Clinical trial of Inofer: half of the patients already recruited
The tenth patient of twenty has now been recruited for the clinical study of the iron tablets Inofer, which Drugsson AB (subsidiary of Double Bond Pharmaceutical) has the rights to in Sweden, Norway, Denmark and Finland. This means that the study is proceeding according to plan. The clinical trial of Inofer was approved as previously reported, by the Swedish Medical Products Agency and the Ethical vetting board on 20 June, commencing on October 4 when the first patient received treatment with Inofer tablets. The study is conducted at Skellefteå Hospital and is led by chief physician Kurt Boman, senior professor at Umeå University.
“I am very pleased that the recruitment process is proceeding according to plan and we expect all patients to be recruited before April next year,” commented Igor Lokot, CEO of Double Bond Pharmaceutical and Drugsson AB. “We look forward to getting results that show that Inofer increases 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 symptoms and often to hospitalizations. Treatment with common iron tablets does not work due to insufficient intestinal uptake. Therefore, 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: here and here.
More about Drugsson AB: www.drugsson.com
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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.