A New Horizon: Cancer-Killing Nanomedicine

Doesn’t this sound wonderful? What an exciting new future on our horizon. But wait…that horizon just became the present. Targeted drug delivery to specific cells has been accomplished in clinical trials. What? These drugs are being used on the public?

Before a drug is placed on the market a drug company must prove that it is safe and is effective for its intended purpose. First the drug must be tested on cells or tissue in the lab collected from many different types of mammals. These tissue “samples” may be obtained from living or dead tissue of animal or human origin. After exhaustive preclinical testing, the drugs enter Phase I testing. This first clinical phase for these investigative new drugs or IND’s are performed on small numbers of either healthy volunteers or extremely ill patients. This purpose of this level of testing is to determine the correct therapeutic dosage of a drug. After lengthy human testing in Phase I the drug will enter a Phase II test where it will be used on patients who have the disease that the drug was designed to treat. Altogether a drug must pass three clinical phases before the FDA gets a new drug application submitted by the manufacturer. The FDA carefully reviews all of the data and then makes its determination if the drug company can go to market.

Currently in clinical trials is one of the first nanoparticle delivery gene therapies designed to seek out the cancer lesion in subjects with Stage IV cancer. The delivery system is designed to seek out metastatic tumors and then cross the cell membrane layer of the lesion and destroy the tumors. Whoa!!! What can this target system be composed of?  The layman’s answer would be a “mystery wrapped in an enigma”. The understandable, scientific version is an adaptive molecular engineering of von Willebrand (blood coagulation) factor combined with enough stealthy external cloaking to keep our own cells from attacking the outer surface membrane that is formed into rigid capsules coupled with enzymes (Gordon, E., Chan, M., Geraldino, N., Lopez, F., Cornelio, G., Lorenzo III, C., Levy, J., Reed, R., Liu, L., Hall, F.). The drug, Rexin-G, has already been used extensively in the Republic of the Philippines and has been approved there for the treatment of all solid tumors. Currently the drug is in Phase II confirmatory trials in the US for soft tissue sarcoma, advanced pancreatic cancer, osteosarcoma, and metastatic breast cancer. The drug has been granted orphan drug status by the USDA in recognition of its limited application (Epeius Biotech). This status is granted for drugs that will have a smaller market because of a reduced number of patients that can be served by the drug. Tax incentives and exclusive rights to market the drug for seven years are granted to a drug company after final approval under this program. Rexin-G has shown favorable results for treating both soft tissue and chemotherapy resistant metastatic bone sarcomas. It is followed by a companion drug, using the same delivery technique.The payload of this companion drug, Reximmune-C, consists of a cytokine that attract macrophages, B-cells, T-cells, and NK cells to the area (Epeius Biotech). The drug has a self-programmed  suicide time to destroy itself to prevent overstimulation of the body’s immune system. The video link that I am posting next is a must watch event. The video discusses the drug, its action and effects, and the quality of this video is excellent!!

Epeius Biotech Oncology Video

References

Gordon, E., Chan, M., Geraldino, N., Lopez, F., Cornelio, G., Lorenzo III, C., Levy, J.,

     Reed, R., Liu, L., Hall, F., (2007). Le morte du tumour: Histological features of

     tumor destruction in chemo-resistant cancers following intravenous infusions of

     pathotropic nanoparticles bearing therapeutic genes, Inernational Journal of

     Oncology 30: 1297-1307.

Reximmune-C Fact Sheet, retreived October 12, 2009, from

     http://www.epeiusbiotech.com/oncology-Reximmune-factsheet.asp

Rexin-G Fact Sheet, retreived October 12, 2009, from 

     http://www.epeiusbiotech.com/oncology-RexinG-factsheet.asp