Clinical Trials

Colorectal Cancer Trial: Phase I/II in Denmark

A clinical trial using MelCancerVac® was conducted at the University Hospital of Copenhagen, Gentofte. Enrollment of patients started in October 2004 and the study ended in September 2006. The title of this study is: "Vaccination with autologous dendritic cells loaded with Lysate of allogeneic melanoma cells (MelCancerVac®) for treatment of patients with advanced colorectal cancer".

The purpose of this open phase I/II study was to study the tolerability and effect of MelCancerVac® given as intradermal injections to patients with metastasizing colorectal cancer, where there is no indication for surgery or chemotherapy. The first part was a phase I study to investigate whether treatment with MelCancerVac® is in any way toxic. No toxicity was observed and the study continued into phase II to study the effect and tolerability of MelCancerVac®. At the completion of the study stable disease was observed in 20% (4/20) patients. The clinical and immunological data was reported in a poster at the DC-thera meeting in Bamberg, July 2007.

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Colorectal Cancer Trial: Phase II in Singapore

An open phase II clinical study was conducted to investigate the efficacy of intradermal vaccination with MelCancerVac® in patients with advanced colorectal cancer.

The purpose of the study is to investigate the objective efficacy and specific immunologic response of the MelCancerVac® vaccination. The first patient was enrolled in June 2005, as of June 2007 a total of 20 patients had been treated and evaluated. The vaccine was given to patients with advanced chemotherapy-pretreated colorectal cancer, where there is no further indication for surgery or treatment with chemotherapy. The study utilized DanDrit's new patented procedure for generating dendritic cells and all of the included patients had tumours which antigenically correlated with the vaccine, i.e. were MAGE-A positive. Treatment with MelCancerVac® did not adversely affect quality of life which remained both high and stable throughout the study period.

MelCancerVac® induced objective responses in 7 of 20 patients (6 responses were stable disease and 1 response was partial loss of tumor mass). Significant immunological responses were observed in vivo as a delayed type hypersensitivity (DTH) reaction against the vaccine product. Results from the trial were presented orally at the AACR meeting in Singapore in November 2007. A larger phase IIb trial is currently scheduled to begin in late 2008.

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Non-Small-Cell Lung cancer, Phase II

A clinical trial was conducted at Herlev Hospital, University of Copenhagen with MelCancerVac®. The title of the study is: "Vaccination with Autologous Dendritic Cells Pulsed with Allogeneic Tumour Lysate (MelCancerVac) for the Treatment of Patients with Advanced or Metastatic Non-Small Cell Lung Cancer".

The study was designed as an open, phase II clinical study. Patients shall have disseminated, inoperable NSCLC after chemotherapy, where the patient does not want further chemotherapy, and no other systemic treatments can be offered.

The primary objective is to measure the antigen specific immunological reaction between vaccine antigens and the patients' immune system in vivo and in vitro. The secondary objectives are to estimate the patients' survival time, to estimate response according to RECIST criteria, and to estimate the patients' quality of life during the study period.

A total of 28 patients have been included in the trial. In this Phase IIa trial (n=28) a 43% response rate was observed, with 6 patients showing stable disease. Five of these patients were immunologically responding to the vaccine (ELISPOT –IFN Gamma positive) while 8 of 9 patients with SD had no IFN gamma response.