Results from a randomised controlled Phase II clinical trial, 'IMAGE 1', which looked at IMM-101 (a bacterially derived systemic immunomodulator administered intradermally) in combination with gemcitabine in the treatment of advanced pancreatic cancer, have indicated consistent and significant improvements in overall survival (OS) and progression free survival (PFS).
In the predefined sub-group with metastatic disease (82 of the 110 patients randomised), a 3.1 month or 700/0 improvement in overall survival compared to patients receiving gemcitabine alone (median of 7.5 vs 4.4 months) was demonstrated (HR 0.46, 95% CI 0.28-0.76, p=0.002).
In this study, IMM-101 does not appear to confer an incremental safety burden beyond that associated with chemotherapy and the disease itself.
"There is a real need for treatments for pancreatic cancer which significantly improve survival without additional toxicity and these data suggest that immunomodulation with IMM-l0l offers that hope" said Prof Angus Dalgleish, Chief Investigator of IMAGE 1.
Dr Kevin Bilyard, Immodulon CEO, commented:
"Significant survival benefit in a randomised controlled clinical trial of this size is very encouraging and provides clear direction for the further development of IMM-101 in combination with chemotherapy as a first line treatment option for metastatic pancreatic cancer. We are now initiating discussions with regulatory authorities to determine a development pathway that will allow us to confirm these preliminary findings as quickly as possible. Although metastatic pancreatic cancer is the lead indication for IMM-101, we expect it to be effective in other tumour types as well."
Source: Immodulon Therapeutics