View:
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): February 12, 2007
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.)
7 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 February 12, 2007, Pro-Pharmaceuticals, Inc. issued a news release announcing
it has requested a meeting with the U.S. Food & Drug Administration to discuss
the filing of a New Drug Application for co-administration of DAVANAT(R) with
5-Fluorouracil for treatment of cancer 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 February 12, 2007.
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: February 12, 2007
Exhibit 99.1
Pro-Pharmaceuticals Requests Meeting with the FDA to Discuss New Drug
Application for Co-administration of DAVANAT(R) with 5-FU to Treat
Cancer Patients
5-FU is one of the most widely used chemotherapy drugs in the world
NEWTON, Mass.--(BUSINESS WIRE)--Feb. 12, 2007--Pro-Pharmaceuticals,
Inc. (Amex: PRW), a developer of novel carbohydrate compounds, today
announced it has requested a meeting with the U.S. Food & Drug
Administration (FDA) to discuss data and plans for submitting a New Drug
Application (NDA), under Section 505 (b)(2), for DAVANAT(R) to be
co-administered with 5-Fluorouracil (5-FU) to treat cancer patients.
DAVANAT(R), the Company's lead drug candidate, is a carbohydrate
polymer, composed of mannose and galactose (galactomannan). 5-FU is an
FDA-approved chemotherapy drug that is used to treat various types of
cancers, including colorectal, breast and gastrointestinal.
"Our goal is to commercialize our compounds and get them to market
in multiple applications and indications," said David Platt, Ph.D.,
President & Chief Executive Officer, Pro-Pharmaceuticals, Inc. "To
gain FDA marketing approval for our lead compound DAVANAT(R) would be
a major milestone in the development of our technology. Pharmaceutical
companies are also evaluating our carbohydrate compounds for use with
their chemotherapeutic agents."
The Company is using DAVANAT(R) to obtain more timely and
efficient marketing approval of new formulations of previously
approved therapeutics which incorporate the Company's proprietary drug
target delivery compound through Section 505(b)(2). The FDA has
approved galactomannans for oral and topical applications. The Company
is seeking approval for co-administration of DAVANAT(R) (a
galactomannan) with 5-FU for intravenous injection in the treatment of
cancer.
About Section 505(b)(2)
Section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act allows the
FDA to approve an NDA submission where data is available from
scientific literature or data previously cited by the FDA as the basis
for the approval of related drugs. This procedure makes it easier and
potentially faster for drug developers to obtain approval of new drugs
or new formulations based, in part, on proprietary safety or
effectiveness data of the developer of the original drug. Examples of
505(b)(2) applications include changes to dosage forms or routes of
administration. In the case of DAVANAT(R), the application is for
intravenous co-administration with 5-FU for the treatment of cancer.
Further information can be found at: "Guidance for Industry;
Applications Covered by Section 505(b)(2)"
http://www.fda.gov/cder/guidance/2853dft.pdf and "Guidance for
Industry; Formal Meetings with Sponsors and Applicants for PDUFA
Products" http://www.fda.gov/cber//gdlns/mtpdufa.pdf.
About DAVANAT(R)
DAVANAT(R), the Company's lead drug candidate, is a polysaccharide
(carbohydrate polymer) composed of mannose and galactose
(galactomannan). The Company believes DAVANAT(R)'s mechanism of action
is based upon binding to lectins on the cell surface. Lectins are
carbohydrate-binding proteins found in increased amounts on cell
surfaces. DAVANAT(R), when injected into humans, recognizes and
attaches to lectins. It is theorized that DAVANAT(R) targets specific
lectin receptors (Galectins) that are over-expressed on cancer cells.
Current research indicates that Galectins affect cell development and
play important roles in cancer, including tumor cell survival,
angiogenesis and tumor metastasis. This form of targeted delivery may
allow for higher doses of chemotherapy administration with no increase
in toxicity.
Product Pipeline
DAVANAT(R) is a powerful target delivery technology that may
enhance the safety and efficacy profile of a variety of FDA-approved
chemotherapy drugs. The Company continues to develop and expand its
pipeline of drug candidates using DAVANAT(R) and 5-FU in combination
with other chemotherapeutics and biologics, such as irinotecan and
AVASTIN(R).
The Company also is using its carbohydrate technology to develop
novel anti-fibrosis drugs. In a research collaboration on liver
fibrosis with the Mount Sinai School of Medicine, early results are
promising and further pre-clinical research is underway. Mount Sinai
has one of the world's largest, most productive and well-respected
liver research programs. According to the American Liver Foundation,
approximately 25 million Americans are or have been afflicted with
liver and biliary diseases. The Company also is developing new
chemical entities based on anti-fungal drugs and statin molecules.
Phase II Clinical Trials
The Company is conducting two Phase II clinical trials that are
actively recruiting patients at 8 sites. The studies are evaluating
DAVANAT(R) with 5-FU in first line therapy in biliary and colorectal
cancers. AVASTIN(R) and Leucovorin are also being administered in
treating colorectal patients. The company expects additional sites to
become active shortly. Additional information on these clinical trials
can be found at www.clinicaltrials.gov. Key word: DAVANAT(R). The
Company successfully completed a Phase I trial for end-stage cancer
patients with all solid tumors and a Phase II trial for end-stage
colorectal cancer patients.
Pro-Pharmaceuticals, Inc. - Advancing Drugs Through
Glycoscience(R)
Pro-Pharmaceuticals is a development stage pharmaceutical company
engaged in the discovery, development and commercialization of
carbohydrate-based therapeutic compounds for advanced treatment of
cancer, liver, microbial, cardiovascular and inflammatory diseases.
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 compound, 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. The Company
is developing other carbohydrate-based therapeutic compounds that are
currently in the pre-clinical stage of development. 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 product 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 bio-pharmaceutical 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.
DAVANAT and Advancing Drugs Through Glycoscience are registered
trademarks of Pro-Pharmaceuticals. CARBOSOME is a trademark of
Pro-Pharmaceuticals. AVASTIN is a registered trademark of Genentech,
Inc.
CONTACT: Pro-Pharmaceuticals, Inc.
Anthony D. Squeglia, 617-559-0033
squeglia@pro-pharmaceuticals.com