Epix to develop high resolution blood clot imaging agent for MRI

Contrast agent developer Epix Medical hopes to change the way clinicians treat cardiovascular disease. The company has announced that it is developing EP-862, an MRI imaging agent designed to detect blood clots. Although Epix has not yet begun human clinical trials for the agent, it believes that EP-862 could revolutionize how MRI is used: Rather than primarily imaging the head, neck, and joints, the modality could be used to scan for cardiovascular disease, a systemic condition.

Currently being tested in preclinical animal models, gadolinium-based EP-862 binds to the protein fibrin found in clots, which has never been targeted, according to Epix. Complicating the task of marking fibrin is a similar protein, fibrinogen, which appears in the blood and is a precursor to fibrin, and the fact that fibrin is at a much lower concentration than fibrinogen.

“No one’s ever used fibrin as (a contrast agent target),” said Michael Webb, Epix CEO. “Fibrin is difficult to target by itself. But we’ve been able to find a targeting group that only marks fibrin and avoids fibrinogen.”

The company believes that both EP-862 and the firm’s other agent, AngioMark, have advantages over modalities traditionally used to image arterial plaque or blood clots. For atherosclerosis, x-ray angiography is invasive, and clinicians can image only one arterial bed at a time. For thromboembolic disease, ultrasound or nuclear medicine scans are less invasive, but also less specific. Used with MRI, a noninvasive modality, the new agent can image submillimeter arterial and venous blood clots throughout the body in one MR exam. EP-862 highlights the clot, making it bright and the surrounding blood dark.

When AngioMark and EP-862 are brought to market, they will change both the way clinicians use MRI and the way they diagnose and treat cardiovascular disease, according to Webb.

“What’s important about both products is that they will allow the diagnosis of these major cardiovascular diseases to be done in a systemic way. Atherosclerotic and thromboembolic diseases are systemic: If you have plaque buildup or a blood clot in one place, you probably have it in others. But diagnosis and treatment are local,” Webb said. “By using these contrast agents with MRI, clinicians will be able to look at diseases systemically, which will allow the modality to take on a whole new role in cardiovascular disease management.”

Epix plans to seek a sales, marketing, and manufacturing partner for the agent in the coming year, Webb said, but continues to focus on R&D, rather than the marketing side of its business. The company will present its preclinical trial results for EP-862 at this month’s North American Society for Cardiac Imaging meeting in Atlanta, GA.

As for AngioMark, Epix has begun multicenter, comparative, phase III trials for the agent. The trials will compare the diagnostic accuracy of AngioMark-enhanced MRI scans with x-ray angiography, the standard for imaging vascular disease. As it continues to develop AngioMark, Epix plans to exercise its credit option under a collaboration agreement with Mallinckrodt of St. Louis, established last year (SCAN 9/16/98). Epix recently joined forces with Mallinckrodt and Siemens to develop contrast-based cardiovascular MR imaging technologies to improve the diagnosis of atherosclerosis and related diseases (SCAN 10/13/99).

On the financial front, sharply decreased revenues and higher than expected manufacturing costs contributed to lower third quarter (end-September) results for Epix. In both 1998 and 1999, Epix’s third quarter revenues derived from product development contracts, but this year’s results were dramatically lower than last year’s: Epix posted revenues of $70,000, compared with 1998’s $396,000. The company also saw an increase in its net loss for the period, reporting $4.6 million compared with $4 million in 1998.

Epix’s research and development expenses increased by $60,000 for the quarter, which it attributed to higher than anticipated manufacturing costs of material provided to the company’s partner, Daiichi Radioisotope Laboratories of Japan. Increased R&D expenditures were offset in part by decreased clinical trial costs, the company said. Also during its third quarter, Epix forged an alliance with Siemens, adding to its list of MRI scanner manufacturer partners. The company already has partnerships with GE Medical Systems and Philips Medical Systems.

In other Epix news, the company has promoted CFO Stephen Knight to president and COO. Webb, who previously held the title of president, will continue as CEO and assume additional responsibilities for finance and corporate administration.