Pro-Pharma updates product pipeline: It's the SUGARS!

Pro-Pharmaceuticals Updates Clinical Trials Progress


Pro-Pharmaceuticals, Inc.a developer of novel carbohydrate therapeutic compounds, today updated its clinical trials progress.
"We continue to make excellent progress in the clinic with DAVANAT®, our lead product candidate," said David Platt, Ph.D., Chief Executive Officer, Pro-Pharmaceuticals. "The outstanding results from our Phase I and Phase II trials of end-stage patients, who were refractory to chemotherapy, have led us to initiate three clinical trials with line one and line two patients. We believe we will improve the clinical benefit to patients over the current stand-of-care for colorectal and biliary cancer. We plan to begin dosing patients shortly.

"DAVANAT® is a complex carbohydrate drug that when given in combination with chemotherapeutic agents demonstrates reduced toxicity and increased efficacy by targeting the delivery and penetration of the chemotherapy to the tumor [see below targeting sugars to bind to sugars to target drugs]. The move to line l patients is recognition of the safety profile of DAVANAT®," Dr. Platt stated.

Clinical Trial Progress:

Phase I, line three/four, all Solid Tumors Trial and Phase II, line three/four, Colorectal Cancer Trial Results
Phase I and Phase II clinical trials of DAVANAT® with 5-FU data shows 1 patient with an objective partial tumor response and 20 patients stabilized out of 60. These patients had tumors, on average of 100mm,[that's big!] had a minimum of 12 weeks to live and were refractory to chemotherapy, including 5-FU. One patient from Phase II continues to be treated for 26 weeks. A Cholangiocarcinoma patient from our Phase I trial was treated for more than 56 weeks. The results of these studies compare very well and exceed results from similar recent studies in the same patient populations.

Phase II, line one, Colorectal Cancer Trial U.S.-based Phase II, line one clinical trial of DAVANAT® with
Avastin®, 5-FU and leucovorin for patients with locally advanced and unresectable [ can't be removed surgically] or metastatic colorectal cancer unable to tolerate intensive chemotherapy.

Phase III, line two, Colorectal Cancer Trial Europe-based Phase III, line two clinical trial for patients with
metastatic colorectal cancer is a multi-center, randomized with control groups study to evaluate the safety and efficacy of DAVANAT® in combination with 5-FU, leucovorin and irinotecan and/or oxaliplatin.

Phase II, line one, Biliary Cancer Trial U.S.-based Phase II, line one clinical trial of DAVANAT® with
5-FU [ 5 fluoro-uracil inhibits DNA synthesis, but is a very nasty chemical] for patients with biliary cancer. Biliary cancer may represent an opportunity for orphan drug status approval.


DAVANAT polysaccharide polymer [ a suger molecule] comprised of mannose and galactose carbohydrates in a CARBOSOME formation that enables the targeted delivery of chemotherapy drugs to protein receptors (lectins) [sugars binding to other sugars on the cell surface- a new way to target drugs to specific cells] on cancer cells.

Pro is down today on the AMEX (PRW) 13% to 0.64 cents.