EX-99.1 2 dex991.htm MASS OPPORTUNITIES PRESENTATION MASS OPPORTUNITIES PRESENTATION


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Amex: P R W
Forward Looking Statements
Any
statements
in
this
presentation
about
future
expectations,
plans
and
prospects
for
the
Company,
including
statements
containing
the
words
"believes,"
"anticipates,"
"plans,"
"expects,"
and
similar
expressions,
constitute
forward
looking
statements,
which
are
subject
to
the
safe
harbor
for
such
statements
in
the
Private
Securities
Litigation
Reform
Act
of
1995.
Future
events
could
cause
actual
results
to
differ
materially
from
those
indicated
by
such
statements.
Reference
is
made
to
the
factors
discussed
in
the
“Management
Discussion
and
Analysis"
and
"Risk
Factors"
sections
of
the
Company's
most
recent
quarterly
or
annual
report
filed
with
the
Securities
and
Exchange
Commission.
The
forward-looking
statements
herein
represent
the
Company's
views
as
of
the
date
of
this
presentation
and
should
not
be
relied
upon
to
represent
the
Company's
views
as
of
a
subsequent
date.
While
the
Company
anticipates
that
subsequent
events
may
cause
the
Company's
views
to
change,
the
Company
disclaims
any
obligation
to
update
such
forward-looking
statements.
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Amex: P R W
Mission
Advancing Drugs Through
Glycoscience
®
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Amex: P R W
Key Investment Points
Clinical stage pharmaceutical company
Completed Phase I/II cancer trials w/ DAVANAT
®
Stabilized 35% of end stage patients: 2-13 months
Two ongoing Phase II front line trials
DAVANAT
®
increased the half life of 5-FU
8 fold with no increase in toxicity
DAVANAT
®
/5-FU model can be applied to
other chemotherapy agents
4


Clinical Trial Program
Completed Phase I/II cancer trials w/ DAVANAT
®
Stabilized 35% of end stage patients: 2-13 months
Two ongoing Phase II front line trials
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Phase I/II End Stage Cancer Trials
Summary
35% stabilized at the highest dose level
Maximum Tolerated Dose & Dose
Limiting Toxicity not reached
DAVANAT
®
significantly increased half
life of 5-FU with no increase in toxicity
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Amex: P R W
Phase I Clinical Trial Summary
DAVANAT
®
was well tolerated
Maximum Tolerated Dose and Dose Limiting Toxicity
of DAVANAT
®
not reached
DAVANAT
280
mg/m²
recommended
Phase
II
dose
Pharmacokinetics
Half life of 5-FU alone is 6-22 minutes
Half life of 5-FU with DAVANAT
®
is 28-137 minutes
No increase in 5-FU toxicity w/ increased exposure
Stable disease in 14 of 26 efficacy evaluable patients
7/10 patients stabilized at the highest DAVANAT
®
dose level
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Amex: P R W
SD
Stable Disease
PD
Progressive Disease
NM
Non-Measurable Disease
Cycles Completed
Dose, cycle 2
/m2
1+2
3
4
5
6
7
1001
PD
1002
SD
2001
Hepatocellular
PD
2002
Hepatocellular
SD
3001
PD
3002
SD
3004
PD
3003
PD
5001
SD
2004
SD
3005
PD
4001
PD
4002
Colorectal
PD
3006
Prostate
NM
2005
Colorectal
SD
5003
Colorectal (appendix)
NM
5004
SD
4003
PD
2007
Spindle Cell
PD
5005
Pancreatic
SD
2008
Colorectal
SD
2009
Colorectal
SD
5006
Billiary
SD
2010
Colorectal (cecal)
SD
2014
Breast
SD
2016
Hepatic
PD
2018
Cholangiocarcinoma
SD
5008
Pancreatic
PD
280 mg
150 mg
Patient
Number
Tumor Type
Outcome, end
of cycle 2
(RECIST)
C   Y   C   L   E   S
Colorectal
Colorectal
210 mg
30 mg
60 mg
Colorectal
100 mg
Colorectal
Phase l Patient Summary:
Stabilized 70% at Highest Dose Level
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Phase II Colorectal Cancer Trial Summary
Trial conducted with end-stage patients
Anti-tumor activity was seen with
DAVANAT
®
/5-FU
1 patient experienced Partial Response
6 patients stabilized
No increase in 5-FU toxicity w/ increased
exposure
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DAVANAT
®
/5-FU
Enrolling Phase II Colorectal Cancer Trial
Indication:
First-line treatment of patients who are
unable to tolerate irinotecan or oxaliplatin
Regimen:
DAVANAT
®
/5-FU, Leucovorin,
AVASTIN
®
Repeat cycles every 2 weeks to disease progression or
toxicity
Objectives:
Complete/Partial Response
Stable Disease; Progression Free Survival; Safety;
Quality of Life
Design:
Multi-center, open label study
Simon Optimal 2-stage design
Patients:
Up to 50 patients  
Begin enrolling/ dosing patients in Q4 2006
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Amex: P R W
DAVANAT
®
/5-FU
Enrolling Phase II Biliary Cancer Trial
Indication:
First line treatment of patients with biliary
tract cancer
Regimen:
DAVANAT
®
(280
mg/m²)
+
5-FU
(600
mg/m²)
IV
daily
x
4
days
Repeat cycles every 28 days to disease
progression or toxicity
Objectives:
Complete/Partial Response     
Stable Disease; Progression Free Survival; Safety;
Quality of Life
Design:
Multi-center, open label study
Simon Optimal 2-stage design
Patients:
Up to 35
Begin enrolling/dosing patients in Q4 2006
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DAVANAT
®
Increases the
Half Life of 5-FU, 8 Fold
with No Increase in
Toxicity
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DAVANAT
®
Increases Half Life
of 5-FU in Patients, 8 times
5-FU / DAVANAT –
Day 4
5-FU / DAVANAT –
Day 1
5-FU –
Historical


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Amex: P R W
5-FU
in
the
presence
of
DAVANAT
®
Does
Not
Change
Key
Toxicity
Markers
0
10
20
30
40
0
10
20
30
40
AUC
Hematocrit
Hemoglobin
Red blood cells
White blood cells
Platelets


The DAVANAT
®
/5-FU Model
Can Be Applied To
Increasing Efficacy/
Decreasing Toxicity of Other
Chemotherapy Agents
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Amex: P R W
DAVANAT
®
with another Chemotherapy Agent
100
1000
10000
0
10
20
30
40
Time post implanatation (Days)
Control
IR40/DAV6
IR40/DAV30
IR40/DAV120
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Amex: P R W
Mechanism of Action:
Targeting Lectins on Cancer Cells
DAVANAT
®
binds to lectins
Galectins are a type of lectin that are over-
expressed on cancer cells
Galectins affect cell development,
differentiation, apoptosis and tumor
metastasis
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Amex: P R W
Key Investment Points
Clinical stage pharmaceutical company
Completed Phase I/II cancer trials w/ DAVANAT
®
Stabilized 35% of end stage patients: 2-13 months
Two ongoing Phase II front line trials
DAVANAT
®
increased the half life of 5-FU
8 fold with no increase in toxicity
DAVANAT
®
/5-FU model can be applied to
other chemotherapy agents
18