Kancera AB (Nasdaq First North Growth Market: KAN) today announces that the company intends to complete the final phase of the Phase Ib study of the drug candidate KAND567 in Finland instead of, as previously planned, in Sweden. In August 2019, Kancera applied for permission from the Swedish Medical Products Agency to change the dosing strategy in the study to enable an optimal dosage for patients. The Swedish Medicines Agency has announced that the authority wants supplementary information and a new application for a permit to continue the study. Kancera has compiled the requested information and prepared a new application, but in order to maintain the timetable for the phase IIa study, the company chooses to apply for the final part of the phase Ib study in Finland. The company believes that this will allow the phase Ib study to be completed with unchanged budget during the first quarter of 2020. The previously announced plan to apply for a phase IIa study during the second quarter of 2020 is thus unchanged.
The Fractalkine blocker KAND567 has been primarily developed to effectively reduce inflammation of the heart and vessels following a heart attack. In a planned phase IIa study, treatment with KAND567 will be evaluated in patients with acute myocardial infarction.
In the acute phase after the infarction, you want to quickly achieve effective blood concentrations of KAND567 and an initial intravenous infusion is therefore required. The purpose of the Phase Ib study in healthy subjects is to study the safety and tolerance of such intravenous infusion of KAND567, as well as to generate information on optimal infusion rate to quickly reach the calculated active blood concentration.
In June, Kancera announced positive interim results from the Phase Ib study of KAND567, which showed that KAND567 has a good safety profile on short-term infusion and that the calculated effective blood concentration of the drug candidate reaches the heart within five minutes of starting treatment, which is according to plan. To reduce local vascular irritation during prolonged intravenous infusion, Kancera then announced its intention to test a more advanced dosing strategy (sequential intravenous and oral therapy) that is in line with clinical practice for cardiac protection of patients after heart attack.
“The results of the Phase I studies, together with all the preclinical documentation, shows that the proposed dosing strategy will be safe, effective and work well in a clinical setting. We have compiled all the information that the authorities require and are now choosing the most effective way forward to be able to evaluate the treatment in patients as soon as possible,” says Thomas Olin, CEO of Kancera.
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 is expected to enter the clinical phase II study during the first half 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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