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Avasopasem for treatment of severe oral mucositis induced by radiotherapy, the phase III ROMAN trial failed to reach the primary endpoint

 Last Update: 2021-11-02
 Source: Internet
 Author: User

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Oral mucositis is a side effect of radiotherapy and is characterized by severe pain, inflammation, ulcers, and oral bleeding
.

For patients with head and neck cancer, radiotherapy is the main treatment method

prevention

Galera Therapeutics, a clinical-stage biopharmaceutical company, today announced the results of the avasopasem phase III ROMAN trial, which evaluated avasopasem treatment of severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) who received standard radiotherapy.
However, the trial did not reach the primary endpoint of reducing the incidence of SOM
.

The results of the Phase III ROMAN trial of avasopasem were announced today.
The trial evaluated severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) who received standard radiotherapy with avasopasem.
However, the trial did not reach the main point of reducing the incidence of SOM.
The end
.

The results of the Phase III ROMAN trial of avasopasem were announced today.

FDA

The main findings of the OMAN trial include:

Compared with the placebo group (64%) in the avasopasem treatment group (54%), the incidence of SOM was relatively reduced by 16% (p=0.

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