Study Results Demonstrate Analytical Treatment Interruption to Assess Antiviral Activity of Argosīs ArcelisT Personalized Immunotherapy for Treatment of HIV Patients, AGS-004, Is Acceptable Strategy for At Least 16 Weeks
Study Results Published in Journal of Medical Virology
Durham, NC- May 3, 2012 - Argos Therapeutics Inc. today announced that study results demonstrated that analytical treatment interruption to
assess the antiviral activity of Argosīs ArcelisT personalized immunotherapy for the treatment of HIV patients, AGS-004, is an acceptable
strategy for at least 16 weeks. Study results were published in the Journal of Medical Virology (84:885-889, 2012).
"Establishing the safety of analytical treatment interruptions of at least 16 weeks is an important step forward in assessing
the impact of immunotherapy on viral load control," said Charles Nicolette, Ph.D., chief scientific officer and vice president of research
and development of Argos. "Therapeutic vaccines such as AGS-004 have the potential to decrease long-term antiretroviral therapy which
has limitations such as drug toxicity, the risk of developing resistance and others. We look forward to advancing our Phase 2b
trial of AGS-004 to further demonstrate its efficacy and safety for the treatment of HIV patients."
The potential risks of short-term interruption of antiretroviral therapy in the AGS-004-001 study were assessed in a
retrospective subgroup study analyzing data from patients in the strategies for management of anti-retroviral therapy (SMART) study
with matched eligibility criteria. The subgroup analysis included 440 of 2,720 on the drug conservation (DC) arm and 436 of 2,752
on the viral suppression (VS) arm that matched the AGS-004-001 inclusion criteria and were used in the SMART subgroup analysis.
In the first 16 weeks following randomization into the SMART study there were no deaths in either subgroup. There were two
AIDS-related events in the DC subgroup and one in the VS subgroup, making the overall risk of AIDS related events two per
100 person years (0.005%) and one per 100 person years (0.002%) in the two subgroups, respectively. There were
6/440 subjects (1.4%) in the DC subgroup and 4/436 subjects (0.92%) in the VS subgroup who experienced grade
2 adverse events defined as AIDS-related event, a cardiovascular disease, renal or hepatic event, cancer or death.
About the ArcelisT Technology
Arcelis is Argos´s proprietary technology for personalizing RNA-loaded dendritic cell immunotherapies. This platform is based on
optimizing a patient´s own (autologous) dendritic cells to trigger a tumor- or pathogen-specific immune response. To address
the challenge of the unique genetic profile of each patient´s disease and the genetic mutations of that disease, Argos
loads the autologous dendritic cells with a sample of messenger RNA ("mRNA") isolated from the patient´s disease.
Through this process, dendritic cells can potentially prime immune responses to the entire antigenic repertoire,
resulting in an immunotherapeutic that is fully personalized for each patient´s disease.
About Argos Therapeutics, Inc.
Argos Therapeutics is a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for
the treatment of cancer and infectious diseases based on its ArcelisT technology platform. Using biological components from each patient,
Arcelis-based immunotherapies employ the patientīs dendritic cells to activate an immune response specific to the patientīs disease.
Argosī most advanced product candidates include AGS-003 for the treatment of metastatic renal cell carcinoma, or mRCC, and AGS-004
for the treatment of HIV. www.argostherapeutics.com
Safety and Efficacy Study of AGS-004 During Analytical Treatment Interruption
Source: Argos Therapeutics, Inc.
Contact: Jeff Abbey
"Reproduced with permission - Argos Therapeutics"