The peer-reviewed and highly recognized journal 'The Lancet HIV' has published the results of the REDUC Part B trial
(Oslo, Norway, 9 July 2016) Bionor Pharma ASA (Bionor) (OSE:BIONOR) announced today that the positive results from the clinical trial REDUC Part B has been published for the first time in the peer-reviewed and highly recognized journal The Lancet HIV.
The manuscript is entitled “Combined effect of Vacc-4x, recombinant human granulocyte macrophage colony-stimulating factor vaccination, and romidepsin on the HIV-1 reservoir (REDUC): a single-arm, phase 1B/2A trial”.
The manuscript concludes that the REDUC trial was safe and provided the first evidence for the feasibility of a combined Shock & Kill strategy, but also emphasizes that further optimization of this strategy is needed to achieve a sizeable effect on the latent reservoir that will translate into clinically measurable benefits for people living with HIV.
The REDUC Part B trial resulted in the following important findings:
- Latent HIV reservoir was significantly reduced by approximately 40% measured by Total HIV DNA and qVOA. Measured by Integrated HIV DNA, a statistical non-significant decrease of 19% was observed.
- Viral load (Plasma HIV-1 RNA) remained below the limit of detection (20 copies/ml) after each romidepsin infusion in 11 of 17 patients while on cART despite a documented viral reactivation in CD4+ T cells. Of the six patients with detectable viral load, four patients had measureable but low HIV in the blood after one of the three romidepsin infusions. Importantly, only two of 17 patients had detectable viral load after each of the three romidepsin infusions.
- The treatment of Vacc-4x/rhuGM-CSF and romidepsin (Istodax®, supplied by Celgene Corporation) was safe and well tolerated. All adverse reactions were consistent with the known side effects of either romidepsin or Vacc-4x/rhuGM-CSF.
These results are encouraging and show that Vacc-4x, administered with rhuGM-CSF, is capable of priming the immune system to control HIV in the blood after the virus has been ‘shocked’ out of its dormant state by a latency reversing agent. The trial results are supported by previous data, demonstrating that Vacc-4x/rhuGM-CSF reduced the viral load set-point during antiretroviral treatment interruption in a placebo-controlled trial (CT BI-Vacc-4x 2007/1).
The abstract (freely available) and the full manuscript can be accessed at www.thelancet.com.
Unni Hjelmaas, Acting CEO, +47 915 19 651, email@example.com
Jørgen Fischer Ravn, VP Investor Relations & Communications,
+45 2030 3903, firstname.lastname@example.org
Bionor Pharma is a Norwegian biopharmaceutical company focused on advancing its proprietary therapeutic vaccine Vacc-4x in combination with other medicines toward a functional HIV cure. The company believes it has first mover potential based on clinical results to date and early adoption of now recognized clinical strategy. In December 2015, Bionor announced that the HIV ’Shock & Kill’ trial REDUC with Vacc-4x and romidepsin successfully met its primary endpoint by reducing latent HIV reservoir and further demonstrated control of viral load. Bionor currently retains full ownership rights to Vacc-4x, i.e., the upside potential from partnering or licensing remains with the company’s shareholders. Bionor is listed on Oslo Børs (OSE:BIONOR). More information about Bionor is available at www.bionorpharma.com.