Kancera AB (Nasdaq First North Premier Growth Market: KAN) announces that the recruitment of patients for the exploratory phase IIa study with KAND567 has ended after just over 80 percent of the originally planned number of COVID-19 patients have received their dose. The decision is made in light of the fact that the number of cases in need of hospital care has decreased significantly and the current patient base is considered sufficient to provide important and relevant results that can guide the further clinical development of KAND567 against hyperinflammation, including COVID-19. The study results are expected to be presented during the fourth quarter of 2021.
The purpose of the clinical study is to document the effect on a number of bodily functions during oral administration of KAND567 or placebo for up to seven days. Furthermore, a follow-up is done 90 days after starting treatment in order to follow the rehabilitation.
During the recruitment phase, close to 800 patients underwent a medical and safety assessment prior to potential inclusion in the study. As COVID-19 is a new disease with highly variable individual clinical presentation, this extensive work has resulted in 33 of the planned 40 being able to be selected for the study.
The results from this exploratory study are now being evaluated in the usual way, which includes quality assurance and evaluation of clinical documentation, analyses in specialist laboratories, statistical processing and compilation of data. Due to the pandemic, both hospitals and laboratories have limited resources and the results will therefore be analyzed in their entirety after data from follow-up day 90 have become available. Kancera expects to be able to present the study's overall results during the fourth quarter of 2021. The study's results are expected to provide important and relevant information that will guide Kancera's continued clinical development of KAND567 – including the safety and tolerability profile when combined with standard therapy, effects on the immune system at the cellular, protein and gene levels associated with hyperinflammation, and results indicative of a possible lung protective effect in viral infection.
Kancera's development program for the drug candidate KAND567 consists of two fully-funded clinical phase II studies. The purpose of the studies is to document the potential for a tissue-protecting effect of KAND567 in inflammation associated with myocardial infarction (application for a permit for this study is being reviewed by the British Medicines Agency MHRA) and uncontrolled inflammation triggered by viral infections. Based on recently published preclinical findings, Kancera is also developing KAND567 and KAND145 for chemotherapy-resistant cancers, such as ovarian cancer. With positive results from the ongoing dose-determining preclinical cancer studies, another already funded clinical study could start in 2022, this time in patients with treatment-resistant cancer.
”I would like to thank patients, our partners in hospitals and laboratories as well as consultants for their outstanding commitment and contribution under challenging conditions to a study that may provide valuable knowledge both about KAND567 and how the care of severe COVID-19 can be further improved", says Thomas Olin, CEO of Kancera.
The COVID-19 study was conducted at four hospitals: Capio Sankt Göran's and Västmanland's hospitals in Sweden and Hvidovre and Odense University hospitals in Denmark.
For further information:
Thomas Olin, CEO, Kancera AB
Tel: 0735-20 40 01
About Kancera AB (publ)
Kancera AB is developing a new class of drugs for the treatment of inflammation and cancer. The company's drug candidates exert their effect through a newly discovered control system for immune cells and cancer cells, the so-called fractalkine system. Kancera is conducting and preparing, respectively, two fully funded Phase IIa clinical trials with its most advanced drug candidate KAND567 against heart and lung damage caused by hyperinflammation associated with heart attack and severe viral infections. These clinical studies are expected to deliver results in 2021 and 2022, respectively. Kancera also conducts preclinical development of the drug candidate KAND145, which is primarily intended for the treatment of autoimmune diseases and cancer. The stock is traded on the Nasdaq First North Premier Growth Market. FNCA Sweden AB (firstname.lastname@example.org, tel. 08-528 00 399) is the company's Certified Adviser.