Site Map | Links | Contact Us
ABOUT PROXINIUM

Proxinium™ is a medication that is being used to treat advanced squamous cell cancer located in the head and neck. Proxinium™ is a protein therapeutic that has been designed to target a molecule called Ep-CAM that resides on the surface of cancerous squamous cells. To treat head and neck cancer, Proxinium™ is injected directly into the tumor. Once inside the tumor, Proxinium™ will attach to the Ep-CAM molecule and will then enter the cancerous cell where Proxinium™ is then able to kill the cancerous cell.

Proxinium™ has been tested in a variety of preclinical studies and has demonstrated therapeutic potential in various cellular and animal models of cancer, including animal models of lung and head and neck cancer. In animal studies, Proxinium™ has been shown to induce significant tumor regression for many well established tumors, and has even generated complete tumour responses in several animals.

“Proxinium™ has been designated an Orphan Drug for the treatment of advanced head and neck cancer in the United States and the European Union. An Orphan Drug Designation is reserved for new therapies being developed to treat life-threatening or very serious diseases that affect a small percentage of the population. Proxinium™ has not been approved by the Food and Drug Administration (FDA) or other country health authorities. Currently, two Phase I clinical trials have been completed with Proxinium™. A North American Phase II study and a Global Phase II/III study are now underway to further evaluate the safety and efficacy of Proxinium™.”

 
Orphan Drug Designation
In the United States the orphan drug designation may be granted by the Food and Drug Administration to a product that treats a rare disease or condition, which “means any disease or condition which (a) affects less than 200,000 persons in the U.S. or (b) affects more than 200,000 persons in the U.S. but for which there is no reasonable expectation that the cost of developing and making available in the U.S. a drug for such disease or condition will be recovered from sales in the U.S. of such drug".

In Europe the orphan drug designation may be granted by the European Medical Agency (EMEA) to a product that treats a disease that affects fewer than five in 10,000 persons. The EMEA represents 25 EU countries, including France, Germany, Italy, Spain and the United Kingdom.