Date: 2013-02-05
Type of
information: Initiation of the trial
phase:
Announcement: initiation of the study
Company: Bayer (Germany) Janssen Pharmaceuticals (J&J - USA) Portola Pharmaceuticals (USA)
Product: Xarelto® (rivaroxaban) and PRT4445
Action
mechanism:
- anticoagulant agent/oral direct Factor Xa inhibitor/protein. Rivaroxaban is an oral anticoagulant and is marketed under the brand name Xarelto®. It is approved for use in the following venous arterial thromboembolic (VAT) indications.
- Portola Pharmaceutical’s PRT4445 is a novel recombinant protein designed to reverse the anticoagulant activity in Factor Xa inhibitor-treated patients suffering from an uncontrolled bleeding episode or undergoing emergency surgery. It is similar to native Factor Xa but has structural modifications intended to restrict its biological activity to reverse the effects of Factor Xa inhibitors. PRT4445 works by acting as a decoy for Factor Xa inhibitors in the blood, thereby preventing them from inhibiting the activity of native Factor Xa. As a result, the native Factor Xa is available to participate in the coagulation process and restore normal clotting. Results of a Phase I single ascending dose safety and tolerability study, conducted by Portola in 32 healthy volunteers in the United States, showed that PRT4445 was generally well tolerated with no apparent safety signals.
Disease:
Therapeutic
area: Cardiovascular diseases
Country:
Trial
details:
Latest
news:
- Bayer HealthCare and Janssen Pharmaceuticals have announced a clinical collaboration agreement with Portola Pharmaceuticals to evaluate the safety of PRT4445, an investigational antidote for Factor Xa inhibitors, in healthy volunteers who have been administered the oral anticoagulant Xarelto® (rivaroxaban). This proof-of-concept study, comprising multiple cohorts with different anticoagulants being tested, is expected to be completed in the second half of 2013.
- The study is designed to evaluate the safety of multiple dosage strengths of PRT4445 in combination with Xarelto® in order to determine the dose of PRT4445 that would be required to reverse the anticoagulant activity of Xarelto in emergency situations. Standard clinical measures are currently employed to manage these patients and events. Bayer and Janssen will make an undisclosed payment to Portola and will provide development and regulatory guidance for the study. Portola retains all global development and commercialization rights for PRT4445.
Is
general: Yes
