Results from Orviglance comparison study to gadolinium accepted for oral presentation at the ESGAR conference
15 februari, 2022
15 februari, 2022
Ascelia Pharma AB (publ) (ticker: ACE) today announced that the study where Orviglance® was compared against a gadolinium-based contrast agent has been accepted as an oral scientific presentation at the ESGAR conference to be held in May 31 – June 3 in Lisbon, Portugal.
“We are very pleased that the study has been selected as an oral scientific presentation at the prestigious European Society of Gastrointestinal and Abdominal Radiology (ESGAR) annual conference. The study provides robust evidence of the diagnostic value that Orviglance can offer once it is available to patients and physicians.”, said Carl Bjartmar, Chief Medical Officer at Ascelia Pharma.As communicated earlier, the results showed that a higher number of liver lesions was detected by the three independent readers for Orviglance compared to the liver-specific gadolinium contrast agent. All three readers were also able to see smaller lesions with Orviglance compared to gadolinium. With respect to lesion border delineation and lesion contrast to liver, two out of three readers reported higher scores for Orviglance compared to gadolinium. While the efficacy parameters show higher scores for Orviglance, this crossover study was comprised only of 20 patients with liver metastases and hence the difference was not statistically significant.The results also showed that Orviglance-enhanced MRI provides improved efficacy in terms of lesion detection and visualization compared to MRI without a contrast agent.
Contacts
Magnus Corfitzen, CEOEmail: moc@ascelia.comTel: 46 735 179 118
Mikael Widell, IR & CommunicationsEmail: mw@ascelia.comTel: +46 703 11 99 60
About us
About Ascelia PharmaAscelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates – Orviglance® (Mangoral) and Oncoral – in clinical development. Ascelia Pharma has its global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit www.ascelia.com.About Orviglance (previously referred to as Mangoral)Orviglance (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance, which has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA), is currently in Phase 3 development, including the global multi-center SPARKLE study.
Attachments
Results from Orviglance comparison study to gadolinium accepted for oral presentation at the ESGAR conference
15 februari, 2022
Ascelia Pharma AB (publ) (ticker: ACE) today announced that the study where Orviglance® was compared against a gadolinium-based contrast agent has been accepted as an oral scientific presentation at the ESGAR conference to be held in May 31 – June 3 in Lisbon, Portugal.
“We are very pleased that the study has been selected as an oral scientific presentation at the prestigious European Society of Gastrointestinal and Abdominal Radiology (ESGAR) annual conference. The study provides robust evidence of the diagnostic value that Orviglance can offer once it is available to patients and physicians.”, said Carl Bjartmar, Chief Medical Officer at Ascelia Pharma.As communicated earlier, the results showed that a higher number of liver lesions was detected by the three independent readers for Orviglance compared to the liver-specific gadolinium contrast agent. All three readers were also able to see smaller lesions with Orviglance compared to gadolinium. With respect to lesion border delineation and lesion contrast to liver, two out of three readers reported higher scores for Orviglance compared to gadolinium. While the efficacy parameters show higher scores for Orviglance, this crossover study was comprised only of 20 patients with liver metastases and hence the difference was not statistically significant.The results also showed that Orviglance-enhanced MRI provides improved efficacy in terms of lesion detection and visualization compared to MRI without a contrast agent.
Contacts
Magnus Corfitzen, CEOEmail: moc@ascelia.comTel: 46 735 179 118
Mikael Widell, IR & CommunicationsEmail: mw@ascelia.comTel: +46 703 11 99 60
About us
About Ascelia PharmaAscelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates – Orviglance® (Mangoral) and Oncoral – in clinical development. Ascelia Pharma has its global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit www.ascelia.com.About Orviglance (previously referred to as Mangoral)Orviglance (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance, which has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA), is currently in Phase 3 development, including the global multi-center SPARKLE study.
Attachments
Results from Orviglance comparison study to gadolinium accepted for oral presentation at the ESGAR conference
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