Washington Editor

BioVascular Inc.'s merger with Revitus, a drug development firm founded by an Oregon biomedical engineering professor, immediately gave the San Diego-based firm its second compound in clinical development for thrombotic vascular diseases.

Under the terms of the merger, BioVascular acquired the full worldwide rights to BVI-007, a thrombopoietin antagonist that reduces platelet production without impacting platelet function.

As part of the merger, Revitus's CEO Stephen Hanson, who heads the department of biomedical engineering at Oregon Health & Science University in Beaverton, will join BioVascular's board of directors. No other terms of the merger were disclosed.

The firms announced the merger just days after the first human subject was dosed in a Phase Ia clinical trial of BVI-007, said BioVascular CEO John H. Parrish. BVI-007 is being developed for the prevention of myocardial infarction, thrombotic stroke and death in patients who have had a previous cardiovascular event, he told BioWorld Today.

Parrish noted that BVI-007 is a compound that reduces platelet production and is very different than products that are used to control platelet aggregation - the clumping together of platelets in the blood, which leads to blood clots.

The safety and tolerability of the product is being tested in 12 healthy volunteers, Parrish said. The firm plans to test dose escalation of the orally administered product in 50 participants in a Phase Ib trial expected to start in the fourth quarter of 2007, Parrish said, adding that both studies are being conducted in Europe.

Results of recent studies in survivors of a first myocardial infarction showed that patients with high platelet counts had a higher risk of a second heart attack compared with those with average or low platelet counts, he noted.

"We believe that a new cardiovascular risk factor has been identified," Parrish said, adding that reducing platelet counts has been shown to reduce a second heart attack and death.

BVI-007, Parrish said, complements BioVascular's Saratin, a polypeptide derived from leech saliva.

Saratin currently is being studied in Europe in two Phase I/II clinical trials for vascular graft failures due to intimal hyperplasia, the thickening of a blood vessel in response to an injury. Intimal hyperplasia is one of the most common reasons for vascular graft failures, Parrish noted. The first of the two Phase I/II studies involves about 50 patients undergoing hemodialysis vascular access graft surgery, and the second involves about 100 patients with peripheral arterial disease undergoing bypass graft surgery, Parrish said.

The product, applied during surgery to the endovascular surface to prevent intimal hyperplasia, is expected to extend the life of those grafts, which have a high rate of failure, he said.

Saratin originally was discovered, developed and patented by Darmstadt, Germany-based Merck KGaA. Merck licensed Saratin to BioVascular in 2005 and remains an investor in the San Diego firm, Parrish noted.

BioVascular's other founding investor, Princeton, N.J.-based Domain Associates LLC, acted as a major catalyst in bringing the San Diego firm together with Revitus, Parrish said, adding that Domain has been a major investor in at least three other firms he previously founded.