Kancera announces that an application for a clinical phase IIa study with KAND567 after heart attack has been submitted to the UK Medicines Agency (MHRA)
2021-05-24
Kancera AB (Nasdaq First North Premier Growth Market: KAN) announces today that the application for permission to start a phase IIa study evaluating the safety and cardioprotective effect of KAND567 in heart attack patients has been submitted to the UK Medicines and Healthcare Products Regulatory Agency, MHRA. The study will be conducted at Freeman Hospital under the direction of Professor Ioakim Spyridopoulos and the Newcastle upon Tyne Hospital NHS Foundation Trust. MHRA has a processing time of approximately 60 days, which means that the previously communicated schedule remains with the planned start of the clinical study during the third quarter of 2021.
When patients with acute heart attack receive their life-saving treatment, a hyper-inflammation is often activated which is linked to the risk of serious complications such as chronic heart problems or death. Studies show that the risk is especially high in patients who have an activated fractalkine system. Complications associated with the fractalkine system are, for example, impaired function in the important small blood vessels that supply the heart muscle and a change in the appearance and function of the heart muscle after the heart attack, which is closely linked to chronic heart failure. The cancer drug candidate KAND567 blocks the fractalkine system and has been shown to reduce inflammation and heart damage in several disease models.
The planned Phase IIa clinical trial will include sixty patients admitted to the hospital for myocardial infarction in the anterior wall of the ventricle. Patients are treated for three days with KAND567 or placebo. An evaluation of safety, markers of cardioprotective effect, inflammation and general health takes place on days 30 and 90 after the first dose.
Kancera has previously announced that an agreement has been signed with the Foundation for Newcastle Hospitals and Newcastle University, which means that the phase II study of KAND567 in heart attack patients can be carried out according to Kancera’s previously planned clinical budget of approximately SEK 20 million.
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 (info@fnca.se, tel. 08-528 00 399) is the company’s Certified Adviser.
For further information:
Thomas Olin, CEO, Kancera AB
Tel: 0735-20 40 01
www.kancera.com
This is a translation of a press release in Swedish dated 2021-05-21