Xspray Pharma gets go-ahead from the Swedish MPA for clinical study
Xspray Pharma has obtained approval from the Swedish Medical Products Agency (MPA) to carry out a previously announced clinical study of the formulation of the company’s product candidate HyNap-Dasa. The study is part of Xspray’s clinical program and will be completed during the third quarter. The objective is to confirm the bioequivalence of the optimized formulation developed by Xspray, based on the company’s patented RightSize-technology.
“We are pleased with the progress of the project and following the decision of the MPA, we can now proceed with our plan for clinical studies,” commented Per Andersson, CEO of Xspray Pharma.
The current study is intended to confirm the formulation of the product candidate HyNap-Dasa. The results will form the basis of the following registration studies. The results from the current study are expected to be available by the end of the third quarter.
HyNap-Dasa is the first in a portfolio of product candidates that Xspray Pharma is developing with the target to haver products ready to launch on the US market during 2020-2026. All of the product candidates in the portfolio are versions of cancer drugs currently on the market, based on protein kinase inhibitors (PKI) and used for cancer treatments.
For further information, please contact:
Per Andersson, CEO, Xspray Pharma AB (publ)
Mobile: +46 (0)706 88 23 48
About Xspray Pharma
Xspray Pharma AB (publ) is a product development company with several product candidates under clinical development. Xspray uses its innovative RightSize-technology in order to develop improved and generic versions of already marketed cancer drugs, primarily protein kinase inhibitors (PKI), for treating cancer. The segment is the second largest within the oncology department and the drug prices are very high. Through its innovative technology, Xspray can enter the market as first competitor to the original drugs available today without the hindrance of secondary patents. Xspray’s goal is to have up to seven products ready for launch on the American market, with a first product launched at the latest by 2021. The company has patents on production technology, equipment and the resulting products. The shares in Xspray Pharma (publ) are traded on Nasdaq First North Stockholm and Redeye is the Certified Adviser for the company.
Xspray Pharma AB (publ)
Gunnar Asplunds Allé 32
171 63 Solna