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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): September 13, 2005
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.)
189 Wells Avenue, Newton, Massachusetts 02459
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (617) 559-0033
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Not Applicable
(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 September 13, 2005, Pro-Pharmaceuticals, Inc. issued a news release
announcing it filed a Phase ll protocol with the FDA for DAVANAT(R)/5-FU for the
treatment of first line cholangiocarcinoma (bile duct 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 September 13, 2005.
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: September 13, 2005
Exhibit 99.1
Pro-Pharmaceuticals Files Phase ll Protocol for DAVANAT(R)/5-FU in First Line
Cholangiocarcinoma Study; ''Compassionate Use'' Patient Continues to Respond
Well after 10 Months of Treatment with DAVANAT(R)/5-FU
NEWTON, Mass.--(BUSINESS WIRE)--Sept. 13,
2005--Pro-Pharmaceuticals, Inc. (Amex: PRW), a developer of novel
carbohydrate compounds that enable the targeted delivery of
chemotherapy drugs to cancer cells, today announced it has submitted a
clinical protocol for a Phase II study of its lead carbohydrate
compound DAVANAT(R) with chemotherapeutic agent 5-Fluorouracil (5-FU)
for first line treatment of patients with cholangiocarcinoma (cancer
of the bile duct).
In May of this year, the U.S. Food & Drug Administration (FDA)
approved an application for a "compassionate use" Investigational New
Drug to continue treating a patient for cholangiocarcinoma with liver
metastases who participated in the Company's Phase l trial. The
patient has been treated for 10 months and continues to respond well.
About Cholangiocarcinoma Cancer
The American Cancer Society estimates there will be approximately
4,000 new cases of cholangiocarcinoma in the U.S. this year. Most of
the people who get this disease are between 50 and 70 years old. Bile
duct cancer affects men more than women.
Phase l Solid Tumor Clinical Trial
The Phase l study, for patients with recurrent or metastatic solid
tumors, was completed in March 2005. Data, published in the American
Society of Clinical Oncology's (ASCO) Annual Meeting Proceedings,
showed DAVANAT(R)/5-FU was well tolerated. Dose Limiting Toxicity and
Maximum Tolerated Dose were not reached when DAVANAT(R) was
administered alone or in combination with 5-FU at the highest dose
levels. More information is available at www.asco.org (search word:
DAVANAT).
Phase II Colorectal Cancer Trial
The Company has an ongoing Phase II clinical trial of
DAVANAT(R)/5-FU in refractory colorectal cancer patients. Recruiting
and treatment of patients is currently ongoing at three clinical
sites. More information is available at www.clinicaltrials.gov.
About DAVANAT(R)
DAVANAT(R) is a proprietary polysaccharide in a CARBOSOME(TM)
formation that target delivers chemotherapy drugs to protein receptors
(lectins) that are specific to cancer cells.
Pro-Pharmaceuticals, Inc. - Advancing Drugs Through
Glycoscience(R)
Pro-Pharmaceuticals is a drug development company commercializing
a new generation of anti-cancer treatments using carbohydrate
compounds to Glyco-Upgrade(TM) the safety and efficacy of FDA-approved
chemotherapy drugs. The Company has been conducting pre-clinical
studies for irinotecan, doxorubicin, oxaliplatin, paclitaxel,
cisplatin, and bevacizumab both in combination with DAVANAT(R) as well
as other polysaccharide compounds. Human colon and breast xenography
are being used to optimize formulations and results show that
DAVANAT(R) exhibits a broad spectrum of activity with tested drugs.
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. Because of uncertainties and risks facing the Company,
many of which are outside of the Company's control, future events
could cause actual results to differ materially from those indicated
by such 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
herein 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. Glyco-Upgrade and CARBOSOME are
trademarks of Pro-Pharmaceuticals.
CONTACT: Pro-Pharmaceuticals, Inc.
Anthony D. Squeglia, 617-559-0033
squeglia@pro-pharmaceuticals.com