Bayer reveals next step in Alfimeprase tests

Bayer has said that it has begun the patient enrolment in a second phase III trial of a drug, which has received a Special Protocol Assessment (SPA) agreement from the United States Food and Drug Administration (FDA).

An SPA is granted by the FDA as a written agreement regarding the design and size of a clinical trial with the vision that it will form the basis of a New Drug Application (NDA).

Alfimeprase, a thrombolytic or blood clot dissolver, is the drug awaiting a second phase III trial. Bayer HealthCare has an agreement with Nuvelo regarding the collaboration and commercialisation of the product.

The trial is known as Napa-3 (Novel Arterial Perfusion with Alfimeprase-3) and is primarily evaluating the drugs efficacy for avoiding the need for open vascular surgery within 30 days of the treatment. Other issues, such as safety, are also being evaluated.

“Now that we have initiated Napa-3 and have plans to initiate additional trials in stroke and deep venous thrombosis (DVT), we are well on our way to bringing this potentially transformational therapy to the millions of patients suffering from clot related disorders,” said Dr Michael D Levy, senior vice president of research and development for Nuvelo.

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