TeaRx partners with ChemDiv’s IPHARMA clinical division for Phase II clinical trial of its innovative anticoagulant – novel oral direct Factor Xa inhibitor
January 13, 2014 – Moscow, Russia – IPHARMA announces that it was selected by TeaRx LLC to provide comprehensive Phase II clinical services for TeaRx’s novel anticoagulant TeaRx, an oral Factor Xa inhibitor. This new class of anticoagulants is being introduced and applied across the world addressing highly unmet needs in prevention and treatment of such common cardiovascular disorders as deep venous thrombosis and thromboembolism, and also stroke in patients with atrial fibrillation associated with acute coronary syndrome.
The drug candidate, TeaRxaban, contains an active pharmaceutical ingredient developed by Roche, which has conducted a wide range of preclinical studies and Phase I clinical trials. In 2011 Roche granted TeaRx LLC an exclusive license to develop, manufacture and commercialize this novel antithrombotic agent in Russia and the CIS.
The main advantages of the emerging new class of oral anticoagulants over older vitamin K antagonists (i.e. warfarin) are more rapid onset and cessation of action, minimal impact of inter-drug interactions on efficacy and safety, and elimination of the need for laboratory monitoring of clotting speed (INR), which is usually required to adjust dosages of warfarin and other vitamin K antagonists. An equally important advantage of this class of drugs is the high selectivity of their effect on coagulation factors, which makes their effects more predictable and the dosages used more universal. Simple oral administration of a capsule, instead of injection will be a major convenience for patients.
The clinical trial will determine the range of optimal dosages, and evaluate safety and efficacy when administered to prevent venous thromboembolic complications following knee replacement, in comparison with standard Enoxaparin therapy. The trials will be conducted at ten research centers in various regions of Russia.
Kirill Volynchik, MD, PhD, Director of Development at TeaRx LLC: “Preclinical and clinical studies of TeaRxaban demonstrated that the drug has a high therapeutic index and its pharmacological properties and safety may have several advantages over currently approved anticoagulants. Launch of such innovative Russian drug with potentially higher efficacy and safety than drugs in current clinical practice is of strategic significance for better treatment of patients in Russia, and the development of the Russian pharmaceutical industry.”
Mikhail Zamyatin, MD, Professor, Head of Department of Anesthesiology and Intensive Care, FGBI “Pirogov National Medical Surgical Center”, Ministry of Health of Russian Federation: “More than 30 million people in Russia are prone to diseases caused by thrombosis, and most of them need preventive medication. The high risk group for deep vein thrombosis and life-threatening pulmonary embolism includes patients who have undergone knee joint replacement. Conducting clinical trials of the first Russian drug in the group of oral Factor X inhibitors and proving its efficacy in this patient population will expand the therapeutic arsenal available to Russian physicians and patients.”
About TeaRx LLC
TeaRx LLC is a private specialty pharmaceutical company incorporated in 2011 as an entity of the ChemRar Group. The major focus of the company is development and commercialization of innovative anticoagulants for prophylaxis and treatment of thrombosis and thromboembolism. TeaRx performs full cycle of pre-clinical and clinical trials implicating experience and knowledge of foreign partners and Russian scientists. For more information about TeaRx LLC please visit company`s website: www.tearx.ru
About ChemDiv Inc.
ChemDiv is a fully integrated discovery and development Contract Research Organization (CRO) headquartered in San Diego, CA, USA, with subsidiaries in Russia and Ukraine. We offer an Integrated Discovery outSource solutions that cover a complete range of disciplines needed to bring a new project in CNS, oncology, inflammation, metabolic, infectious and other diseases from identification of a biological target (protein expression, assay development etc.) to clinical drug candidates (ADME/DMPK, toxicity and safety studies, efficacy models etc.) to Proof of Concept drug candidate (Phase I and II) and to the market. ChemDiv collaborates with pharmaceutical and biotech partners by enabling them to accelerate R&D programs to higher value clinical inflection points. With successful 20 years business record in life sciences and over 500 research associates employed globally, we put forward unique translational capabilities from Research to Clinical Development. More about ChemDiv at www.us.www.chemdiv.com
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