Positive Phase II preliminary results of Validive for the prevention of Severe Oral Mucositis in Head and Neck cancer patients
Improved oral mucositis related symptoms and decreased adverse events related to radiotherapy
03-Nov-2014
- France
- Significant decrease in the incidence of severe oral mucositis (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.
- 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 oral mucositis and radiation therapy, especially dysphagia, nausea and vomiting in both Validive® groups.
- No significant difference in efficacy observed between Validive® 50 µg and 100 µg groups.
- In terms of safety, Validive® showed a good safety profile with no major difference in the nature, incidence and severity of adverse events in the placebo and the Validive® groups.
Based on these preliminary data the Board has recommended pursuing the development of Validive® with the initiation of a Phase III trial in the same patient population. The company plans to initiate this trial in 2015.
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