Navigation Links
Pro-Pharmaceuticals Updates Progress of Clinical Trials &,Davanat 505 (b)(2) Filings

NEWTON, Mass.--(BUSINESS WIRE)--Jul 9, 2007 - Pro-Pharmaceuticals, Inc. (Amex: PRW), a company "Advancing Drugs Through Glycoscience(R)", today updated the progress of its Phase II clinical trial for first-line treatment of metastatic, unresectable colorectal cancer patients who are unable to tolerate irinotecan and/or oxaliplatin, and its Phase II clinical trial for first-line treatment of biliary cancer patients. Treatment for both indications may represent orphan drug status for DAVANAT(R), the Company's target delivery compound. In addition, the Company plans to submit the manufacturing data requested by the FDA this year for DAVANAT(R) 505 (b)(2) filings as a functional excipient.

Phase II, First Line Treatment, Colorectal Cancer Trial

To date, eight patients have been dosed with DAVANAT(R) in combination with 5-FU, Avastin(R) and leucovorin. Two patients have tumor shrinkage of greater than 30%, a partial response according to Response Evaluation Criteria for Solid Tumors (RECIST). Five patients have stable disease for up to seven months and one had non-drug related progressive disease. Patients experienced no increase in drug-related toxicity and reduced side effects with increased exposure to 5-FU and AVASTIN(R). The Simon two-stage designed study is an open-label, multi-center trial. The primary objectives of the trial are tumor shrinkage and progression-free survival. Six sites are actively recruiting patients. Additional sites are expected to be active shortly. Nine of 25 (36%) end-stage colorectal cancer patients from Phase I/II trials were stabilized from 2 to 8 months.

Phase II, First Line Treatment, Biliary Cancer Trial

To date, seven patients have been dosed with DAVANAT(R) in combination with 5-FU. One patient has tumor shrinkage of greater than 30%, a partial response according to RECIST. Five patients have stable disease for up to five months and one had non-drug related progressive disease. Patients experienced no increase in drug-related toxicity and reduced side effects with increased exposure to 5-FU. The Simon two-stage designed study is an open-label, multi-center trial to evaluate the efficacy and safety of DAVANAT(R) in combination with 5-FU. The primary objectives are complete/partial tumor response (RECIST), stable disease and progression-free survival. Five sites are actively recruiting patients. Two additional sites are expected to be active shortly. A bile duct cancer patient from the Phase I trial remained on study for 13 months, far exceeding expectations.

"We are encouraged by the promising data from our clinical trials," said David Platt, Ph.D., Chief Executive Officer, Pro-Pharmaceuticals, Inc. "Our lead drug candidate, DAVANAT(R), co-administered with 5-FU, successfully completed Phase I/II trials of end-stage cancer patients where 21 of 45 (43%) of end-stage cancer patients were stabilized from 2 to 13 months. As a result, we have moved from end-stage patients to first-line therapies. Our goal is to improve the clinical benefit by reducing toxicity and improving efficacy of regimens for colorectal and biliary cancer. The need to improve drug therapies, particularly anti-cancer agents, is significant and represents a large market opportunity."

DAVANAT(R) Submissions for 505 (b)(2) Filings as a Functional Excipient

The Company has submitted data to begin 505 (b)(2) filings for DAVANAT(R), as a functional excipient, to be co-administered intravenously with 5-FU and to be co-administered with Irinotecan to treat cancer. The FDA stated in a letter to the Company that DAVANAT(R) does not require additional toxicity or clinical trial data for 505 (b)(2) filings. The FDA requested additional chemistry, manufacturing and controls data. The Company plans to submit the additional information this year.

"Our goal is to get DAVANAT(R) to market in a timely manner with multiple chemotherapy drugs," stated Dr. Platt. "We submitted pre-clinical and clinical data to the FDA that demonstrates DAVANAT(R) improves 5-FU, and pre-clinical data that indicates DAVANAT(R) improves Irinotecan, efficacy on tumor and toxicology data. In other pre-clinical studies, DAVANAT(R) also improved activity of other FDA-approved chemotherapeutics, such as Oxaliplatin, Cisplatin, Avastin(R), Taxol and Doxorubicin.

"We are also continuing our clinical development plan for DAVANAT(R) in combination with 5-FU and other chemotherapy and biological drugs for a superiority claim over the current standard of care. In that context, the FDA provided comments on the design of our Phase III colorectal cancer trial," said Dr. Platt.

DAVANAT(R) as a Functional Excipient

The Company is using Section 505 (b)(2) to obtain more timely and efficient marketing approval of new formulations of previously approved therapeutics that incorporate DAVANAT(R), the Company's drug target delivery compound. The Company is seeking approval for DAVANAT(R), a galactomannan, to be co-administered with FDA-approved 5-FU and to be co-administered with Irinotecan, both for intravenous injection in the treatment of cancer. In complex products such as chemotherapeutics, the functional role of an excipient is important when used as a drug target delivery to reduce toxicity and/or increase efficacy.

In radioactive experiments, DAVANAT(R) demonstrated its target delivery capability by increasing the concentration of the chemotherapy drug in the tumor compared with the chemotherapy drug without DAVANAT(R). In pre-clinical and clinical studies, DAVANAT(R) has demonstrated it significantly improves 5-FU activity in the tumor as measured by tumor shrinkage and reduced toxicity. Galactomannans have been approved by the FDA for formulation and deliveries, such as oral, topical and vaginal delivery of drugs. DAVANAT(R) extends the use of galactomannans to the delivery of chemotherapeutic drugs.


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

Pro-Pharmaceuticals, Inc. - Advancing Drugs Through Glycoscience(R)

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. The need to improve drug therapies, particularly anti-cancer agents, is significant and represents a large market opportunity. Founded in 2000, the Company is headquartered in Newton, Mass. Additional information is available at Additional information on the clinical trials and participating sites can be found at 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 forwa rd-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. More information about those risks and uncertainties is contained in the Company's most recent quarterly or annual report 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. AVASTIN is a registered trademark of Genentech, Inc.


Pro-Pharmaceuticals, Inc.
Anthony D. Squeglia, 617-559-0033


Related medicine technology :

1. Pro-Pharmaceuticals to Present Abstract at the International Society of Oncodevelopmental Biology and Medicine Conference
2. Avalon Updates the AVN944 Phase I Hematologic Malignancies Trial
3. Medtronic Updates Long-Term ENDEAVOR I-II Clinical Data Showing Sustained Safety and Significant Reductions in Repeat Procedures
4. NCCN Updates Esophageal and Gastric Cancer Guidelines
5. Isis Pharmaceuticals Updates Its Positive Phase 2 Data for ISIS 301012 in Familial Hypercholesterolemia Patients
6. Pieris Progresses Proprietary Asthma Program: Validation of Pulmonary Delivery of Anticalin-Based Protein Product Candidate
7. Neuroblastoma Expert Reviews Progress and Challenges in Fighting Difficult Pediatric Cancer
8. Pieris Progresses Development of its Proprietary Biotherapeutics Platform: Successful Demonstration of Dual Targeting With Duocalin(R) Technology
9. Biodel Inc. to Present VIAject Clinical Progress at the 2007 American Diabetes Association Meeting
10. Can-Fite Proceeds with Development of Third Drug; Progress in Development of CF502 Will Be Presented at the Annual European Congress of Rheumatology
11. Treating Heart Disease Risk Factors May Slow Alzheimers Disease Progression
Post Your Comments:
(Date:6/23/2016)... PARK RIDGE, Ill. and INDIANAPOLIS ... caliber of students receiving a Lilly Diabetes Tomorrow,s Leaders ... hands. The 2016 scholarship winners, announced today online at ... refused to let type 1 diabetes stand in the ... Lilly Diabetes has supported the Foundation,s scholarship program since ...
(Date:6/23/2016)... 23, 2016 Revolutionary technology includes ... Oticon , industry leaders in advanced audiology and hearing ... Oticon Opn ™, the world,s first internet connected hearing ... IoT devices.      (Photo: ... number of ,world firsts,: , TwinLink™ - ...
(Date:6/23/2016)... , June 23, 2016 The vast ... an outpatient dialysis facility.  Treatments are usually 3 times ... hours per visit, including travel time, equipment preparation and ... patient, but especially grueling for patients who are elderly ... a skilled nursing and rehabilitation centers for some duration ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of ... of the latter, setting the bar too high can result in disappointment, perhaps even ... progress toward their goal. , Research from reveals that behind ...
(Date:6/24/2016)... ... , ... June 19, 2016 is World Sickle Cell Observance Day. In an ... of holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued a ... Cell Disease (SCD) is a disorder of the red blood cells, which can cause ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Global law ... magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition are ... , Seven Greenberg Traurig Shareholders received special honors as members of this year’s Legal ...
(Date:6/24/2016)... ... ... BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a ... an hour by 2020 and then adjusting it yearly to increase at the same rate ... assure the wage floor does not erode again, and make future increases more predictable. , ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute ... Dr. Barry M. Weintraub as a prominent plastic surgeon and the network’s newest ... world, and the most handsome men, look naturally attractive. Plastic surgery should be ...
Breaking Medicine News(10 mins):