Nordic Life Science 1
CLINICAL TRIALS PH A SE I I The company has start
ed a Phase II clinical study to evaluate the safety and efficacy of the company’s lead candidate drug AP1189 in adults diagnosed with COVID-19 and with early signs of Acute Respiratory Distress Syndrome (ARDS). Data from the innovaTV 204 phase 2, single-arm clinical trial evaluating tisotumab vedotin as monotherapy in patients with previously treated recurrent and/or metastatic cervical cancer has been announced. TISOTUMAB VEDOTIN IS AN investigational antibody-drug conjugate (ADC) directed to tissue factor, which is prevalent on solid tumors including cervical cancer, and can promote tumor growth, angiogenesis and metastasis. Patients had previously received a doublet chemotherapy and, if eligible, bevacizumab as first-line therapy. Results from the trial showed a 24 percent confirmed objective response rate by independent central review with a median duration of response of 8.3 months. The most common treatment-related adverse events included alopecia, epistaxis, nausea, conjunctivitis, fatigue and dry eye. “The trial results suggests that tisotumab vedotin as a monotherapy could potentially become an important option for women with metastatic and or recurrent cervical cancer,” says Jan van de Winkel, CEO, Genmab. T NON- INTERVENTIONAL THE WORLD’S LARGEST STUDY OF CARDIOVASCULAR DISEASE IN TYPE 2 DIABETES NOVO NORDISK HAS ANNOUNCED RESULTS FROM THE CAPTURE STUDY, A GLOBAL NON-INTERVENTIONAL STUDY TO UNCOVER THE PREVALENCE OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR DISEASE RISK AND ITS MANAGEMENT IN PEOPLE LIVING WITH TYPE 2 DIABETES. THE STUDY, THE FIRST OF ITS KIND and involving nearly 10,000 participants from 13 countries across five continents, showed that 1 in 3 people with type 2 diabetes have established cardiovascular disease, and 9 in 10 of these have atherosclerotic cardiovascular disease. “It is critical that we prioritize cardiovascular disease as a key factor in the management of type 2 diabetes. People with type 2 diabetes need to be more aware of their risk factors and physicians need to be actively screening for them. Today we can address this risk through treatments with proven cardiovascular benefits, as recommended by various treatment guidelines,” says study investigator Ofri Mosenzon, who consults for Novo Nordisk and the Diabetes Unit at the Hadassah Medical Center in Israel. For the first time, information on cardiovascular disease in type 2 diabetes has been gathered from both primary and secondary care settings, also reflecting that a significant proportion of people with type 2 diabetes are being treated by primary care physicians in conjunction with diabetes specialists. HE PATIENTS WILL be enrolled at medical centers in Brazil in a collaboration between SynAct Pharma, Queen Mary University, London, UK, and Universidade Federal de Minas Gerais, Belo Horizonte, Brazil, to explore resolution therapy as a novel option for the treatment of hyperinflammation associated with COVID-19. The first part of the study, which is an open-label study in six patients to evaluate the safety of the compound in a specific clinical setting, will be initiated as soon as medicine for the study has arrived at the clinical site. The second part of the study will evaluate the safety and efficacy of a two-week dosing regimen in patients with moderate manifestations of COVID-19, compared with standard care. Approximately 54 patients will be randomized in a 2:1 ratio to receive AP1189 100 mg once daily, in addition to standard care. The study is set up with the aim to characterize the compound’s ability to promote inflammatory resolution in COVID-19 infected patients. The primary clinical objective of the study is to show reduction in time to respiratory recovery (i.e. time to normalization of oxygen saturation on ambient air). 20 NORDICLIFESCIENCE.ORG PHOTO TUALA HJARNØ