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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
December 22, 2006
Date of Report (Date of earliest event reported)
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PRO-PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
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NEVADA 000-32877 04-3562325
(State or Other Jurisdiction (Commission File Number) (IRS Employer
of Incorporation) 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)
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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))
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Item 8.01 Other Events.
On December 22, 2006, Pro-Pharmaceuticals, Inc. issued a news release providing
a corporate update of its 2006 achievements and 2007 objectives. A copy of
Pro-Pharmaceuticals news release is attached as Exhibit 99.1 hereto and
incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(D) Exhibits
99.1 News release of Pro-Pharmaceuticals, Inc., dated December 22, 2006.
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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/ David Platt
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David Platt
Chief Executive Officer
Date: December 22, 2006
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EXHIBIT INDEX
Exhibit
Number Exhibit
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99.1 News Release of Pro-Pharmaceuticals, Inc., dated December 22, 2006.
Exhibit 99.1
Pro-Pharmaceuticals Provides Corporate Update
of 2006 Achievements and 2007 Objectives
NEWTON, Mass.--(BUSINESS WIRE)--Dec. 22,
2006--Pro-Pharmaceuticals, Inc. (Amex: PRW), a developer of novel
carbohydrate compounds, is providing a corporate update of its 2006
achievements and 2007 objectives.
Key Highlights
The initial focus of our carbohydrate technology platform is the
target delivery of chemotherapeutics in the multi-billion dollar,
anti-cancer market. Our completed Phase I and Phase II clinical trial
results show that our lead compound, DAVANAT(R), when co-administered
with 5-Fluorouracil (5-FU), stabilized 43% of end-stage cancer
patients with measurable disease from 2 to 13 months. The results also
show that DAVANAT(R) increased the half life of 5-FU by 10 times with
no increase in toxicity.
As a result of these excellent findings, we are actively
recruiting patients in two Phase II studies that address first line
therapies in colorectal and biliary cancers with DAVANAT(R) in
combination with chemotherapeutics and biologics.
In addition, we believe our carbohydrate technology can lower the
toxicity of effective, but highly toxic drugs and/or increase their
half life. We also believe we can improve the pharmacokinetic profile
of existing drugs which will provide greater efficacy for these
compounds. We are developing new chemical entities with carbohydrate
polymers. We are engaged in the discovery, development and
commercialization of carbohydrate-based therapeutic compounds for
advanced treatment of cancer, liver, microbial, cardiovascular and
inflammatory diseases, and viral infections.
We have taken our Company from inception to Phase II clinical
trials in approximately five and one-half years and $28 million. Our
technology was developed "in-house" and we retain full product rights.
We have a broad intellectual property position and have an experienced
management team.
Clinical Progress
Phase I Trial for End Stage Cancer Patients with All Solid Tumors
The pharmacokinetic (PK) results of the Phase I clinical trial
show that 5-FU, in combination with DAVANAT(R), remained significantly
longer in the bloodstream (up to 10 times), without increasing 5-FU's
toxicity in these fragile patients. The increased exposure to 5-FU may
explain why 54% (14 of 26) of the end-stage cancer patients, who had
measurable disease, were stabilized from 2 to 13 months and 70% (7 of
10) were stabilized at the highest DAVANAT(R) dose level. The PK data
may indicate a trend for administering significantly higher dose
levels of 5-FU.
Phase II Trial for End Stage Colorectal Cancer Patients
In the Phase II clinical trial for end stage colorectal cancer
patients, 30% (6 of 20) were stabilized from 2 to 8 months and 1
patient experienced a partial tumor response, as determined by an
independent lab. The Phase II trial results are in the process of
being audited. Patients had no increase in toxicity with increased
exposure to 5-FU in the presence of DAVANAT(R).
In the Phase I/II cancer trials, 43% (20 of 46) of end-stage
cancer patients, who had measurable disease, were stabilized from 2 to
13 months. We are very pleased with the results of these DAVANAT(R)
studies as they compare very well and exceed results from recent
studies in similar patient populations.
Phase II, First Line, Colorectal Cancer Trial
We recently began dosing patients in our Phase II, first line,
colorectal cancer trial. The Phase II trial is an open-label,
multi-center trial of DAVANAT(R) with Avastin(R), 5-FU and Leucovorin
in patients with locally advanced, unresectable or metastatic
colorectal cancer and unable to tolerate intensive chemotherapy with
an endpoint of tumor shrinkage.
Phase II, First Line, Biliary Cancer Trial
We are actively recruiting patients in a Phase II study of
DAVANAT(R) with 5-FU for first line treatment of advanced biliary
cancer. The primary objectives of the trial are a partial or complete
tumor response and stable disease. Secondary outcomes include
progression-free survival and quality of life. A cholangiocarcinoma
(bile duct cancer) patient from the Phase I trial remained on study
for 13 months, far exceeding expectations. Treatment of biliary cancer
may represent an opportunity for orphan drug status approval.
Additional information on the two first line Phase II clinical
trials and participating sites can be found at www.clinicaltrials.gov
website, key word: DAVANAT(R).
Phase III, Second Line, Colorectal Cancer Trial
We initiated a Phase III clinical trial for second line treatment
of patients with metastatic colorectal cancer who failed combination
therapies that included irinotecan or oxaliplatin. The trial will be
conducted at clinical sites in the European Union (EU) and countries
outside of the EU. We have delayed the dosing of patients in this
trial to focus our resources on the two, first line, Phase II trials
as they present an opportunity to provide results more quickly and
cost effectively.
Product Pipeline
DAVANAT(R) is a powerful target delivery technology that may
enhance the safety and efficacy profile of a variety of FDA-approved
drugs. We continue to develop and expand our pipeline of drug
candidates using DAVANAT(R) and 5-FU in combination with other
chemotherapeutics and biologics. Pre-clinical data indicates
DAVANAT(R) exhibits broad-spectrum enhancement of anti-tumor drugs in
human colon and breast tumors.
We entered a research collaboration with Mount Sinai School of
Medicine to evaluate the anti-fibrotic effects of some of our novel,
carbohydrate compounds. Mount Sinai has one of the world's largest,
most productive and well-respected liver research programs. According
to the American Liver Foundation, approximately 25 million Americans
are or have been afflicted with liver and biliary diseases.
Collaborating with Mount Sinai represents an exciting opportunity to
partner with a premier liver research program to develop a novel
method for treating liver disease.
We also are developing new chemical entities based on anti-fungal
drugs and statin molecules.
Intellectual Property
The U.S. Patent & Trademark Office issued two new patents covering
methods and composition for reducing toxicity of a toxic agent, and
co-administration of a carbohydrate with a chemotherapy agent to treat
cancer.
People
We strengthened the management team with the addition of Anatole
Klyosov, Ph.D., D.Sc., as Chief Scientist and Tomasz Zastawny as
Clincal Trials Director. In addition, Henry Esber, Ph.D. was elected
to our Board of Directors and James T. Gourzis, M.D., Ph.D. was
appointed to our Board. Dr. Esber replaced David Smith who resigned
from the Board. We thank Mr. Smtih for his contributions.
Other Events
-- Raised $10 million in a private placement transaction that,
based on our current plan, will enable us to fund operations
through at least June.
-- An abstract covering our research program to better understand
the mechanism of action for DAVANAT(R) and to confirm the
pharmacokinetic results from the Phase I trial was published
in the American Society of Cancer Oncology's "Proceedings" at
ASCO's annual meeting.
-- The FDA allowed a "compassionate use" Investigational New Drug
Application for a patient with cancer of the bile duct.
-- Three of our executives and a member of our Scientific
Advisory Board edited a new book "Carbohydrate Drug Design"
and authored six chapters. The book was published by the
American Chemical Society (ACS) as part of their Symposium
Series which was first published in 1974. Contributing to the
book were David Platt, Ph.D., Chief Executive Officer; Anatole
Klyosov, Ph.D., D.Sc., Chief Scientist; Eliezer Zomer, Ph.D.,
Executive Vice President of Manufacturing & Product
Development, and Zbigniew J. Witczak, a member of our
Scientific Advisory Board, Associate Professor at the Nesbitt
School of Pharmacy, Wilkes University and former chair of the
ACS Division of Carbohydrate Chemistry.
2007 Objectives
Building on our 2006 achievements, in 2007 we plan to continue
dosing patients in our Phase II, first line, colorectal cancer trial
and begin dosing patients in the Phase II, first line, biliary cancer.
We plan to continue to actively discuss potential collaborations with
large pharmaceutical companies who are evaluating our technology. Our
goal is to facilitate collaborations that will enable us to get our
compounds to market quickly and in multiple applications. We plan to
begin dosing patients in the Phase III, second line, colorectal cancer
trial later in the year. We also plan to file an Investigational New
Drug application with the FDA for a combination therapy and plan to
continue filing new patent applications.
About DAVANAT(R)
DAVANAT(R), the Company's lead drug candidate, is a carbohydrate
(polysaccharide) polymer derived from plant sources composed of
mannose and galactose. We believe the mechanism of action for
DAVANAT(R) is based upon binding to specific lectins called Galectins.
Lectins are cell surface proteins that bind certain carbohydrates.
Galectins are a type of lectin that specifically binds galactose
molecules. Current research indicates that Galectins affect cell
development and play important roles in cancer, including tumor cell
survival, angiogenesis and tumor metastasis. This form of targeted
delivery may allow for higher doses of chemotherapy administration
with no increase in toxicity.
Pro-Pharmaceuticals, Inc. - Advancing Drugs Through
Glycoscience(R)
Pro-Pharmaceuticals is a development stage pharmaceutical company
engaged in the discovery, development and commercialization of
carbohydrate-based therapeutic compounds for advanced treatment of
cancer, liver, microbial, cardiovascular and inflammatory diseases.
Initially, the product pipeline is principally focused on increasing
the efficacy and decreasing the toxicity of approved chemotherapy
drugs. The Company has been conducting clinical and pre-clinical
studies with its lead compound, DAVANAT(R), in combination with 5-FU,
leucovorin, irinotecan, doxorubicin, oxaliplatin, paclitaxel,
cisplatin, and bevacizumab (Avastin(R)). Results show that DAVANAT(R)
exhibits a broad spectrum of activity with tested drugs. The Company
is developing other carbohydrate-based therapeutic compounds that are
currently in the pre-clinical stage of development. Founded in 2000,
the Company is headquartered in Newton, Mass. Additional information
is available at www.pro-pharmaceuticals.com. Information on the
Company's Phase II clinical trials and participating sites can be
found at www.clinicaltrials.gov website, key word: DAVANAT(R).
FORWARD LOOKING STATEMENTS: Any statements in this news release
about future expectations, plans and prospects for the Company,
including without limitation statements containing the words
"believes," "anticipates," "plans," "expects," and similar
expressions, constitute forward-looking statements as defined in the
"safe harbor" provisions of the Private Securities Litigation Reform
Act of 1995. These forward-looking statements are based on
management's current expectations and are subject to a number of
factors and uncertainties, which could cause actual results to differ
materially from those described in such statements. We caution
investors that actual results or business conditions may differ
materially from those projected or suggested in forward-looking
statements as a result of various factors including, but not limited
to, the following: uncertainties as to the utility and market for our
potential products; uncertainties associated with pre-clinical and
clinical trials of our product candidates; our limited experience in
product development and expected dependence on potential licensees and
collaborators for commercial manufacturing, sales, distribution and
marketing of our potential products; possible development by
competitors of competing products and technologies; lack of assurance
regarding patent and other protection of our proprietary technology;
compliance with and change of government regulation of our activities,
facilities and personnel; uncertainties as to the extent of
reimbursement for our potential products by government and private
health insurers; our dependence on key personnel; our history of
operating losses and accumulated deficit; and economic conditions
related to the biotechnology and bio-pharmaceutical industry. We
cannot assure you that we have identified all the factors that create
uncertainties. Readers should not place undue reliance on
forward-looking statements.
More information about those risks and uncertainties is contained
and discussed in the "Management Discussion and Analysis of Financial
Condition and Results of Operations" and "Risk Factors" sections of
the Company's most recent quarterly or annual report and in the
Company's other reports filed with the Securities and Exchange
Commission. The forward-looking statements represent the Company's
views as of the date of this news release 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.
DAVANAT and Advancing Drugs Through Glycoscience are registered
trademarks of Pro-Pharmaceuticals. CARBOSOME is a trademark of
Pro-Pharmaceuticals. AVASTIN is a registered trademark of Genentech,
Inc.
CONTACT: Pro-Pharmaceuticals, Inc.
Anthony D. Squeglia, 617-559-0033
squeglia@pro-pharmaceuticals.com.