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Onxeo reports positive preliminary results from Validive Phase II trial for oral mucositis

French biopharmaceutical firm Onxeo has reported positive preliminary top-line results from its Phase II clinical trial of Validive (mucoadhesive buccal tablet MBT clonidine Lauriad) to prevent severe oral mucositis (OM).

OM is a radio/chemotherapy related condition and it occurs frequently in patients undergoing head and neck cancer treatment.

This condition is considered as ‘non severe’ for grades 0 to 2, based on level of pain and burden for the patients, as per the WHO scale.

The company said that from grade 3 to 4, OM is rated severe, based on symptoms such as pain and mouth dryness which prevents patients from drinking and eating and induces increased hospitalization and treatment breaks.

The company has also conducted a large international randomized, double-blind, placebo-controlled Phase II trial in 183 patients with head and neck cancer.

The trial compared the efficacy and safety of Validive 50µg and 100µg applied once daily to those of placebo in the prevention and treatment of chemoradiation therapy-induced severe oral mucositis in these patients.

During the trial, all patients received a postoperative radiochemotherapy with a mean cumulative dose of 61 Gray in combination with cisplatin-based chemotherapy in most of the cases.

The trial’s endpoints were to compare the incidence, severity, time to onset and duration of severe OM as well as use of opioids and other adverse events related to cancer radiation treatment between the Validive pooled groups and placebo.

Based on these preliminary results the Advisory Board has recommended pursuing the development of Validive with the start of a Phase III trial in the same patient population in 2015.

Onxeo CEO Judith Greciet said: "With these promising positive Phase II results for Validive and the product ready to enter Phase III, Onxeo now has a second program reaching the last stage of development, ahead of registration."