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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 16, 2005
PRO-PHARMACEUTICALS, INC.
________________________________________________________________________________
(Exact name of registrant as specified in its charter)
Nevada 000-32877 04-3562325
________________________________________________________________________________
(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
________________________________________________________________________________
(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 16, 2005, Pro-Pharmaceuticals, Inc. issued a news release announcing
that the Phase l data published in the American Society of Clinical Oncology's
(ASCO) Annual Meeting Proceedings, indicates DAVANAT(R) and DAVANAT(R) /5-FU are
well-tolerated in cancer patients with advanced solid tumors. The data show Dose
Limiting Toxicity and Maximum Tolerated Dose were not reached. A copy of
Pro-Pharmaceutical's news release is attached as Exhibit 99.1 hereto and
incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits
99.1 News release of Pro-Pharmaceuticals, Inc. dated May 16, 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
-----------------------------------
Carl Lueders
Chief Financial Officer
Date: May 18, 2005
Exhibit 99.1
Pro-Pharmaceuticals' Phase I Data Show DAVANAT/5-FU Well-Tolerated in Cancer
Patients with Advanced Solid Tumors
NEWTON, Mass.--(BUSINESS WIRE)--May 16, 2005--
Disease Stabilized in 54% of Patients with Measurable Disease; 60%
Stabilized at Highest Dose Level; 71% Received Additional Cycles
Pro-Pharmaceuticals, Inc. (Amex: PRW), a developer of novel
carbohydrate compounds that enable the targeted delivery of
chemotherapy drugs to cancer cells today announced that the Phase l
data published in the American Society of Clinical Oncology's (ASCO)
Annual Meeting Proceedings, indicates DAVANAT(R) and DAVANAT(R) /5-FU
are well-tolerated in cancer patients with advanced solid tumors. The
data show Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose
(MTD) were not reached when DAVANAT(R) (280 mg/m2) was administered
alone or in combination with 5-FU (500 mg/m2).
Of the 40 patients enrolled in the Phase l trial, 28 completed the
study (26 had measurable disease and 2 were non-measurable). The
disease stabilized in 14 (54%) of the 26 patients with measureable
disease and 12 (46%) had progressive disease. Of the 14 stabilized
patients, 10 (71%) received additional cycles of DAVANAT(R) /5-FU. Six
of the ten patients in the sixth and final cohort (highest dose level)
were stabilized.
Of the 28 patients who completed the study, 18 (64%) had
colorectal cancer: 10 (55%) were stabilized, 7 (39%) had disease
progression and 1 was non-measurable. Efficacy results are based on
Response Evaluation Criteria in Solid Tumors (RECIST) following
completion of the second cycle of treatment.
The Phase l data reflects refractory cancer patients with a
minimum of 12 weeks to live who had recurrent or metastatic solid
tumors that include colorectal, liver, pancreatic, prostate and breast
cancers. Three patients had serious adverse events, thought to be at
least possibly related to DAVANAT(R): dehydration, dyspnea and
thrombocytopenia. One unrelated on-study death occurred, due to
unexpectedly rapid disease progression. Adverse events of
DAVANAT(R)/5-FU were similar to those expected for 5-FU alone.
"DAVANAT(R) is a powerful target delivery technology within a new
paradigm that may enhance the safety and efficacy profile of existing
FDA-approved chemotherapy drugs," said David Platt, Chief Executive
Officer, Pro-Pharmaceuticals. "We look forward to confirming the
efficacy and safety of DAVANAT(R) /5-FU in the Phase II/lll clinical
trials."
Phase l Clinical Trial
The Phase l open-label trial was designed for cancer patients with
advanced solid tumors that were not amenable to surgery, radiation, or
chemotherapy and have a minimum of 12 weeks to live. The objectives of
the study were to determine the Maximum Tolerated Dose and Dose
Limiting Toxicity of DAVANAT(R) as a single agent, and when
administered in combination with 5-FU; to determine the
pharmacokinetic profile of 5-FU in the presence of DAVANAT(R); and, to
determine the effect of DAVANAT(R) /5-FU on tumor size in patients
with measurable disease.
The study design included a screening period followed by two
consecutive 28-day treatment cycles: In cycle 1, patients were dosed
with DAVANAT(R) intravenously as a single agent for four consecutive
days, followed by a 24-day monitoring period. In cycle 2, patients
were dosed intravenously with DAVANAT(R) /5-FU for four consecutive
days, followed by a 24-day monitoring period. In the Phase l study,
DAVANAT(R) was dose escalated from 30mg/m2 in the first cohort to 280
mg/m2 in the sixth and final cohort, while the dose level of 5-FU was
held constant at 500 mg/m2. The Phase l study closed in March.
The four renowned cancer centers that participated in the study
are the Ochsner Cancer Institute in New Orleans, LA; Norris Cotton
Cancer Center at Dartmouth-Hitchcock Medical Center in Lebanon, NH;
University of Michigan Comprehensive Cancer Center in Ann Arbor, MI;
and, Florida Oncology Associates in Jacksonville, FL.
Phase II Clinical Trial
The Company initiated a Phase II clinical trial of its lead
anti-cancer compound DAVANAT(R)/5-FU in refractory colorectal cancer
patients. The study will evaluate the efficacy and safety of
DAVANAT(R)/5-FU for colorectal cancer patients using the same regimen
as the final cohort of Phase l: 280 mg/m2 of DAVANAT(R) and 500 mg/m2
of 5-FU. The objectives for the Phase II study are to document the
complete and partial response and the rate of stable disease with
DAVANAT(R)/5-FU therapy when administered in monthly cycles to
patients whose tumor has failed to respond to, or has progressed
despite standard first- and second-line chemotherapy, and to evaluate
the safety of DAVANAT(R)/5-FU in this population. Dosing of patients
in Phase ll began this month.
DAVANAT(R)
DAVANAT(R) is a proprietary polysaccharide in a CARBOSOME(TM)
formation 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