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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 17, 2007
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.)
7 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 17, 2007, Pro-Pharmaceuticals, Inc. today announced it is issuing a
news release with a corporate update in a letter that is being mailed to
shareholders. 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 17, 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
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David Platt
Chief Executive Officer
Date: April 17, 2007
EXHIBIT 99.1
Pro-Pharmaceuticals Issues Corporate Update
Outlines Achievements and Key Goals
NEWTON, Mass.--(BUSINESS WIRE)--April 17,
2007--Pro-Pharmaceuticals, Inc. (Amex: PRW), a developer of novel,
first-in-class carbohydrate compounds today announced it is issuing a
corporate update in the following letter that is being mailed to
shareholders.
Dear Shareholder:
2006 was a challenging year for our Company. We raised $10 million
to fund our operations at a time when early stage pharmaceuticals were
"out-of-favor" and we had only Phase I results. As a result, the terms
and conditions of this financing were not ideal and put pressure on
our share price. We have since restructured this financing. Our
current plan is to raise capital to fund our development activities on
more favorable terms. We plan to raise this capital through an equity
financing, collaboration with pharmaceutical companies, or through
other sources.
Despite this challenge, we made excellent progress towards our
goal to develop and commercialize our first-in-class
carbohydrate-based therapeutic compounds. We sent substantial
information to the U.S. Food & Drug Administration (FDA) to submit a
New Drug Application (NDA) under Section 505 (b)(2) to allow
DAVANAT(R) to be used intravenously with 5-Fluorouracil (5-FU) for
cancer applications. We are using Section 505 (b)(2) to obtain more
timely and efficient marketing approval of new formulations of
previously approved therapeutics. The FDA requested additional
chemistry, manufacturing and controls data for our NDA. We plan to
file an NDA as soon as we complete the additional manufacturing
information needed.
Our lead drug DAVANAT(R), combined with 5-FU, has successfully
completed a Phase I trial of end-stage patients with all solid tumors
and a Phase II trial of end-stage colorectal cancer patients. Data
from these trials show that DAVANAT(R), when co-administered with
5-FU, stabilized 43% (20 of 46) of end-stage cancer patients with
measurable disease from 2 to 13 months. The pharmacokinetic results
show that DAVANAT(R) increased the exposure time of 5-FU in cancer
patients with no increase in toxicity, thereby improving the quality
of life for these end-stage patients. As a result, we have moved from
clinical trials for end-stage cancer patients to first-line therapies.
5-FU is one of the most effective and widely used chemotherapy
agents and has been administered extensively to treat various cancers
such as colon, pancreatic, and stomach. 5-FU, however, is highly toxic
to various organs within the body. 5-FU side effects include nausea,
vomiting, cardiovascular damage, mouth sores, gastrointestinal
ulceration and bleeding, skin darkening, fatigue, and even death.
Therefore, 5-FU typically cannot always be administered to patients
for sufficient periods of time or in adequate doses to be clinically
efficacious. 5-FU historically has a half- life of approximately 6 to
22 minutes, averaging 10 minutes in the bloodstream.
By combining DAVANAT(R) with 5-FU, we increased the half-life of
5-FU by 28 to 137 minutes. We found virtually no change in the area
under the curve, suggesting that the presence of DAVANAT(R) does not
change key toxicity markers in the bloodstream, such as white blood
cells and blood platelet counts. When chemotherapy drugs are
administered, an increase in toxicity and a decrease in different
blood component levels are generally found. Although 5-FU is in the
bloodstream of the patient for a longer duration, we found no increase
in toxicity, thereby allowing 5-FU to work more effectively.
5-FU is a case study as DAVANAT(R) has broad application and has
been tested in clinical and pre-clinical studies in combination with
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 need to
improve drug therapies, particularly anti-cancer agents, is
significant and represents a large market opportunity.
Our initial focus is the development of a new generation of
anti-cancer treatments using carbohydrate polymers with the intent to
enhance the safety and efficacy of chemotherapy agents. Our technology
capitalizes on certain natural properties of carbohydrates which we
believe may increase efficacy and reduce toxicity, "rescue" drugs that
were shelved for toxicity or half-life issues, increase the solubility
of existing drugs, and to develop new chemical entities.
Clinical Progress
Phase II, First Line, Colorectal Cancer Trial (Ongoing)
We began dosing patients in our Phase II, first line, colorectal
cancer trial. The Phase II study is an open-label, multi-center trial
of DAVANAT(R) combined with 5-FU in a regimen with Avastin(R) and
leucovorin in patients with locally advanced, unresectable or
metastatic colorectal cancer and who are unable to tolerate intensive
chemotherapy.
Phase II, First Line, Biliary Cancer Trial (Ongoing)
We recently began dosing patients in a Phase II study of
DAVANAT(R) with 5-FU for first line treatment of advanced biliary
cancer. This is an open-label, international study to evaluate the
efficacy and safety of DAVANAT(R) in combination with 5-FU. Treatment
of biliary cancer may represent an opportunity for Orphan Drug status
approval.
Additional information on these two trials and participating sites
can be found at www.clinicaltrials.gov website, key word: DAVANAT(R).
2007 Goals
Building on our 2006 achievements, our 2007 goals are to:
- Submit a New Drug Application with the FDA to allow DAVANAT(R)
to be used intravenously with 5-FU for cancer applications, and to
design a Phase III pivotal clinical trial;
- Continue dosing patients and report interim results of our Phase
II, first line, colorectal cancer trial and our Phase II, first line,
biliary cancer trial;
- Enter into a collaboration with a pharmaceutical partner who is
evaluating our technology, and
- Gain Orphan Drug status for DAVANAT(R) with the European
Medicines Agency for biliary cancer
In closing, we are proud of our accomplishments and grateful to
our board of directors, our scientific and medical advisory boards,
our management team and our associates. We will continue to work hard
to deliver value to our shareholders. I am grateful for your
confidence and look forward to the opportunities ahead for our
Company.
David Platt, Ph.D.
President & Chief Executive Officer
FORWARD LOOKING STATEMENTS: Any statements in this letter about
future expectations, plans and prospects for the Company, such as
prospects for future financing, results of FDA reviews, clinical trial
results, 2007 goals, and 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. 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 SEC.
CONTACT: Pro-Pharmaceuticals, Inc.
Anthony D. Squeglia, 617-559-0033
squeglia@pro-pharmaceuticals.com