Guard Therapeutics announces today that all 12 patients have been included in the company’s clinical phase 1b study of ROSgard, which is being conducted in people undergoing open heart surgery who have additional risk factors for acute kidney injury. The study is being conducted at the University Hospital in Münster, Germany. Top-line results are expected to be presented in September 2021.
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.
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.
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.
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.
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.
Guard Therapeutics has obtained patent protection in Australia for their biological investigational drug ROSgard, both as product and for its use in medicine.
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).
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.
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.