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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): April 11, 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 (IRS Employer
of incorporation) File Number) 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 April 11, 2007, Pro-Pharmaceuticals, Inc. issued a news release announcing
that the U.S. Food & Drug Administration (FDA) responded, in a letter, to
questions from the Company to discuss the submission of a New Drug Application
(NDA) for DAVANAT(R) to be used as a functional excipient to be co-administered
with 5-Fluorouracil (5-FU) to treat cancer patients.
The FDA recommended that the Company provide the chemistry, manufacturing and
controls (CMC) information necessary to support an NDA submission. 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 April 11, 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: April 11, 2007
Exhibit 99.1
Pro-Pharmaceuticals Receives Letter from the FDA
for New Drug Application for DAVANAT(R)/ 5-FU
FDA Considers DAVANAT(R) a "Novel" Excipient
NEWTON, Mass.--(BUSINESS WIRE)--April 11, 2007--Pro-Pharmaceuticals, Inc.
(Amex: PRW), a developer of novel first-in-class carbohydrate compounds, today
announced that the U.S. Food & Drug Administration (FDA) responded, in a letter,
to questions from the Company to discuss the submission of a New Drug
Application (NDA) for DAVANAT(R) to be used as a functional excipient to be
co-administered with 5-Fluorouracil (5-FU) to treat cancer patients.
The FDA recommended that the Company provide the chemistry, manufacturing
and controls (CMC) information necessary to support an NDA submission.
DAVANAT(R), the Company's lead drug candidate, is a carbohydrate polymer,
composed of mannose and galactose (galactomannan). 5-FU is an FDA-approved
chemotherapy drug that is used to treat various types of cancers, including
colorectal, breast and gastrointestinal. 5-FU is one of the most widely used
chemotherapy drugs in the world. The Company is using DAVANAT(R) to obtain more
timely and efficient marketing approval of new formulations of previously
approved therapeutics which incorporate the Company's proprietary drug target
delivery compound.
About DAVANAT(R)
DAVANAT(R), the Company's lead drug candidate, is a polysaccharide,
carbohydrate polymer, composed of mannose and galactose (galactomannan). The
Company believes DAVANAT(R)'s mechanism of action is based upon binding to
lectins on the surface of cancer cells. 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.
Product Pipeline
DAVANAT(R) is a target delivery technology that may enhance the safety and
efficacy profile of a variety of FDA-approved drugs. The Company continues to
develop and expand its pipeline of drug candidates using DAVANAT(R) and 5-FU in
combination with other chemotherapeutics and biologics, such as irinotecan and
AVASTIN(R).
The Company also is using its carbohydrate technology to develop novel
anti-fibrosis drugs. In a research collaboration with Mount Sinai School of
Medicine on liver fibrosis, early results are promising and further pre-clinical
research is underway. 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. Early in-vitro results are promising. The
Company also is developing new chemical entities based on anti-fungal drugs and
statin molecules.
Phase II Clinical Trials
The Company is currently conducting two Phase II clinical trials that are
actively recruiting patients at 9 sites. The studies are evaluating DAVANAT(R)
with 5-FU in first line therapy in biliary and colorectal cancers. The company
expects additional sites to become active shortly. Additional information on
these clinical trials can be found at www.clinicaltrials.gov, key word:
DAVANAT(R). The Company successfully completed a Phase I trial for end-stage
cancer patients with all solid tumors and a Phase II colorectal cancer trial for
end-stage patients.
Pro-Pharmaceuticals, Inc. - Advancing Drugs Through Glycoscience(R)
Pro-Pharmaceuticals is a development stage pharmaceutical company engaged
in the discovery, development and commercialization of first-in-class
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. AVASTIN is a registered trademark of Genentech, Inc.
CONTACT: Pro-Pharmaceuticals, Inc.
Anthony D. Squeglia, 617-559-0033
squeglia@pro-pharmaceuticals.com