Argos Therapeutics
May 13, 2015
Add to Briefcase

Argos Therapeutics Provides Update on Enrollment Progress for Ongoing Pivotal Phase 3 ADAPT Clinical Trial

Update to be Presented in Poster Session at American Society of Clinical Oncology Annual Meeting, Positions Trial for Full Enrollment by End of June 2015

DURHAM, N.C., May 13, 2015 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, today announced that more than 1,000 tumor samples have been collected and approximately 400 eligible patients have been randomized to the company's ongoing, pivotal phase 3 ADAPT clinical trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC).

"We have observed a significant level of interest in this trial evaluating AGS-003, a fully customized and well-tolerated immunotherapy, in combination with standard surgery and targeted therapy for patients who present with newly diagnosed, metastatic kidney cancer," said ADAPT trial principal investigator Dr. Robert Figlin, the Steven Spielberg Family chair in hematology oncology and professor of medicine and biomedical sciences at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute. "With the strong multidisciplinary collaboration between urologists and oncologists across our study base, we are excited to be completing enrollment to this important trial in the coming weeks."

Argos is developing AGS-003, which is a fully personalized immunotherapy designed to induce a durable memory T-cell response specific to each patient's cancer. It is produced using a small sample from a patient's own tumor and dendritic cells derived from a leukapheresis procedure. For most patients, multiple years of treatment can be produced using this tumor sample and just one leukapheresis procedure, based upon the advanced Arcelis® technology platform.

The ADAPT trial is designed to enroll approximately 450 patients. To qualify, patients must be good candidates for standard surgery and targeted drug therapy. Thus far more than 50 percent of patients who have consented for tumor collection and been screened for the treatment phase of the trial have been ineligible for treatment because of non-clear cell histology, ineligibility for targeted drug therapy, poor performance status, poor prognosis after surgery, a lack of evaluable metastatic disease, and other factors. The company expects to conclude the enrollment phase of the ADAPT trial by the end of June 2015.

Dr. Figlin will present ADAPT trial insights at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting at McCormick Place in Chicago during the Genitourinary (Nonprostate) Cancer poster session on Monday, June 1st from 1:15-4:45pm CT. The poster is titled, "Patient identification and eligibility insights in the synchronous metastatic RCC population: An update from the ongoing ADAPT phase 3 study experience" (abstract TPS4582).

"We continue to be pleased and highly encouraged by the tremendous interest in the largest global trial ever performed in the newly diagnosed, unfavorable risk mRCC patient population," said Jeff Abbey, president and CEO of Argos. "Even with surgery and approved targeted therapies, these mRCC patients are only expected to survive an average of 15 months after diagnosis. We look forward to the readout from this trial by the second half of 2016, when we hope to confirm the encouraging survival results we observed in our phase 2 trial involving AGS-003 combined with sunitinib."

About the Arcelis® Technology Platform

Arcelis® is a fully personalized 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 collected and optimized following 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, 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 and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if product candidates obtain approval, they will be successfully distributed and marketed; and other factors discussed in the "Risk Factors" section of Argos' Annual Report on Form 10-K for the year ended December 31, 2014 which is on file with the SEC. In addition, the forward-looking statements included in this press release represent Argos' views as of May 13, 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 May 13, 2015.

CONTACT: Media contact:
         Adam Daley
         Berry & Company Public Relations
         [email protected]
         Investor contact:
         Nancy Yu
         Burns McClellan
         [email protected]

Argos Therapeutics, Inc. logo

Source: Argos Therapeutics, Inc.

News Provided by Acquire Media