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Merix Bioscience Launches Trial for New Kidney Cancer Vaccine
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
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
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.
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
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