Date: 2012-08-13
Type of information:
phase:
Announcement: authorization of a clinical trial application
Company: Bionor Pharma (Norway
Product: Vacc-4x and Revlimid® (lenalidomide)
Action
mechanism: Vacc-4x is a therapeutic HIV-vaccine based on four, slightly modified peptides (building blocks of proteins) from conserved parts of the HIV-virus. Endocine is an adjuvant shown to enhance the immune response to vaccine antigens delivered nasally.
This investigational HIV vaccine Vacc-4x has already completed a large exploratory phase II randomized, multinational (USA and 4 European countries), double-blind, placebo-controlled trial. It has shown that patients achieved a statistical significantly lower viral load compared to the placebo group.
Further immunological analysis have documented that the \'quality\' of immune responses between the two groups was different. This qualitative difference in immune responses may have contributed to the killing of HIV infected cells, leading to the above mentioned reduction in viral load.
Disease: HIV-Aids
Therapeutic area: Infectious diseases
Country: Germany
Trial
details: The study will be conducted at four different clinics in Germany, and will include HIV patients who do not recover a normal CD4 T-cell count (measurement of the immune system) despite receiving conventional HIV medicine (antiretroviral therapy, ART). The study will be coordinated by the principal investigator Prof. Jan van Lunzen, MD, who is head of Infectious Diseases and Clinical Trial Unit at the University Medical Centre Hamburg-Eppendorf.
The first phase of the study will determine the optimal dose of Revlimid® in combination with Vacc-4x.
The second phase is placebo-controlled, double-blind and includes 24 patients, where half of them will receive Vacc-4x in combination with the selected Revlimid® dose, while the other half will receive Vacc-4x alone.
The study period of the second phase is 26 weeks. Bionor Pharma is the study sponsor and the costs will be shared evenly between Bionor Pharma and Celgene Corp.
The objectives of the study are to evaluate changes in immune responses in the two different Vacc-4x treated patient groups (with and without Revlimid®), measured by numbers and quality of the immune cells (CD4 and CD8). Despite that the patients have well controlled viral load from ART treatment, a secondary endpoint of the study is also to evaluate the effect on HIV viral load, by sensitive analysis methods.
Latest
news: SBionor Pharma has announced that the clinical trial application for the placebo-controlled study with Vacc-4x in combination with Celgene's Revlimid® has been approved by the German health regulatory authorities. This placebo-controlled, double-blind clinical study will start at four clinics in Germany. Study seeks to improve the immunological response in patients who have failed to recover normal immune cell levels, despite well controlled viral load on conventional HIV medicine
