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Argos Therapeutics and DC Bio Corp. Announce New Clinical Trial to Begin for Chronic Lymphocytic Leukemia Using Argos´ Personalized Dendritic Cell Vaccine


Durham, NC- November 8, 2005 - Immunotherapy pioneer Argos Therapeutics in conjunction with Toronto-based DC Bio Corp., announced that a clinical trial for chronic lymphocytic leukemia (CLL) is scheduled to begin in Q1 2006 using Argos´s proprietary RNA-loaded dendritic cell vaccine technology. The investigator-sponsored Phase I/II study will be conducted at McMaster University in Hamilton, Ontario, Canada, by Graeme Fraser, M.D., F.R.C.P.C. McMaster University received a $573,000 grant from the Ontario Cancer Research Network (OCRN) to conduct the clinical trial.

“We are looking forward to using the personalized dendritic cell vaccine approach in treating patients with CLL,” said Dr. Fraser. “By using the patient´s own immune system to fight the cancer, we hope to make a fundamental difference in patient care. For CLL, we will be able to monitor progress easily through blood tests and anticipate clinical data in 2006.”

According to Lothar Finke, M.D., chief medical officer and vice president of regulatory affairs for Argos, this is the first vaccine of its kind for a hemotologic cancer. “The CLL trial will apply the same technology and process being used in other Argos RNA-loaded dendritic cell vaccine clinical trials. Later this month, we plan to release results from our Phase I/II corporate-sponsored clinical trial for renal (kidney) cell cancer,” Finke said.

The Argos approach differs fundamentally from other cancer vaccines in that it targets tumor antigens unique to each patient, circumventing the difficult challenge of needing to be able to know the identity of — and characterize — each of those antigens. This technology is applicable to all types of cancer and allows expansion into new indications without reinventing the manufacturing process each time.

According to the American and Canadian Cancer Societies, CLL is one of the most common forms of leukemia. CLL occurs in lymphocytes, a type of white blood cell that normally produces antibodies and serves important immune functions. It is estimated that approximately 9,730 patients in the United States will be diagnosed with CLL this year, and about 4,600 people will die of CLL during 2005. The most recent statistics for CLL in Canada are from 2000-2001 with 1,320 new cases reported, and approximately 509 deaths from CLL.

Argos Therapeutics´ Joint Licensing Agreement with DC Bio Corp.
Earlier this year, Argos Therapeutics entered into a joint licensing agreement with DC Bio Corp., a privately-held biotechnology company, to further advance the use of Argos Therapeutics´ RNA-loaded dendritic cell technology. This technology is focused on developing personalized vaccines for oncology, HIV, and other anti-viral programs.

“Our alliance with DC Bio leverages our shared industry knowledge and technical expertise, and accelerates the speed at which we pursue the development of superior, personalized immunotherapy treatments for patients suffering from diseases such as renal cell carcinoma (RCC), chronic lymphocytic leukemia (CLL), and human immunodeficiency virus (HIV),” said Jeff Abbey, vice president of business development for Argos Therapeutics.

Under the agreement, Argos granted rights to DC Bio to use its technology platform for select disease indications in Canada. Additionally, Argos received an ownership interest in DC Bio Corp., as well as rights to DC Bio inventions outside of Canada and other considerations, including royalties on sales of products by DC Bio in Canada.

“Personalized immunotherapy is one of the most promising medical approaches being developed and Argos´ expertise in dendritic cell biology has led to the development of novel treatments for a variety of immune-related diseases,” said Brian Underdown, president of DC Bio Corp. “We are pleased with the opportunity to further develop these personalized treatments and provide new hope for individuals suffering from cancer and viral diseases. Our efforts will further Argos´ technology through research conducted at major academic centers in Canada, including University of Montreal, McMaster University in Hamilton, Ontario, Princess Margaret Hospital in Toronto, Ontario, and Jewish General Hospital in Montreal, Quebec.”

Argos Therapeutics
Argos Therapeutics, Inc., is dedicated to becoming a market leader in the field of immunotherapy. By using proprietary technology, proven therapeutic methods, and expertise in dendritic cell biology, Argos is developing the next generation of therapies in the areas of oncology, infectious diseases, autoimmune disorders and transplantation. Argos´ focus is bringing to market therapeutic options that not only offer new promise for treatment of intractable diseases, but also an improved safety profile and better patient quality of life during treatment. Please visit Argos at www.argostherapeutics.com

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