31 October 2014 - 31 October 2014 - Onxeo SA (CPH:ONXEO; EPA:ONXEO), the company resulting from the merger of Danish Topotarget A/S and French BioAlliance Pharma SA, unveiled Thursday encouraging preliminary topline findings from its Phase II study of Validive (mucoadhesive buccal tablet MBT clonidine Lauriad) for prevention of severe oral mucositis (OM).

OM is a radio/chemotherapy-related condition occurring very often in patients undergoing head and neck cancer treatment.

Onxeo has conducted a large international randomised, double-blind, placebo-controlled Phase II study designed to compare the efficacy and safety of Validive 50 μg and 100 μg applied once daily to those of placebo in the prevention and treatment of chemoradiation therapy-induced severe OM in 183 patients with head and neck cancer.

All patients in the study received a postoperative radiochemotherapy with a mean cumulative dose of 61 Gray in combination with cisplatin-based chemotherapy in most of the cases. The study's goals were to compare the incidence, severity, time to onset and duration of severe OM as well as use of opioids and other side effects related to cancer radiation treatment between the Validive pooled groups and placebo. They were assessed twice a week throughout the whole radiotherapy treatment.

The key findings of the Phase II study demonstrated a significant decrease in the incidence of severe OM (grades 3 and 4) in the Validive pooled arms versus placebo. Overall incidence of severe OM was 45% in the Validive groups, with a maximum absolute decrease of 16% compared to placebo.

Furthermore, the results show that occurrence of severe OM has been delayed in the Validive groups compared to placebo. Higher doses of radiation have been received by the Validive treated patients before severe OM occurred. Improvement of critical conditions related to severe OM and radiation therapy was observed in both Validive groups, particularly dysphagia, nausea and vomiting.

No significant difference in efficacy was observed between Validive 50 μg and 100 μg groups. Validive exhibited a good safety profile with no major difference in the nature, incidence and severity of side effects in the placebo and the Validive groups.

Notably, patient's compliance was very high, with over 80% of patients applying Validive or placebo tablets on the gum every day throughout radiation therapy, as was requested in the study.

Based on these preliminary findings, the trial Advisory Board has recommended pursuing the development of Validive with the start of a Phase III study in the same patient population. The company anticipates initiation of this study in 2015.

Back in January, Validive obtained a Fast Track designation from the US FDA. The therapy also enjoys orphan status in Europe.

Onxeo's CEO, Judith Greciet, said the positive preliminary data from the study confirm the interest of Validive as a highly promising treatment to tackle a devastating inflammation in heavily stressed patients, with virtually no side effects. With the encouraging Phase II findings and the product ready to enter Phase III, the company now has a second programme reaching the last stage of development, ahead of registration, Greciet added.

Validive is a therapeutic application of clonidine based on the mucoadhesive technology Lauriad.