(Oslo, Norway, 17 November 2015) Bionor Pharma ASA (OSE:BIONOR) today announced the submission of a clinical trial application (CTA) to the Danish Medicines Agency requesting approval to initiate BIOSKILL in Denmark. BIOSKILL (BIOnor Shock and KILL) will enroll patients internationally and further CTAs will be submitted to national medicines agencies in the coming months.
BIOSKILL is a planned multicenter, randomized, double-blind, placebo controlled Phase II clinical trial to confirm and expand on the results from the REDUC trial. As such, BIOSKILL is designed to provide evidence that Vacc-4x can contribute to controlling viral load after the latent reservoir has been activated by romidepsin and HIV particles released into the blood. As in previous clinical trials, Vacc-4x will be administered together with the adjuvant GM-CSF.
Final results from all 20 patients in REDUC are expected year-end 2015 with the final report expected in the first half of 2016. Following approval of the CTA, it is expected that the BIOSKILL trial will be initiated in 2016.
David Horn Solomon, President and CEO commented:
“Assuming a successful completion of the REDUC trial, we are excited to soon be able to advance the combination of Vacc-4x and romidepsin into a full-scale proof of concept Phase II clinical trial. We believe that Vacc-4x has the potential to become a core component of a functional cure for HIV. The completion of BIOSKILL will be an important clinical and strategic advancement for Bionor, and will give hope to HIV patients that significant improvements to current treatment options are still possible.”
Bionor’s strategy is to advance Vacc-4x in combination with other medicines in order to contribute to a possible functional HIV cure, and the company believes it has first mover potential due to early adoption of the “Shock & Kill” therapeutic approach. Among several therapeutic vaccines in development for a functional HIV cure, Vacc-4x is the most advanced. Bionor believes that BIOSKILL may lead to a major value inflection point and partnering opportunities.
Bionor Pharma is a Norwegian biopharmaceutical company focused on advancing its proprietary therapeutic vaccine Vacc-4x in combination with other medicines toward a possible 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. Bionor is currently planning BIOSKILL, a proof-of-concept Phase II clinical trial, which may lead to a major value inflection point and partnering opportunities. Bionor currently retains full ownership rights of Vacc-4x, i.e., the upside potential from partnering or licensing remain with the company. Bionor is based in Oslo, Norway, and also has offices in Copenhagen, Denmark and New York City, New York. Bionor is listed on Oslo Børs (OSE:BIONOR). More information about Bionor is available at www.bionorpharma.com.
Announcement as PDF.