Epeius Biotechnologies Corporation received a certificate of product registration for Rexin-G from the Philippine Bureau of Food and Drugs (BFAD), enabling the commercialisation of its lead product as a safe and effective treatment for a broad spectrum of intractable cancers.
Developed as a tumour-targeted anticancer agent, that actively seeks out and destroys metastatic cancers, Rexin-G exhibits unprecedented single-agent efficacy where other agents, including targeted biologics, have failed. Moreover, Rexin-G has established an exemplary record of clinical safety, virtually eliminating the systemic toxicities routinely encountered with chemotherapies, thus enhancing quality of life.
Rexin-G is among the first gene-based medicines to be approved anywhere in the world, and remarkable in that it is the first targeted gene delivery system ever developed that actually works in humans.
According to Dr. Frederick L. Hall, president and CEO, Epeius, "It is most fitting that Rexin-G receives its first product registration in the Philippines which brought forth the stellar physician-scientist whose drive and determination to engineer a better medicine made Rexin-G possible, and also it was first in the Philippines where the dedicated clinicians, oncologists, regulatory authorities, and medical institutions worked tirelessly for years to bring this targeted genetic medicine to the bedside."
Rexin-G is commercially available in Philippines and Epius hopes to expand its reach to the ASEAN countries also. Epeius Biotechnologies has intensified its efforts to gain product registration in the United States, following several years of safety studies in the USA, Epeius has formally opened three advanced phase I/II trials in San Marino and Santa Monica, California, for chemo-resistant pancreatic cancer, breast cancer, and sarcoma. The US FDA recently approved a phase II registration protocol for osteosarcoma which includes participation of children and adolescents.