Indication cardiovascular inflammation
The status of Kancera's preparation for clinical Phase IIa studies is reported in conjunction with the presentation of the company at Financial Hearings, on the 5th of September in Stockholm.
Furthermore, it is reported from internal and independent researchers that a blockade of the Fractalkine system in the context of acute myocardial infarction is expected to positively affect the healing and function of the heart, protect renal function and reduce the risk of recurrent vessel complications. The planning of the Phase IIa study is thus broadened to include biomarkers for all three effects, which in turn indicates that the probability increases for the study to demonstrate an attractive opportunity for further development of KAND567.
Development and production of pharmaceutical product for intravenous (IV) administration, toxicology studies and complementary preclinical efficacy studies are proceeding according to plan and will continue during the autumn. In parallel, completion of clinical study protocols and the establishment of a consortium for the implementation of the Phase IIa study are ongoing. Overall, this means that two clinical studies are expected to start in the first half of 2019, including a preporatory IV-dose study in humans during the first quarter of 2019 and the Phase IIa study in the second quarter of 2019. The implementation of the Phase IIa study may be adapted to interim results which are estimated to be available 6-9 months after the start of the study. Adjustments to these timetables may occur as the clinical consortium for the Phase IIa study is not yet established.
Kancera's Fractalkine project was awarded SEK 1 million last year in funding from the Swedish Innovation Innovation Agency Vinnova Strategic Innovation Program (SWElife). The appropriation is aimed at projects "having a very high level of innovation and commercialization potential". The one-year project has now been completed and Vinnova has approved the final report.
In the project, the first step in developing a drug product of KAND567 for oral administration has been conducted which includes the development of a solid formulation of KAND567 for rapid release from capsules, which is required for phase II studies in cancer. Furthermore, in collaboration with Per Kogner's research team at Karolinska Institutet, a study has been carried out in an animal model of the childhood cancer neuroblastoma. The treatment with KAND567 did not show a statistically significant decrease in tumor growth in this study, which may be due to the unexpected rapid growth of the tumors and delayed start of treatment. However, laboratory studies have shown that the KAND567 and Fractalkine system can inhibit repair enzymes necessary to protect the cancer cells DNA. Against this background, Kancera continues to study how KAND567 can be combined with treatments (cytostatics or radiation) that cause breaks in the cancer cells DNA.
The clinical biomarker study in lymphoma patients conducted in collaboration with Karolinska Institutet is proceeding as planned and, so far, samples from approximately 50 patients have been analyzed. The study is expected to be completed in the fourth quarter of 2018. In this so-called phase 0 study, biomarkers for an activated Fractalkine system and the effect of KAND567 on these biomarkers in isolated blood from the patients are evaluated. An activated Fractalkine system has been proposed by independent academic researchers to accelerate the progression of lymphoma by increasing blood flow into the tumor and/or counteracting an attack from the patient's immune system. The study aims to provide information on which patients could benefit clinically from treatment with KAND567 and thus how a possible Phase IIa clinical study could be conducted.
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 leukemia and solid tumors, by regulating the immune system, blocking survival signals in the cancer cell and addressing cancer metabolism. Kancera’s operations are based in the Karolinska Institute Science Park in Stockholm and the company employs around 20 people. Kancera shares are traded on NASDAQ First North and the number of shareholders was more than 7500 as of August 17th, 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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