Nanexa launches clinical trial for NEX-18
Nanexa AB (publ) today announces that the company has started its first clinical study with PharmaShell®, a phase I study in Nanexa's product project NEX-18, at the Karolinska University Hospital.
The study aims to show that the company's NEX-18 product, a long-acting formulation of azacitidine (the active substance in the drug Vidaza), provides the desired safety and pharmacokinetic profile. In the study, two doses of NEX-18 will be studied. The study will be conducted at Karolinska University Hospital in Stockholm and Akademiska Sjukhuset in Uppsala.
“The start of this study is a very big milestone in Nanexa's development. It is with great enthusiasm that we now see that the study is getting started. We expect the study to be completed during the third quarter.”, said David Westberg, CEO of Nanexa.
The NEX-18 product is being developed to improve the treatment of MDS (Myelodysplastic Syndrome), a form of hematological cancer that mainly affects the elderly. This is done by utilizing the unique properties of the PharmaShell® concept to create a controlled release depot formulation. Today's treatment means that injections are given at hospitals seven days in a row each month. The goal of the NEX-18 project is to simplify treatment by only having to give one injection. In addition to greatly simplifying for patients, Nanexa sees that NEX-18 will provide significant cost savings compared to current treatment.
“With the results of this study, we intend to continue the clinical development with a phase II study to achieve clinical Proof of Concept. After that, the goal is to run NEX-18 further towards commercialization, either through a license partner or as an own project, whatever option is deemed to create most value for Nanexa”, said David Westberg.