Epeius Biotechnologies announced the opening of a vaccine-assisted phase I/II clinical trial for metastatic breast cancer that is refractory to conventional chemotherapy. The innovative protocol introduces Reximmune-CTM, the second in a series of targeted biologic therapies designed to seek out, accumulate in, and destroy metastatic tumour nodules, while sparing normal cells and tissues.

The lead product, Rexin-GTM, has recently been granted Orphan Drug Status by the FDA. Based on "Pathotropic" (disease-seeking) targeting technologies developed at the University of Southern California School of Medicine and Childrens Hospital Los Angeles, these targeted biologics are designed to operate within the human circulatory system to deliver genetic medicine precisely where it is needed.

The new Tri-Rex Vaccination Protocol for Breast Cancer involves the targeted delivery of a cancer-killing designer gene to reduce the tumour burden, followed by the targeted delivery of a powerful immune activating gene, followed by a repeat of the cancer-killing cycle in order to generate additional tumour debris and present tumour antigens to the now-activated and localized immune cells.

The new Tri-REX Therapeutic Vaccination Protocol stems from direct observations in previous clinical trials that Rexin-GTM, not only accumulates in primary tumours and metastatic sites, but also drains, like metastatic tumour cells, into sentinel lymph nodes where the therapy remains biologically active and tumouricidal. The demonstrations of dead and dying cancer cells in cancerous lymph nodes following Rexin-GTM infusions in pancreatic cancer, breast cancer, and malignant melanoma patients open up an opportunity for targeted autovaccination to encourage the patient's immune system to participate in the tumour eradication and to lower the incidence of recurrence.

According to Dr Frederick L. Hall, Chief Scientific Officer of Epeius Biotechnologies-"This approach to therapeutic vaccination is likely to succeed where many, as in many, have failed. You see, biologic targeting is the key: the key to efficient gene delivery in the body, the key to effective cancer therapy, and the key to successful cancer vaccinations." This month, the Tri-REX Vaccination Protocol will be tested on a limited number of patients in Manila in a phase I/II clinical trial sponsored by Epeius Biotechnologies.