Accelerated review for Epeius' Rexin-G in the Philippines

California, USA-based Epeius Biotechnologies says that the Bureau of Food and Drugs, the Philippine drug regulatory body, has granted accelerated approval for the company's lead clinical product, Rexin-G, said to be the world' s first tumor-targeted injectable gene therapy vector for the treatment of all solid tumors. This approval closely follows the recent granting of an Expanded Access Program by the BFAD for Rexin-G, which extended the product's clinical applications to patients with solid tumors, including but not limited to pancreatic cancer.

"With Rexin-G, Epeius is advancing genetic medicine worldwide. Our technology offers new treatment options for many cancer patients who are refractory to conventional chemotherapy treatment regimens," said Erlinda Maria Gordon, the firm's vice president of operations and medical affairs, adding: "our preclinical and clinical data show that Rexin-G has a favorable safety profile without the serious side effects generally associated with chemotherapy."

Rexin-G is currently in clinical trials in the USA for pancreatic cancer, where it has been granted Orphan Drug status by the Food and Drug Administration, and in the Philippines for all solid tumors. It was developed to target primary and metastatic cancers, while limiting side effects within the body and is designed to function in the human circulatory system.