Hellerup, Denmark, September 29, 2014. Azanta A/S, a Danish specialty pharmaceutical company, today announced that they have entered an exclusive option agreement with Aarhus University, Denmark, to acquire the rights to commercialize a companion diagnostic for identification of Head and Neck Cancer patients with hypoxic tumors.
The companion diagnostic will be used to predict which patients are most likely to respond to Azanta's leading oncology compound Nimoral, which is currently in phase III clinical trials. The test measures the expression levels of 15 biomarkers or genes that are responsive to hypoxia in the tumor. Hypoxia is a low-oxygen state within the tumor cells caused by tumors outgrowing their blood supply. Classification into "more" or "less" hypoxic tumors is accomplished by using this test comprising of the 15 selected genes that have demonstrated the capability of identifying tumors as hypoxic.
Dr. Claus Møller, Chief Executive Officer of Azanta, commented: "Securing the rights to the companion diagnostic allows us to analyze tumor biopsies both in the ongoing randomized phase III trial with Nimoral, conducted by the EORTC, as well as in other trials conducted by Azanta and later on commercially. We will prospectively test tumor biopsies to validate the companion diagnostic. Upon such validation, we will be able to predict which cancer patients will benefit from Nimoral. Beyond being a great scientific advancement in the field of understanding hypoxia and how it affects the outcome of cancer treatment, this test will potentially also make Nimoral a personalized medicine and provide significant benefit to a patient population that is difficult to treat with existing treatments."
To test the companion diagnostic's potential for predicting which tumors are hypoxic and could benefit from the use of the radiosensitizer, Nimoral, the companion diagnostic was retrospectively applied to HNSCC biopsies from patients enrolled in the DAHANCA-5 trial. Samples were available from 323 patients, all of which were analyzed (167 received nimorazole, 156 received placebo, both in combination with conventional radiation therapy). Based on the results of the diagnostic test, 114 tumors were classified as more hypoxic and 209 were classified as less hypoxic. It was found that there was a beneficial effect from the addition of nimorazole versus placebo based on locoregional tumor control if the cohort was evaluated without classification (50% vs. 36%, p=0.02). However, if patients were classified as either more or less hypoxic in accordance with our companion diagnostic, a significantly greater effect of nimorazole was observed in those tumors classified as more hypoxic. HNSCC patients with tumors that were classified as more hypoxic had a significant improvement in five-year locoregional control when treated with nimorazole as compared with those patients treated with placebo (49% vs. 18%, p=0.001). In contrast, there was no significant difference in the rate of five-year locoregional control for patients whose tumors were classified as less hypoxic (50% vs. 44%, n.s.). Based on these findings, we believe that the companion diagnostic was shown to be capable of predicting which tumors benefited from the addition of nimorazole and which tumors did not benefit from the additive treatment.
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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.
For further information, please visit www.azanta.com.
Tel: + 45 - 70 25 95 45