Awaiting data from an ongoing Phase II trial of Locteron, a controlled-release interferon-alpha candidate for hepatitis C, Biolex Therapeutics Inc. closed a $30 million Series C round to advance that compound into Phase III.

Funds from the oversubscribed round primarily will be invested in Locteron, which is finishing up a Phase II trial in combination with ribavirin in hepatitis C patients, though some money also will be used to support further development of other pipeline products, said Jan Turek, president and CEO of the Pittsboro, N.C.-based firm. Biolex creates its drug candidates based on its LEX System, an expression system designed to produce hard-to-make proteins and to optimize monoclonal antibodies.

That system produced BLX-883, the recombinant interferon-alpha which is combined with the PolyActive controlled-release drug delivery technology from OctoPlus NV to make Locteron. The companies have a co-development partnership dating back to early 2005 aimed at improving the formulation and administration of interferon. Existing treatment of hepatitis C involves a co-therapy regimen featuring an antiviral agent - most commonly ribavirin, though several investigational protease inhibitors and polymerase inhibitors have shown promise in the clinic - in combination with a modified version of interferon, such as Pegylated interferon.

The downside of Pegylated interferon, however, is that it has to be dosed on a once-weekly basis and produces side effects, such as a "quite debilitating flu-like illness," that can last for two days, Turek said. He added that Locteron offers a "substantial improvement" to that by requiring less frequent dosing - once every two weeks. "And we were able to fine-tune the way the drug is delivered to greatly diminish" those flu-like side effects.

Trial data so far have shown that only at the highest dose tested do some of the side effects start showing up, but even then the symptoms often only lasted for one day instead of two, Turek said.

The overall hepatitis C market is expected to grow to as much as $10 billion in the next few years, making it a competitive space for biotech and pharma. Among Biolex's potential competitors is Rockville, Md.-based Human Genome Sciences Inc., which has started Phase III with Albuferon, a long-acting formulation of interferon that, like Locteron, is designed for dosing once every two weeks.

In addition, companies such as Cambridge, Mass.-based Vertex Pharmaceuticals Inc., with its protease inhibitor telaprevir (VX-950), are looking to develop new antiviral agents. While Biolex's clinical program for Locteron has, to date, tested the product in combination with the standard ribavirin, Turek said it's likely that "over the course of clinical development," Locteron will be tested alongside some of those investigational compounds as well.

Biolex has not disclosed a specific timeline for starting Locteron's Phase III development, but Turek estimated that, pending positive pivotal results, the product "could be launched somewhere in the 2012 range."

Behind Locteron, the company has BLX-155, a direct-acting thrombolytic aimed at busting clots in certain diseases, such as acute peripheral arterial disease and deep vein thrombosis. That compound is set to enter the clinic later this year.

In addition, Biolex has partnerships with several other companies, such as Medarex Inc., Genmab A/S, and Centocor Inc., involving the use of its LEX System. The system combines natural characteristics of the Lemna, a tiny, aquatic plant also known as duckweed, with genetic engineering to produce proteins that historically have been too difficult or costly to make. To date, it's demonstrated capabilities in producing proteins, such as peptides and cytokines, as well as monoclonal antibodies.

While Turek said he could not disclose the status of collaborative programs, he told BioWorld Today he is "very pleased with the progress" of those deals. Most recently, Biolex signed animal health company Merial Ltd. to use the LEX System to provide vaccine antigens in exchange for research support and development milestones during the initial phase of the collaboration.

The company declined to disclose how much it had raised to date, though Turek said Biolex has been fortunate to "access the funding required to proceed with" its pipeline development. The company's last financing round, a Series B closed in 2005, brought in $36 million. (See BioWorld Today, Sept. 1, 2005.)

The Series C round was led by Investor Growth Capital, of New York, and included other new investors JP Morgan Securities Inc. and Easton Capital, both also of New York. Existing shareholders included: Philadelphia-based Quaker BioVentures; Boston-based Polaris Venture Partners; Durham, N.C.-based Intersouth Partners; New York-based Mitsui & Co. Venture Partners; New Brunswick, N.J.-based Johnson & Johnson Development Corp.; and Midland, Mich.-based Dow Venture Capital.

Sunny Sharma, of Investor Growth Capital, joined the Biolex board.

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