The final part of the Phase Ib program for KAND567 was a randomized, double-blind, placebo-controlled study in healthy subjects aimed at studying the safety and tolerability of KAND567. Three different doses of KAND567 were administered intravenously over six hours to three groups of a total of 17 healthy subjects. Another 6 healthy subjects received placebo. In total, KAND567 has now been administered to 92 healthy subjects in Phase I studies.
The drug candidate KAND567 is developed to protect the heart and blood vessels from injuries associated with acute myocardial infarction. In the acute phase after the infarction an intravenous administration is required to rapidly obtain effective plasma concentrations of KAND567. Kancera has previously reported that the concentration of KAND567 that gives the desired effect on the immune system reaches the heart within two minutes of the start of the intravenous infusion. The desired tolerability profile reported today for intravenous administration complements the previous Phase I studies that show the same desired characteristics after oral treatment for seven days.
Kancera now has a well-founded dosing strategy for KAND567 ahead of a planned Phase IIa study, where dosing with KAND567 will begin before vasodilatation and be completed in conjunction with the patient being discharged from the hospital approximately three days later. The expected cardiovascular protective effect of KAND567 will be followed by magnetic resonance imaging (MRI) and blood markers for inflammation and heart damage.
“The comprehensive Phase Ib program for KAND567 has returned positive results and we look forward to initiating a Phase II study in patients with acute myocardial infarction. This study is expected to be completed and reported within one year from the start.” says Thomas Olin, CEO of Kancera AB.
Kancera develops drugs that counteract damage during acute and chronic inflammation. The Fractalkine blocker KAND567 is primarily developed to effectively and selectively reduce the inflammation of the heart and vessels following a heart attack and it is expected Kancera will apply for a permit for a clinical phase II study during the second quarter of 2020. Since scientific studies have shown elevated levels of fractalkine not only in heart attacks but also in inflammatory diseases and certain forms of cancer, there are several possible development opportunities for the fractalkine blockers KAND567 and KAND145. Kancera also develops preclinical drug projects against cancer aimed at stopping survival signals in the cancer cell and preventing the cancer cell's ability to be repaired. Kancera operates at Karolinska Institutet Science Park in Stockholm. The share is traded on Nasdaq First North. FNCA Sweden AB (tel. 08-528 00 399, email@example.com) is the company's Certified Adviser. MD PhD Charlotte Edenius, MD PhD Anders Gabrielsen, Professor Carl-Henrik Heldin and Professor Håkan Mellstedt are all scientific advisors and board members of Kancera AB.
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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