Chemotherapy consisting of a combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in combination with immunotherapy targeting CD20 such as rituximab (so-called R-CHOP therapy) is the standard initial treatment of newly diagnosed DLBCL. CHOP treatment together with valproate was shown to have significant antiproliferative effects in vitro (Ageberg et al. 2013) and this was later supported in vivo where significant clinical effects on e.g. overall survival were demonstrated when combining valproate with R-CHOP in patients with DLBCL in a phase I/IIa study (VALFRID trial, Drott et al., 2018).

Patients less than 70 years of age with intermediate or high risk might require intensified treatment with the addition of etoposide, so-called R-CHOEP. Howeveronly recently the effect of valproate with this treatment combination has t been investigated in vitro, using two different lymphoma B-cell lines. For the first time it was demonstrated that etoposide decreased cell proliferation and the combination of valproate and etoposide enhanced the antiproliferative effect in both cell lines. This would thus indicate that not only R-CHOP treated patients would benefit from the addition of valproate but also the more severely ill patients in need for R-CHOEP therapy.

We are excited about the new results which further emphasize the potential of VAL001 for the treatment of DLBCL. In addition, the preliminary clinical results from the ongoing pharmacokinetic study in healthy subjects of VAL001, which is the tailored formulation of valproate, have recently been evaluated by the internal Safety Review Committee. The relatively high doses of VAL001 given in the study are considered safe and achieved the anticipated concentrations. Thus, the study continues according to protocol, says CEO Johan Drott in a comment.

This disclosure contains information that Respiratorius is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 24-03-2022 10:34 CET.