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Argos Therapeutics Announces Trial of Personalized Melanoma Vaccine

2005-04-12 - Erlangen, Germany: Immunotherapy specialist Argos Therapeutics has announced the start of a clinical trial using a novel personalized melanoma vaccine based on the company's proprietary technology. The product is made from the patient's own tumor RNA and immune cells and is the first of its kind to be developed for melanoma.

Argos, previously called Merix Bioscience prior to late 2004, traces its roots to Duke University, where company founders developed a unique RNA-based vaccine technology.

This investigator-sponsored trial marks an expansion by the company into a second form of cancer. Studies will test Argos' RNAloaded autologous dendritic cell vaccine among patients with Stage IV melanoma. Argos is headquartered in Durham, North Carolina, USA, but the trial will be conducted at the University Hospital of Erlangen in Erlangen, Germany. A subisdiary of Argos is based in

"Our expertise in dendritic cell biology is enabling the development of new therapies to treat cancer, infectious diseases, autoimmune disorders, and transplantation rejection. Our personalized vaccines have the ability to trigger an individual's immune system to fight the invading disease," said Clint G. Dederick, chairman and CEO of Argos Therapeutics. "The melanoma trial extends Argos' vaccine technology to treat yet another type of cancer. Our goal as a company is to make more effective and tolerable treatment options available to patients."

Argos' RNA-loaded dendritic cell vaccine is currently in a Phase I/II corporate-sponsored clinical trial for renal (kidney) cell cancer at five sites across the United States and Canada. According to Lothar Finke, M.D., chief medical officer and vice president, regulatory affairs for Argos, the company is applying the same technology and process to the melanoma trial.

"By using all of the patient's tumor antigens to create a personalized therapeutic treatment, we are able to harness the ability of that patient's immune system to fight the disease," said Dr. Finke. "This approach differs fundamentally from other cancer vaccines in that it targets tumor antigens unique to each patient, bypassing the requirement to know the identity of and characterize those antigens. This technology is applicable to all types of cancer and allows expansion into new indications without reinventing the manufacturing process each time."

To create the personalized vaccine, Argos scientists' pair dendritic cells from the patient's body with RNA amplified from the patient's tumor, thereby making it specific to each person's cancer. The vaccine is then put back into the patient's body and stimulates the immune system to recognize and fight the cancer - in this case - melanoma. With this approach, a large number of vaccine doses can be prepared from a single manufacturing run and only a small tumor specimen is required.

"World-wide prevalence of melanoma continues to rise, and new late-stage melanoma treatment options are scarce," said Gerold Schuler, M.D., principle investigator and Professor of Dermatology and Chairman of the Department of Dermatology, University Hospital of Erlangen. "We look forward to making progress with this personalized vaccine treatment because there have not been significant advances in medical therapies - or survival - for patients with advanced melanoma in over three decades."

Cutaneous malignant melanoma, a tumor of the pigment producing cells, is considered to be one of the most aggressive solid tumors. There is no evidence to date that any available treatment improves survival of melanoma patients with distant metastases. Malignant melanoma shows the highest growth rate of all malignant tumors. During the last 40 years, incidence has doubled every 10 to 15 years. According to the American Cancer Society, over 59,500 new cases will be reported in 2005 in the United States, and approximately 7,770 persons are expected to die from melanoma. In Europe, melanoma is the 17th most commonly diagnosed cancer in males and eighth most common in females. In the year 2000, approximately 26,100 males and 33,300 females were diagnosed with melanomas in Europe, and around 8,300 males and 7,600 females died of cutaneous malignant melanoma in Europe.

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