Rexin-G™ Fact Sheet
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About Rexin-G™
Scientists at Epeius Biotechnologies have developed the technologies that can deliver a new class of powerful biological therapy directly to tumors that have spread throughout the body (metastatic cancer). The lead product, Rexin-G™ , is a gene delivery vehicle, a tumor-targeted nanoparticle that is designed to deliver a tumor-killing designer gene precisely where it is needed. Rexin-G™ has been shown clinically to be highly active against a broad spectrum of chemo-resistant tumor types, causing tumor shrinkage in patients suffering from metastatic cancer, without eliciting harmful systemic side effects.
Milestones
- Rexin-G™ received orphan drug designation by the U.S. Food and Drug Administration
- Rexin-G™ received accelerated approval in the Philippines for use in all solid tumors
- Rexin-G™ is currently in clinical trials internationally, including the U.S., for advanced pancreatic and other metastatic cancer
How Rexin-G™ Works
Each nanoparticle of Rexin-G™ is only 100 nanometers wide; yet despite its small size, it is a highly complex structure. Each component—the envelope, matrix, capsid, enzymes, and genetic material has its purpose, and in concert they enable each nanoparticle to deliver a lethal payload. The payload is a tumor-killing designer gene, which selectively kills cancer cells and their associated blood supply, while sparing normal cells and healthy tissues.
The delivery of the lethal payload by the nanoparticles is “pathotropic,” meaning it is specifically targeted to diseased tissues. Rather than targeting the cancer cells themselves, Rexin-G™ efficiently targets a common histopathological property of all invasive tumors. Pathotropic targeting allows Rexin-G™ to seek out and destroy tumors regardless of their location in the body, thereby reducing tumor burden, prolonging survival, and enhancing the patient’s quality-of-life.
Highlights
- The only targeted cancer gene delivery system that can be effectively administered intravenously
- Designed to seek out and destroy both primary and metastatic tumors
- Highly active as a single agent in a broad spectrum of chemo-resistant cancers
About Metastatic Cancer
Cancer is a progressive illness, originating from primary tumors located in specific tissues or organs. Tumor cells detach from the primary tumor and are carried to other sites in the body through the bloodstream to neighboring tissues, creating a secondary or metastatic tumor. Metastatic tumors often present in essential organs, making treatment difficult. Common treatment options for metastatic tumors include chemotherapy, radiation therapy, surgery or combinations of these treatment options, which often have limited success while causing severe side effects that significantly diminish the quality of life for the patient.
Clinical Experience with Rexin-G™
Early clinical and preclinical data suggest that Rexin-G™ is safe and effective when used as a single agent therapeutic for the treatment of chemo-resistant tumors.
United States
Rexin-G™ is currently in Phase I trials at the Mayo Clinic in Rochester, Minnesota
for locally advanced and metastatic pancreatic cancer that is refractory to
traditional chemotherapy.
A single-use clinical trial evaluating Rexin-G™ for the treatment of metastatic cancer that is refractory to standard chemotherapy has been initiated at the University of Texas M.D. Anderson Cancer Center, Houston, Texas, Pittsburgh Hillman Cancer Center, Pittsburgh, PA., The Sarcoma Oncology Clinic, Santa Monica, CA. and the Epeius Clinical Research Unit, San Marino, CA.
Philippines
Rexin-G™ has been granted accelerated approval for the treatment of all solid
tumors. Rexin-G™ has also been approved for the Expanded Access Program
by the Bureau of Food and Drugs in the Philippines. Under these programs in
the Philippines, Rexin-G™ is approved for use as a first-line and adjuvant
therapy for pancreatic and breast cancer and a second-line therapy for all other
solid tumors that are refractory to standard chemotherapy.
Japan
Dr. Takaki Imamura has initiated an independent study of Rexin-G™ in a variety
of metastatic cancers. He completed his first round of trials in December 2006.
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