MALP-2S: human studies
1. In a phase I study with a limited number of patients MALP-2S was tested for tolerability when injected into the wound bed of small punch biopsies punches. In this study MALP-2S caused a transient erythema but no further side effects, neither local nor systemic2.
2. In an exploratory pivotal (phase I/II) trial, the safety and efficacy of MALP-2S in combination with gemcitabine was investigated in patients with pancreatic carcinoma. Male and female patients with incompletely resectable pancreatic carcinomas were eligible, while those with R0 or R1 resections or with peritoneal carcinosis were excluded. Ten patients were injected intratumorally during surgery with 20-30 μg MALP-2S followed by postoperative standard chemotherapy. Up to 20 μg MALP-2S was well tolerated, and no systemic side effects were noted.
The mean survival at the time of publication (July 31, 2007) was 17.1±4.2 months; the median survival was 9.3 months. Regarding follow up as of December 2008, the outcome of the study is shown in the figure below incorporating survival times of patients treated with a control group of matched patients in the same department treated with standard chemotherapy alone.
Figure: Kaplan-Meier analysis comparing the survival time of ten patients treated with MALP-2S plus gemcitabine versus patients treated with gemcitabine alone. Phase I/II study, University Medical School of Heidelberg.
Literature:
1. Niebuhr M, Muhlradt PF, Wittmann M, Kapp A, Werfel T. Intracutaneous injection of the macrophage-activating
lipopeptide-2 (MALP-2) which accelerates wound healing in mice - a phase I trial in 12 patients. Exp
Dermatol [Epub ahead of print Aug 18] 2008.
2. Schmidt J, Welsch T, Jager D, Muhlradt PF, Buchler MW, Marten A. Intratumoural in jection of the toll-like
receptor-2/6 agonist ‚macrophage-activating lipopeptide-2‘ in patients with pancreatic carcinoma: a phase I/II
trial. Br J Cancer 2007;97(5):598-604.