Form 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


FORM 8-K

 


CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

October 18, 2006

Date of Report (Date of earliest event reported)

 


PRO-PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Charter)

 


 

NEVADA   000-32877   04-3562325

(State or Other Jurisdiction

of Incorporation)

  (Commission File Number)  

(IRS Employer

Identification No.)

7 WELLS AVENUE

NEWTON, MASSACHUSETTS

02459

(Address of Principal Executive Offices) (Zip Code)

(617) 559-0033

(Registrant’s telephone number, including area code)

 


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 



Item 7.01. Regulation FD Disclosure.

David Platt, Ph.D., Chief Executive Officer of Pro-Pharmaceuticals, Inc. (“Company”) on October 18, 2006 presented an updated corporate presentation as reflected in the slides attached as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”) at the BIO Investor Forum at The Palace Hotel in San Francisco, California.

The information in this Report, including the slides attached hereto as Exhibit 99.1, is being furnished pursuant to this Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933 or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Report.

By filing this Report and furnishing this information, the Company makes no admission as to the materiality of any information in this Report. The information contained in the slides is summary information that is intended to be considered in the context of the Company’s filings with the Securities and Exchange Commission (the “SEC”) and other public announcements that the Company makes, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this Report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.

The Company cautions you that information included in the slides attached hereto as Exhibit 99.1 that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors that, if they do not materialize or prove to be accurate, could cause the Company’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. Such forward-looking statements are made based on management’s current expectations and beliefs and should not be regarded as a statement or representation by the Company that any of its plans, including its anticipated milestones, will be achieved on time or at all. The potential risks and uncertainties that could cause actual results to differ materially include, but are not limited to: the risk that the Company will be unable to raise sufficient capital to fund the projects necessary to meet its anticipated or stated goals and milestones; the potential to attract a strategic partner and the terms of any related transaction; the ability to timely enroll subjects in the Company’s current and anticipated clinical trials; the potential for DAVANAT® to receive regulatory approval for one or more indications on a timely basis or at all, and the uncertain process of seeking regulatory approval; other difficulties or delays in developing, testing, manufacturing and marketing of and obtaining regulatory approval for DAVANAT®; the market potential for carbohydrate-based compounds, and the Company’s ability to compete in those markets; unexpected adverse side effects or inadequate therapeutic efficacy of DAVANAT® or the Company’s other products that could


delay or prevent regulatory approval or commercialization, or that could result in recalls or product liability claims; the risk that preclinical results are not indicative of the success of subsequent clinical trials and that products will not perform as preclinical data suggests or as otherwise anticipated; the potential for regulatory authorities to require additional preclinical work or other clinical requirements to support regulatory filings; the scope and validity of patent protection for DAVANAT® and the Company’s other product candidates; and other risks and uncertainties more fully described in the Company’s press releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at http://www.sec.gov.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company assumes no obligation to revise or update any forward-looking statement, including any information included in the slides attached hereto as Exhibit 99.1, to reflect events or circumstances arising after the date on which it was made. This caution is made under the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933 or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Report.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

The list of exhibits called for by this Item is incorporated by reference to the Index to Exhibits filed with this report.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

PRO-PHARMACEUTICALS, INC.
By:  

/s/ Carl L. Lueders

  Carl L. Lueders
  Chief Financial Officer

Date: October 19, 2006


EXHIBIT INDEX

 

Exhibit
Number
 

Exhibit

99.1   BIO Investor Forum - Presentation Slides - dated October 18, 2006
BIO Investor Forum- Presentation Slides
P  R  O            P  H  A  R  M  A  C  E  U  T  I  C  A  L  S ,
I  N  C .
www.Pro-Pharmaceuticals.com                                             
Amex: PRW
A D V A N C I N G   D R U G S   T H R O U G H   G L Y C O S C I E N C E®
Exhibit 99.1


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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.
2


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Mission
Develop novel
carbohydrate-based
therapeutic compounds
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Amex: P R W
Advancing Drugs Through Glycoscience
®
Drug design based on carbohydrate
chemistry
In-house scientific expertise in carbohydrate
chemistry and manufacturing
Strong patent portfolio covering critical
carbohydrate chemistry technologies and
products
Research and Development by strategic
collaboration and outsourcing
4


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Carbohydrates as Therapeutics
A novel class -
now being explored for therapeutic potential
Structurally
heterogeneous
-
linear
and
branched,
small
and
large molecules
Diverse biological forms -
as glycoproteins, glycolipids,
sugars, and complex carbohydrates in plants, animals, fungi,
and bacteria
Diverse biological roles -
structure, energy, signaling,
adhesion, protection
Natural biological sources
Interact with lectins -
carbohydrate-specific proteins involved
in cell-cell and cell-matrix interactions
5


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Applications
Oncology
Liver
Microbial
Inflammatory
Cardiovascular
Autoimmune
Viral infections
6


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First Application: Oncology
DAVANAT
®
The first chemotherapeutic
complex carbohydrate drug
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Proprietary polysaccharide galactomannan (GM)
polymer consisting of galactose units attached to a
mannan backbone
Derived from seeds of the plant Cyamopsis
tetragonoloba (Guar Gum)
Binds to galectin molecules
Changes the efficacy, toxicity, pharmacokinetic and
distribution properties of chemotherapeutic drugs
DAVANAT
®
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Targeting Lectins on Cancer Cells
Lectins are cell surface proteins that bind 
certain carbohydrates
Galectins are a type of lectin that specifically
bind galactose molecules
Galectins have been shown to affect cell
development, differentiation, apoptosis and
tumor metastasis
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Pre-clinical Studies
Selected 5-FU to investigate modulation of
chemotherapeutic effects
Screened galactomannans for ability to
reduce 5-FU toxicity in mice
Selected a galactomannan from Guar Gum
for its potential therapeutic utility
Investigated DAVANAT
®
modulation of
effects of other chemotherapeutics
(irinotecan, doxorubicin, 5-FU, leucovorin,
and Avastin
®
)
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GROUP
MORTALITY
WEIGHT GAIN/
SIGNS
LOSS, 2 WKS
OF TOXICITY
5-FU (alone)
80%
-1.9g
Very Severe
DAVANAT/5-FU
0
-.6g
Mild
Pre-clinical Studies
Decreasing Toxicity -
3X Lethal Dose 50
11


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CONTROL
Pre-clinical Studies
Increasing Efficacy: Effect of DAVANAT
®
/5-FU on Tumor Size
SRI Inc. Experiments
5-FU (alone)
DAVANAT
®
/5-FU
TUMOR SIZE (110 MG)
AT START OF STUDY
1400 mg
1200 mg
1000 mg
800 mg
600 mg
400 mg
200 mg
0
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A D V A N C I N G   D R U G S   T H R O U G H   G L Y C O S C I E N C E ®
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Response of HT-29, Human Colon Tumor Xenografts           
to DAVANAT®
in Combination with 5-FU and Leucovorin
Charles River Labs
(Dose: I.V., Q4D x 4, of 5-FU: 48 mg/kg; DAVANAT
®
: 120mg/kg; Oral, Leucovorin 25 mg/kg;)
13


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A D V A N C I N G   D R U G S   T H R O U G H   G L Y C O S C I E N C E ®
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Response of SC ZR75-1,Human Mammary Tumor Xenografts,
to dose escalation DAVANAT
®
in combination with Irinotecan
Southern Research Institute  (Dose I.V., Q4D x 4, of IR 40 mg/kg; DAVANAT
®
: 6, 30 & 120 mg/kg)
100
1000
10000
0
10
20
30
40
Time post implanatation (Days)
Control
IR40/DAV6
IR40/DAV30
IR40/DAV120
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Response of COLO 205, Human Colon Tumor Xenografts,
to DAVANAT
®
Co-Administrated with AVASTIN
®
and 5-FU
Southern Research Institute (Dose: I.V., Q4D x 4, of 5-FU 50 mg/kg; DAVANAT
®
: 120 mg/kg; AVASTIN: 20-80 mg/kg)
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DAVANAT
®
polymer exists as a “3D”
structure
in solution with lectin targeting units
protruding from the mannan backbone
Technology Platform: CARBOSOME™
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A D V A N C I N G   D R U G S   T H R O U G H   G L Y C O S C I E N C E ®
Amex: P R W
Amex: P R W
Product Development Pipeline:
October ‘06
PRODUCT
INDICATION
DEVELOP
PRE-CLINICAL
PHASE 1
PHASE 2
DAVANAT
®
/ 5-FU/ LV
Irinotecan/ Oxaliplatin
DAVANAT
®
/ 5-FU/LV/
Bevacizumab
DAVANAT
®
/ 5-FU
PRO-GR 300
Colorectal
Cancer
Colorectal
Cancer
Colorectal
Cancer
Liver Disease
Microbial Disease
PHASE 3
DAVANAT
®
/ 5-FU
Biliary Cancer
PRO-NAC 050
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P R O           P H A R M A C E U T I C A L S ,  I N C.
A D V A N C I N G   D R U G S   T H R O U G H   G L Y C O S C I E N C E ®
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Second Application: Liver Disease
Research collaboration w/ Mt. Sinai School of
Medicine to evaluate the anti-fibrotic effects of
carbohydrate compounds
Fibrosis (scarring) is the reason patients develop
liver failure & may need a transplant
25 million Americans are or have been afflicted by
liver/biliary disease
More than 4 million Americans w/ Hepatitis C virus;
many will develop severe fibrosis &  liver failure
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What is the Clinical
Trial Program?
19


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Phase I Clinical Trial –
All Solid Tumors
Indication:
All solid tumors.
End stage patients;
minimum 12 weeks to live
Objectives:
Primary –
Safety
Secondary –
Tumor
progression
Design:
Multi-center (4 sites),
open label study.
Two cycles; six cohorts.
Cycle 1 –
DAVANAT
®
alone
Cycle 2-
DAVANAT
®
/5-FU
Regimen:
DAVANAT
®
escalating dose
level (30-280 mg/m
2
)
; 5-FU 
constant at 500 mg/m
2
;
dose for 4 consecutive
days, observe for 24 days
Patients:
40; 3-10 per cohort
Completed:
March 2005
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Phase l Tumor Type Distribution
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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
Stable
Disease
(RECIST) in 14
of 26 patients
with
measurable
disease
7/10 patients
stabilized at
the highest
dose level
>> 13 cycles completed
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Phase I Clinical Trial Summary
DAVANAT
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(with and without 5-FU) was well tolerated
MTD of DAVANAT
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(with and without 5-FU) not reached
DAVANAT 280 mg/m²
brought forward as the recommended
Phase II dose
Pharmacokinetic conclusions
Data suggest increase in 5-FU AUC
0-last
and C
max
at highest
DAVANAT
®
dose (280 mg/m²)
5-FU when co-administered with DAVANAT
®
is 28-137
minutes; compared with 6-22 minutes for 5-FU alone
Trend to increase in 5-FU AUC
0-last
and C
max 
with repeated
daily X 4 dosing
Stable disease (RECIST) in 14 of 26 efficacy evaluable patients
7/10 patients stabilized at the highest DAVANAT
®
dose level
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Phase II (Third/Fourth Line) Colorectal Cancer Trial
Indication:
Colorectal cancer;
Third/fourth line patients.
Objectives:
Complete/ partial tumor
response (RECIST); stable
disease.
Design:
Multi-center (6 sites), open
label study.  Evaluate at least
two cycles or to disease
progression.
Regimen:
DAVANAT
®
280 mg/m²;
5-FU 500 mg/m²;
dose for 4 consecutive days,
observe for 24 days.
Patients:
Began dosing in May 2005.
Study finalized in August
2006.
Results:
20 patients:
1 Partial Response (RECIST)
(unconfirmed)
6 Stable Disease
DAVANAT
®
/5-FU
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Phase II Clinical Trial Summary
Evidence of anti-tumor activity was seen with
DAVANAT
®
/5-FU in this study.
1 patient experienced Partial Response, as
assessed by the Core Laboratory, with a duration
of ~2 months
6 patients had Stable Disease, as determined by
the Investigator and Core Laboratory
No clear effect on tumor markers or other efficacy
parameters, including weight, ECOG performance
status, and quality of life were seen in this study
25


P R O           P H A R M A C E U T I C A L S ,  I N C.
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Phase II Clinical Trial Summary
(continued)
DAVANAT
®
/5-FU was well tolerated
Most adverse events were Grade 1 or 2 in
intensity and manageable
Common adverse events included general
gastrointestinal disorders (i.e., nausea,
vomiting, diarrhea, and constipation
with/without abdominal pain) and fatigue
DAVANAT
®
/5-FU does not appear to be
associated with any systematic changes in
clinical laboratory measurements
Results compare very well with recent studies
in similar patient populations
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Phase II (First Line) Colorectal Cancer Trial
Indication:
First line treatment of patients
with metastatic, unresectable
colorectal cancer.
Objectives:
Complete/partial tumor
response (RECIST); 14 of 41
responders (34%). 
Progression Free Survival at
6 and 12 months.
Design:
Multi-center, open label study. 
Evaluate for at least 2 cycles
or to disease progression.
Regimen:
DAVANAT
®
, AVASTIN
®
, 5-FU
& Leucovorin.  Dose for
3 consecutive days.  Repeat
cycles every 2 weeks until
disease progression or
unacceptable toxicity.
Patients:
Up to 50.  Begin enrolling/
dosing patients in 2006.
DAVANAT
®
/ AVASTIN
®
/ 5-FU / LV
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DAVANAT
®
/5-FU
Phase II (First Line) Colorectal Cancer Trial
Indication:
First-line treatment of patients with
mCRC who are unable to tolerate irinotecan or
oxaliplatin
Regimen:
DAVANAT
®
/5-FU, LV, AVASTIN
®
Repeat cycles every 2 weeks to disease progression or
toxicity
Objectives:
Complete/Partial Response (RECIST)
Stable Disease; PFS at 6 and 12 months; Safety; QoL
Design:
Multi-center, open label study
Simon Optimal 2-stage design
Patients:
17 + 24  
Begin enrolling/ dosing patients in 2006
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Amex: P R W
Phase II (First Line) Biliary Cancer Trial
Indication:
Biliary cancer
(cholangiocarcinoma).
First line therapy.
Objectives:
Complete/ partial tumor
response (RECIST);
7 of 35 responders (20%).
Design:
Multi-center, open-label
study. 
Regimen:
DAVANAT
®
with 5-FU. 
Evaluate for 2 cycles or to
disease progression. 
Measure after 8 & 12 weeks.
Patients:
Up to 42.  Begin enrolling/
dosing patients in 2006. 
DAVANAT
®
/ 5-FU
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Amex: P R W
DAVANAT
®
/5-FU
Phase II (First Line) 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 (RECIST)    
Stable Disease; PFS; Safety; QoL
Design:
Multi-center, open label study
Simon Optimal 2-stage design
Patients:
18 + 17
Begin enrolling/dosing in 2006
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Amex: P R W
Phase lll (Second Line) Colorectal Cancer Trial
FOLFOX+DAVANAT
®
FOLFOX
FOLFIRI
FOLFIRI +DAVANAT
®
Indication:
Metastatic colorectal
cancer; Second-line
therapy.
Objectives:
Progression-free survival
6 months); Response
rate, time-to-progression,
and quality of life. No
minimum vs control.
Design:
Multi-center, randomized,
double blind study. 
Regimen:
DAVANAT
®
with 5-FU/
leucovorin, irinotecan or
oxaliplatin.  Evaluate for
at least 2 cycles or to
disease progression.
Patients:
100 patients. Begin
enrolling/ dosing patients
in 2007.
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Company
&
Management
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P R O           P H A R M A C E U T I C A L S ,  I N C.
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Amex: P R W
Founded: July 2000
Capital raised: $36M (cumulative )
Inception to Phase ll: $26M
Cash: $9.7M (06/30/06)
Burn rate: $2M per quarter
Shares outstanding: 28M (08/07/06)
Fully diluted: 37M (08/07/06)
Corporate Overview
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Amex: P R W
Management Team
David
Platt,
Ph.D.,
Chairman
&
Chief
Executive
Officer-
PRW
co-founder, 
co-developer of Glycoscience (carbohydrate) technology.  Founder: Safe Science,
developed anti-angiogenesis drug.  Univ. of Michigan, Weizmann Institute, Hebrew
Univ.
Anatole
Klyosov,
Ph.D.,
D.Sc.,
Chief
Scientist-
Fellow, World Academy of
Arts & Sciences; National Prize in Science & Technology (Russia); Former Visiting
Prof. of Biochemistry (8 years) at Harvard Medical.  Moscow State Univ.
Carl Lueders, M.B.A., C.P.A., Chief Financial Officer-
20+ years in finance &
strategic planning at Polaroid
Maureen
Foley,
Chief
Operating
Officer-
eHealthDirect,
Thermo
Electron
Eliezer Zomer, Ph.D., Exec. V.P., Product Development & Mfg-
Former Research
Associate at Harvard Medical.
Anthony
Squeglia,
M.B.A.,
V.P.,
Investor
Relations-
20+
years
in
IR
James Gourzis, M.D., Ph.D., Brian Hamilton, M.D., Ph.D., Medical
Safety
Monitors (Consultants)
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Amex: P R W
Scientific Advisory Board
David Platt, Ph.D.
Edgar Ben-Josef, M.D., Assoc. Prof. of Radiation Oncology, 
University of Michigan Medical School
Mildred Christian, Ph.D.,
Dale Conaway, M.S., D.V.M.,
Research Oversight, U.S. Dept. of Health & Human Services
Henry Esber, Ph.D., Former Sr.V.P., Primedica
Irwin Goldstein, Ph.D., Prof. Emeritus, Univ. of Michigan;
Guggenheim Fellow; Pasteur Institute; Hudson Award
Anatole Klyosov, Ph.D.,  D.Sc.
Zbigniew Witczak, Ph.D., Assoc. Prof., Wilkes Univ.; former Chair,
Carbohydrate Chemistry Division, ACS
Eliezer Zomer, Ph.D.
35
President & CEO, Argus International
Chief Veterinary Medical Officer, Office of


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Amex: P R W
Medical Advisory Board
Edgar Ben-Josef, M.D.
Leslie R. Laufman, M.D., President of Hematology Oncology Cons.
Served as P.I. for the Columbus (OH) Community Clinical Oncology
Program and investigator for the Ohio State University
Comprehensive Cancer Center
John S. Macdonald, M.D., Professor of Medicine at New York
Medical College, and Chief of Gastrointestinal Oncology Service at
Saint Vincent’s Comprehensive Cancer Center
Bruce Silver, M.D., F.A.C.P., 20+ years of oncology practice. 
Principal, Clinical Science and Development; former Senior
Director, Global Product Development Services, PRA International
36


P R O           P H A R M A C E U T I C A L S ,  I N C.
A D V A N C I N G   D R U G S   T H R O U G H   G L Y C O S C I E N C E ®
Amex: P R W
Summary and Conclusions
Company strength in carbohydrate chemistry with
strong patent position
Pre-clinical animal data shows DAVANAT
®
improves
toxicity and efficacy characteristics of co-
administered chemotherapeutics
Phase I results show that DAVANAT
®
is well-tolerated
in cancer patients, with/without co-administered 5-FU
Phase II colon cancer study suggests efficacy of
DAVANAT
®
with 5-FU in stabilizing disease
Stable disease in 20/60 end-stage patients, who were
refractory to chemotherapy
Enrolling Phase II studies address first line therapies
with DAVANAT
®
in combination with other
chemotherapeutics and biologics
Experienced management team
37