Argos Therapeutics' gets FDA nod for its renal cancer drug

The approval of the Argos Therapeutics' renewed Special Protocol Assessment (SPA) with respect to the phase III clinical trial study by the FDA regulatory body has paved the way for use of the drug AGS-003 in establishing successful clinical results
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sydney, Australia ( August 1, 2012 - 1 August 2012, Australia ( The updated Special Protocol Assessment (SPA) of the Argos Therapeutics' pertaining to its Phase III evaluative study of its metastatic renal cell carcinoma therapeutic drug that has been code named AGS-003 has got a green signal from the FDA (Food and Drug Administration) regulatory agency.
The clinical study with the objective of attaining an overall survival rate of this potential kidney cancer medication is expected to initiate the dosing options in the cancer patients mostly in the second half of the year.
Due to the specificity and potency of the drug to the tumor, the treatment approach has verified the lack of toxicity. The current immune therapy relies on the mutated tumor antigens, which are believed to quirk up the progression of the tumor health complications.
It is not known by many individuals that nearly 70% of renal cancers posses the potential to undergo metastases to the lungs, bones, liver, brain, lymph nodes, etc.

The vice president of the R&D department and chief scientific officer of Argos Therapeutics', Charles Nicolette has claimed that the patient's immune system acknowledges the mutated tumor antigens as foreign, thereby allowing the drug AGS-003 to execute a specific and potent immune response against the target cells and hence hinder the tumor progression.
Whereas, Jeff Abbey, CEO of Argos Therapeutics said that the approval of their revised SPA by the FDA is a momentous achievement and a significant forward stride to sustain their clinical implication of their AGS-003 medication for the therapeutic approach in patients who are recently diagnosed with metastatic renal cell carcinoma.
The company claimed that depending on the long term survival phase II clinical trial study of the combination drug that included AGS-003 and sunitinib, it has changed its phase III so as to spotlight on the primary endpoint of the drug combination with that of the drug sunitinib alone in enhancing the overall survival rate in patients.
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Tag Words: renal cancer
Categories: Health

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