Date: 2015-11-17
Type of information: Submission of a clinical trial application
phase: 2
Announcement: submission of a clinical trial application
Company: Bionor Pharma (Norway)
Product: Vacc-4x
Action
mechanism: peptide/immunotherapy product. 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.
Disease: HIV infection
Therapeutic area: Infectious diseases
Country: Denmark
Trial details:
Latest
news: * On November 17, 2015, Bionor Pharma 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. 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.
