Argos Therapeutics
Dec 10, 2015
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Independent Data Monitoring Committee Recommends Continuation of ADAPT Phase 3 Clinical Trial of AGS-003 for Metastatic Renal Cell Carcinoma Following Second Planned Interim Analysis

Argos Therapeutics to Host Conference Call With Principal Investigator Dr. Robert Figlin on Thursday, December 10, 2015 at 5:00pm EST

DURHAM, N.C., Dec. 10, 2015 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of fully individualized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, today announced its independent data monitoring committee (IDMC) has recommended the continuation of the company's pivotal phase 3 ADAPT clinical trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC) based on results of the committee's second planned interim data analysis.

"The ADAPT phase 3 trial to evaluate AGS-003 in front line mRCC, the largest global trial ever performed in newly diagnosed, unfavorable risk mRCC patients, continues to progress nicely," said Dr. Figlin, the Steven Spielberg Family chair in hematology oncology, professor of medicine and biomedical sciences at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute and the principal investigator for the ADAPT trial. "We anticipate that we are approaching the mid-point for the expected number of events and look forward to the next interim review of the trial data in approximately six months."

AGS-003 is a fully individualized immunotherapy that captures mutated and variant antigens that are specific to each patient's tumor and is designed to induce an immune response targeting that patient's tumor antigens. In an open-label phase 2 study, treatment with AGS-003 plus sunitinib yielded a median overall survival of more than 30 months in newly diagnosed, unfavorable (intermediate and poor) risk mRCC patients. The randomized phase 3 ADAPT trial evaluating AGS-003 plus standard targeted therapy enrolled a total of 462 mRCC patients and has a primary endpoint of overall survival. AGS-003 is Argos' most advanced Arcelis-based product candidate.

"We are excited by the IDMC's recommendation to continue with the trial," said Jeffrey D. Abbey, president and chief executive officer of Argos. "This is an important step for the ADAPT trial and for the clinical development of AGS-003."

Conference Call and Webcast Details

Argos executive management will host a conference call with Dr. Figlin beginning at 5:00pm EST on Thursday, December 10, 2015 to discuss the IDMC recommendation to continue the trial, and to answer questions.

To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 4042406. A live and archived audio webcast can be accessed through the Investors section of the Company's website at The archived webcast will remain available on the Company's website for 12 months following the call.

About the Arcelis® Technology Platform

Arcelis® is a fully individualized immunotherapy technology that captures mutated and variant antigens that are specific to each patient's disease. It is designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. The Arcelis® process uses only a small tumor or blood sample and the patient's own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient's disease sample to program dendritic cells to target disease specific antigens. The activated, antigen-loaded dendritic cells are then formulated into the patient's plasma and administered via intradermal injection.

About Argos Therapeutics

Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer using its Arcelis® technology platform. Argos' most advanced product candidate, AGS-003, is being evaluated in the pivotal ADAPT phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). The Company is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of HIV, which is currently being evaluated in a phase 2 clinical trial aimed at HIV eradication in adult patients. For more information about Argos Therapeutics, visit

Forward Looking Statements

Any statements in this press release about Argos' future expectations, plans and prospects, including statements about Argos and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including whether Argos' cash resources will be sufficient to fund our continuing operations for the period anticipated; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether Argos' product candidates will advance through the clinical trial process on a timely basis; whether the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Argos' product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; and other factors discussed in the "Risk Factors" section of Argos' Form 10-Q for the quarter ended September 30 , 2015, which is on file with the SEC. In addition, the forward-looking statements included in this press release represent Argos' views as of December 10, 2015. Argos anticipates that subsequent events and developments will cause Argos' views to change. However, while Argos may elect to update these forward-looking statements at some point in the future, Argos specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Argos' views as of any date subsequent to December 10, 2015.

CONTACT: Media contacts:
         Adam Daley
         Berry & Company Public Relations
         [email protected]
         Investor Contact:
         John Menditto
         Argos Therapeutics, Inc.
         [email protected]

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Source: Argos Therapeutics, Inc.

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