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Pierre van der Bruggen of the Ludwig Institute in Brussels, Belgium as a collaboration with Galectin Therapeutics restore the ability of T cells to kill tumor cells GM CT 01 Restores Ability of Immune Cells to Kill Tumor Cells 2012 Galectin Therapeutics OTC:GALT 28 Melanoma Clinical Trial Design (I) 2012 Galectin Therapeutics OTC:GALT 29 Phase I/II study of peptide vaccination associated with GM CT 01, a galactomannan oligomer that inhibits galectin 3, in patients with advanced metastatic melanoma IMPD approved by EMA Tumor Immune Enhancement Development Program 2012 Galectin Therapeutics OTC:GALT 30 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2012 2013 2014 Preclinical Efficacy Studies GM CT 01 GR MD 02 GM CT 01 Phase I/II Melanoma Trial Top line results in Stage 1 First patient enrolled Top line results in Stage 2 Human CD8 T Cell/Tumor assay Efficacy in immune competent mice with syngeneic tumors Efficacy in combination with a tumor vaccine (partnership) Pursue Partnering Discussions Development Program In Cancer Immunotherapy Galectin proteins secreted by tumor cells are directly responsible for inhibiting the ability of immune cells to kill tumors GM CT 01 restores the ability of immune cells to kill tumor cells Initial clinical trial for treatment of metastatic malignant melanoma Market for tumor vaccines is expected to grow to $7B by 2015 Potential important therapy for many cancers 2012 Galectin Therapeutics OTC:GALT 31 Pipeline 2012 Galectin Therapeutics OTC:GALT 32 Pre Clinical Registration Submitted Chemotherapy Colorectal Cancer: GM CT 01 International (Colombia) United States Immune Enhancer Melanoma: GM CT 01 Liver Fibrosis Post Tx: GR MD 02 NASH: GR MD 02 Phase 1 Phase 3 Phase 2 Galectin Therapeutics Highlights Leader in galectin science Pipeline of carbohydrate based drug compounds that inhibit galectins Focus on proven galectin activity in fibrosis and cancer Liver Fibrosis Target validated in convincing pre clinical data Two indications: NASH and Post transplantation fibrosis Clinical trials expected to begin in end of 2012 Cancer Therapy Galectin inhibitor added to chemotherapy Enhancement of immune function activates patient s own immune system to kill tumor cells Clinical trial to begin January 2012 33 2012 Galectin Therapeutics OTC:GALT
Pierre van der Bruggen of the Ludwig Institute in Brussels, Belgium as a collaboration with Galectin Therapeutics Tumor Specific Cytotoxic T Cell Lymphocytes Blocking Galectins Enhances Tumor Killing By Immune System 2012 Galectin Therapeutics OTC:GALT 27 Tumor Cells Cytotoxicity Addition of our drugs, which inhibit galectins, Experiments performed by Dr.
Pierre van der Bruggen of the Ludwig Institute in Brussels, Belgium as a collaboration with Galectin Therapeutics Tumor Specific Cytotoxic T Cell Lymphocytes Blocking Galectins Enhances Tumor Killing By Immune System 2012 Galectin Therapeutics OTC:GALT 26 Tumor Cells However, these T cells lose the ability to kill tumor cells. A key reason is that Galectin 3 secreted by tumors bind to T cells and turn off their ability to kill tumor cells Experiments performed by Dr.
In similar patients, Erbitux had a 6.1 month survival compared to 4.6 months with no therapy Notably, serious adverse events were markedly lower in our studies with 5 FU/GM CT 01 than in comparison to other studies using 5 FU 2012 Galectin Therapeutics OTC:GALT 23 Development Approach In Colorectal Cancer Studies demonstrate potential utility of galectin inhibitors in combination with chemotherapy in cancer FDA has confirmed that preclinical and clinical data are adequate to proceed with large clinical trials We are deferring new clinical trials pending data from the tumor immunology clinical trial that may improve the design of future studies More rapid international registration is an approach that may provide revenue to support development programs and gain additional clinical experience with GM CT 01 2012 Galectin Therapeutics OTC:GALT 24 Tumor Specific Cytotoxic T Cell Lymphocytes Blocking Galectins Enhances Tumor Killing By Immune System 2012 Galectin Therapeutics OTC:GALT 25 Tumor Cells Cytotoxicity There are tumor specific cytotoxic T cells in patients with cancer that are capable of killing tumor cells Experiments performed by Dr.
Ji yao Wang of Fudan University, Shanghai, China GR MD 02 is Most Effective in Reducing Collagen Content in Fibrotic Rats 2012 Galectin Therapeutics OTC:GALT 14 0 1 2 3 4 5 6 7 % Collagen Vehicle GR MD 01 GR MD 02 N=8 N=8 N=8 One way ANOVA Bondferroni P 0.001 P 0.05 P 0.05 P 0.05 Mouse NASH Model (Non Alcoholic Steatohepatitis, Fatty Liver Disease ) 2012 Galectin Therapeutics OTC:GALT 15 GM CT 01 (120 mg/kg 2X/week) GR MD 02 (60 mg/kg 2X/week) Early Rx Late Rx Early Rx Late Rx 2012 Galectin Therapeutics OTC:GALT 16 GR MD 02 Markedly Improves NASH in a Mouse Model When it is Administered During Development of Disease and After Establishment of Disease Early Rx Vehicle GR MD 02 Vehicle GR MD 02 Late Rx In a Mouse NASH Model GR MD 02 Prevents and Completely Reverses Fibrosis 2012 Galectin Therapeutics OTC:GALT 17 normal mouse 0.33 Early Rx Late Rx Development Program Markets Pursue two indications for human proof of concept NASH Post Transplant Hepatitis C Fibrosis NASH NIH estimates 5% of US population has NASH Projected to become the number one reason for liver transplant Multiple candidates in development but none have multiple sites of action, effect on fibrosis, or safety profile Post Transplant Hepatitis C Fibrosis Much smaller population but high unmet medical need Orphan disease status possible Expansion to other indications is possible Other liver diseases such as hepatitis and alcoholic disease Pulmonary, renal, and heart fibrosis 2012 Galectin Therapeutics OTC:GALT 18 2012 Galectin Therapeutics OTC:GALT 19 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2012 2013 2014 Phase II Post Tx Fibrosis Trial Phase I DE NASH GR MD 02 Design Phase II Trial NASH NASH Fibrosis Development Program Preclinical Efficacy Studies GR MD 02 First patient enrolled Pre Clinical (Target SQ) Oral Formulation Development Lung fibrosis: Bleomycin and radiation Kidney fibrosis: Ureteral obstruction; diabetic nephropathy Heart fibrosis: Heart failure and arrhythmia First patient enrolled Top line results Top line results Pursue Partnering Discussions GR MD 02 Post Transplant Fibrosis Summary Of Development Program In Liver Fibrosis Liver fibrosis represents a very large unmet medical need Galectin 3 protein is proven target Drugs reverse liver fibrosis in animals and show efficacy in human cell culture models of fibrosis Non toxic drugs with little likelihood of drug interactions Rapid clinical development pathways Evaluation of two clinical indications 2012 Galectin Therapeutics OTC:GALT 20 Disease Area Development Programs Cancer Fibrosis Liver Fibrosis Immunotherapy GALECTINS Chemotherapy 2012 Galectin Therapeutics OTC:GALT 21 Roles Of Secreted Galectins In Cancer The vast majority of cancers secrete large amounts of galectins Tumor cell invasion: extracellular matrix adhesion detachment Stromal cell function Metastasis: cell invasion and migration Angiogenesis Tumor immunity 2012 Galectin Therapeutics OTC:GALT 22 Clinical Trial Performed In Metastatic Colorectal Cancer (DAVFU 003) Cancer Trial (DAVFU 003) Day 0 Day 28 GM CT 01 Chemo (5 FU) Phase 2 trial of 5 FU plus GM CT 01 in line 3/4 therapy of metastatic colorectal cancer showed 6.7 months median survival.
Galectin inhibitors reverse experimental fibrosis in rats induced by both fibrosis and fatty liver. 2012 Galectin Therapeutics OTC:GALT 12 Key Evidence: Key Evidence: Galectin Inhibitors Effectively Treat Toxin Induced Liver Fibrosis in Rats Liver Fibrosis, induced by injection of chemical toxin for 8 weeks Regression of Fibrosis after 4 weeks of treatment with GR MD 02 2012 Galectin Therapeutics OTC:GALT 13 Study performed under contract by Dr.
Galectin 3 is produced in large amounts by human fibrotic liver. 2. Galectin 3 is essential in mice for the development of liver fibrosis. Fibrosis due to toxin exposure or fatty liver does not occur in mice that lack the galectin 3 gene. 3. Galectin inhibitors block production of fibrogenic markers in the key human cell (stellate cells) responsible for liver fibrosis. 4.
American Association for the Study of Liver Disease, May 2001 Multiple Diseases Lead To Liver Fibrosis And Cirrhosis With Serious Medical Consequences Liver Cirrhosis Is A Major Problem In The United States Transplants (6,291*) Wait List (17,000**) Death (44,677 # ) Cirrhosis (400,000 ## ) Millions of people with liver disease that may progress to cirrhosis * Performed in US in 2010 (UNOS) * * Prevalence in US 2010 (UNOS) The ONLY current therapy is liver transplantation 2012 Galectin Therapeutics OTC:GALT 11 # Deaths in 1998 (AASLD Workshop, 2001) ## Prevalence in US 1976 1980 (NIDDK) Galectin 3 Is A Critical Target For Therapy of Liver Fibrosis 1.
Fibrosis 2. Cancer 3. Inflammation 1. Bind to cell surface and matrix glycoproteins 2. Modulate cell signaling 3. Promote cell cell interactions 4. Promote cell matrix interactions (galactose residues) Galectin Proteins Galectin Inhibitor Our Galectin Inhibitors Are Novel Carbohydrate Based Drug Compounds 2012 Galectin Therapeutics OTC:GALT 6 Target secreted galectins and those associated with cell membrane Strong binding to multiple galectin proteins and multiple galectins per drug molecule High molecular weight allows long exposure to galectin containing compartment Low toxicity potential as a carbohydrate with no toxic metabolites Low manufacturing costs Strong patent protection with no licensing encumbrance Two major classes of compounds under development: GM CT and GR MD Galectins Are Involved In The Pathogenesis Of Many Diseases Fibrosis of organs Nearly all cancers Heart failure Ischemic cardiovascular and cerebrovascular disease Arthritis Allergic disease Eczema and skin inflammation Inflammatory bowel disease Eye inflammation Inflammatory and autoimmune disorders Response to infections Kidney disease 2012 Galectin Therapeutics OTC:GALT 7 Galectins implicated in: Disease Area Development Programs Cancer Fibrosis Liver Fibrosis Immunotherapy Chemotherapy GALECTINS 2012 Galectin Therapeutics OTC:GALT 8 Disease Area Development Programs Cancer Fibrosis Liver Fibrosis Immunotherapy Chemotherapy GALECTINS 2012 Galectin Therapeutics OTC:GALT 9 Healthy Cirrhosis 2012 Galectin Therapeutics OTC:GALT 10 Hepatitis C (57%) Alcoholic liver disease (24%) Non alcoholic fatty liver (9.1%) Hepatitis B (4.4%) Miscellaneous (5.5%) Source: Burden of liver disease in the United States: Summary of a workshop.
We cannot assure that we have identified all risks or that others may emerge which we do not anticipate. You should not place undue reliance on forward looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward looking statements. 2012 Galectin Therapeutics OTC:GALT 2 Galectin Therapeutics Highlights Leader in galectin science Pipeline of carbohydrate based drug compounds that inhibit galectins Focus on proven galectin activity in fibrosis and cancer Liver Fibrosis Target validated in convincing pre clinical data Two indications: NASH and Post transplantation fibrosis Clinical trials expected to begin in end of 2012 Cancer Therapy Galectin inhibitor added to chemotherapy Enhancement of immune function activates patient s own immune system to kill tumor cells Clinical trial to begin January 2012 3 2012 Galectin Therapeutics OTC:GALT 2012 Galectin Therapeutics OTC:GALT 4 Galectin Proteins Are Normal Cell Proteins That Promote Interactions Between Glycoproteins Galectin Proteins Are Important In Disease Pathogenesis 2012 Galectin Therapeutics OTC:GALT 5 Secreted Galectin Proteins PROMOTE PATHOLOGY Markedly Increased in: 1.
They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward looking statements include, among others: incurrence of operating losses since our inception, uncertainty as to adequate financing of our operations, extensive and costly regulatory oversight that could restrict or prevent product commercialization, inability to achieve commercial product acceptance, inability to protect our intellectual property, dependence on strategic partnerships, product competition, and others stated in risk factors contained in our SEC filings.
Company Overview January 2012 OTC: GALT Exhibit 99.1 Forward Looking Statements This presentation contains, in addition to historical information, forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as may, estimate, could, expect and others.