Attached files
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| 8-K - FORM 8-K - GALECTIN THERAPEUTICS INC | d237073d8k.htm |
| EX-99.2 - GALECTIN THERAPEUTICS INC. PRESS RELEASE DATED SEPTEMBER 29, 2011 - GALECTIN THERAPEUTICS INC | d237073dex992.htm |
 Company Update
September 27, 2011
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. 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. 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.
©
2011 Galectin Therapeutics OTC:GALT
2 |
 Recent
Highlights •
March 2011: New CEO
•
May 2011: Announced new strategic priorities, new web
site
•
May 2011: Name changed to Galectin Therapeutics
(Formally Pro-Pharmaceuticals)
•
July 2011: Analyst coverage initiated by Shiv Kapoor of
Morgan Joseph TriArtisan
•
August 2011: Analyst coverage initiated by Vernon
Bernardino of Dawson James Securities
•
September 2011: Presentation at Rodman & Renshaw
Conference, New York, New York
©
2011 Galectin Therapeutics
OTC:GALT
3 |
 Galectin Therapeutics Highlights
•
Leader in galectin science
•
Pipeline of carbohydrate-based drug compounds that inhibit
galectins
•
Liver fibrosis program goal to be first therapy for this
indication
•
Target validated in convincing pre-clinical data
•
Clinical trials expected to begin in 2012
•
Cancer Therapy
•
Galectin inhibitor added to chemotherapy
•
Cancer immunotherapy program activates patient’s own immune
system to kill tumor cells
4
©
2011 Galectin Therapeutics OTC:GALT |
 Galectin Proteins Are Important In
Disease Pathogenesis
©
2011 Galectin Therapeutics
OTC:GALT
5
Secreted
Galectin
Proteins
1.
Bind to cell
surface and matrix
glycoproteins
(galactose residues)
2.
Modulate cell
signaling
3.
Promote cell-cell
interactions
4.
Promote cell-
matrix interactions
PROMOTE
PATHOLOGY
Markedly Increased in:
1.
Fibrosis
2.
Cancer
3.
Inflammation |
 Galectin
Proteins
Galectin
Inhibitor
Our Galectin Inhibitors Are Novel
Carbohydrate-Based Drug Compounds
©
2011 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 |
 We Are
The Leaders In Galectin Inhibitor Drug Development
•
Only company with galectin inhibitors in clinical
development
•
Published authoritative books in the field
7
©
2011 Galectin Therapeutics OTC:GALT |
 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
8
Galectins implicated in:
©
2011 Galectin Therapeutics OTC:GALT |
 So,
How Do We Choose Diseases For Drug Development?
•
Galectins are proven important in the mechanism of
disease
•
There are serious, life threatening consequences to
patients
•
There are no, few, or ineffective therapies
•
Rapid development pathways are possible
9
Treat important diseases where:
©
2011 Galectin Therapeutics OTC:GALT |
 Disease Area Development Programs
Cancer
Fibrosis
Liver Fibrosis
Chemotherapy
Immunotherapy
GALECTINS
10
©
2011 Galectin Therapeutics OTC:GALT |
 Disease Area Development Programs
Cancer
Fibrosis
Liver Fibrosis
Chemotherapy
Immunotherapy
GALECTINS
11
©
2011 Galectin Therapeutics OTC:GALT |
   Many
Diseases Lead To Liver Fibrosis And Cirrhosis With Serious Medical Consequences
Healthy
Cirrhosis
12
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. American Association for the Study of Liver Disease, May
2001 ©
2011 Galectin Therapeutics OTC:GALT |
 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
13
#
Deaths in 1998 (AASLD Workshop, 2001)
##
Prevalence in US 1976-1980 (NIDDK)
©
2011 Galectin Therapeutics OTC:GALT |
 Galectin-3 Is A Critical Target For
Therapy of Liver Fibrosis
1.
Galectin-3 is produced in large amounts by human fibrotic liver
2.
Galectin-3 is essential in mice for the development of liver
fibrosis
3.
Galectin inhibitors block production of fibrogenic markers in
the key human cell responsible for liver fibrosis
4.
Galectin inhibitors reverse experimental fibrosis in rats
©
2011 Galectin Therapeutics
OTC:GALT
14
Key Evidence:
Key Evidence: |
 Galectin Inhibitors Effectively Treat
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-01
15
©
Galectin Therapeutics OTC : GALT |
 Summary Of Development Program
Rationale 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
•
Initial indication provides opportunity for orphan disease status,
fast track, priority review, and potentially accelerated approval
©
Galectin Therapeutics OTC : GALT
16 |
 Development Program & Markets
•
Initial Indication: Post transplant recurrent Hepatitis C with
fibrosis
•
Focus of first phase II clinical trial
•
Orphan disease designation possible
•
Additional peri-transplant indications:
•
Established cirrhosis of various etiologies but not eligible for
transplantation
•
Established cirrhosis of various etiologies, on transplant list
•
Expansion of indications
•
Non-alcoholic fatty liver disease (NASH)
•
Viral hepatitis C and B with fibrosis
•
Alcoholic fibrosis
©
2011 Galectin Therapeutics
OTC:GALT
17 |
 Fibrosis Pipeline: Drug Advancement
December 2011
Pre-Clinical
Phase 1
Phase
Phase
Registration
Submitted
Liver Fibrosis
GM-CT-01
GM-CT-02
GR-MD-01
GR-MD-02
©
2011 Galectin Therapeutics
OTC:GALT
18
More advanced than typical pre-clinical development program:
Efficacy shown in human cells as well as animals
Proven safety in animals and humans (GM-CT-01)
Low potential for toxicity for all compounds
Low potential for drug interactions
2
3 |
 Fibrosis Clinical Program (First
Indication Clinical Trials)
©
2011 Galectin Therapeutics
OTC:GALT
19
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
2011
2012
2013
Pre-IND Meeting
Initiate P-II
Initiate P-I
Submit IND
GM-CT-01
Others |
 Disease Area Development Programs
Cancer
Fibrosis
Liver Fibrosis
Immunotherapy
Chemotherapy
GALECTINS
©
2011 Galectin Therapeutics
OTC:GALT
20 |
 Roles
Of Secreted Galectins In Cancer The vast majority of cancers secrete large
amounts of galectins •
Galectins impact
cancer growth at
many points
•
Interfering with
galectin function has
been shown to have
beneficial effects
•
Galectin Therapeutics
has proprietary
compounds that
leverage this benefit
21
©
2011 Galectin Therapeutics
OTC:GALT |
 Phase
2 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
Twenty (20) patients enrolled who all had 3 to 4 previous courses of
chemotherapy, including 5-FU and biologicals
Overall median survival was 6.7 months.
In similar patients, Erbitux
®
had a 6.1 month survival compared to 4.6
months with no therapy
Suggests efficacy of regimen |
 GM-CT-01 Reduces 5-FU
Chemotherapy Related Side Effects
Simultaneous
improved
efficacy
with
reduction
in
side
effects
of
standard
chemotherapy would be desirable in cancer therapeutics
Data
on
5-FU+GM-CT-01
compiled
from
patients
receiving
full
dose
therapy
in
studies
DAVFU-001,
003,
006, and 007
©
2011 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
•
Our colorectal cancer program remains active, but 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
©
2011 Galectin Therapeutics
OTC:GALT
24 |
 Registration And Marketing GM-CT-01
In Colombia And Latin America
•
The government of Colombia, and oncology key opinion leaders in
that country, expressed an interest in making GM-CT-01 available for
use in Colombia for patients with metastatic colorectal cancer
•
Equally
interested
in
the
increased
tumor
efficacy
and
reduction
in
5-
FU related side effects
•
Our partner Pro-Caps has submitted a marketing application to
INVIMA (FDA equivalent) and has indicated our clinical data should
be sufficient for approval
•
With approval, Pro-Caps expects sales to begin in 2012
•
Upon success in Colombia, we have the opportunity to seek approval
in other Latin American countries (reciprocity with 12 other countries)
©
2011 Galectin Therapeutics
OTC:GALT
25 |
 Disease Area Development Programs
Cancer
Fibrosis
Liver Fibrosis
Immunotherapy
GALECTINS
Chemotherapy
©
2011 Galectin Therapeutics
OTC:GALT
26 |
 Enhancing Anti-Tumor Immunity Is A
Promising Effect Of Blocking Galectins
©
2011 Galectin Therapeutics
OTC:GALT
27
•
Tumor cell invasion:
extracellular matrix
adhesion & detachment
•
Stromal cell function
•
Metastasis:
cell invasion and
migration
•
Angiogenesis
•
Tumor immunity |
 Tumor-Specific
Cytotoxic T-Cell
Lymphocytes
Blocking Galectins Enhances Tumor
Killing By Immune System
Studies done in collaboration with Ludwig Institute, Brussels, Belgium
©
2011 Galectin Therapeutics
OTC:GALT
28
Tumor Cells
Cytotoxicity |
 GM-CT-01 Restores Ability of Immune
Cells to Kill Tumor Cells
©
2011 Galectin Therapeutics
OTC:GALT
29 |
 GM-CT-01 In Tumor Immunotherapy
•
A Phase 1/2 study is scheduled to begin in Q4 2011
•
IMPD (Investigational Medicinal Product Dossier) was submitted to
the EMA (European Medicines Agency) on September 20, 2011
•
Patients with advanced metastatic melanoma
•
Treatment Regimen:
•
Tumor-specific peptide vaccination (previously tested)
•
GM-CT-01 administered between peptide vaccinations
•
Primary endpoint: Partial or complete response
•
Historical controls who received same peptide vaccine
•
Galectin Therapeutics provides study drug
•
The Ludwig Institute and Cancer Center funds Stage 1 of the trial
•
Trial conducted in 6 centers in Europe (Belgium, France,
Luxembourg)
©
2011 Galectin Therapeutics
OTC:GALT
30 |
 Melanoma Clinical Trial Design (I)
©
2011 Galectin Therapeutics
OTC:GALT
31
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 |
 Melanoma Clinical Trial Design (II)
©
2011 Galectin Therapeutics
OTC:GALT
32
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 |
 Regimen of GM-CT-01 in Melanoma
Trial Versus Colorectal Cancer Trial
©
2011 Galectin Therapeutics
OTC:GALT
33
GM-CT-01
Melanoma
Trial
Day 0
Day 21
Vaccine
Cancer Trial
(DAVFU-003)
Day 0
Day 28
GM-CT-01
Chemo (5-FU) |
 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
©
2011 Galectin Therapeutics
OTC:GALT
34 |
 Pre-Clinical
Phase 1
Phase 2
Phase 3
Registration
Submitted
Colorectal Cancer
GM-CT-01
•
International (Colombia)
•
United States
Tumor Vaccine
GM-CT-01
Liver Fibrosis
GM-CT-01
GM-CT-02
GR-MD-01
GR-MD-02
Pipeline
35
©
2011 Galectin Therapeutics OTC:GALT |
 Catalyst Milestones
•
Fibrosis Program
•
Complete pre-clinical assessment and announce drug or drugs to
take into clinical development: December 2011
•
Commence phase 2 trial Q2 2012 with top line results Q2/Q3 2013
(GM-CT-01)
•
Commence phase 1 trial Q3 2012 and phase 2 trial Q4 2012 with
top line results Q4 2013 (GR-MD series)
•
Tumor Immunology Program
•
Commence phase 1/2 trial Q4 2011
•
Top line results on first stage second half of 2012
•
Chemotherapy Program
•
Colombia final approval to market GM-CT-01 by Q2 2012
•
Sales initiated 2012
©
2011 Galectin Therapeutics
OTC:GALT
36 |
 Galectin Therapeutics Highlights
•
Leader in galectin science
•
Pipeline of carbohydrate-based drug compounds that inhibit
galectins
•
Liver fibrosis program goal to be first therapy for this
indication
•
Target validated in convincing pre-clinical data
•
Clinical trials expected to begin in 2012
•
Cancer Therapy
•
Galectin inhibitor added to chemotherapy
•
Cancer immunotherapy program activates patient’s own immune
system to kill tumor cells
37
©
2011 Galectin Therapeutics OTC:GALT |
 Thank You
OTC: GALT |