Pancreatic cancer is a serious disease for which surgical resection currently offers the only chance of cure. However, only 15 to 20 percent of patients have resectable disease at initial diagnosis; the majority have either locally advanced or metastatic cancer. Available chemotherapy regimens only offer short overall survival. There is a very significant unmet medical need for these patients.
In 2013 Cytovac initiated a prospective, open-label, multiple-dose, single arm, single center, phase I trial, CV004, in pancreas cancer of 24 weeks duration. The primary objective was to investigate the safety and tolerability of ALECSAT in patients with locally advanced pancreatic cancer who had terminated or declined treatment with the Folfirinox regimen. After 12 of the planned 15 patients had been enrolled in the trial, a new treatment for pancreatic cancer became available. Given this change in recommended treatment, Cytovac found it unethical to keep the trial open for recruitment of the last patients. As the primary objective of the study was fulfilled, the trial was therefore closed in 2015. Six of the 12 enrolled patients received the 3 planned ALECSAT treatments.
The study showed ALECSAT treatment to be well tolerated with no serious side effects associated to the treatment. However, due to the low number of enrolled patients with follow-up MRI (4 out of 12), no efficacy conclusions could be made.
Based on the clinical phase I data, ALECSAT treatments of pancreatic cancer should be followed up in a clinical phase II trial. Cytovac seeks partners for such a trial.