Spago Nanomedical initiated a Phase IIa clinical trial with SpagoPix in patients with suspected endometriosis, a chronic, debilitating condition that affects up to 10% of women of reproductive age.
LUND, SWEDEN / ACCESSWIRE / February 2, 2023 / Spago Nanomedical (STO:SPAGO.ST)(FRA:7UX.F) New possibilities for SpagoPix
OCTOBER - DECEMBER IN BRIEF
· Net sales for the quarter amounted to KSEK 142 (KSEK 99)
· The loss for the quarter amounted to KSEK -11,158 (KSEK -11,293)
· Operating expenses for the quarter amounted to KSEK -13,335 (KSEK -13,078)
· Earnings per share, before and after dilution, for the quarter amounted to SEK -0.12 (SEK -0.27)
· Cash and cash equivalents at the end of the quarter amounted to KSEK 62,101 (KSEK 52,640)
JANUARY - DECEMBER IN BRIEF
· Net sales for the year amounted to KSEK 1,054 (KSEK 660)
· The loss for the year amounted to KSEK -39,197 (KSEK -39,071)
· Operating expenses for the year amounted to KSEK -45,925 (KSEK -45,723)
· Earnings per share, before and after dilution, for the year amounted to SEK -0.61 (SEK -0.99)
SIGNIFICANT EVENTS DURING THE QUARTER
· Spago Nanomedical initiated a Phase IIa clinical trial with SpagoPix in patients with suspected endometriosis, a chronic, debilitating condition that affects up to 10% of women of reproductive age. The first patient was dosed shortly after. The study will include up to 18 patients.
· The Phase I clinical trial SPAGOPIX-01 in patients with confirmed breast cancer conducted at two hospitals in Sweden was concluded during the quarter. A total of 14 patients were included and dosed. The initial results show that the primary and secondary objectives of the study were met showing that SN132D is well tolerated and provides clear contrast in MRI images of solid tumors in the breast, as well as good contrast enhancement in the pancreas and liver. The results were presented at the 2022 San Antonio Breast Cancer Symposium and the final report of the study is in preparation.
SIGNIFICANT EVENTS AFTER THE QUARTER
· The paper, titled “Characterization and Efficacy of a Nanomedical Radiopharmaceutical for Cancer Treatment”, was published in the peer reviewed scientific journal ASC Omega. The results shows that the candidate drug 177Lu-SN201 within the Tumorad project accumulates in tumors to the same extent as a comparable market approved benchmark and is well suited for systemic treatment of cancer. Furthermore, 177Lu-SN201 delays tumor growth and prolongs survival in a preclinical model of colon cancer.
CEO STATEMENT
The fourth quarter concludes an eventful 2022 in which we achieved significant progress in both our leading imaging diagnostics development projects, SpagoPix, and the radionuclide therapy Tumorad®.
A milestone in the SpagoPix project occurred at the end of the fourth quarter when we announced the start of the company’s first Phase II clinical trial with the MRI contrast agent SN132D in endometriosis, a severely undertreated disease affecting up to 10 percent of women of reproductive age. Today, it often takes a long time for affected women to receive an accurate diagnosis and relevant treatment. The need for better imaging diagnostics is vast and the study will allow us to position SpagoPix in an indication where current contrast agents and other diagnostics do not work optimally.
The Phase IIa study evaluates the efficacy of SN132D in up to 18 patients with suspected endometriosis and is being conducted at Skåne University Hospital in Malmö, Sweden. Screening of patients is proceeding according to plan and several patients have already been enrolled. Our aim is to present study results around mid-2023.
At the same time as we announced the start of the Phase II trial, we also announced the completion of the SPAGOPIX-01 trial in breast cancer. Based on previously communicated interim data, we have concluded that our main objectives with the study, to document safety and contrast enhancement in tumors in patients with breast cancer, have been met. The results show that SN132D is well tolerated and provides clear contrast enhancement in MRI images of solid breast tumors. Furthermore, we see good contrast enhancement in the pancreas and liver. The initial results were presented at the San Antonio Breast Cancer Symposium 2022 in December and a final report is now being compiled.
In the Tumorad project, we focus on the initiation of the first clinical trial of the drug candidate 177Lu-SN201 in cancer patients. We plan to shortly submit the application to start a phase I/IIa trial in cancer patients to the regulatory authorities and the goal is to recruit the first patient at the beginning of the summer. The need for more effective methods to treat metastatic and aggressive cancers remains very high and the interest in radionuclide therapies is steadily increasing among both pharmaceutical companies and investors. The background to the increased interest is that modern radionuclide therapy can combine the effectiveness of radiation treatment with high-precision targeting to treat tumors that were previously not possible to access. So far, there are only a few tumor types that can be targeted with biologically targeted drugs. In this context, Tumorad may have a place due to its mechanism based on physiological targeting, which means that significantly more types of tumors could be treated.
The initiation of the planned clinical study is based on the positive results achieved with 177Lu-SN201 during the preclinical development phase. In January 2023, a summary of preclinical data was published in the scientific journal ASC Omega which, in brief, shows that 177Lu-SN201 accumulates well in cancer tumors, slowing tumor growth, leading to longer survival in preclinical tumor models. These results, together with previous favorable data from regulatory toxicology studies, reinforce our view that 177Lu-SN201 is a promising new radionuclide therapy for physiological targeting and tumor-selective treatment of cancer with the potential to target multiple solid tumor types.
Considering the uncertainty in the world and its impact on financial markets, we are carefully managing the company’s resources while focusing on areas where we see the greatest opportunity to take projects forward and create long-term value. Spago Nanomedical has a unique platform technology and a strong team, and with positive momentum from an eventful 2022, I look forward to further important progress for the company in 2023.
Mats Hansen, CEO Spago Nanomedical AB
For further information, please contact Mats Hansen, CEO Spago Nanomedical AB, +46 46 811 88, mats.hansen@spagonanomedical.se
Spago Nanomedical AB is a Swedish nanomedicines company in clinical development phase. The company´s development projects are based on a platform of polymeric materials with unique properties for more precise diagnosis and treatment of life-threatening and debilitating diseases. Spago Nanomedical´s share is listed on Nasdaq First North Growth Market (ticker: SPAGO). For further information, see www.spagonanomedical.se.
FNCA Sweden AB is the Certified Adviser of the company.
Attachments
Spago Nanomedical year-end report January-December, 2022
SOURCE: Spago Nanomedical
View source version on accesswire.com:
https://www.accesswire.com/737832/Spago-Nanomedical-Year-end-Report-January-December-2022
