Vasogen Inc. entered an underwriting agreement on a bought-deal basis for a C$17 million (US$10.84 million) financing to advance clinical trials of its immune modulation therapy.

Toronto-based Vasogen sold about 3.5 million shares at C$4.85. It now has about 52 million shares outstanding, and had C$45 million in cash as of April 30, President and CEO David Elsley said. The syndicate of underwriters was led by Research Capital Corp., also of Toronto.

“The money will enable us to immediately accelerate into a Phase III trial for congestive heart failure based on our Phase II results,” Elsley said, adding that the positive results reported earlier this year put the company two years ahead of schedule in that indication.

Elsley said the Phase III trial will take about two years to complete.

When the results of the Phase II trial were reported in February, Elsley said he expected to file with the FDA’s Bureau of Medical Devices by the end of 2004. Previously, the company expected to launch the product in that indication in early 2006 or 2007. Following the Phase II results, he said he expected the product launch to occur as early as 2005. (See BioWorld Today, March 1, 2002.)

The Phase III trial in congestive heart failure will be the company’s second. A Phase III trial is under way in peripheral arterial disease, for which Vasogen expects results in late 2003, Elsley said.

Immune modulation therapy is delivered during a 20-minute outpatient procedure involving the stressing of a small sample of a patient’s blood using a medical device, followed by the administration of the stressed cells back to the patient. By interacting with the patient’s immune system, macrophages and dendritic cells are triggered by the stressed cells to produce regulatory cytokines. That is intended to lead to a decrease in pro-inflammatory Th1 cells and cytokines. Simultaneously, the number of Th2 cells is increased, which leads to increased production of regulatory cytokines. The process of modulating levels of both anti-inflammatory and pro-inflammatory cytokines leads to a decrease in inflammation, the company said.

Additionally, the company has a Phase I/II trial in chronic lymphocytic leukemia, a Phase II trial in psoriasis, and a pilot Phase I/II trial in graft-vs.-host disease, which, if successful, would lead to a larger study, Elsley said.

Vasogen also is studying preclinical candidates in neurology.

Vasogen’s stock (TSE:VAS) fell C49 cents Tuesday to close at C$4.90.

No Comments