Finally a Phase III trial... HANGZHOU, China, -- March 21, 2019 -- Adlai Nortye Ltd. ("Adlai Nortye"), a global clinical-stage biopharmaceutical company today announced that it has received a clearance from the National Medical Products Administration (NMPA) of China for initiating the open-label, randomized, multicenter, global phase III clinical trial for pelareorep (AN1004) in combination with paclitaxel in patients with advanced/ static breast cancer in China.
Pelareorep is a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. In the presentation of pelareorep clinical data, additional randomized phase II data in static breast cancer demonstrates doubling (21.8 months vs. 10.8 months) of overall survival in Hormone Receptor Positive (ER+PR+)/HER2- patients. Pelareorep has received Fast Track designation and Special Protocol Assessment Agreement for Phase III Clinical Trial from FDA for the treatment of static breast cancer.
Carsten Lu, Chairman and CEO of Adlai Nortye said: " The incidence of breast cancer ranks No. 1 among female malignant tumors in China. Adlai Nortye focuses on discovering and developing innovative treatments in cancer patients, trying to transform cancer into a chronic disease condition even cure the cancer disease. The NMPA gave detailed and constructive guidance to the pelareorep phase III clinical program. We are very pleased and encouraged by the result. We will launch the clinical trial to join our global partner Oncolytics Biotech Inc. when they initiate their phase III registration study. We will continue to bring more options to cancer patients."
Funny how ONCY still lists Adlai Nortye as a partner (and according to Matt, having such a respected partner validated Pela) but AN does't mention Pela or ONCY anymore, must be a silly oversight. Now that ONCY won't be running an mBC trial with a checkpoint inhibitor, and just run a doublet study, that AN were approved for 1/2 a decade ago, I'm surprised they don't just get on and run it... success is guaranteed isn't it Notable?