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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
Date of Report (Date of earliest event reported): February 7, 2007
PRO-PHARMACEUTICALS, INC.
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(Exact name of registrant as specified in its charter)
Nevada 000-32877 04-3562325
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(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)
Registrant's telephone number, including area code: (617) 559-0033
Not Applicable
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(Former name or former address, if changed since last report.)
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:
[ ] 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 8.01 Other Events.
On February 7, 2007, Pro-Pharmaceuticals, Inc. issued a news release announcing
it has begun the process of submitting a New Drug Application (NDA) with the FDA
for co-administration of DAVANAT(R) with 5-Fluorouracil (5-FU) for treatment in
cancer patients. 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.
(c) Exhibits
99.1 News release of Pro-Pharmaceuticals, Inc. dated February 7, 2007.
SIGNATURE
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 thereunto duly authorized.
PRO-PHARMACEUTICALS, INC.
By:/s/ David Platt
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David Platt
Chief Executive Officer
Date: February 7, 2007
Exhibit 99.1
Pro-Pharmaceuticals' Begins Process of New Drug Application Submission
with the FDA for Co-administration of DAVANAT(R) with 5-FU in Cancer Patients
NEWTON, Mass.--(BUSINESS WIRE)--Feb. 7, 2007--Pro-Pharmaceuticals,
Inc. (AMEX:PRW), a developer of novel carbohydrate compounds, today
announced it has begun the process of submitting a New Drug
Application (NDA) with the U.S. Food & Drug Administration (FDA) for
co-administration of DAVANAT(R) with 5-Fluorouracil (5-FU) for
treatment in cancer patients.
"Our goal is to get our lead compound, DAVANAT(R) to market," said
David Platt, Ph.D., President & Chief Executive Officer,
Pro-Pharmaceuticals, Inc. "Based on recent data analysis from our
Phase l and Phase ll clinical trials, we believe DAVANAT(R) has the
potential to improve the pharmacokinetic profile of 5-FU, as well as
other FDA-approved anti-cancer drugs, with out increasing toxicity
markers as would be expected with increased 5-FU exposure. In
addition, we continue discussions with pharmaceutical companies who
are evaluating our technology. Our goal is to facilitate
collaborations that will enable us to get our compounds to market
quickly in multiple indications and modalities."
Analysis of the pharmacokinetic data of the Phase l clinical trial
indicates that 5-FU, in combination with DAVANAT(R), remained longer
in the bloodstream (up to 10 times), without increasing 5-FU's
toxicity in these fragile patients. 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. In the Phase
ll clinical trial for end stage cancer patients, patients had no
increase in toxicity with increased exposure to 5-FU in the presence
of DAVANAT(R).
The Company is actively recruiting and dosing patients in two
international Phase ll trials both designed as first-line therapies in
colorectal and biliary cancers, administering DAVANAT(R) in
combination with 5-FU. In the colorectal trial, AVASTIN(R) and
Leucovorin are also administered. Additional information on these two
trials can be found at www.clinicaltrials.gov.
About DAVANAT(R)
DAVANAT(R), the Company's lead drug candidate, is a carbohydrate
(polysaccharide) polymer composed of mannose and galactose. The
Company believes DAVANAT(R)'s mechanism of action is based upon
binding to lectins on the cell surface. Lectins are
carbohydrate-binding proteins found in increased amounts on cell
surfaces. DAVANAT(R), when injected into humans, recognizes and
attaches to lectins. It is theorized that DAVANAT(R) targets specific
lectin receptors (Galectins) that are over-expressed on cancer cells.
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.
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