The phase II trial will examine Davanat with Avastin, 5-Fluorouracil (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.
Davanat targets specific lectin receptors (Galectins) that are over-expressed on cancer cells. According to the company, this form of targeted delivery may allow for higher doses of chemotherapy administration with no increase in toxicity.
“When we combine the results from this front line trial, with the positive results from our phase I/II trials of end stage cancer patients, we believe it will prove the efficacy enhancing affect and toxicity reduction of Davanat when co-administered with chemotherapeutics and biologics to treat cancer,” said Tomasz Zastawny, director Clinical Trials, Pro-Pharmaceuticals.
Additionally, the company is actively recruiting and dosing 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 patient from the phase I trial remained on study for 13 months, far exceeding expectations.