ORVACS Phase II Clinical Study Combines Immunomodulatory Intervention and Antiretroviral Intensification to Attack Viral R

Main Hypothesis of this European Study is that Combination of the Most Potent and Synergistic of Antiretroviral Drugs with Immunomodulating Agent May Result in a Decrease in HIV Reservoirs and Provide a Means for the Ultimate Eradication of the Virus

PARIS--(BUSINESS WIRE)-- ORVACS (Objectif Recherche VACcin Sida) has launched a Phase II study designed to test the hypotheses that combination therapy with potent antiviral agents and immunomodulator can lead to a decrease in the HIV viral reservoirs and, ultimately, to eradication of the virus. The study is currently being conducted at clinical sites in France, Spain, Italy, and the United Kingdom.

Known as ERAMUNE 01, the Phase II clinical trial is scientifically coordinated by Christine Katlama as Principal Investigator, Brigitte Autran, Vincent Calvez and Dominique Costagliola from the University Pierre et Marie Curie and will use Cytheris’ investigative immunomodulatory agent, recombinant human interleukin-7 (CYT107), in combination with two potent antiretroviral drugs represented by the integrase inhibitor, raltegravir (ISENTRESS® - Merck & Co.) and the CCR5 inhibitor, maraviroc (SELZENTRY™ - ViiV Healthcare). The main hypothesis of this study is that by combining the most potent and synergistic antiretroviral drugs, coupled with an immunomodulating agent capable of targeting or inducing activation of latently infected cells, the reservoirs of HIV can be decreased and, in the best case scenario, eradication of the virus may be feasible.

ERAMUNE 01 is sponsored by ORVACS and has been designed by the members of its international scientific advisory board. ORVACS is a non-profit organization based in Paris, France, that is supported and funded by the Bettencourt Schueller Foundation. The mission of ORVACS is to promote and conduct research on therapeutic vaccines and immunotherapeutic approaches in the field of AIDS. Created in 2001, ORVACS has a two-fold objective:

  • The development of new therapeutic immunization strategies through clinical trials evaluating the safety, immunogenicity, and efficacy of new vaccines
  • The pre-clinical development of new anti-HIV vaccine approaches

To optimize and further its mission, ORVACS has created a network of international academic research teams that are leaders in the field of immunology and antiretroviral therapy (ART) and on the development of innovative vaccine strategies against HIV. The objective of this vaccine therapy is to stimulate a weakened immune system and to amplify immune response.

The study is under the direction of Prof. Christine Katlama, MD (Principal Investigator), Head of the AIDS Clinical Research Unit, Department of Infectious Diseases, Hopital Pitie-Salpetriere, Paris, France.

“The novelty of the approach in this study is three-fold,” said Prof. Katlama. “First, the use of highly potent antiretroviral therapy combining drugs with different HIV enzyme targets or receptors and different penetrations in cells, to suppress the virus to truly undetectable levels; secondly, the addition of immunomodulatory therapy that specifically targets viral reservoirs; and lastly, the rigorous selection of patients already having a low HIV reservoir as measured by peripheral blood HIV DNA content.”

Other participants in the study include Bonaventura Clotet, MD, PhD (co-Principal Investigator), Chief of the Internal Medicine HIV Unit, University Hospital Germans Trias i Pujol, Barcelona, Spain. Additional key participants from the Université Pierre et Marie Curie and the Groupe Hospitalier Pitié-Salpêtrière include: Prof. Brigitte Autran, MD, PhD (Immunology); Prof Vincent Calvez, MD, PhD (Virology); and, Dominique Costagliola (Methololody).

The ERAMUNE 01 study, “International, multicenter, randomized, non-comparative controlled study of therapeutic intensification plus immunomodulation in HIV-infected patients with long-term viral suppression,” is being conducted in Paris, France (Groupe Hospitalier Pitié-Salpêtrière); Milan, Italy (San Raffaele Scientific Institute); Badalona, Spain (Fundacio Irsicaixa); Barcelona, Spain (University Hospital Clinic of Barcelona); and London, United Kingdom (Royal Free Hospital).

Additional information about the study can be found at: www.clinicaltrials.gov

About ORVACS – www.fondationbs.org
The mission of ORVACS is to promote and conduct research on therapeutic vaccines and immunotherapeutic approaches in the field of AIDS. Created in 2001, ORVACS has a two-fold objective: (1) The development of new therapeutic immunization strategies through clinical trials evaluating the safety, immunogenicity, and efficacy of new vaccines; and, (2) The pre-clinical development of new anti-HIV vaccine approaches. To optimize and further its mission, ORVACS has created a network of international academic research teams that are leaders in the field of immunology and antiretroviral therapy (ART) and on the development of innovative vaccine strategies against HIV. The objective of this vaccine therapy is to stimulate a weakened immune system and to amplify immune response.

About Cytheris – www.cytheris.com
Cytheris SA is a privately held clinical-stage biopharmaceutical company focused on research and development of new therapies for immune modulation. These drugs aim at reconstituting and enhancing the immune system of patients suffering from cancer, chronic viral or bacterial infections such as HCV, HBV and HIV, or lympho-depleting treatments such as chemotherapy, radiotherapy, bone marrow transplantation (BMT) and hematopoietic cell transplantation (HCT). The company operates from its headquarters and laboratories in Issy-les-Moulineaux, a suburb of Paris, and its U.S. subsidiary in Rockville, Maryland.



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