
New clinical trial
HIV Vacc-4x in combination with Revlimid® (Lenalidomide)
Oslo - 25.August 2011: Bionor Pharma ASA Announces Exploratory Study of its Lead Therapeutic HIV-Vaccine Candidate Vacc-4x in Combination with Leading Cancer
The study will determine:
1. The ability of Vacc-4x to improve immune function in patients that fail to regain a healthy immune defense despite that their viral load is well controlled on conventional HIV-medicines (antiretroviral therapy - ART).
2. The effect of Revlimid® on Vacc-4x’s ability to improve immune function. Revlimid® is a leading drug for treatment of multiple myeloma and anemia due to myelodysplastic syndrome associated with a deletion in the long arm of the fifth chromosome.
The target patient population for the study will be HIV-patients whose immune system have not fully recovered (defined by
CD4+ (helper) T-cell count in the interval 250-400 cells per mL) despite being on a long term antiretroviral therapy. This
patient group is relatively similar to the patient population in Bionor Pharma’s previously reported phase IIa study, where
positive effects on CD4+ counts were observed. With few treatment options, this patient group represents a high unmet medical
need.
“This unique study provides a “first glimpse” at an innovative combination therapy for a patient group with a high unmet medical
need,” commented Vidar Wendel Hansen, CMO of Bionor Pharma. “We view this as a recognition of the strength of our platform
technology and Vacc-4x’s potential therapeutic effects.”
The study will be randomized, double blinded and placebo-controlled comprising 24 virtually controlled HIV-patients on ART.
Twelve patients will receive Vacc-4x in combination with Revlimid®, while the other twelve will receive Vacc-4x alone. The
treatment and observation period is 26 weeks. The trial will be preceded by an open-label dose finding study to select the
most appropriate Revlimid® dose.

