Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Adherex Technologies, a biopharmaceutical company focused on the development of eniluracil and 5-fluorouracil, has enrolled first patient in the Phase 2 clinical trial for Metastatic Breast Cancer, comparing the oral regiment of eniluracil + 5-fluorouracil (5-FU) and leucovorin versus capecitabine.
Subscribe to our email newsletter
Patients eligible for this comparative study are previously treated with an anthracycline and a taxane during first-line therapy for metastatic disease.
Phase 2 trial underlines Phase 1 eniluracil/5-FU/leucovorin trial that produced durable tumor responses and no hand-foot syndrome in advanced colorectal cancer patients.
Eniluracil, an inactivator of DPD, prevents the formation of alpha-fluoro-beta-alanine (F-Bal), which causes hand-foot syndrome, neurotoxicity, and also decreases the antitumor activity of 5-FU in laboratory animals.
The eniluracil/5-FU/leucovorin regimen undergoes two modifications of the Phase 1 regimen by increasing the dose to 40 mg to minimize neurotoxicity and by administering it in the night before 5-FU to prevent high eniluracil:5-FU ratios that interfere with the antitumor activity.
The study reported that patients, who showed disease progression while being treated with capecitabine, are eligible to crossover to receive eniluracil/5-FU/leucovorin treatment.
The primary endpoint of the trial is progression-free survival compared to secondary endpoint which included the overall toxicity, antitumor response rate, disease control rate, duration of response, and time-to-treatment response.
Adherex chief scientific officer Tom Spector said that the goal of the trial is to show superior antitumor activity and tolerability for eniluracil/5-FU/leucovorin.