Adlai Nortye, one of the leading biopharmaceutical companies of China, has recently announced dosing its first patient in the global phase 3 clinical trial (BURAN) at Shanghai Eastern Hospital Center in the country.
Reports suggest that the clinical BURAN study evaluates the effects of Buparlisib, an oral PI3K inhibitor, in combination with paclitaxel for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The recent accomplishment represents the first global multicenter phase 3 trial for HNSCC in the genre of PI3K inhibitors.
As per credible sources, the trial is an open-label, randomized, multicenter phase 3 study to analyze the efficiency and safety of Buparlisib along with paclitaxel compared to paclitaxel alone in the patients with metastatic or recurrent HNSCC. Apparently, the study plans to recruit about 500 HNSCC candidates from around 150 clinical centers across 15 major countries and regions in APAC, Europe, and North America.
Speaking on the latest patient enrollment, Professor Denis Soulieres, Primary Investigator for the BURAN study cited that the objective of BURAN is to be able to provide HNSCC patients with treatments better than taxol. In fact, the results are expected to add to the success of the previously completed phase 2 trial for Buparlisib.
Meanwhile, Director of Phase 1 Clinical Trial center of Shanghai East Hospital and a Member of the Head and Neck Cancer Committee of CSCO, Prof. Guo Ye, reportedly quoted that the Phase 3 BURAN study is poised to change the paradigm of second-line treatment for HNSCC, which looks to offer novel treatment option for patients in China and worldwide.
Prof. Ye added that as a physician, he is elated to welcome more clinical trials to be carried out in the country and with this trial, he is looking forward to offering the firsthand data in terms of efficiency and safety in Chinese patients.
CMO of Adlai Nortye, Dr. Lars Birgerson mentioned that through collaboration with the world-class researchers to conduct high-quality clinical trials, the firm hopes to deliver a safer and more effective treatment to patients in a timely manner to save lives.
Source Credit: https://www.prnewswire.com/news-releases/adlai-nortye-announces-first-patient-dosed-in-global-phase-iii-clinical-trial-of-buparlisib-an2025-in-combination-with-paclitaxel-for-the-treatment-of-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinoma-301269338.html