Washington Editor

For any young biotech, finances generally determine the pace at which a firm can pursue product development, said Jim Pachence, CEO of Princeton, N.J.-based Virium Pharmaceuticals Inc.

The more money a company has, the more aggressive it can be in getting into the clinic, he said, noting that his firm so far has raised $3.7 million in its first round from a single investor group, SCO Capital Partners, of New York.

But, Pachence said, vital to Virium's strategy - in-licensing late-stage preclinical and early-stage clinical small organic molecules and further developing the compounds in oncology - is not only the company's financial strength and capacity to identify compounds with the potential to make it to the market, but the firm's ability to identify organizations with which it can build strong relationships.

"We look for, obviously, world-class places that we feel could be added value to the company," he said.

Currently, the 2-year-old biopharmaceutical firm has agreements with the National Cancer Institute (NCI) and Birmingham, Ala.-based Southern Research Institute (SRI).

While Pachence would not disclose the specific financial terms of the NCI and SRI deals, both agreements, which he described as being "approximately the same," have "pretty traditional milestones and royalties associated with a compound that is in midstage development."

Under its deal with NCI, Virium is developing phenylbutyrate, an amino acid derivative, as a histone-deacetylase inhibitor to treat glioblastoma, a deadly form of brain cancer.

Phenylbutyrate is approved in the U.S. to treat urea cycle disorders and is sold under the brand name Buphenyl by Ucyclyd Pharma, a wholly owned subsidiary of Scottsdale, Ariz.-based Medicis Pharmaceutical Corp.

"There's no conflict, no overlap between the intellectual property that we have and what Medicis is doing," Pachence emphasized.

The NCI agreement includes access to a large portfolio of phenylbutyrate Phase I data, he noted, adding that the studies demonstrated some indication of efficacy for glioblastoma.

The NCI phenylbutyrate portfolio, Pachence explained, includes about 25 patents.

"It's a very strong patent library, and it covers phenylbutyrate for many indications," he said. "Our goal is to pursue the cancer indications and then provide licenses to those folks who want to look at other indications, such as CNS diseases and dermatology applications for phenylbutyrate."

The firm expects to start a Phase II trial of phenylbutyrate in glioblastoma in the second quarter of 2008, Pachence said.

In addition to the glioblastoma indication, Virium plans to pursue at least one other cancer indication for phenylbutyrate.

"With the NCI data, there is possible efficacy for a number of leukemia indications as well as the possibility for certain solid tumors," Pachence said.

The timeline for starting the Phase II trials of the second yet-to-be determined cancer indication for phenylbutyrate is contingent on the company's future financing, he said, noting that Virium is in discussions with an undisclosed group for a second round of funding, expected to close in the first quarter.

Under a cash and stock deal with SRI, Virium gained the rights to SR9025, a third-generation nucleoside analogue that has shown activity in two Phase I trials against certain types of leukemia and autoimmune diseases.

Virium renamed the analogue VP700 and will develop the nucleoside as a series of compounds, Pachence said.

The company plans to enter Phase II trials in the second quarter of 2008 with the first drug, known currently as VP701, in certain gastrointestinal and leukemia cancers.

The VP700 series, Pachence said, "potentially has some broad noncancer indications, which we are going to purse with the Southern Research Institute."

In addition to its two lead compounds, Virium plans to develop other early stage compounds under agreements with the University of Medicine and Dentistry of New Jersey (UMDNJ) and an undisclosed organization, Pachence said.

The UMDNJ deal, he noted, came about through the company's relationship with pharmacology professor William Welsh, whom Pachence described as an "up-and-coming entrepreneurial scientist."

"We've built a nice relationship with him and his laboratory, and we feel that this is one compound of many that can be developed," he said. Virium will develop the UMDNJ compound, which is in early preclinical development, in colorectal cancer.

Because Virium was in the process of finalizing the deal with the undisclosed firm, Pachence said he could not divulge any details about the agreement or the compound involved.

"We consider it close enough to getting the deal done, but we feel like we don't want to disclose it quite yet."

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