ThromboGenics Ltd announced the initiation of 2 separate clinical trials for SY162, a novel thrombolytic (clot-dissolving) agent. One of these early Phase II trials will evaluate SY162 for the treatment of central venous catheter (CVC) occlusion, while the other will evaluate SY162 for the treatment of acute peripheral arterial occlusive disease (PAOD).
"The initiation of these trials marks a significant milestone in the history of ThromboGenics," stated Desire Collen, CEO of ThromboGenics. "The company has now advanced 3 programs into Phase II clinical development. This serves as an important validation of the company's ability to efficiently move compounds into the clinic."
The CVC trial will enroll approximately 48 patients, while the PAOD trial will enroll approximately 20 patients. Both trials are being performed in Belgium. Medisearch International has been contracted to monitor both trials.
"The medical community currently has very limited treatment options for either PAOD or CVC occlusion," commented Steve Pakola, M.D., ThromboGenics' Vice President of Clinical Development. "We believe SY162 has the potential to fill an unmet need in both of these indications."
Acute PAOD is associated with significant mortality and morbidity. Treatment options include surgical intervention and intra-arterial administration of a thrombolytic agent. Intra-arterial thrombolysis has the potential advantage of reducing the need for surgery, or for patients who still require surgery after thrombolysis, permitting a less extensive surgical procedure.
CVCs are access devices for chronic administration of medication and for withdrawal of blood for laboratory testing. In excess of 5 million such devices are inserted per year in the United States alone. CVC malfunction (primarily due to thrombotic occlusion) is a common complication requiring intervention. Surgical intervention has numerous disadvantages, which make salvage of the occluded CVC via thrombolysis the preferred treatment option. Because of its unique mechanism of fibrin-specificity, SY162 may prove attractive for the treatment of both CVC malfunction and PAOD.
ThromboGenics Ltd., based in Dublin, Ireland, is a privately-held company focused on developing drugs for the treatment of cardiovascular diseases. The company's lead program, PEG-Sak (pegylated staphlyokinase variant) for treatment of acute myocardial infarction (AMI), is currently being evaluated in a large, Phase II trial. In addition to PEG-Sak and SY162, the company has 5 additional programs in pre-clinical development for thromboembolic diseases, including acute coronary syndromes and stroke.