Clinical trial of Inofer: last patient out
All samples from patients included in the clinical study of the iron tablets Inofer have now been obtained. As earlier announced, a clinical trial of Inofer was approved by the Swedish Medical Products Agency and the National Ethical Committee June 20, 2018, and the study started on October 4 when the first patient received treatment with Inofer tablets. The study was conducted at Skellefteå Hospital and was led by the chief physician Kurt Boman, senior professor at Umeå University. Drugsson AB, which is the subsidiary of Double Bond Pharmaceutical (DBP), has the rights to distribute Inofer in Sweden, Norway, Denmark and Finland.
Next step is that the company, in collaboration with a certified analytical laboratory in Sweden, initiates the analysis of the collected patient samples.
"I am very pleased that the inclusion process went well and that “last patient out“ took place in Q2 according to the plan”,- comments Igor Lokot, CEO of Double Bond Pharmaceutical and Drugsson AB. "We look forward to receive the analyzed data by the end of the year and we expect it to prove Inofer to increase the iron levels in heart failure patients.”
More about iron deficiency and heart failure: About 15% of the world's population is suffering from iron deficiency. About 250,000 people in Sweden have symptomatic heart failure and half of them have iron deficiency at the same time. This combination of diagnoses leads to increased severity of symptoms and often to hospitalizations. Treatment with common iron tablets does not work due to insufficient intestinal uptake. In order to treat iron deficiency in heart failure patients, iron-containing drugs must currently be injected intravenously in a healthcare facility, which is resource-intensive. If it appears that ferrous succinate tablets can treat iron deficiency in heart failure patients, it would be a significant benefit for patients and for the health care, as treatment may be performed at home.
More about the Inofer study: /mbpublicbinaryproxy/Main/12720/2554728/864387.pdf, /mbpublicbinaryproxy/Main/12720/2635792/921363.pdf, /mbpublicbinaryproxy/Main/12720/2671302/944456.pdf, https://mb.cision.com/Main/12720/2730422/984760.pdf
More about Drugsson AB: www.drugsson.com
More about DBP: www.doublebp.com
This information is information that Double Bond Pharmaceutical International AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 14 of May 2019.
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Igor Lokot, CEO
Information on Double Bond Pharmaceutical International AB
DBP is a pharmaceutical company with the primary focus on development of therapies against cancer based on the company’s own developed drug delivery technology BeloGal®. The company was granted Orphan Drug Designation status by European Medicines Agency (EMA) in June 2015 for its first product, SA-033, for treatment of hepatoblastoma. Double Bond Pharmaceutical acquired rights to Temodex, a drug registered in Belarus for treatment of brain tumours, in October 2015, and was granted Orphan Drug Designation status by EMA for in July 2016 for this formulation of temozolomide for the treatment of glioma. The formulation is now being further developed for registration in EU and globally and has a working name SI-053 in DBP pipeline. DBP has during the past year also started two subsidiaries, Drugsson AB for the distribution of fully developed human pharmaceutical and medical device products and dietary supplements in Scandinavia, and FarmPharma AB for the development of innovative veterinary products.