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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): May 9, 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
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 May 9, 2005, Pro-Pharmaceuticals, Inc. issued a news release announcing the
dosing of patients in a Phase II trial of its DAVANAT(R)/5-FU product has
commenced. The Phase II clinical trial is in metastatic colorectal cancer
patients who have disease progression after receiving standard chemotherapeutic
regimens. A copy of Pro-Pharmaceutical's 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 May 9, 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/ Carl Lueders
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Carl Lueders
Chief Financial Officer
Date: May 18, 2005
Exhibit 99.1
Pro-Pharmaceuticals Announces Dosing of Cancer Patient with DAVANAT/5-FU in a
Phase II Clinical Trial at Medical Oncology & Hematology, P.C.
NEWTON, Mass.--(BUSINESS WIRE)--May 9, 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 the
dosing of a colorectal cancer patient in a Phase II trial of its DAVANAT(R)/5-FU
product candidate at Medical Oncology & Hematology, P.C. in Waterbury,
Connecticut. The Phase II clinical trial is in metastatic colorectal cancer
patients who have disease progression after receiving standard chemotherapeutic
regimens.
Commenting on the announcement, Eliezer Zomer, Ph.D., Executive Vice
President of Product Development, Pro-Pharmaceuticals said: "We welcome Dr. Kert
D. Sabbath and his staff at Medical Oncology & Hematology, who have joined our
Phase II clinical trial, as we continue to make solid progress in advancing our
lead product candidate DAVANAT(R) through the clinical assessment program."
Phase ll Clinical Trial
The Company initiated a Phase II, multi-center, open-label trial to
evaluate the efficacy and safety of intravenous DAVANAT(R) in combination with
5-Fluorouracil (5-FU) when administered in monthly cycles as third-, or
fourth-line therapy for metastatic colorectal cancer. Seven medical centers will
take part in this trial, which expects to enroll up to 38 patients and uses
Simon's 2-stage design.
About DAVANAT(R)
DAVANAT(R) is a proprietary polysaccharide in a CARBOSOME(TM) formulation
that enables the targeted delivery of chemotherapy drugs to protein receptors
(lectins) that are unique 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 most recently with
bevacizumab both in combination with DAVANAT(R) and 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 press 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