Diatide submits NDA for AcuTect

Peptide-based imaging agent developer Diatide passed a milestone last month when the company filed a new drug application with the Food and Drug Administration for its lead product, AcuTect. Formerly known as P280, AcuTect is a technetium-labeled agent designed for the detection and localization of acute venous thrombosis.

AcuTect is designed to be an improvement on existing imaging technologies because it can determine whether a thrombus is acute and actively forming or chronic and stable. Acute thrombi present more of a threat because they can cause a life-threatening pulmonary embolism, unlike chronic thrombi.

Current imaging technologies can detect whether there is a flow disturbance or blockage in the affected blood vessel, but not whether the blockage is an acute or chronic thrombus. AcuTect can determine the difference because its peptide component is designed to adhere to receptors on the surface of activated platelets, which are integral parts of acute thrombi. As thrombi age and become chronic, the activated platelets break down, and AcuTect will no longer image the thrombus.

Diatide also believes that AcuTect will be easier to use in some applications than either ultrasound or contrast venography. Ultrasound has difficulties imaging veins in the upper calf or extremities, according to the company, and contrast venography is painful for patients and can have side-effects. Diatide estimates that three million procedures are conducted worldwide each year to diagnose deep vein thrombosis.

Norwegian contrast firm Nycomed has distribution rights to AcuTect in Europe, South Africa, and the Middle East, and shares distribution rights with Diatide for the U.S. market. Nycomed plans to file for European regulatory approval of AcuTect in the fourth quarter.