31 May 2021
Guard Therapeutics establishes a scientific committee with prominent international physicians and researchers in cardiothoracic surgery, intensive care and nephrology
Guard Therapeutics today announces that the company has established an external Scientific Advisory Committee (SAC) initially consisting of five global experts. The committee’s main task in the near future will be to contribute their expertise in the final design of the planned phase 2 study of the company’s investigational drug ROSgard in patients undergoing cardiac surgery.
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09 Apr 2021
· Regulatory information
Guard Therapeutics receives an Intention to Grant notice in Europe for ROSgard
Guard Therapeutics AB (publ.) today announces that the company has received an Intention to Grant notice from the European Patent Office (EPO) for a patent application concerning its biological investigational drug ROSgard as a product, including its medical use. The next step in the process is a formal EPO approval, which provides a patent protection until 2037.
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07 Apr 2021
Guard Therapeutics obtains a granted patent from USPTO concerning ROSgard as product
Guard Therapeutics AB (publ.) today announces that the United States Patent and Trademark Office (USPTO) has granted the company’s patent application no. 16/085,500 directed to the biological investigational drug ROSgard as product (composition of matter). The granted patent follows the Notice of Allowance that was issued and communicated in December 2020.
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19 Mar 2021
First patient dosed in Guard Therapeutics’ phase 1b study of company’s investigational drug ROSgard
Guard Therapeutics today announces that the first patient has been dosed in a phase 1b study of the company’s investigational drug ROSgard. The study is being conducted in patients undergoing open heart surgery who have additional risk factors for acute kidney injury. The phase 1b study is being conducted at Münster University Hospital in Germany.
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15 Feb 2021
· Regulatory information
Guard Therapeutics appoints Sara Thuresson as Head of Clinical Operations
Guard Therapeutics today announces that Sara Thuresson has been recruited to a newly created position as Head of Clinical Operations. She held a similar position at Oncopeptides before joining Guard Therapeutics and will take up her new post on 24 May 2021.
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11 Feb 2021
Guard Therapeutics patent granted in Australia
Guard Therapeutics has obtained patent protection in Australia for their biological investigational drug ROSgard, both as product and for its use in medicine.
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29 Dec 2020
· Regulatory information
Guard Therapeutics completes successful pre-IND meeting with FDA
Guard Therapeutics today announces that the company has completed a pre-IND meeting with the US Food and Drug Administration and has received positive feedback on its planned clinical development programme for its investigational drug ROSgard. This is an important validation of the quality of the project and is a significant step towards an application to include American study centres in future clinical studies (Investigational New Drug Application, IND).
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28 Dec 2020
· Regulatory information
Guard Therapeutics appoints Ann-Kristin Myde as Head of Global Project Management
Guard Therapeutics today announces that Ann-Kristin Myde has been appointed new Head of Global Project Management for the company. She will take up her post on 1 April 2021.
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11 Dec 2020
· Regulatory information
Guard Therapeutics receives Notice of Allowance from USPTO for ROSgard
Guard Therapeutics AB (publ.) today announces that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for company’s patent application 16/085,500 directed to the biological investigational drug ROSgard as product (composition of matter). A formal approval is expected shortly, and if granted the patent is valid until 2037. The Notice of Allowance further strengthens Guard Therapeutics' patent portfolio and improves market exclusivity for ROSgard in one of the company’s key markets.
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28 Sep 2020
· Regulatory information
Guard Therapeutics reports positive top-line results from phase 1 study of ROSgard in individuals with renal impairment
Guard Therapeutics today announced positive top-line results from a phase 1 study of its investigational drug ROSgard in individuals with renal impairment. The main aim of the study was to characterize the pharmacokinetic properties and safety profile of ROSgard in patients with renal impairment. The company believes that these results, together with previously reported positive results from a clinical phase 1 programme in healthy subjects, provide an excellent foundation for continued development of ROSgard in the area of acute kidney injury.
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