Cel-Sci Corporation have approval from the Canadian regulatory agency for biological agents to initiate a phase III trial of their immunotherapeutic agent, Multikine, in patients with advanced primary squamous cell carcinoma of the oral cavity.
Multikine is a mixture of naturally occurring cytokines, including interleukin-2, other interleukins, interferons and colony-stimulating factors, as well as chemokines. Giving Multikine before standard therapy for head and neck cancer — surgical resection followed by either radiotherapy or concurrent radiotherapy and chemotherapy — has been shown in phase II studies to increase tumour cell sensitivity to the radiotherapy. The cytokines recruit anti-tumour T-cells and other inflammatory cells, leading to a massive anti-tumour response. In particular, Multikine stimulates prolonged production of CD4-positive T-cells that infiltrate the tumour. The overall response rate in a phase II trial in 39 patients with advanced primary oral squamous cell carcinoma was 42% before standard therapy. The treatment had no toxic effects. The patients who responded to Multikine had tumours that were negative for the cell surface marker HLA (human leukocyte antigen) class II. Use of this marker might provide a way of selecting the patients that are best suited for treatment with Multikine.
