnose and track the progression the disease. Today I’d like to explore the different non-invasive tests being developed. There are two basic approaches I will discuss: tests where blood (or serum) is tested for specific biomarkers, and the physical assessment of the liver using some form of imaging technology. I will use several prominent examples, but this will not cover every test being evaluated or available. I will also discuss tests of liver function and blood flow in future Perspectives.
Serum tests
Serum tests (serum is the clear fluid that results after blood clots) are already commonly used in support of liver biopsy for a variety of liver diseases. A liver biopsy can indicate that a patient has viral hepatitis, for example, but there is no definitive way of knowing whether it’s hepatitis A, B, C, D or E without a blood test.
Might we be able to take the next step and use a blood test without resorting to a biopsy? These tests are problematic from several fundamental standpoints. One reason is that you don’t necessarily know without rigorous empirical research whether what’s in the serum is reflective of what’s in the liver. For example, the galectin-3 protein is markedly increased in the liver tissues in animal models with NASH, but galectin-3 levels in the serum aren’t reflective of what’s going on in the tissue. The same holds true for many of the thousands of other proteins involved.
Despite this, there are many researchers who are trying to devise sophisticated blood tests that provide much of the information found on a liver biopsy, which has been called a “liquid biopsy.” Researchers have been using proteomic approaches to examine the thousands of different proteins and modified proteins that are in the blood to see whether there are tests that reflect either the etiology or the degree of damage in the liver. In other cases, researchers are measuring all the products of metabolism, called metabolomics, to investigate the correlation with biopsy findings. People are also looking at microRNA circulating in the blood, as well as micro vesicles, which are small pieces of cells that break off and circulate in the blood. These approaches, while promising, are far from well-defined enough to be used in clinical medicine.
To simplify our discussion, let’s concentrate on some of the currently available blood tests that look to determine the degree of fibrosis in the liver. Many approaches have been tried on this problem, such as testing for single compounds like hyaluronic acid or compiling multiple different serum tests together to determine a combined score, such as FibroTest® or the ELF (Enhanced Liver Fibrosis) test. Research shows that many of these tests correlate in various ways between serum levels and the degree of fibrosis, but they’re not very precise. They can tell you whether there’s little fibrosis or a lot of fibrosis, but they can’t tell you all the different gradations in between. There’s no solid evidence that they’re going to be useful in their current iterations for testing the effect of a drug, because such effects are likely to be found in those gradations.
We studied several of these serum tests in our Phase I study of GR-MD-02, and, as I discussed in an earlier CEO Perspective, we noticed that the alpha 2 macroglobulin protein, which is part of the FibroTest, appeared to be decreased with drug treatment. That said, in my view the accuracy, precision and reliability of serum tests have not gotten to the point where they could be used as a reliable surrogate for a biopsy in clinical trials of antifibrotic drugs.
Physical assessment of the liver
Another possibility for non-invasive testing of the liver is through physical assessment, often through some form of diagnostic imaging. A fibrotic liver has very different physical characteristics than a normal liver, and some of this can be assessed by external means.
There are some imaging techniques that wouldn’t work for the assessment of liver fibrosis. CT (computed tomography) and standard ultrasound tests show liver tissue, but they are really only effective for examining the overall structure of the liver, its size, and whether there are tumors — not that useful for determining fibrosis.
A variety of ultrasound-based tests are the best studied methods for staging liver fibrosis, including FibroScan®, acoustic radiation force impulse imaging (ARFI), and real-time shear wave elastography (SWE). All of these tests essentially evaluate the stiffness of the liver, because the more fibrosis a patient has, the stiffer the liver becomes. FibroScan, developed by Echosens and approved for diagnostic use in the US, measures the speed of a mechanical pulse as it goes through the liver, which correlates that to stiffness and produces a pressure measurement, kilopascals. While FibroScan only measures a core of liver tissue, it is about 100 times bigger than the area measured by a liver biopsy. Liver disease and fibrosis are often not uniform throughout the entire liver, so analyzing a small sample might lead to either over- or underestimating the amount of fibrosis. FibroScan has many desirable characteristics for a test of liver fibrosis in that it is quick, inexpensive, can be done in a provider office setting, and is painless. We utilized this test in the third cohort of our Phase 1 clinical trial (more here) and have included it in our two Phase 2 ongoing clinical trials, NASH-FX and NASH-CX.
Magnetic resonance elastography, or MRE, which is available from several manufacturers of imaging machines, uses low frequency vibrations applied to the patient. The MRI can pick up the perturbations as the pulse moves through the liver tissue. If the liver is very stiff, the pulse will move quickly. As with FibroScan, the results of MRE are reported in kilopascals and have been correlated to the degree of fibrosis as diagnosed through biopsy. It has the advantage of evaluating the entire liver, thereby eliminating sampling error of ultrasound based methods, and it simultaneously evaluates the liver for lesions such as tumors. While MRE compares favorably to FibroScan, and in some studies is more useful for staging fibrosis, it is much more expensive and less easily used in a clinical setting. We are also using this test in the NASH-FX study.
Software analyses of MRI data can be used to derive additional information. Such software-driven tests can measure various tissue parameters (so called multi-parametric tests) such as the amount of fluid, iron, fat and interstitial space – that is the space between the cells – in the liver. Since fibrosis and much of the inflammation are found in the interstitial space, this can be a useful test. Software combines all these elements to give a score that provides some indication of how much fibrosis there is in the liver. Similar to MRE, multi-parametric MRIs may be superior to a liver biopsy, because an MRI looks at the entire liver, slice by slice, while biopsy only samples 1/50,000th of the liver. We’re using multi-parametric MRI software called LiverMultiScan®, developed by Perspectum Diagnostics, as a monitoring tool in our NASH-FX trial.
There is good correlation between LiverMultiScan and the results of liver biopsies (1), and a recent paper shows that it also correlates with patient outcomes (2). In other words, you can predict which patients are going to have bad outcomes from their liver disease based on the LiverMultiScan results. Furthermore, the results of a LiverMultiScan change in response to treatment. The most dramatic change reported was in a patient who had NASH with fibrosis and then underwent an intestinal bypass as a weight loss procedure. The patient’s LiverMultiScan score and fibrosis went down dramatically with the loss of weight. While this test is approved for diagnostic use in Europe and the U.S., we still need a lot more data before it would be accepted as a regulatory end point by FDA for drug approval, but it is a promising approach towards non-invasive evaluation.
Each of these three imaging methods are approved by regulatory agencies for diagnostic use and are currently available to physicians, mostly in selected locations. However, they have not been used in prospective, therapeutic clinical trials to assess the efficacy of a drug in liver fibrosis. Well controlled clinical trials will be necessary, as we and other companies are currently undertaking, to validate these methods for use in drug approvals.
We’re not there yet, but I think we will see these sorts of approaches evolve quickly. The goal is to get to the point where we can characterize the underlying fibrosis even more quantitatively and effectively as with a liver biopsy. When we’re able to do that, it will eliminate the risk and the pain associated with a liver biopsy, and enable us to evaluate the whole liver, not just 1/50,000th of it, multiple times with a patient.
Reference List
1. Banerjee R, Pavlides M, Tunnicliffe EM, Piechnik SK, Sarania N, Philips R, et al. Multiparametric magnetic resonance for the non-invasive diagnosis of liver disease. J Hepatol 2014 Jan;60(1):69-77.
2. Pavlides M, Banerjee R, Sellwood J, Kelly CJ, Robson MD, Booth JC, et al. Multi-parametric magnetic resonance imaging predicts clinical outcomes in patients with chronic liver disease. J Hepatol 2015 Oct 12.
These “CEO Perspectives” are a regular feature of our communication activities and may contain forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events and use words such as “may,” “might,” “could,” “expect” and others. These statements include those regarding the hope that Galectin Therapeutic’ s development program for GR-MD-02 will show that it can be both safe and effective when used in combination with other drugs for the treatment of patients with cancer. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.
The post A Brief Overview of Non-Invasive Testing in Liver Fibrosis appeared first on NASH & Liver Fibrosis | Galectin Therapeutics.
]]>The post 2015 – 2016, Progress and Possibilities appeared first on NASH & Liver Fibrosis | 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. Importantly, this progress forms the basis for numerous milestones expected in 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.
CEO Perspectives, Dr. Traber’s blog introduced last year, 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, which can be found here.
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.
Our Clinical Programs
NASH with advanced liver fibrosis
Development of GR-MD-02 for the treatment of non-alcoholic steatohepatitis (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.
This finding alone defines 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. We published a comprehensive piece on the results of the Phase 1 study in a CEO Perspectives blog post, which can be found 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 are on multiple medications over long periods of time and may take other medications on an 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. We published a CEO Perspectives piece on this topic, which 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 and the other in NASH patients with cirrhosis. 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, the NASH-CX trial, 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 can be found at www.clinicaltrials.gov and in a CEO Perspectives blog post, which can be found here.
We are pleased with the pace of the NASH-CX study and we remain on track to provide data readout in at the end of 2017, as we have previously indicated.
In September we initiated a 30-patient study with GR-MD-02 in NASH patients with advanced fibrosis, our NASH-FX study, 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. This study is also proceeding as planned, with top-line data expected around the end of the third quarter of 2016. We published a CEO Perspectives piece on this trial, which is available here.
Psoriasis
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 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 can be found here.
Melanoma
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 blockade therapies, or so-called checkpoint inhibitors, a new class of drugs. GR-MD-02 is progressing through a Phase 1b study in combination with Yervoy®, and a Phase 1b study in combination with Keytruda® was initiated in the fourth quarter of 2015 with enrollment to begin early in 2016. Preclinical work in mouse cancer models with GR-MD-02 added to checkpoint inhibitors shows a boost in anti-tumor immunity, a reduction in tumor size and increased survival. Both of these studies are being conducted at the Providence Cancer Center in Portland, Oregon. Galectin is providing GR-MD-02 to the investigators, who are funding the costs of these studies. We published a CEO Perspectives on these trials, which is available here.
In the trial combining Yervoy and GR-MD-02, two dosing cohorts have been completed and the third cohort delivering 4 mg/kg of GR-MD-02 is enrolling now. Of the seven patients that have received the combination therapy, there has been no dose limiting toxicity. Following completion of the 4 mg/kg dose cohort, a total of 10 patients will be dosed at 8 mg/kg. Immune markers as well as tumor response are being monitored in this study.
Significant Presentations and Publications
Galectin’s researchers presented at several important industry meetings during the year. Dr. Traber delivered an invited presentation of the company’s research with GR-MD-02 in NASH at the American Association for the Study of Liver Diseases (AASLD) Industry Colloquium in March. He participated in the session entitled “NASH: Clinical Endpoints and Drug Development” and discussed the role of galectin-3 in organ fibrosis generally and liver fibrosis in particular, and GR-MD-02 as a galectin-3 inhibitor. He reviewed the published preclinical data showing that GR-MD-02 is effective in reversing inflammation and fibrosis in a mouse model of NASH and also in reversing cirrhosis and improving portal hypertension in a rat model of cirrhosis. He also reviewed the company’s Phase 1 study results and its Phase 2 clinical program design. The abstract of Dr. Traber’s presentation can be found here.
In addition, preclinical research from a study led by Stefanie Linch, Ph.D. in the laboratory of tumor immunology expert William L. Redmond, Ph.D. of the Providence Cancer Center’s Earle A. Chiles Research Institute was presented in November at the Society for Immunotherapy of Cancer’s (SITC) 30th Anniversary Annual Meeting. The studies presented were conducted by the Institute in collaboration with Galectin Therapeutics. The poster presentation “Galectin-3 inhibition using novel inhibitor GR-MD-02 improves survival and immune function while reducing tumor vasculature” and an abstract was published in the Journal for ImmunoTherapy of Cancer. The poster presentation is available for review here.
Interviews with Dr. Traber appeared in a number of publications throughout 2015, including R&D Magazine in a piece entitled “Finding the Holy Grail Treatment for Fatty Livers,” available here, Obesity News Today published its Q&A article entitled, “Exclusive: Dr. Peter Traber Discusses Non-alcoholic Fatty Liver Disease”, available here, and MD Magazine, which conducted an online interview with Dr. Traber at the AASLD meeting. That interview can be found here.
Galectin management also participated in a number of investment conferences throughout the year, including programs for institutional investors, retail investors and family offices.
Foundational Support for our Business
During 2015 we considerably strengthened our intellectual property portfolio and received a U.S. patent Notice of Allowance for the use of pectin compounds to reduce fibrosis in multiple diseases. This patent is particularly important because it not only permits GR-MD-02 use for NASH with fibrosis, but it covers other compounds in our pipeline and a multitude of diseases with a fibrotic etiology. We also continued to build our international patent portfolio with patents issued or allowed in Israel and Australia.
We also made excellent progress with our Chemistry, Manufacturing and Controls (CMC), all of which are vital to the proper conduct of our clinical trials with GR-MD-02 and are essential components of the final application to the FDA for a drug’s approval. We discussed this progress during the year in the CEO Perspective post found here. We also reached a very significant milestone in our preclinical toxicology program, having completed chronic administration of GR-MD-02 in two animal species, allowing chronic administration in human subjects.
Lastly, we were very pleased to have completed a $9.8 million financing during the fourth quarter. This capital is expected to fund currently planned operations through the first quarter of 2017, and will be used mainly for clinical trial expenses and other research and development expenses, as well as for general corporate purposes.
Looking Ahead to 2016
We are looking forward to executing on several important milestones in 2016, with highlights including the following:
We are fully aware that yesterday’s accomplishments set tomorrow’s expectations, and we look forward to creating shareholder value by executing on numerous milestones during 2016. We are grateful to our long-standing, loyal shareholders for their continued support and to the hard-working staff at Galectin Therapeutics who share a unifying commitment to addressing significant unmet clinical needs in NASH, as well as in oncology and psoriasis.
These “CEO Perspectives” are a regular feature of our communication activities and may contain forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events and use words such as “may,” “might,” “could,” “expect” and others. These statements include those regarding the hope that Galectin Therapeutic’ s development program for GR-MD-02 will show that it can be both safe and effective when used in combination with other drugs for the treatment of patients with cancer. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements
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