The study will be conducted at the European Pancreas Center of the University of Heidelberg Clinic for Surgery. Enrolment will include up to 43 patients with advanced, inoperable pancreatic cancer who will also receive co-therapy with oral capecitabine.
Previously WF10 was administered to four patients, to supplement each individual treatment regimen. All four patients demonstrated a clinical response that exceeded the expected survival time and quality of life. Three of the four patients had metastatic disease with a predicted median survival of approximately six months with standard chemotherapy.
Following various combinations of chemotherapy and radiotherapy in combination with WF10, they survived 12, 14 and 22 months, respectively. The fourth patient has locally-advanced disease, normally associated with a median survival of 6-10 months, and is still alive after 16 months.
“Pancreatic cancer is by no means the most common cancer but 85% of patients have inoperable disease at presentation and its poor prognosis makes it the fourth leading cause of cancer death. The Canadian Cancer Society reported over 3,300 deaths from this malignancy in 2004. Currently available treatments are not adequate”, said Dr Henrich Guntermann, president and CEO of Dimethaid. “These anecdotal clinical cases suggest very encouraging results and we look forward to formally studying the potential of WF10 for this indication.”
Current concepts in cancer biology suggest that the inflammatory environment in the pancreas enhances signalling pathways of tumor growth factors and other chemokines. Treatment with WF10 has been shown in previous work to modulate the immune response by influencing the monocyte/macrophage system, natural killer cells and cytotoxic T lymphocytes.
It is proposed that this activity will exert an adjuvant anti-tumor effect resulting in increased survival and improved quality of life in patients with pancreatic cancer. A further rationale for combining WF10 and capecitabine is a potentially beneficial interaction between the two drugs within the cancer cells.