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The US National Cancer Institute initiates phase I study with Medivir’s birinapant and radiation therapy

Uli Hacksell

Medivir has announced that the first patient has been enrolled in a phase I study to investigate the safety and tolerability of a combination treatment of birinapant and radiation therapy in patients with recurrent Head and Neck Squamous Cell Carcinoma (HNSCC).

The initiative for the study came from researchers at the US National Cancer Institute (NCI). The study is sponsored and financed as part of NCI’s Cancer Therapy Evaluation Program (CTEP).

Medivir provides birinapant and will be afforded full access to all reports from the study under its Cooperative Research and Development Agreement with NCI for birinapant. The primary goals of which are to evaluate the safety of the combination treatment and to establish a maximum tolerated dose for further studies. The potential signs of a treatment response in the patients are also investigated.

Medivir’s decision to support this study was based on preclinical data from NCI showing good effects from birinapant in combination with radiotherapy in models of various types of cancer of the head and neck region.

“We believe that birinapant has the potential to form part of several different combination treatments for various types of cancer,” says Uli Hacksell, CEO of Medivir. “The birinapant-radiation therapy combination treatment yielded impressive results in the preclinical cancer models, and we are eagerly awaiting the results of the phase I study, which will be a good complement to the ongoing phase II combination study of birinapant and Keytruda.”