Clinical trial has received regulatory approval and involves endometriosis candidate SN132D
Spago Nanomedical has announced that it has received regulatory approval to initiate a phase 2a clinical study of its endometriosis candidate SN132D.
The condition is a chronic condition that affects up to 10% of women during reproductive age. Recruitment for the trial has already started and the first patient is expected to be dosed shortly.
The trial is an open label, proof-of-concept study led by associate professor Dr Ligita Jokubkiene, senior consultant at the Department of Obstetrics and Gynecology at Skåne University Hospital in Sweden.
The study will evaluate the safety and MRI enhancing properties of SN132D in participants with suspected endometriosis. Furthermore, comparisons will be made to transvaginal ultrasound and conventional MRI in order to consider the diagnostic potential of SN132D the therapy.
“Endometriosis is a chronic condition that has a tremendous effect on the quality of life for so many women and girls. Pain and infertility are the clinical hallmarks of the disease, affecting not only those affected with endometriosis, but also their partners, families and the wider society,” commented Dr Ligita Jokubkiene.
“The need for better treatments options and initial diagnosis enabling early detection of the disease is vast. I am excited to lead this highly anticipated trial and to provide hope to women around the world suffering from endometriosis.”
Meanwhile, the company’s SPAGOPIX-01 study into breast cancer has been concluded and a final report is being prepared.
The SPAGOPIX-01 study in breast cancer was conducted at two hospitals in Sweden with the primary objective of studying safety at different doses of SN132D. A total of 14 patients with confirmed breast cancer were enroled and dosed, while results from the study will be presented at the 2022 San Antonio Breast Cancer Symposium.
“We are very pleased that SPAGOPIX-01 meets the primary objectives set out for the study and that the results with SpagoPix in breast cancer provide a clinical validation of our nanomedical platform. Based on ongoing discussions with potential partners and experts in the field, we have decided to focus our resources within the SpagoPix programme on endometriosis,” concluded Mats Hansen, chief executive officer at Spago Nanomedical.
It is estimated that more than 176 million women of reproductive age are affected by endometriosis worldwide.