AGS-004 (Argos): candidato vaccino terapeutico

Notizie scientifiche e mediche riguardanti il virus, l'infezione e la malattia da HIV. Farmaci, vaccini e cure in sperimentazione.
Dora
Messaggi: 7493
Iscritto il: martedì 7 luglio 2009, 10:48

Re: AGS-004 (Argos): candidato vaccino terapeutico

Messaggio da Dora » martedì 15 ottobre 2013, 7:07

Dora ha scritto:Da “TOWARDS AN HIV CURE”: IAS 2013 SYMPOSIUM (JUNE 2013) l'annuncio di Argos del suo (assai pomposo) *programma di eradicazione dell'HIV*: il vaccino terapeutico AGS-004, ora in fase II, per distruggere le cellule contenenti virus riattivato con qualche strategia antilatenza tipo HDACi (c'è lo zampino - o anche qualcosa di più - di Margolis).


Comunicato stampa: Argos Therapeutics Announces Plans for HIV Eradication Study.
CTN 256 - Phase IIB study of efficacy and safety of AGS-004

Il trial clinico canadese è pronto a partire e sta reclutando partecipanti (a Montreal e a Ottawa).
Si tratta di uno studio randomizzato, in doppio cieco, di fase IIb per testare efficacia e sicurezza dell'AGS-004 nel controllare la replicazione dell'HIV durante un'interruzione analitica della terapia antiretrovirale.
Questo studio si basa sui dati clinici raccolti in altri due trial: CTN 229 e CTN 239.

Obiettivo dello studio è scoprire
  • - se è sicuro fare a persone con HIV diverse iniezioni di questa immunoterapia sperimentale costruita sulla base delle cellule dendritiche e dell'HIV del singolo paziente;
    - se questa immunoterapia aumenta la risposta immune all'HIV;
    - se quando si sospende la ART questa immunoterapia è in grado di controllare la replicazione del virus.
Dal momento che di uso di HDACi per risvegliare il virus dalla latenza non si fa cenno, immagino che questo trial sia propedeutico al *programma di eradicazione dell'HIV* pomposamente annunciato quest'estate. Con calma, eh?



Dora
Messaggi: 7493
Iscritto il: martedì 7 luglio 2009, 10:48

Re: AGS-004 (Argos): candidato vaccino terapeutico

Messaggio da Dora » mercoledì 5 marzo 2014, 12:58

Non so se, né quando avrò tempo di approfondire la relazione che Argos ha portato al CROI per l'AGS-004, quindi questo comunicato stampa per adesso vale come reminder:


Argos Therapeutics Presents New Data From Clinical Research for AGS-004 Patient-Specific Immunotherapy in Treatment of HIV

Clinical Results Showing Induction of Memory T Cell Responses in Acute and Chronic HIV Infected Patients Presented at Conference on Retroviruses and Opportunistic Infections (CROI) Meeting in Boston

DURHAM, Mar 04, 2014 (GLOBE NEWSWIRE via COMTEX)

Argos Therapeutics Inc., a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis(TM) technology platform, today presented data from clinical studies of AGS-004, the company's patient-specific immunotherapy currently in development for the treatment of HIV infection. Results were presented in two poster presentations at the Conference on Retroviruses and Opportunistic Infections (CROI) meeting in Boston.

The first poster, entitled Immune Function and Viral Load Post-AGS-004 Administration to Chronic HIV Subjects Undergoing STI, presents new findings from a Phase 2a clinical trial to assess safety and efficacy of AGS-004 during a 12-week antiretroviral therapy (ART) structured treatment interruption (STI) in chronic HIV-1 infected patients. The goal of intervention was to induce long-term immunity against each patient's unique viral variants and determine the impact on viral load control after stopping ART drug therapy. Results showed that AGS-004 induced anti-HIV T memory stem cell-like immune responses (TSCM) that were associated with a longer time to viral rebound after ART treatment interruption. In addition, the longer time to viral rebound was also associated with lower expression of the checkpoint inhibitor PD-1 on activated CD8+ T cells.

"This is the first demonstration that AGS-004 can induce anti-viral TSCM-like immune responses in chronic HIV patients and that these responses are associated with viral load control in the absence of ART drugs. Establishing long-lasting immune memory is a critical component of durable viral load control and bodes well for our planned eradication and functional cure studies," said Charles Nicolette, PhD, chief scientific officer and vice president of research and development for Argos Therapeutics.

The second poster, entitled Immunogenicity of AGS-004 Dendritic Cell Therapy in Patients Treated During Acute HIV Infection, highlights results from an open-label, single arm study where treatment with AGS-004 was administered to patients who initiated ART within 45 days of primary HIV infection. The study was led by David Margolis, MD, Joseph Eron, MD, Nancie Archin, PhD, and Cynthia Gay, MD, faculty at the University of North Carolina School of Medicine, and Charles B. Hicks, MD, professor of medicine at Duke University Medical Center. Results showed that new anti-HIV memory T cell immune responses were induced in all six patients treated. One patient was able to maintain sufficient viral control while off ART drugs for approximately five months and another patient continues ART treatment interruption after nearly nine months. Additionally, three of six patients had decreases in circulating CD4+ T cells containing HIV DNA of 25%, 47% and 63%, respectively, when measured after three doses of AGS-004 while on ART.

"This study demonstrates that AGS-004 can induce anti-viral memory T cell responses in acute patients and may result in depletion of persistent HIV infection in ART-suppressed patients in combination with anti-latency therapy," said Dr. Margolis.

The Argos AGS-004 clinical research program is supported by funding from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. N01-AI-60019. (...)



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