Saturday, May 1, 2021

Nanexa AB started the first clinical study with ALD based PharmaShell® at the Karolinska University Hospital

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.

ALD – The coating technology behind the drug delivery system PharmaShell®

The technology used by Nanexa to manufacture the shells that make up PharmaShell® is Atomic Layer Deposition (ALD). In ALD, reactive gases are used which, with atomic layer by atomic layer, build up a surface coating with high precision. ALD has been used in the electronics industry for decades and is thus well established for larger scale production and automation.

ALD can also be used at low temperatures, down to room temperature, unlike other surface coating techniques which usually use considerably higher deposition temperatures, thereby risking inactivating the drug. A further advantage of ALD is that the coating is carried out under dry conditions, which makes it possible to coat drugs that are quickly dissolved in water or other solvents.

By building up an atomic layer for atomic layer with ALD, the thickness of the coating can be controlled with extremely high precision. Drug particles of various sizes and shapes can be coated since the only thing required for coating to be formed is that the reaction gases can reach the surface.
About Nanexa AB (publ)

Nanexa AB is a nanotechnology drug delivery company focusing on the development of PharmaShell®, a new and groundbreaking drug delivery system with great potential in a number of medical indications. Within the framework of PharmaShell®, Nanexa has partnership agreements with among others, AstraZeneca.

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