Oncology Products

Tumor-Targeted Genetic Medicine that ‘Seeks Out’ Metastatic Cancer

Landmark Clinical Trials of Rexin-G® Lead to Registration in the Philippines and Orphan Drug Status by the U.S. FDA.

Rexin-G, the world’s first tumor-targeted genetic medicine, was validated in the crucible of international clinical trials: from Compassionate Use and Phase I safety studies, to advanced studies of efficacy and cumulative toxicity, leading to an Expanded Access Program and Accelerated Approval in the Philippines. Rexin-G was formally registered by the Philippine BFAD (in December of 2007) as a safe and effective treatment for all solid tumors that are refractory or intolerant to standard chemotherapy.

Following a similar path in the United States, Rexin-G was first administered to cancer patients under Compassionate Use protocols, Phase I safety studies, Adaptive Phase I/II dose escalation studies, and Phase II confirmatory trials, respectively. Based on critical evaluations of overall safety and efficacy by the U.S. FDA, Rexin-G has been granted Orphan Drug Designation for three clinical indications: (i) metastatic pancreatic cancer, (ii) osteosarcoma, and (iii) soft tissue sarcomas. Advanced Phase I/II trials in the U.S. have confirmed the remarkable dose-dependent efficacy of Rexin-G when administered as a single therapeutic agent, as well as its outstanding record of safety.

Rexin-G was initially studied in poor-prognosis (end-stage) cancers as second-line therapy, when standard treatment(s) had failed. However, with the therapeutic utility of Rexin-G validated in terms of overall safety and broad-spectrum anti-tumor activity, additional Clinical Trials using Rexin-G as first-line therapy, in combination with standard chemotherapy, are currently in development (see Current Trials).

Once Progression is Halted, Reximmune-C® Provides an Opportunity for a Personalized Cancer Vaccination

Reximmune-C has recently been approved by the Philippine BFAD for clinical trials and is available to a limited number of patients who have achieved stable disease but are still at risk of cancer progression.

Click Current Trials for additional information.

[PDF] Phase I/II Study of Rexin-G for Breast Cancer, NIH/FDA Announcement
[PDF] Phase I/II Study of Rexin-G for Pancreatic Cancer, NIH/FDA Announcement

Video View the Rexin-G / Reximmune-C Animation

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