Pro-Pharmaceuticals Provides Corporate Update of 2006 Achievements and 2007 Objectives.NEWTON, Mass. -- Pro-Pharmaceuticals, Inc. (Amex: PRW "Parents are watching." See digispeak. ), a developer of novel carbohydrate compounds, is providing a corporate update of its 2006 achievements and 2007 objectives. Key Highlights The initial focus of our carbohydrate technology platform is the target delivery of chemotherapeutics in the multi-billion dollar, anti-cancer market. Our completed Phase I and Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II results show that our lead compound, DAVANAT([R]), when co-administered with 5-Fluorouracil (5-FU), stabilized 43% of end-stage cancer patients with measurable disease measurable disease Oncology A condition characterized by a lesion or tumor that can be measured in size, information which is used to evaluate response to treatment. See Occult disease. from 2 to 13 months. The results also show that DAVANAT([R])increased the half life of 5-FU by 10 times with no increase in toxicity. As a result of these excellent findings, we are actively recruiting patients in two Phase II studies that address first line therapies in colorectal and biliary cancers with DAVANAT([R])in combination with chemotherapeutics and biologics. In addition, we believe our carbohydrate technology can lower the toxicity of effective, but highly toxic highly toxic Occupational medicine adjective Referring to a chemical that 1. Has a median lethal dose–LD50 of ≤ 50 mg/kg when administered orally to 200-300 g albino rats 2. drugs and/or increase their half life. We also believe we can improve the pharmacokinetic profile of existing drugs which will provide greater efficacy for these compounds. We are developing new chemical entities with carbohydrate polymers. We are engaged in the discovery, development and commercialization of carbohydrate-based therapeutic compounds for advanced treatment of cancer, liver, microbial microbial pertaining to or emanating from a microbe. microbial digestion the breakdown of organic material, especially feedstuffs, by microbial organisms. , cardiovascular and inflammatory diseases, and viral infections. We have taken our Company from inception to Phase II clinical trials in approximately five and one-half years and $28 million. Our technology was developed "in-house" and we retain full product rights. We have a broad intellectual property position and have an experienced management team. Clinical Progress Phase I Trial for End Stage Cancer Patients with All Solid Tumors The pharmacokinetic (PK) results of the Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I show that 5-FU, in combination with DAVANAT([R]), remained significantly longer in the bloodstream (up to 10 times), without increasing 5-FU's toxicity in these fragile patients. The increased exposure to 5-FU may explain why 54% (14 of 26) of the end-stage cancer patients, who had measurable disease, were stabilized from 2 to 13 months and 70% (7 of 10) were stabilized at the highest DAVANAT([R])dose level. The PK data may indicate a trend for administering significantly higher dose levels of 5-FU. Phase II Trial for End Stage Colorectal Cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. Patients In the Phase II clinical trial for end stage colorectal cancer patients, 30% (6 of 20) were stabilized from 2 to 8 months and 1 patient experienced a partial tumor response, as determined by an independent lab. The Phase II trial results are in the process of being audited. Patients had no increase in toxicity with increased exposure to 5-FU in the presence of DAVANAT([R]). In the Phase I/II cancer trials, 43% (20 of 46) of end-stage cancer patients, who had measurable disease, were stabilized from 2 to 13 months. We are very pleased with the results of these DAVANAT([R]) studies as they compare very well and exceed results from recent studies in similar patient populations. Phase II, First Line, Colorectal Cancer Trial We recently began dosing patients in our Phase II, first line, colorectal cancer trial. The Phase II trial is an open-label, multi-center trial of DAVANAT([R]) with Avastin([R]), 5-FU and Leucovorin in patients with locally advanced, unresectable or metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. colorectal cancer and unable to tolerate intensive chemotherapy with an endpoint of tumor shrinkage. Phase II, First Line, Biliary Cancer Trial We are actively recruiting patients in a Phase II study of DAVANAT([R]) with 5-FU for first line treatment of advanced biliary cancer. The primary objectives of the trial are a partial or complete tumor response and stable disease. Secondary outcomes include progression-free survival and quality of life. A cholangiocarcinoma (bile duct cancer Bile Duct Cancer Definition Bile duct cancer, or cholangiocarcinoma, is a malignant tumor of the bile ducts within the liver (intrahepatic), or leading from the liver to the small intestine (extrahepatic). ) patient from the Phase I trial remained on study for 13 months, far exceeding expectations. Treatment of biliary cancer may represent an opportunity for orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the status approval. Additional information on the two first line Phase II clinical trials and participating sites can be found at www.clinicaltrials.gov website, key word: DAVANAT([R]). Phase III, Second Line, Colorectal Cancer Trial We initiated a Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the for second line treatment of patients with metastatic colorectal cancer who failed combination therapies that included irinotecan or oxaliplatin. The trial will be conducted at clinical sites in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community (EU) and countries outside of the EU. We have delayed the dosing of patients in this trial to focus our resources on the two, first line, Phase II trials as they present an opportunity to provide results more quickly and cost effectively. Product Pipeline DAVANAT([R])is a powerful target delivery technology that may enhance the safety and efficacy profile of a variety of FDA-approved drugs. We continue to develop and expand our pipeline of drug candidates using DAVANAT([R]) and 5-FU in combination with other chemotherapeutics and biologics. Pre-clinical data indicates DAVANAT([R])exhibits broad-spectrum enhancement of anti-tumor drugs in human colon and breast tumors. We entered a research collaboration with Mount Sinai School of Medicine
Mount Sinai School of Medicine is a medical school found in the borough of Manhattan in New York City. to evaluate the anti-fibrotic effects of some of our novel, carbohydrate compounds. Mount Sinai has one of the world's largest, most productive and well-respected liver research programs. According to the American Liver Foundation The American Liver Foundation (ALF) is a non-profit organization that promotes liver health and disease prevention. ALF provides research, education and advocacy for those affected by hepatitis and other liver diseases. The ALF has 26 chapters across the U.S. , approximately 25 million Americans are or have been afflicted with liver and biliary diseases. Collaborating with Mount Sinai represents an exciting opportunity to partner with a premier liver research program to develop a novel method for treating liver disease Liver Disease Definition Liver disease is a general term for any damage that reduces the functioning of the liver. Description The liver is a large, solid organ located in the upper right-hand side of the abdomen. . We also are developing new chemical entities based on anti-fungal drugs and statin stat·in n. Any of a class of drugs that inhibit a key enzyme involved in the synthesis of cholesterol and promote receptor binding of LDL cholesterol, resulting in decreased levels of serum cholesterol. molecules. Intellectual Property The U.S. Patent & Trademark Office issued two new patents covering methods and composition for reducing toxicity of a toxic agent, and co-administration of a carbohydrate with a chemotherapy agent to treat cancer. People We strengthened the management team with the addition of Anatole Klyosov, Ph.D., D.Sc., as Chief Scientist and Tomasz Zastawny as Clincal Trials Director. In addition, Henry Esber, Ph.D. was elected to our Board of Directors and James T. Gourzis, M.D., Ph.D. was appointed to our Board. Dr. Esber replaced David Smith who resigned from the Board. We thank Mr. Smtih for his contributions. Other Events * Raised $10 million in a private placement transaction that, based on our current plan, will enable us to fund operations through at least June. * An abstract covering our research program to better understand the mechanism of action for DAVANAT([R]) and to confirm the pharmacokinetic results from the Phase I trial was published in the American Society of Cancer Oncology's "Proceedings" at ASCO's annual meeting. * The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. allowed a "compassionate use compassionate use Pharmacology The use of an agent to treat Pts for whom conventional therapies have failed, or for whom no other drug exists; CU refers to the use of an agent on humanitarian grounds before it has received regulatory–FDA–approval " Investigational New Drug Application for a patient with cancer of the bile duct. * Three of our executives and a member of our Scientific Advisory Board edited a new book "Carbohydrate Drug Design" and authored six chapters. The book was published by the American Chemical Society The American Chemical Society (ACS) is a learned society (professional association) based in the United States that supports scientific inquiry in the field of chemistry. Founded in 1876 at New York University, the ACS currently has over 160,000 members at all degree-levels and in (ACS (Asynchronous Communications Server) See network access server. ) as part of their Symposium Series which was first published in 1974. Contributing to the book were David Platt, Ph.D., Chief Executive Officer; Anatole Klyosov, Ph.D., D.Sc., Chief Scientist; Eliezer Zomer, Ph.D., Executive Vice President of Manufacturing & Product Development, and Zbigniew J. Witczak, a member of our Scientific Advisory Board, Associate Professor at the Nesbitt School of Pharmacy, Wilkes University and former chair of the ACS Division of Carbohydrate Chemistry. 2007 Objectives Building on our 2006 achievements, in 2007 we plan to continue dosing patients in our Phase II, first line, colorectal cancer trial and begin dosing patients in the Phase II, first line, biliary cancer. We plan to continue to actively discuss potential collaborations with large pharmaceutical companies who are evaluating our technology. Our goal is to facilitate collaborations that will enable us to get our compounds to market quickly and in multiple applications. We plan to begin dosing patients in the Phase III, second line, colorectal cancer trial later in the year. We also plan to file an Investigational New Drug application with the FDA for a combination therapy and plan to continue filing new patent applications. About DAVANAT([R]) DAVANAT([R]), the Company's lead drug candidate, is a carbohydrate (polysaccharide polysaccharide: see carbohydrate. polysaccharide Any of a large class of long-chain sugars composed of monosaccharides. Because the chains may be unbranched or branched and the monosaccharides may be of one, two, or occasionally more kinds, ) polymer derived from plant sources composed of mannose mannose /man·nose/ (man´os) a six-carbon sugar epimeric with glucose and occurring in oligosaccharides of many glycoproteins and glycolipids. man·nose n. and galactose. We believe the mechanism of action for DAVANAT([R]) is based upon binding to specific lectins Lectins A class of proteins of nonimmune origin that bind carbohydrates reversibly and noncovalently without inducing any change in the carbohydrate. Lectins bind a variety of cells having cell-surface glycoproteins (carbohydrate bound proteins) or glycolipids called Galectins. Lectins are cell surface proteins that bind certain carbohydrates. Galectins are a type of lectin lectin /lec·tin/ (lek´tin) any of a group of hemagglutinating proteins found primarily in plant seeds, which bind specifically to the branching sugar molecules of glycoproteins and glycolipids on the surface of cells. that specifically binds galactose molecules. Current research indicates that Galectins affect cell development and play important roles in cancer, including tumor cell survival, angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization. an·gi·o·gen·e·sis n. and tumor metastasis metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases 1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to . This form of targeted delivery may allow for higher doses of chemotherapy administration with no increase in toxicity. 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 doxorubicin /doxo·ru·bi·cin/ (dok?so-roo´bi-sin) an antineoplastic antibiotic, produced by Streptomyces peucetius, which binds to DNA and inhibits nucleic acid synthesis; used as the hydrochloride salt and as a liposome-encased , oxaliplatin, paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); , cisplatin cisplatin /cis·plat·in/ (sis´plat-in) DDP; a platinum coordination complex capable of producing inter- and intrastrand DNA crosslinks; used as an antineoplastic. cis·plat·in n. , 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. Information on the Company's Phase II clinical trials and participating sites can be found at www.clinicaltrials.gov website, key word: DAVANAT([R]). 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion