Enrollment In Argos Therapeutics, Inc.' Pivotal Phase 3 ADAPT Trial Of AGS-003 For Metastatic Renal Cell Carcinoma Surpasses Fifty Percent
DURHAM, N.C., Sept. 18, 2014 (GLOBE NEWSWIRE) -- Argos Therapeutics, Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today announced it has recently surpassed fifty percent of the target enrollment for the company's ongoing pivotal Phase III ADAPT trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC).
"This is an important milestone for the ADAPT trial as we continue to be pleased with the pace of enrollment and the opportunity to advance this promising, fully personalized immunotherapy in newly diagnosed, synchronous metastatic RCC patients," said Robert A. Figlin, MD, FACP, primary investigator for the ADAPT trial. "We remain encouraged by the potential for AGS-003 to represent an important advance for the immunotherapy field as well as the treatment of advanced RCC in the years ahead."
AGS-003 is an investigational, fully personalized immunotherapy for cancer comprised of autologous tumor RNA-loaded dendritic cells. The ADAPT trial is a randomized, international Phase III trial comparing standard targeted therapy plus AGS-003 to standard therapy alone in 450 mRCC patients. In total, more than 225 patients at more than 120 active ADAPT trial sites have been enrolled and randomized in the trial. In addition, more than 600 patients have participated in the initial tumor collection phase of the trial.
In the Company's completed Phase II study, treatment with AGS-003 in combination with sunitinib in unfavorable risk mRCC patients resulted in median progression free survival of 11.2 months and median overall survival of 30.2 months. In recently published findings from the International mRCC Database Consortium, unfavorable risk mRCC patients had an expected median progression free survival of 5.7 months and median overall survival of 14.7 months. For the patients with intermediate risk (1-2 risk factors) mRCC in the Company's Phase II study, treatment with AGS-003 in combination with sunitinib resulted in median overall survival of 57.1 months or nearly 5 years.
Adverse events associated with the use of AGS-003 in the Phase II study were minor with no grade 3 or 4 adverse events and no evidence of autoimmunity.
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 infectious diseases and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized 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 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 a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases 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 second Arcelis-based product candidate, AGS-004, for the treatment of HIV, currently being evaluated in a phase 2 clinical trial in combination with a latency reversing drug for HIV eradication in adult patients. For more information about Argos Therapeutics, visit www.argostherapeutics.com.
Forward Looking Statements
Any statements in this press release about the Company's future expectations, plans and prospects, including statements about the Company 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 the Company's cash resources will be sufficient to fund our continuing operations for the period anticipated; whether the Company will obtain the financing needed to complete the leasing, build-out and equipping of a new commercial manufacturing facility when needed; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether findings regarding treatment with sunitinib from clinical trials conducted by third parties or in independent databases will be predictive of the outcome of our phase 3 clinical trial; whether AGS-003 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 this product candidate obtains approval, it will be successfully distributed and marketed; and other factors discussed in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q which is on file with the SEC. In addition, the forward-looking statements included in this press release represent the Company's views as of September 18, 2014. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to September 18, 2014.
CONTACT: Media contact: Adam Daley Berry & Company Public Relations adaley@berrypr.com 212-253-8881 Investor contact: Angeli Kolhatkar Burns McClellan akolhatkar@burnsmc.com 212-213-0006 