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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): June 23, 2004
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PRO-PHARMACEUTICALS, INC.
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(Exact Name of Registrant as Specified in its Charter)
Nevada
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(State or Other Jurisdiction of Incorporation)
000-32877 04-3562325
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(Commission File Number) (IRS Employer Identification No.)
189 Wells Avenue, Newton, Massachusetts 02459
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(Address of Principal Executive Offices) (Zip Code)
(617) 559-0033
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(Registrant's Telephone Number, Including Area Code)
Not Applicable
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(Former Name or Former Address, If Changed Since Last Report)
Item 5. Other Events and Regulation FD Disclosure
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On June 23, 2004, Pro-Pharmaceuticals, Inc. issued a press release, which
is attached hereto as Exhibit 99.1.
Item 7. Financial Statements and Exhibits
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(c) Exhibits.
99.1 Press Release of Pro-Pharmaceuticals, Inc. dated June 23, 2004
SIGNATURE
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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, Ph.D.
President and Chief Executive Officer
Date: June 23, 2004
Exhibit 99.1
Pro-Pharmaceuticals Reports Phase I for DAVANAT-1 in Refractory Cancer
Patients is Now in Its Sixth and Final Cohort
NEWTON, Mass.--(BUSINESS WIRE)--June 23, 2004--
Results From the First Five Dose Escalations Indicate DAVANAT(R)
in Combination With 5-fluorourcil (5-FU) is Well Tolerated in Patients
With Advanced Solid Tumors
Pro-Pharmaceuticals, Inc. (AMEX:PRW), a developer of novel carbohydrate
compounds for Targetedelivery(TM), today reported positive interim Phase l
results of its lead compound DAVANAT(R) alone and in combination with the proven
chemotherapeutic drug 5-FU (DAVANAT(R)-1) in refractory solid tumor patients.
The Phase l study, which is currently in its sixth and final cohort, is expected
to evaluate a total of 32 patients.
Commenting on the interim results, Eliezer Zomer, Ph.D.,
Pro-Pharmaceuticals' Vice President Product Development & Manufacturing, said,
"Both DAVANAT and DAVANAT-1 were well tolerated in patients in their respective
first and second cycles without any drug-related serious adverse events. The
interim pharmacokinetics analysis for cohorts one through five indicated the
mean exposure parameters, AUC(0-last) and Cmax, tended to increase with repeated
dosing of 5-FU and with escalating doses of DAVANAT. We are very encouraged with
the initial clinical activity and look forward to completing the Phase I study
and to confirming the benefit of this combination therapy in the upcoming Phase
II trial."
Dr. Zomer added, "5-FU is effective in the treatment of carcinoma of the
colon, rectum, breast, stomach and pancreas. The drug is the primary
chemotherapeutic agent used to treat solid tumors alone and in combination with
other drugs. 5-FU is a very effective drug, yet is highly toxic with a narrow
margin of safety, and has known side effects such as severe gastrointestinal and
hematological toxicity."
David Platt, Ph.D., Pro-Pharmaceuticals' Chief Executive Officer and
President, said, "The interim Phase I results are a clear indication of the
power of our platform technology and demonstrate the potential for a paradigm
shift in the way drugs are designed. Our mission is to `glyco-upgrade'
pre-approved FDA chemotherapy drugs and give them a `Targetedelivery(TM)'
mechanism by utilizing our Carbosome(TM) technology."
Phase l Clinical Trial
Phase I is an open-label study to evaluate the safety and tolerability of
escalating doses of DAVANAT alone and in combination with a constant dose of
5-FU in patients with advanced solid tumors. Different doses of DAVANAT will be
given alone in Cycle 1, and in combination with 5-FU in cycle 2. The study will
determine the ability of cancer patients to tolerate escalating doses of DAVANAT
while receiving a stable dose of 5-FU (500 mg/m2) for treatment. The primary
objectives of the study are to: (1) determine the maximum tolerated dose of
DAVANAT alone and when administered with a stable dose of 5-FU, (2) define the
dose-limiting toxicities of DAVANAT alone and in combination with 5-FU, (3)
determine the pharmacokinetic profile of 5-FU in the presence of DAVANAT (doses
ranging from 30 mg/m2 to 280 mg/m2), and (4) determine the effect of DAVANAT-1
on tumor size in patients with measurable disease.
The four clinical sites participating in the ongoing Phase l trial are: The
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center in Lebanon,
NH; The University of Michigan Comprehensive Cancer Center in Ann Arbor, MI; The
Ochsner Cancer Institute in New Orleans, LA; and Florida Oncology Associates in
Jacksonville, FL.
Phase ll Clinical Trial
In January 2004, Pro-Pharmaceuticals announced submission of a clinical
protocol to the FDA for a Phase II clinical trial of DAVANAT-1 in refractory
colorectal cancer patients. The study will evaluate the efficacy and safety of
intravenous DAVANAT-1 when administered in monthly cycles as third-line therapy
for metastatic colorectal cancer. The objectives for the Phase II study are to
document the rate of response and stabilization of the disease with DAVANAT-1
therapy, and to evaluate the safety of DAVANAT-1 in this population.
Pre-clinical Studies
Initial studies were performed to test the reduction in toxicity of
anti-cancer drugs, and demonstrated that DAVANAT might significantly decrease
the toxicity of 5-FU and doxorubicin. Independent efficacy studies on
co-administration of DAVANAT with anti-cancer drugs conducted at independent
research laboratories demonstrated that DAVANAT might also increase efficacy of
5-FU, when tested in various animal models carrying human colon and breast
tumors.
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 molecules to upgrade
their safety and efficacy. Founded in 2000 and headquartered in Newton, MA, the
Company is a leader in the use of structure-based drug design, an approach to
drug discovery that integrates advanced biology and chemistry. Additional
information is available at www.pro-pharmaceuticals.com.
FORWARD-LOOKING STATEMENTS
Any statements in this press release about future expectations, plans and
prospects for the Company, including without limitation statements containing
the words "believes," "anticipates," "plans," "expects," "will" 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's
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. Targetedelivery is a trademark of Pro-Pharmaceuticals.
CONTACT: Pro-Pharmaceuticals, Inc.
Anthony D. Squeglia, 617-559-0033