tiakis receives GLP Certificate from Competent Authority
February 2019 –
tiakis BIOTECH AG today announced that the competent Good Laboratory Practice (GLP) Monitoring Authority of the German State of Schleswig-Holstein (State Office for Agriculture, Environment and Rural Areas of the Land Schleswig-Holstein) has performed a GLP inspection resulting in the confirmation that tiakis test site is able to conduct the archiving of documents related to in-house development products in compliance with the Principles of GLP. The establishment of aGLP quality management system is supported by a BFEI grant from the German State of Schleswig-Holstein.
About tiakis Elafin clinical development program
tiakis biopharmaceutical drug candidate Elafin promises an excellent therapeutic benefit risk profile for the use as an anti-inflammatory and tissue protective drug. Elafin is identical to the human protein elafin with high specificity for tissue destroying and inflammation promoting proteases. The development program of Elafin is focused on the late stage development of Elafin in major surgery and early stage development in pulmonary arterial hypertension (PAH). Elafin has received orphan drug designations in the USA and the EU for esophageal cancer surgery (ECS) and PAH. So far, there were no safety concerns after the treatment of 75 patients in three randomized, double-blind, placebo-controlled clinical trials. Postoperative complications in major surgery are the most significant independent risk factor leading to high morbidity and hospital readmissions. Following the completion of two Phase II surgery trials in ECS and coronary artery bypass graft surgery, and a final European Medicines Agency advice letter, a European pivotal trial with Elafin in ECS is in preparation. Treatment of patients undergoing ECS resulted in a significantly shorter intensive care unit stay and a positive postoperative effect on liver and kidney markers. Treatment of patients undergoing coronary artery bypass surgery resulted in a postoperative reduction of the heart damage marker troponin I. In models of PAH it was shown that Elafin reverses obliterative changes in arteries of lung explants from PAH patients and that treatment with Elafin leads to the regression of pulmonary vascular lesions in rats. PAH is still a fatal disease with high medical need for therapies that stop disease progression. A Phase I trial in the US with subcutaneously administered Elafin is planned to commence with recruitment in 2019.
tiakis focuses on the discovery and development of therapeutic solutions based on its innovative biopharmaceutical Elafin for life threatening surgeries and life-threatening diseases such as PAH. tiakis seeks partners and investors for the development, commercial scale manufacturing, marketing and distribution of the product. The company tiakis BIOTECH AG is located in Kiel, Germany (www.tiakis.de).
Certain statements in this news release may contain forward-looking information within the meaning of Rule 175 under the Securities Act of 1933 and Rule 3b-6 under the Securities Exchange Act of 1934 and are subject to the safe harbor created by those rules. All statements, other than statements of fact included in this release, including, without limitation, statements regarding potential future plans and objectives of the company, are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Technical complications that may arise could prevent the prompt implementation of any strategically significant plan(s) outlined above. The company cautions that these forward-looking statements and risks and uncertainties involved are further qualified by other factors including, but not limited to those set forth in the company's Form 10-K filing and other filings with the United States Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any statements in this release, whether as a result of new information, future events or otherwise.
tiakis BIOTECH AG
phone: +49 431 8888-462
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