Azanta A/S, a Danish specialty pharmaceutical company, announced the initiation of a randomized pivotal phase III trial with Nimoral for treatment of squamous cell carcinoma of the head and neck. The study is led by the EORTC in partnership with the Danish Head and Neck Cancer Association (DAHANCA) and sponsored through an educational grant by Azanta A/S.
EORTC trial 1219 is a randomized international multicenter study of accelerated fractionated chemo-radiotherapy with or without Nimoral in 640 patients, who have HPV/p16 negative squamous cell carcinoma of the head and neck. In the study, we plan to prospectively validate a companion diagnostic which measures the expression levels of 15 genes that are biomarkers of hypoxia.
The European Medicines Agency (EMA) has evaluated the protocol, giving EORTC and Azanta scientific advice on the design of the study, indicating that pending the primary endpoint is met – with a significant increase in loco-regional control of the cancer in the Nimoral treatment group – the study data could support a European approval of Nimoral for the treatment of head and neck cancer patients.
Dr. Claus Møller, Chief Executive Officer of Azanta, commented: “We are delighted to initiate this phase III trial with Nimoral together with EORTC, whom we believe will be an excellent partner in engaging leading radiation clinics across Europe as well as a leading radiation clinic in Canada”.
Prof. Vincent Grégoire, EORTC Study Coordinator of the study added: “We are convinced that this study will be a breakthrough in head and neck clinical research. It will not only validate what could become a new standard of care for locally advanced tumors, but for the first time in head and neck clinical research history, it will hopefully show that patients due to respond to this new therapeutic approach can be selected via a molecular signature of tumor hypoxia. This will be the beginning of a new area of treatment personalization”.
Nimoral (nimorazole) is Azanta’s proprietary cancer product in pivotal Phase III development. Nimoral is a radiosensitizer that enhances the effect of radiotherapy in head and neck cancer patients, and the product is being made available under named patient programs throughout the world.
For many cancers, radiotherapy is the main choice of treatment. The effectiveness of radiotherapy treatment depends on various factors, including the ability of the irradiation to kill the cancer cells. When cancer cells are oxygen deprived (hypoxic), they are less prone to die upon irradiation. Nimoral mimics oxygen in rendering cancer cells more responsive to radiotherapy. The active ingredient, nimorazole, has been used in routine clinical practice (according to DAHANCA guideline) in Denmark and Norway for more than two decades. Use of this product in treatment practice by oncologists requires a compassionate use license from the local/national health authorities.
Nimoral, for the treatment of head and neck cancer patients undergoing radiotherapy, received orphan designation by EMA in 2011. A number of phase III trials with Nimoral are either on-going or being planned for near term initiation. Nimoral is proprietary to Azanta, who is responsible for the world-wide development.
About Azanta A/S
Azanta A/S is a privately owned specialty pharma company primarily operating within oncology, women´s health and addiction medicine. The vision of Azanta A/S is to become an international market leader within specialty pharma products and innovative pharmaceutical products. Azanta A/S currently markets or makes available a string of specialty pharma products, including Nimoral, a hypoxic radiosensitizer for the treatment of head and neck cancer patients undergoing primary radiotherapy. In addition, Azanta A/S has a portfolio of low risk development projects for commercialization within the near future.
The EORTC brings together European cancer clinical research experts from all disciplines for trans-national collaboration. Both multinational and multidisciplinary, the EORTC Network comprises more than 2,500 collaborators from all disciplines involved in cancer treatment and research in more than 300 hospitals in over 30 countries.
Through translational and clinical research, the EORTC offers an integrated approach to drug development, drug evaluation programs and medical practices.
EORTC Headquarters, a unique pan European clinical research infrastructure, is based in Brussels, Belgium, from where its various activities are coordinated and run.