Nordic Life Science 1
SPAGO NANOMEDICAL INITIATES NEW TRIAL The company
has conducted a site initiation visit at the Uppsala University Hospital in Uppsala and formally opened the first clinical trial with the tumor selective contrast agent SpagoPix (SN123D). HE TRIAL WILL include up to 20 patients with confirmed breast cancer. The primary objective with the trial is to document safety, but another important objective is to investigate SN132D´s MRI-enhancing effects when used clinically in patients with solid tumors. “There is need for better contrast agents for MRI of solid tumors. If SN132D provides good images, it can become an important part of healthcare in the treatment of breast cancer,” says Associate Professor Fredrik Wärnberg, coordinating investigator for the SPAGOPIX-01 trial and a senior physician at Uppsala University Hospital. SpagoPix (SN132D) is a contrast agent with the potential to significantly improve cancer diagnostics with magnetic resonance imaging (MRI). Spago Nanomedical will focus initially on imaging of breast cancer, a disease that affects approximately 2.1 million people annually. MRI is routinely used today for screening, diagnostics and tumor staging in 15–30% of all breast cancer patients, but the need for better precision is substantial. Liproca Depot could provide an option for physicians to address an unmet medical need. PH A SE I I Preliminary data from the LPC-004 study that aimed to determine the tolerability of Liproca Depot and the Prostate-Specific Antigen (PSA) effect at month five on patients in part II of the study has been announced. HE PSA REDUCTION for part II patients was in line with the expected pattern for Liproca Depot’s sustained release and maximum PSA reduction (PSA nadir) occurred during months 2-4. The patients in part II showed a strong PSA decrease and a continued PSA reduction at month 5, as well as over the full study period of six months, confirming the NanoZolid technology’s sustained release profile. In addition, 67 % of patients receiving 16 ml dose were determined as responders. A responder is defined as a patient experiencing a PSA decrease of 15% or more. In total, 90% of patients who received a 16 ml injection experienced a PSA decrease during their Liproca Depot treatment. The positive preliminary results show Liproca Depot’s ability to reduce PSA levels over a period of six months, proving the NanoZolid technology’s suitability for local cancer treatment. The study also confirmed the technology’s favorable toxicity and tolerability profile. All patients in the study were under active surveillance with low or intermediate risk of cancer progression and these patients currently receive no treatment. “Patients under active surveillance have a risk of cancer progression, which places additional stress on them. Liproca Depot could provide an option for physicians to address an unmet medical need,” says Anders Bjartell, Professor at the Department of Urology, Skåne University Hospital, and LIDDS Board Member. 24 NORDICLIFESCIENCE.ORG PHOTO EMIL AALTONEN