Davant will be examined in combination with 5-Fluorouracil (5-FU) to treat patients with advanced bile duct and gall bladder cancer.
Phase I/II results showed that Davanat, when co-administered with 5-FU, stabilized the disease and improved the quality of life for many of the end-stage cancer patients.
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. Treatment of biliary cancer may represent an opportunity for orphan drug status approval.
“When we combine the very positive results from those trials, with the data expected from the ongoing biliary and colorectal first line cancer trials, we will prove the clinical benefit of Davanat to treat cancer patients,” said David Platt, president and CEO, Pro-Pharmaceuticals.