Ichor Melanoma Vaccine Clinical Trial Moves To Highest Dose Level

Main Category: Immune System / Vaccines
Also Included In: Clinical Trials / Drug Trials;  Cancer / Oncology
Article Date: 06 Mar 2008 - 2:00 PDT

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Ichor Medical Systems, whose advanced TriGrid electroporation system is being tested worldwide for its ability to enhance delivery of DNA drugs and vaccines, announced that recruitment of patients has commenced for the final and highest dose level for their Phase I melanoma vaccine clinical trial in the study being conducted by Memorial Sloan-Kettering Cancer Center.

The vaccine, which was developed by Memorial Sloan-Kettering Cancer Center scientists, consists of DNA encoding a form of the tyrosinase protein. Tyrosinase is found broadly in melanoma cells and is a promising target for immunotherapy. In the first stage of the trial, the vaccine was delivered five times over the course of 15 weeks to six subjects, three each at the low and medium dose levels, with the Ichor's TriGrid.

In contrast to conventional vaccines, DNA vaccines must be delivered intracellularly to elicit an immune response. Ichor's TriGrid uses electroporation to open pathways into cells, dramatically increasing the intracellular delivery of the DNA vaccine into the cells at the site of administration. Studies have shown that TriGrid electroporation can increase potency over 100 times compared to other methods of delivery. Delivering adequate vaccine into cells has been a central challenge to producing an effective DNA vaccine. Electroporation is considered a promising approach for DNA vaccine development.

"We believe that the immune system can be trained to recognize cancer as something that is foreign and dangerous. But delivering enough of the DNA vaccine into cells so that the encoded antigen can be produced in sufficient amounts to cause an immune response has been a significant challenge," said the study's principal investigator Dr. Jedd Wolchok, a medical oncologist specializing in the treatment of melanoma at Memorial Sloan-Kettering.

"We are delighted to be collaborating with Memorial Sloan-Kettering's prestigious team," said Bob Bernard, CEO of Ichor. "DNA-based vaccines hold tremendous promise to treat numerous serious diseases. We are hopeful that results of this and other studies now in progress will show the TriGrid to be an enabling platform for the entire field of DNA-based vaccines."

In addition to their partnership with Memorial Sloan-Kettering, Ichor was recently awarded two Department of Defense contracts, together valued at over $3 million, to assist the Naval Medical Research Center and the United States Army Medical Research Institute of Infectious Diseases in the development of infectious disease and biodefense vaccines. In October Ichor began a clinical trial with the Aaron Diamond AIDS Research Center and the International AIDS Vaccine Initiative to test a preventative HIV vaccine, ADVAX, in human volunteers at Rockefeller University.

About Ichor Medical Systems

Ichor Medical Systems' TriGrid™ Delivery System is the first integrated and fully automated system for electroporation-mediated DNA administration. Ichor, a privately-held biotech company based in San Diego, CA, is collaborating with partners on three continents in a wide range of studies to test the TriGrid as an enabling platform for delivery of DNA drugs and vaccines to treat diseases such as avian flu, hepatitis B, HIV, melanoma, multiple sclerosis, and others. The TriGrid is also being tested by the U.S. military as an efficient means of delivering anti-bioterrorism agents.

Ichor's current research partners include Aaron Diamond AIDS Research Center, Bayhill Therapeutics, Genexine, the International AIDS Vaccine Initiative, the Johns Hopkins Bloomberg School of Public Health, Memorial Sloan-Kettering Cancer Center, the Pasteur Institute, Pharmexa-Epimmune, Rockefeller University, The Scripps Research Institute, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the Naval Medical Research Center (NMRC) and the Vaccine and Infectious Disease Organization (VIDO).

Ichor Medical Systems