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PRW - Pro-Pharmaceuticals Inc.

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  1. Picardo 17 april 2007 15:21
    Pro-Pharmaceuticals Issues Corporate Update
    Tuesday April 17, 7:00 am ET
    Outlines Achievements and Key Goals

    NEWTON, Mass.--(BUSINESS WIRE)--Pro-Pharmaceuticals, Inc. (Amex: PRW - News), 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.
    ADVERTISEMENT


    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® 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®, 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®, 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® 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® 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® 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® 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®). Results show that DAVANAT® 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® combined with 5-FU in a regimen with Avastin® 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® 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® 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®.

    2007 Goals

    Building on our 2006 achievements, our 2007 goals are to:

    - Submit a New Drug Application with the FDA to allow DAVANAT® 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® 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

    --------------------------------------------------------
  2. [verwijderd] 30 april 2007 15:36
    Bericht van 30/04:
    Pro-Pharamceutical and Digna Biotech sign agreement to apply DAVANAT with novel drugs to treat Hepatitis C (PRW) 0.82 : Co announces it has signed an agreement with Digna Biotech to investigate the application of the co's carbohydrate technology platform in combination with Digna's novel drugs to improve treatment of chronic Hepatitis C infections. The investigation will evaluate the ability of carbohydrate compounds to improve the delivery of Digna's novel compounds to enhance activity against chronic Hepatitis C infections.
  3. Picardo 15 mei 2007 16:01
    Pro-Pharmaceuticals Reports First Quarter Results
    Tuesday May 15, 7:00 am ET

    NEWTON, Mass.--(BUSINESS WIRE)--Pro-Pharmaceuticals, Inc. (Amex: PRW - News), a developer of first-in-class carbohydrate-based therapeutic compounds, today reported its first quarter financial results, ended March 31, 2007.
    ADVERTISEMENT


    For the first quarter of 2007, the Company reported a net loss of $5,574,000, or $(0.16) per share, compared with a net loss, as restated, of $8,326,000, or $(0.30) per share, for the same period in 2006. Approximately $3.4 million of the net loss in the first quarter of 2007 was non-cash expense relating to the change in fair value of the convertible debentures and warrant liabilities compared with approximately $6.3 million in the first quarter of 2006.

    "We made excellent progress towards our goal to develop and commercialize our first-in-class, carbohydrate-based therapeutic compounds," said David Platt, Ph.D., Chief Executive Officer, Pro-Pharmaceuticals. "We submitted substantial information to the U.S. Food & Drug Administration (FDA) relating to our plans for submitting DAVANAT®, as a carbohydrate adjuvant, under Section 505 (b)(2), to be administered intravenously in combination with 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 data, primarily manufacturing.

    "In addition, we are conducting Phase II trials for the first-line treatment of colorectal cancer and bile duct cancer and recently announced promising early data. We expect to have interim results later this year. We recently signed an agreement with Digna Biotech of Spain to evaluate the application of DAVANAT® to improve the delivery of Digna's novel compounds to treat chronic Hepatitis C infections. Pharmaceutical companies continue to evaluate our technology for use with their compounds. The need to improve drug therapies, particularly anti-cancer agents, is significant and represents a large market opportunity," Platt stated.

    At March 31, 2007, the Company had cash and cash equivalents of approximately $4.3 million. The Company believes it has adequate cash to fund operations through at least July 2007. The Company plans to obtain adequate financing to fund its development activities and begin to generate a level of revenue. The Company may raise such capital through equity financings or collaborations with pharmaceutical companies.

    Research and development expense for the first quarter of 2007 was $668,000, a 47% increase, compared with $454,000 for the same quarter in 2006. The increase was primarily due to a contract credit that favorably affected 2006 expense. Clinical trial expense shifted from a Phase II trial for end-stage colorectal cancer patients, which was completed last year, to two Phase II trials for early stage colorectal and biliary cancer in 2007. General and Administrative expense for the first quarter of 2007 was $1,256,000, compared with $1,270,000 incurred during the same quarter in 2006.

    First Quarter Business Highlights:

    Began dosing patients in a Phase II, first-line, biliary cancer clinical trial.
    Submitted data to the FDA to allow DAVANAT® as a carbohydrate adjuvant to be co-administered with 5-FU intravenously for cancer.
    Submitted orphan drug status application to the European Medicines Agency.
    Restructured convertible debenture financing.
    Annual Shareholders Meeting

    The Company's Annual Meeting of Shareholders is scheduled to be held on May 24th at 2pm at the Sheraton-Needham Hotel in Needham, Massachusetts.

    About DAVANAT®

    DAVANAT®, the Company's lead drug candidate, is a polysaccharide (carbohydrate polymer) composed of mannose and galactose (galactomannan). The Company believes DAVANAT®'s mechanism of action is based upon binding to lectins on the cell surface. It is theorized that DAVANAT® 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

    The Company also is using its carbohydrate technology to develop novel liver anti-fibrosis drugs through a research collaboration with Mount Sinai School of Medicine and signed an agreement with Digna Biotech, who is evaluating DAVANAT to enhance treatments for Hepatitis C infections. The Company also is developing new chemical entities based on anti-fungal drugs and statin molecules.

    Pro-Pharmaceuticals, Inc. - Advancing Drugs Through Glycoscience®

    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. The Company's initial focus is the development and commercialization of a new generation of anti-cancer treatments using carbohydrate polymers with the intent of enhancing the safety and efficacy of cancer agents. The Company's technology capitalizes on the natural property of carbohydrates to increase the efficacy and reduce the toxicity of chemotherapeutics; "rescue" drugs that were shelved for toxicity or "half-life" issues; increase the solubility of existing drugs, and develop carbohydrate polymers as new chemical entities.

    The Company has been conducting clinical and pre-clinical studies with its lead compound, DAVANAT®, in combination with 5-FU, leucovorin, irinotecan, doxorubicin, oxaliplatin, paclitaxel, cisplatin, and bevacizumab (Avastin®). Results show that DAVANAT® exhibits a broad spectrum of activity with tested drugs. The Company is developing additional 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.

  4. Picardo 15 mei 2007 16:02
    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.

    Advancing Drugs Through Glycoscience and DAVANAT are registered trademarks 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

    --------------------------------------------------------------------------------
    Source: Pro-Pharmaceuticals, Inc.
  5. [verwijderd] 19 juni 2007 23:12
    Een stijger voor morgen ?

    Pro-Pharmaceuticals Enters into Definitive Agreements for a $2.7 Million Financing
    Tuesday June 19, 4:52 pm ET

    NEWTON, Mass.--(BUSINESS WIRE)--Pro-Pharmaceuticals, Inc. (Amex: PRW - News), a company "Advancing Drugs Through Glycoscience®", today announced it has entered into definitive agreements with new and existing institutional investors with respect to a private placement of its securities for gross proceeds of approximately $2.7 million, before commissions and offering expenses. The transaction is subject to customary closing conditions, and is expected to be completed upon approval by the American Stock Exchange. The Company plans to use the proceeds of this transaction for working capital.
    Under terms of the agreements, the Company will sell approximately 4,173,000 shares of its common stock at $0.65 per share, subject to adjustment for six months from the effective date of the resale registration statement required to be filed by the Company on behalf of the investors. As part of the transaction, the investors also will receive warrants to purchase approximately 4,173,000 shares of common stock at an exercise price of $0.80, subject to adjustment. The warrants have a term of seven years, are not exercisable for six months and have anti-dilution provisions.

    For further details, please see the Company's Current Report on Form 8-K to be filed on June 20, 2007.

    The securities to be issued in the private placement have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States in the absence of an effective registration statement or exemption from such registration. This news release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities, nor shall there be any offer or sale of any securities in any state or jurisdiction in which the offer, solicitation, or sale of securities would be unlawful.

    biz.yahoo.com/bw/070619/2007061900646...
  6. [verwijderd] 19 juni 2007 23:36
    quote:

    Jommeke schreef:

    Een stijger voor morgen ?
    Lijkt me toch niet, emissiekoers 0,65 betekent 20% onder huidige beurskoers, meestal met emissienieuws zoekt de koers de emissiekoers op..
  7. [verwijderd] 20 juni 2007 17:19
    quote:

    nudie schreef:

    [quote=Jommeke]
    Een stijger voor morgen ?
    [/quote]
    Lijkt me toch niet, emissiekoers 0,65 betekent 20% onder huidige beurskoers, meestal met emissienieuws zoekt de koers de emissiekoers op..

    Je krijgt gelijk. -14.8%
  8. Picardo 26 juni 2007 17:51
    Wanneer gaat die uitgifte gebeuren .
    Kon het er niet echt uithalen .

    Kan daarna de koers weer snel omhoog.
  9. [verwijderd] 26 juni 2007 18:54
    Picardo

    Deze koers is nu levensgevaarlijk

    Ik ben er met een kleine verlies uit gestapt

    De koers staat te lang onder de dollar daardoor een delisting hangt volgens mij al een tijd in de lucht

    Groet,

  10. Picardo 26 juni 2007 19:29
    quote:

    The Wishbone schreef:

    Picardo

    Deze koers is nu levensgevaarlijk

    Ik ben er met een kleine verlies uit gestapt

    De koers staat te lang onder de dollar daardoor een delisting hangt volgens mij al een tijd in de lucht

    Groet,

    Ja ik weet het ...

    Ik weet alleen niet voor wanneer ze de tijd hebben om de koers op orde te hebben voor de delisting.

    Misschien is een omgekeerde splitsing wel de oplossing.
  11. Picardo 27 juni 2007 01:55
    Pro-Pharmaceuticals Reports Receipt of Notice from Amex
    Tuesday June 26, 6:03 pm ET

    NEWTON, Mass.--(BUSINESS WIRE)--Pro-Pharmaceuticals, Inc. (Amex: PRW - News), a company "Advancing Drugs Through Glycoscience®", today reported that on June 22, 2007, the Company received a notice from the American Stock Exchange Listing Qualifications Department that it is reviewing the Company's eligibility for continued listing. Specifically, the notice cited that the Company does not comply with the Amex's minimum $2 million stockholders' equity and losses from continuing operations and/or net losses in two of its last three years set forth in Section 1003 (a) (i) of the Amex Company Guide. To facilitate the review, the Company has been asked to provide, on or before July 23, 2007, a specific plan and timeframe to achieve and sustain compliance with all Amex market listing requirements. The Company intends to submit a plan to regain compliance on or before the requested date.
    ADVERTISEMENT


    Pro-Pharmaceuticals, Inc. - Advancing Drugs Through Glycoscience®

    Pro-Pharmaceuticals, Inc. is engaged in the discovery, development, and commercialization of therapeutic compounds for advanced treatment of cancer, liver, microbial, cardiovascular and inflammatory diseases. The Company's initial focus is the development of a new generation of anti-cancer treatments using polymers with the intent of enhancing the safety and efficacy of chemotherapy agents. The Company's technology also is directed at "rescuing" drugs that were shelved for toxicity or "half-life" issues; increasing the solubility of existing drugs, and developing polymers as new chemical entities. 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 this or future financings, 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. Such forward-looking statements include statements regarding the expected closing of the private placement and the anticipated use of proceeds. Such factors include uncertainties as to the utility and market for the Company's potential products; uncertainties associated with pre-clinical and clinical trials of the Company's product candidates; the Company's limited experience in product development and expected dependence on potential licensees and collaborators for commercial manufacturing, sales, distribution and marketing of its potential products; possible development by competitors of competing products and technologies; lack of assurance regarding patent and other protection of its proprietary technology; compliance with and change of government regulation of the Company's activities, facilities and personnel; uncertainties as to the extent of reimbursement for the Company's potential products by government and private health insurers, and the Company's history of operating losses and accumulated deficit. 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. More information about those risks and uncertainties is contained in the Company's quarterly or annual report, Form 8-K and in the Company's other reports filed with the Securities and Exchange Commission. 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.

    Contact:
    Pro-Pharmaceuticals, Inc.
    Anthony D. Squeglia, 617-559-0033
    squeglia@pro-pharmaceuticals.com.
  12. [verwijderd] 27 juni 2007 14:03
    quote:

    The Wishbone schreef:

    Picardo

    Deze koers is nu levensgevaarlijk

    Ik ben er met een kleine verlies uit gestapt

    De koers staat te lang onder de dollar daardoor een delisting hangt volgens mij al een tijd in de lucht

    Groet,

    heb je aardig aangevoelt met delisting notification.
    Met weinig cash ziet het er allesbehalve rooskleurig uit. Gaat denk gewoon weer terug naar de 0,30..
  13. [verwijderd] 27 juni 2007 22:05
    een kwart van de koers af vandaag, ahhh! Slot op 0,43, daylow. Had ws ook niemand gedacht dat we ooit weer koersen zouden zien van voor de grote stijging van bijna 600% eerder dit jaar.. maar ja ook met deze toch nu al forse daling ben ik nog niet overtuigd dat dit de bodem is.. wie durft hier al in te stappen?
  14. [verwijderd] 2 juli 2007 21:55
    quote:

    Jommeke schreef:

    + 37% RT 0.48
    0,34 was dan voorlopig de bodem.. overigens denk ik dat meer een fake-rebound is. Emissie ingetrokken, dus hoe ze nu aan geld gaan komen is de grote vraag.
  15. [verwijderd] 10 juli 2007 21:04
    Ik heb er maar weer wat bijgekocht op $ 0.49 Het is wel een beetje een gokfonds maar zwiept soms lekker op en neer. Nu maar weer even op s.v.p. Helpen jullie mee?
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