Kancera AB (Nasdaq First North: KAN) today announces that intermediate goals have been achieved prior to the planned start of clinical trials with the drug candidate KAND567 to demonstrate reduced tissue damage associated with heart attack. In a recent preclinical toxicological study, KAND567 has shown a favorable safety profile, and significant progress has been made in the development of a large-scale production method.
Kancera has previously completed clinical phase Ia which has shown that KAND567 given orally is safe and tolerable in doses expected to produce the desired effect against inflammation. In 2019, clinical studies are planned in which KAND567 is administered intravenously to myocardial infarction patients and two intermediate goals have now been reached for the start of the studies.
Toxicological study of KAND567 on intravenous administration
Kancera has conducted a toxicological animal study to document the safety profile of KAND567 during intravenous administration, which is the dosage form to be used in future studies of patients suffering from myocardial infarction. The results suggest that the dose levels expected to provide the desired cardioprotective effect in patients are also tolerated and safe.
Preparations for the manufacture of trial drugs for clinical studies
Large-scale manufacture of an intravenous dosage form of KAND567 has been successfully accomplished. This enables the production of trial drugs to start during the current quarter.
"With new and positive safety data and the recent advances in production development, our drug candidate KAND567 has taken two further important steps towards the planned Phase 1 study which is to calibrate the intravenous dosage. We will carry out phase 1 in the spring and expect to initiate a phase 2 study in the fall in patients who have suffered from a heart attack, ”says Thomas Olin, CEO, Kancera AB.
KAND567 acts by blocking the fractalkine receptor. The receptor is an important player in the inflammatory process and a promising target for new and more selective anti-inflammatory drugs. Scientific studies have revealed elevated levels of fractalkine in cardiovascular diseases, inflammatory diseases and various forms of cancer.
Kancera develops the basis for new therapeutics, starting with new treatment concepts and ending with the sale of a drug candidate to international pharmaceutical companies. Kancera is currently developing drugs for the treatment of inflammation and cancer, by regulating the immune system, blocking survival signals in the cancer cell and addressing repair mechanisms. Kancera’s operations are based in the Karolinska Institute Science Park in Stockholm and the company employs around 15 people. Kancera shares are traded on NASDAQ First North and the number of shareholders was more than 7400 as of December 28th, 2018. FNCA is Kancera’s Certified Adviser. MD PhD Charlotte Edenius, MD PhD Anders Gabrielsen, Professor Carl-Henrik Heldin samt Professor Håkan Mellstedt are board members and Kancera’s scientific advisers.
For further information, contact:
Thomas Olin, CEO: +46-(0)735-20 40 01
Kancera AB (publ)
Karolinska Institutet Science Park
SE 171 48 Solna
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