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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): October 6, 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 October 6, 2005, Pro-Pharmaceuticals, Inc. issued a news release announcing
final Phase l results. Pharmacokinetics analysis indicates 5-FU, in combination
with DAVANAT(R), remains significantly longer in the bloodstream of cancer
patients, potentially increasing 5-FU's efficacy while lowering toxicity. 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 October 6, 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
---------------------------------
David Platt
Chief Executive Officer
Date: October 6, 2005
Exhibit 99.1
Pro-Pharmaceuticals Announces Final Phase I Results
NEWTON, Mass.--(BUSINESS WIRE)--Oct. 6, 2005--Pro-Pharmaceuticals,
Inc. (Amex: PRW):
-- Pharmacokinetics Analysis Indicates 5-FU, in Combination with
DAVANAT(R), Remains Significantly Longer in the Bloodstream of
Cancer Patients, Potentially Increasing 5-FU's Efficacy While
Lowering Toxicity
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
pharmacokinetics analysis of cancer patients in the sixth and final
cohort of Phase I indicates 5-Fluorouracil (5-FU) remained in the
bloodstream significantly longer when co-administered with DAVANAT(R),
thereby potentially increasing 5-FU's efficacy while lowering its
toxicity.
"DAVANAT(R) is a powerful target delivery technology within a new
paradigm that may enhance the safety and efficacy profile of a variety
of FDA-approved chemotherapy drugs," said David Platt, Ph.D., Chief
Executive Officer, Pro-Pharmaceuticals. "In addition to our positive
Phase I results with 5-FU, we have had positive preclinical results
with irinotecan (Camptosar(R)-Pfizer, Inc., NYSE:PFE), doxorubicin,
oxaliplatin, paclitaxel, cisplatin (PLATINOL(R)- Bristol-Myers Squibb
Company, NYSE:BMY) and bevacizumab (AVASTIN(R)- Genentech, Inc., NYSE:
DNA) in combination with DAVANAT(R), as well as other polysaccharide
compounds. We look forward to confirming the target delivery
capability of DAVANAT(R) in Phase II/III clinical trials."
Specific pharmacokinetics data includes:
-- 5-FU was administered at a dose of 500 mg/m2. As body surface
area of the patients ranged between 1.55 and 2.38 m2, the
actual 5-FU administered to certain cancer patients ranged
between 775 and 1,190 mg/m2 per day for four consecutive days.
-- Concentration time profiles showed no marked differences
between groups or study days.
-- Peak systemic levels were generally achieved at the end of
infusion. 5-FU disappeared in a bi-phasic manner thereafter.
-- Systemic exposure to 5-FU Area Under the Curve (AUC 0-last)
and peak 5-FU systemic Concentrations (Cmax) tended to
increase with repeated doses of 5-FU. These two
pharmacokinetics parameters have almost the same profiles for
days one through four.
-- Systemic exposure to 5-FU (AUC 0-last) and peak 5-FU systemic
Concentrations (Cmax) tended to increase with high doses of
DAVANAT(R) (between 150 and 280 mg/m2).
-- Total systemic clearance values ranged between 1.16 and 4.65
L/min. The highest clearance was achieved at day one and after
giving between 150 and 280 mg/m2 of DAVANAT(R). 5-FU systemic
clearance tended to decrease with increased doses of
DAVANAT(R) thereafter.
-- Half-life values of 5-FU ranged between 28 and 137 minutes
compared with historical 5-FU data of between 8 and 20
minutes.
DAVANAT(R) also enhanced 5-FU anti-tumor activity. The third- and
fourth-line cancer patients in Phase I had solid tumors that averaged
more than 100mm coming into the study, had progressive disease and
were refractory to 5-FU. 5-FU is effective with a narrow margin of
safety, and has known side effects such as severe gastrointestinal and
hematological toxicity.
The disease was stabilized in 14 of 26 patients with measurable
disease. Six of ten patients were stabilized at the highest dose level
(sixth and final cohort). Efficacy results are based on Response
Evaluation Criteria in Solid Tumors (RECIST) following completion of
the second cycle of treatment. According to RECIST, stable disease is
defined as "Neither sufficient shrinkage to qualify for Partial
Response (more than 30% shrinkage) nor sufficient increase to qualify
for Progressive Disease (greater than 20% increase) taking as
reference the smallest sum longest diameter since the treatment
started". Phase I data also indicates that DAVANAT(R)/5-FU was well
tolerated. Dose Limiting Toxicity and Maximum Tolerated Dose were not
reached at the highest dose level when DAVANAT(R) (280 mg/m2) was
administered alone or in combination with 5-FU (500 mg/m2).
Phase I Clinical Trial
The Phase I multi-center, open-label trial was designed for cancer
patients with advanced solid tumors that were not amenable to surgery,
radiation, or chemotherapy, were refractory to 5-FU, and had 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 I 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 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. The Phase I study closed in March. Additional
information is available at www.asco.org (search word: DAVANAT).
Phase II Cholangiocarcinoma Trial
The Company recently submitted a clinical protocol for a Phase II
study of its lead carbohydrate compound DAVANAT(R) with
chemotherapeutic agent 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 I trial. The patient has been treated for 11
months and continues to respond well.
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. Additional 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 by target delivering the drug to cancer cells. 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.
Camptosar(R) is a registered trademark of Pfizer, Inc.,
PLATINOL(R) is a registered trademark of Bristol-Myers Squibb Company,
and AVASTIN(R) is a registered trademark of Genentech, Inc.
CONTACT: Pro-Pharmaceuticals, Inc.
Anthony D. Squeglia, 617-559-0033
squeglia@pro-pharmaceuticals.com