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Experimental Lupus Therapy Shows Promise After Phase I Trial

A new experimental lupus treatment, currently being developed by Argos Therapeutics, has been showing some real promise in its early stage clinical trials. Argos is hopeful that this early success will be enough to attract the interest of a potential pharmaceutical partner.

During the recent European League Against Rheumatism Congress (EULAR) in Berlin, Argos proudly announced the very positive results from the phase I clinical trial for their new lupus treatment (AGS-009).

*Note: If you live near Birmingham Alabama and have been diagnosed with Lupus, you may want to check out Achieve’s Lupus Clinical Trial which is currently enrolling new patients.

From the get-go, Argos has been very forward about their desire to form a partnership in order to further develop AGS-009. Argos is a smaller immunotherapy company based in Durham, North Carolina. They will need the financial support of a bigger pharmaceutical partner in order to see this lupus project through to its end. Unfortunately, most of Argos’ resources are already being directed to their current lead candidate, an experimental treatment for kidney cancer (AGS-003). In April, Argos was able to raise $25 million for their phase III immunotherapy study on kidney cancer.

Initially, Argos had planned on using an initial public stock offering, which had been filed during the last year, to support its continued drug development pipeline. It had been estimated that this IPO could have raised $65 million for the company, but they decided to scrap these plans in March due to uneasy market conditions. However, these proceeds would have been used to fund continued research on AGS-003 in renal cell carcinoma (kidney cancer).

According to the Lupus Foundation of America, an estimated 1.5 million Americans are affected by lupus. This is an autoimmune disorder characterized by inflammation in the patient’s joints, skin, and even the organs. Currently, there is no cure for this disease, and there is an apparent lack of available treatments for patients. Last year, the pharmaceutical company, GlaxoSmithKline, made headlines when its new drug, Benlysta, became the first lupus treatment to be approved in over 50 years! However, Argos has made note of Benlysta’s limitations in its recent securities filings. Apparently, Benlysta does not work for African American patients.

Argos researchers first stumbled upon AGS-009 when performing dendritic cell research. They received a $1 million grant from the Alliance for Lupus Research in 2005 in order to develop a monoclonal antibody-based lupus therapy. In fact, AGS-009 is a monoclonal antibody which can bind to and neutralize interferon alpha (a protein which causes inflammation). Dendritic cells are responsible for producing and activating interferon alpha. During the phase I study, the patients who were given AGS-009 actually adjusted back to normal levels of interferon alpha after just one dose. The patients who were given a placebo did not show a similar change in interferon alpha levels.

These phase 1 results are very positive, but they still may not be enough to land that coveted deal with one of the larger pharmaceutical companies. Most of the bigger pharmaceutical companies will hold off on any partnership deals until after a new drug candidate has advanced to a later stage in its clinical development. This way, they don’t have to take on much risk. However, Argos is willing to commence additional clinical studies on AGS-009 even if they have not found a partner. The CEO of Argos, Jeff Abbey, has publicly stated that they are currently engaged in active partnering discussions over AGS-009, and the company is preparing additional trials in order to advance their new lupus candidate.

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