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