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Clinical trial of Inofer: last patient in

The last patient of twenty has now been included in the clinical study of the iron tablets Inofer, which Drugsson AB (subsidiary of Double Bond Pharmaceutical) has the rights to distribute in Sweden, Norway, Denmark and Finland. A clinical trial of Inofer was approved, as previously reported, by the Swedish Medical Products Agency and the National Ethical Committee June 20, 2018, and started on October 4 when the first patient received treatment with Inofer tablets. The study is being conducted at Skellefteå Hospital and is led by chief physician Kurt Boman, senior professor at Umeå

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

DBP gets free Protocol Assistance from EMA for SI-053

Double Bond Pharmaceutical has submitted an application to EMA for scientific advice, known as Protocol Assistance, for SI-053. The assistance will be given during a pre-submission meeting, where DBP is able to get advice on issues and plans that exist for SI-053 before the more formal procedure starts. The assistance is free of charge since the product has orphan drug status, and is expected to be completed in March 2019. Double Bond Pharmaceuticals goal is to then start the clinical trial with SI-053 as soon as possible. “The possibility to consult the agency to discuss the development

Double Bond aims on adaptive design for SI-053 Phase I

Double Bond Pharmaceutical (DBP) has signed a service contract with Cytel Inc, a leading provider of clinical research services and software, to develop an adaptive model-based study design for upcoming Phase I clinical trial for SI-053. “In our planned Phase I dose-escalation study we aim on using an adaptive model-based design to help identify the maximum tolerated dose (MTD) of SI-053, - says Dr Breezy Lindqvist, CMO of DBP. - This is considered to be much more effective than the traditional 3+3 model and is a crucial step in the clinical development of SI-053, as it also decides the

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