InnaVirVax has announced that it has initiated a Phase I/IIa clinical trial on its VAC-3S immunotherapy agent for the treatment of HIV infections.
This " first-in-class " therapy seeks to protect the immune system of patients infected with HIV-1, and this trial is starting only a little more than three years since InnaVirVax started its operations.
This phase I/IIa clinical trial is being carried out in two major clinical reference centers in Paris, France: the Pitié-Salpêtrière and Cochin Hospitals, and involves 24 patients infected with HIV-1 whose viral load is controlled under antiretroviral therapy, who will receive of escalating doses of treatment.
The primary endpoint is the safety of this immunotherapy. The immunogenicity of the candidate drug is also being studied, as are its effects on laboratory markers of HIV infection (notably the CD4 count, viral load and markers of cellular activation).
Patients will be immunized and then followed for one year. The primary endpoint of the study will be reviewed one month after the last treatment of each patient.
This clinical trial has been awarded a grant of €600,000 from OSEO, the French government-backed agency that supports innovation. This recognition has strengthened InnaVirVax in its resolve to develop VAC-3S.
Professor Christine Katlama, Department of Infectious and Tropical Diseases at Pitié-Salpêtrière Hospital, and Principal Investigator for the Phase I/IIa trial, explained: "The preclinical findings on this immunotherapy suggest that we may be able to protect CD4 T-cells from being destroyed during the disease and reduce cell activation and inflammation. If these results can be replicated in patients, then the therapeutic armementarium of antiretroviral drugs will be significantly enhanced."
According to Professor Odile Launay, Medical Coordinator of the Cochin-Pasteur Clinical Investigation Center on Vaccines at Cochin Hospital and co-investigator of the clinical trial: "This trial has been designed to investigate safety and immunogenicity of the immunotherapy developed by InnaVirVax. This is the first step before we can assess the activity of this immunotherapy in patients during a future proof of concept study."
Joel Crouzet, CEO & CSO of InnaVirVax concluded: "The Team at InnaVirVax is pleased that we can now initiate this clinical trial. We have been working hard for over three years towards evaluating this immunotherapy in humans, as it has the potential to protect the immune system in HIV-1-infected patients, which is significant in light of the preclinical and observational cohort data collected so far. We are also delighted with the financial support we have received from OSEO, which will reinforce the resources deployed for this trial whose initial results are anticipated in late 2012-early 2013."
VAC-3S constitutes a major step forward in the immunotherapy for the treatment of HIV infections. It is designed to counter the pathogenicity of the virus by blocking the mechanism leading to the loss of CD4 + T cells. VAC-3S should thus protect the immune system and reduce immune activation and inflammation.
VAC-3S stems from work carried out at Pitié-Salpêtrière Hospital (AP-HP) by Professor Patrice Debré and Dr. Vincent Vieillard (INSERM-Université Pierre and Marie Curie Joint Research Unit UMRS 946).
Their research has already been the subject of seven publications in peer-reviewed international journals.