"These studies validate the unmatched capabilities of the INACTINE TM pathogen reduction system for red cells in reducing infectious disease risks of blood transfusions, as well as building upon the product's safety profile," said John R. Barr, CEO of Vitex. "Ongoing research and development of the INACTINE TM pathogen reduction system demonstrates Vitex's commitment to enhancing the safety and availability of the world's blood supply."
In the first study, titled "The INACTINE TM PEN110 Chemistry Eradicates the Parasites that Cause Chagas' Disease, Malaria, and Babesiosis," the causative parasites Trypanasoma cruzi, Plasmodium falciparum, and Babesia microti, respectively, were evaluated for inactivation using standard INACTINE TM PEN110 red blood cell process conditions. The results showed that the INACTINE TM PEN110 treatment of the red blood cells infected with the parasites led to complete parasite eradication.
In the second presentation, titled "Clinical Studies of Red Blood Cells after Treatment with the INACTINE TM Pathogen Inactivation Process," results of Phase I and Phase II clinical studies were presented. Results from these studies established the clinical process parameters for INACTINE TM PEN110 treatment of red blood cells including a 42-day storage period, corresponding to currently FDA licensed red blood cells. These INACTINE TM PEN110 process conditions will be used in the company's pivotal Phase III clinical program, which recently received concurrence from the FDA.
About Vitex
Vitex is developing products designed to improve the safety of the world's blood supply. The Company's revolutionary INACTINE TM technology is designed to inactivate a wide range of viruses, bacteria and parasites, and remove blood contaminants including prion and plasma proteins, while preserving the therapeutic properties of red blood cells. The technology works by binding to the RNA or DNA of the pathogen. Once bound, the compound forms an irreversible bond to the pathogenic nucleic acid, preventing replication and thereby "killing" the pathogens. The Company's lead product is INACTINE TM Pathogen Reduction of red blood cells. The Company continues to report on its rapid progress in demonstrating the system's ability to meet the three critical requirements for commercial success with a pathogen reduction system: broad pathogen kill, a wide safety margin for the patient, and maintenance of the therapeutic properties of the red blood cell. Over 40 million red cell units are transfused annually in the US, Europe and Japan, representing an over $4 billion market opportunity. The Company currently has partnerships with Pall Corporation, Haemonetics Corporation, and Amersham Pharmacia Biotech. In collaboration with Oxford University, Vitex is developing a diagnostic test for pathogenic prions using aptamer technology. In their pathogenic form, prions cause "Mad Cow Disease" in cows, or variant Creutzfeldt-Jakob Disease in humans, which is 100% fatal and for which no therapy or diagnostic currently exists. For more information on Vitex, please visit our Web site at: www.vitechnologies.com .
Except for the historical information contained herein, the matters discussed are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, such as quarterly fluctuations in operating results, anticipated clinical trial timelines or results, the timely availability of new products, market acceptance of the company's products, the impacts of competitive products and pricing, government regulation of the company's products and other risks and uncertainties set forth in the company's filings with the Securities and Exchange Commission. These risks and uncertainties could cause actual results to differ materially from any forward-looking statements made herein.