More Resources

PRO-PHARMACEUTICALS REPORTS 2006 ACHIEVEMENTS/2007 GOALS.

Biotech Financial Reports • Feb 1, 2007 •
Article Tools
T   |   T
TEXT SIZE:
printPrint
E-MailE-Mail

Add to My Bookmarks

Adds Article to your Entrepreneur Assist Bookmark page.

Pro-Pharmaceuticals, Inc. (Amex: PRW), Newton, Mass., 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 results show that our lead compound, DAVANAT, when co-administered with 5-Fluorouracil (5-FU), stabilized 43% of end-stage cancer patients with measurable disease from 2 to 13 months. The results also show that DAVANAT 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 in combination with chemotherapeutics and biologics. In addition, we believe our carbohydrate technology can lower the toxicity of effective, but highly toxic 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, 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 show that 5-FU, in combination with DAVANAT, 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 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 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.

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 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 with Avastin, 5-FU and Leucovorin in patients with locally advanced, unresectable or metastatic 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 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) 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 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.

Phase III, Second Line, Colorectal Cancer Trial

We initiated a Phase III clinical trial 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 (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 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 and 5-FU in combination with other chemotherapeutics and biologics. Pre-clinical data indicates DAVANAT 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 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, 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. We also are developing new chemical entities based on anti-fungal drugs and statin molecules.

About DAVANAT

DAVANAT, the company's lead drug candidate, is a carbohydrate (polysaccharide) polymer derived from plant sources composed of mannose and galactose. We believe the mechanism of action for DAVANAT is based upon binding to specific lectins called Galectins. Lectins are cell surface proteins that bind certain carbohydrates. Galectins are a type of lectin that specifically binds galactose molecules. 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"

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, in combination with 5-FU, leucovorin, irinotecan, doxorubicin, oxaliplatin, paclitaxel, cisplatin, and bevacizumab (Avastin[R]). Results show that DAVANAT 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 http://www.pro-pharmaceuticals.com.

Information on the company's Phase II clinical trials and participating sites can be found at http://www.clinicaltrials.gov website, key word: DAVANAT.


COPYRIGHT 2007 Worldwide Videotex Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.
NOTE: All illustrations and photos have been removed from this article.


Browse by Journal Name:
Today on Entrepreneur

e-Business & Technology
Franchise News
Business Book Sampler
Starting a Business
Sales & Marketing
Growing a Business
E-mail*:
Zip Code*: