Azanta receives scientific advice from EMA for Phase III registration study with Nimoral


Summary: Azanta has received scientific advice from EMA concerning the upcoming registration study with the radiosensitiser Nimoral in head and neck cancer patients.

Hellerup, Denmark; April 17, 2013 – Azanta A/S announced today it has received scientific advice from EMA concerning the design of a pivotal trial treating head and neck cancer patients with the radiosensitiser Nimoral (nimorazole) in combination with chemo-radiotherapy. Further, the study will aim at validating the use of a patented gene classifier test for prospective preselection of patients likely to benefit from hypoxic modification of radiotherapy with Nimoral.

“We look forward to initiating this study and aim at offering better treatment through the possibility of preselecting future patients based on their genetic signature and through the clinical benefits of Nimoral”, said Claus Møller, Ph.D., Chief Executive Officer.

The pivotal study will include approximately 640 patients with squamous cell carcinoma of the head and neck (SCCHN), who are HPV/p16 negative.

About Nimoral
Nimoral is a hypoxic radiosensitiser being developed for SCCHN by Azanta. The compound belongs to a class of nitro compounds known as nitromidazoles. A low content of oxygen in hypoxic tumors makes these tumors difficult to irradiate effectively. Nimoral will, due to its high electron affinity, mimic the effect of oxygen in the rendering hypoxic cells upon radiation, thereby making the radiation more effective.

Nimoral was designated as an Orphan Medicinal Product by EMA in 2011.

About the trial
The pivotal SCCHN study with Nimoral will have two co-primary objectives: (1) to evaluate the overall effect of Nimoral in combination with chemo-radiotherapy compared to chemo-radiotherapy and placebo and (2) to evaluate the treatment benefit in the subset of patients who are hypoxic cell signature positive. The primary end point will be locoregional control.

Patients will receive Nimoral tablets or placebo prior to irradiation. The daily scheduled dose is approximately 1,200 mg/m2 body surface given in connection with the first daily irradiation treatment.

A patented hypoxic gene classifier test will be used in the study to identify patients who are hypoxic cell signature positive. The test could potentially be used for future selection of patients with hypoxic tumors for treatment with Nimoral.

About Azanta A/S
Azanta 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.

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This press release contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. Azanta is not under an obligation to up-date statements regarding the future following the publication of this release; nor to confirm such statements in relation to actual results, unless this is required by law.

Contact Azanta:
Claus Møller
Tel: + 45 – 70 25 95 45
Fax: + 45 – 70 25 95 46

For further interest in Azanta’s specialty pharma products or investigational cancer products, please contact your local representative or Azanta’s head office.

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