Durham, N.C. – June 8, 2004 – Durham-based Merix Bioscience, a company pioneering therapeutic cancer vaccines, announced its first corporate-sponsored clinical trial, a trial with potential significant impact on the future treatment of kidney (renal) cancer. The trial for an RNA-loaded autologous dendritic cell vaccine is now in Phase I/II study at five clinical sites in the United States and Canada.

“We have developed a cancer vaccine that harnesses the ability of an individual’s immune system to fight disease,” said Clint G. (Skip) Dederick, Jr., chairman, president and CEO of Merix. “We strongly believe that by utilizing an individual patient’s tumor antigens to create a personalized vaccine, we can induce the broadest possible immune response and maximize the anti-tumor responses.”

The Merix trial focuses on patients newly diagnosed with metastatic renal cell cancer. Dr. Fred Miesowicz, acting head of clinical development at Merix, explained that because the vaccine is composed of dendritic cells taken from the patient’s body and infused with amplified RNA from the patient’s tumor, the RNA-loaded dendritic cell vaccine is personalized for each patient’s specific cancer and primes the patient’s immune system to recognize and fight the cancer utilizing the full arsenal of tumor-specific targets.

Additionally, Miesowicz says the study will address feasibility issues: “Another study objective includes demonstrating the safety and commercial feasibility of processing dendritic cells at a central manufacturing facility with delivery of the vaccine to multiple clinical sites.”

Given the predominance of cancer in the United States, trial investigators are excited by the potential ramifications of such a vaccine’s development.

“Next to heart disease, cancer is the leading cause of death in the United States,” said Michael Wong, M.D., Ph.D., FRCPC, medical director of clinical drug development at Roswell Park Cancer Institute in Buffalo, NY, one of the trial sites and one of the nation’s leading cancer treatment centers. “For the more than 30,000 people diagnosed with renal cancer each year, the goal of clinical trials, such as this one, is to make available more effective and more tolerable treatment options.” 

So far, based on encouraging early-stage clinical studies performed at Duke University, investigators for the trial have positive expectations and anticipate the availability of initial results early next year.

Jennifer Knox, M.D., principle investigator and oncologist at Princess Margaret Hospital at the University of Toronto, Canada, is currently treating a patient with the Merix vaccine. “The patient will be treated until progression,” said Knox. “We’re excited about the potential ability to use the body’s immune system to combat kidney cancer tumors. Our first patient is tolerating the vaccination injections well.”

World-renowned expert Ralph Steinman, M.D., professor at The Rockefeller University, maintains that dendritic cells serve as the ‘eyes and ears’ of the body’s immune system and by learning to control the power of the cells, you can increase the ability to treat disease. Steinman, who discovered the dendritic cell in 1973, equates the dendritic cell as the link between the outside world and the body’s protectorate.

“Dendritic cells amplify potential therapeutic strategies as they deal with harmful agents and orchestrate the body’s immune responses. Without the dendritic cell, the immune system is a powerful machine but without controls. Our growing knowledge of this cell has greatly enhanced the capacity to develop immune-based therapies,” Steinman said.

Merix Bioscience, Inc. – a privately held company headquartered in Durham, North Carolina, and with additional operations in Erlangen, Germany – is dedicated to becoming a market leader in the field of immunotherapy.  Utilizing proprietary technology and proven therapeutic methods and expertise in dendritic cell biology, Merix is developing the next generation of therapies in the areas of oncology, infectious diseases, autoimmune disorders and transplantation. Merix’s initial total tumor RNA-loaded dendritic cell vaccine is currently in a corporate Phase I/II clinical trial for patients with metastatic renal cell carcinoma.

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This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Merix's technology constitute forward-looking statements involving risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, reliance on collaborators, need for additional capital, need for regulatory approvals or clearances, and the maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements.

Editor Contact:
Merix Bioscience, Inc.
Bradd Pavur, APR (Gibbs & Soell, Inc.)
Tel: 919-870-5718
bpavur@gibbs-soell.com

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