Positive Results of Study Evaluating Accuracy and Safety of Agenix Limited's ThromboView(R) Diagnostic Featured in Leading US Peer Review Medical Journal
Published: Jul 08, 2011
The 52 patient multi-centre Phase II study led by Principal Investigator Dr Timothy Morris from the University of California San Diego Medical Center, found ThromboView® was well tolerated by patients and enhanced the ability to accurately diagnose acute pulmonary embolism.
All patients in the study conducted at six hospitals in Canada and the US were being evaluated because of suspected acute pulmonary embolism. The sensitivity and specificity of ThromboView® for acute pulmonary embolism was comparable to what had been previously reported for contrast-enhanced CT scanning.
The researchers reported no adverse events and concluded that ThromboView® was accurate, safe and well-tolerated in patients with a range of co-existing diseases in the chest and elsewhere.
Dr Morris said, "The safe and accurate diagnosis of acute pulmonary embolism remains a challenge and many deaths still occur before the problem is detected. There is a large unmet medical need worldwide for an accurate test that can detect blood clots throughout the body without exposing patients to toxic contrast agents and the high radiation dose to the chest associated with a CT scan.”
Venous thromboembolism is a disease that includes deep vein thrombosis and pulmonary embolism. In the USA alone, there are 600,000 clinically recognized incidences of venous thromboembolism annually. Pulmonary embolism is the third most common cardiovascular illness after acute coronary syndrome and stroke. It is also the third most common cause of hospital-related death and the most common preventable hospital-related death due to a failure by available medical technology to accurately diagnose this life threatening problem.
The current standard for diagnosing pulmonary embolism is a procedure called computed tomography pulmonary angiography. It delivers a substantial radiation dose to the chest and involves the injection of a contrast agent through the patient’s leg or arm. A CAT scanner then takes a series of images of the lungs from different angles.
ThromboView offers a more accurate test without exposing patients to contrast agents that can be highly toxic to the kidneys, nor to the high radiation dosages to the chest associated with computed tomography pulmonary angiography. Thromboview only requires only a standard hospital gamma camera to take a single photon emission tomography (SPECT) image from which the reader can easily identify the presence, absence and location of a blood clot.
Thromboview® has successfully completed two US Food and Drug Administration (FDA) Phase II human clinical trials. Agenix has revitalized its partnering program for this valuable technology and is currently working to establish a number of solid, financially beneficial opportunities with global medical and pharmaceutical partner organisations to help expedite the final clinical phase for the US and European regulatory approval of ThromboView®.
Agenix is working to create access-to-technology and royalty revenue streams which will extend beyond expiry of its patents in 2022, namely 12 years from the date of regulatory approval for biologics in the USA and 10 years in Europe.
A copy of the results and the full article entitled "SPECT Imaging of Pulmonary Emboli with Radiolabeled Thrombus-Specific Imaging Agents" can be found at http://ajrccm.atsjournals.org
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