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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 5, 2006
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 April 5, 2006, Pro-Pharmaceuticals, Inc. issued a news release announcing
preliminary data shows an objective partial tumor response from a patient in
stage 1 of a Simon's 2-stage designed Phase ll trial for third- and fourth-line
treatment of colorectal cancer patients. Based on this preliminary data, the
Company will not enroll patients in stage 2 and plans to begin dosing patients
in a Europe-based Phase lll trial for the second line treatment of colorectal
cancer patients and a U.S.-based Phase ll trial for the first line treatment of
cholangiocarcinoma 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 April 5, 2006.
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 5, 2006
Exhibit 99.1
Pro-Pharmaceuticals Reports
Preliminary Data Shows an Objective Partial Tumor Response in Phase II
Colorectal Cancer Trial Evaluating DAVANAT(R) with 5-FU
NEWTON, Mass.--(BUSINESS WIRE)--April 5,
2006--Pro-Pharmaceuticals, Inc. (Amex: PRW), a developer of novel
carbohydrate-based therapeutic compounds, today announced that
preliminary data shows an objective partial tumor response from a
patient in stage 1 of a Simon's 2-stage designed Phase II trial for
third- and fourth-line treatment of colorectal cancer, according to
Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
RECIST defines an objective response as a patient having a complete or
partial response, with a partial response being at least a 50%
reduction in total tumor size. Based on this preliminary data, the
Company will not enroll patients in stage 2 and expects to begin
dosing patients in a Europe-based Phase III trial for the second line
treatment of colorectal cancer patients by the end of the second
quarter of 2006.
In the Phase II colorectal cancer trial, patients with colon
cancer, which has spread despite treatment with approved therapies,
are receiving DAVANAT(R) plus 5-fluorouracil (5-FU) in monthly cycles
for at least two cycles or until their disease progresses. The study
is designed to evaluate the safety and efficacy of DAVANAT(R) plus
5-FU to shrink tumors or prevent further growth. These patients are
refractory to 5-FU and have a minimum of 12 weeks to live. Dosing of
patients began in May 2005. The Company expects to report preliminary
results in the second quarter of this year as patients continue to
receive treatment. Additional information is available at
www.clinicaltrials.gov.
Phase III Colorectal Cancer Trial
In November 2005, the Company received clearance from the European
Medicines Agency (EMEA) to initiate a Europe-based Phase III clinical
trial for second line treatment of patients with metastatic colorectal
cancer. The trial will be conducted at clinical sites in the European
Union (EU) and countries outside of the EU following regulatory and
ethics approval in each country.
This Phase III study is a multi-center, randomized clinical trial
to evaluate the safety and efficacy of DAVANAT(R) with 5-FU and
leucovorin in combination with irinotecan or oxaliplatin for second
line treatment of metastatic colorectal cancer patients. The primary
endpoint is progression free survival.
Phase II Cholangiocarcinoma Trial
The Company initiated a Phase II study of its lead carbohydrate
compound DAVANAT(R) with 5-FU for first line treatment of patients
with cholangiocarcinoma (cancer of the bile duct). The Company expects
to begin patient enrollment in the second quarter of 2006.
Cholangiocarcinoma has no standard of care and may represent an
opportunity for orphan drug status approval.
About DAVANAT(R)
DAVANAT(R) is a proprietary polysaccharide polymer comprised of
mannose and galactose carbohydrates in a CARBOSOME(TM) formation that
enables the targeted delivery of chemotherapy drugs to protein
receptors (lectins) on cancer cells.
Pro-Pharmaceuticals, Inc. - Advancing Drugs Through
Glycoscience(R)
Pro-Pharmaceuticals is a development stage company engaged in the
discovery, development and commercialization of carbohydrate-based
therapeutic compounds for advanced treatment of cancer, as well as
liver, microbial, cardiovascular and inflammatory diseases, and viral
infections. 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 product candidate, 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. 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 drug delivery 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
biopharmaceutical 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.
AVASTIN is a trademark of Genentech, Inc.
DAVANAT and Advancing Drugs Through Glycoscience are registered
trademarks of Pro-Pharmaceuticals. CARBOSOME is a trademark of
Pro-Pharmaceuticals.
CONTACT: Pro-Pharmaceuticals, Inc.
Anthony D. Squeglia, 617-559-0033
squeglia@pro-pharmaceuticals.com.