for Immediate Release
Contact: Claire R. Wynters, Public Relations
(Saratoga Springs, New York- August 7, 2007) Criterium, Inc. announces that it has been selected over competing vendors by Ichor Medical Systems to participate in a Phase Ia/Ib clinical trial that will involve a novel delivery technology and a proprietary melanoma vaccine. Criterium, Inc. will provide monitoring and data management services for the study, which will take place at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City.
The vaccine, which was developed by Memorial Sloan-Kettering Cancer Center scientists, consists of DNA encoding a form of the tyrosinase protein. This protein is found broadly in melanoma cells and is a promising target for immunotherapy. The vaccine will be administered with the Ichor TriGrid™ Delivery System (TriGrid), which uses electroporation to increase the intracellular delivery of the DNA vaccine to the cells at the site of administration. By “teaching” the body’s own immune or disease-fighting system to target melanoma cells which contain the tyrosinase protein, the vaccine has the potential to alter the course of the disease.
The TriGrid, a small hand-held device used to apply the entire administration procedure, is the first fully automated one-step method for electroporation based DNA delivery. MSKCC has started enrolling patients with stage IIB to IV malignant melanoma for the two-year period of this trial.
According to Ichor Vice President of R&D Drew Hannaman, “We evaluated a number of different contractors for our study. Criterium was selected because we were impressed with the way they approached the study and the team they had in place to execute the project. Cost effectiveness and the ability to meet our project timelines were also key considerations in our evaluation.”
“We are extremely enthusiastic about our participation in this study,” commented Brooke C. Shannon, Project Manager for Criterium, Inc. “there certainly is tremendous potential to positively affect patient outcomes with a combination of progressive delivery technology from Ichor and a compound developed from the facility at MSKCC. This study also shows how Criterium’s processes are flexible to meet the requirements of any trial. Our StudyControl™ system is programmed to seamlessly accept and clean the data from the electronic medical records at MSKCC as the data are received, insuring a timely flow of information.”
Ichor Medical Systems, a privately-held biotech company based in San Diego, CA, has developed the first and only integrated and fully automated system for electroporation- mediated DNA administration. The TriGrid™ Delivery System enables safe, effective, and reproducible clinical application of electroporation in a manner capable of supporting development and commercialization of DNA-based products. Ichor is developing a number of these DNA-based products as well as collaborating with partners on three continents in a wide range of pre-clinical and clinical studies exploring the potential treatment of diseases such as Cancer, Viral Hepatitis, Multiple Sclerosis, Diabetes, and Cardiovascular disease. The technology is also being used to develop vaccines for the prevention / treatment of HIV/AIDS, influenza, hospital acquired infections, and a number of infectious agents that are considered to be high priorities for biodefense.
Ichor’s current research partners include Aaron Diamond AIDS Research Center, Bayhill Therapeutics, Genexine, the Johns Hopkins Bloomberg School of Public Health, the Pasteur Institute, Pharmexa- Epimmune, Rockefeller University, The Scripps Research Institute, U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), and the Vaccine and Infectious Disease Organization (VIDO). For further information, visit www.ichorms.com.