Mitsui Ventures NEWS

NEWS 2005

[10/26/2005]

Biolex Therapeutics Successfully Completes Phase 1 Study For First LEX System Produced Therapeutic Protein


PITTSBORO, NORTH CAROLINA, October 26, 2005 - Biolex Therapeutics, a protein therapeutics company, today announced the successful completion of a Phase 1 clinical trial of BLX-883, a form of alfa interferon. BLX-883 is the first clinical-stage therapeutic candidate produced in Biolex' GMP facilities using its proprietary LEX System?. In the Phase 1 study BLX- 883 was safely administered at a clinically relevant dose and demonstrated bioactivity consistent with IntronR A, a currently marketed alfa interferon used as a comparator. Alfa interferon is used in the treatment of hepatitis C, hepatitis B, and multiple cancers and its worldwide sales currently exceed $3 billion.

The Phase 1 study was designed to evaluate the safety and pharmacology of BLX-883 in 24 healthy volunteers. The study was conducted under an IND submitted to the United States FDA and a CTA filed with the United Kingdom MHRA. Participants were administered one of three doses of BLX- 883. The 12 participants who received the clinically relevant dose of 3 million international units also received the same dose of Intron A to allow for a direct comparison of the two agents. No safety concerns arose during the study, and the side effects attributable to BLX-883 and Intron A were comparable. Bioactivity of the two agents was also compared, and the elevation of specific immune system markers, such as neopterin, measured after administration of BLX-883 was consistent to the elevation measured after administration of Intron A.

Biolex has selected hepatitis C as the first indication for the commercialization of its alfa interferon program. In February of 2005, Biolex formed a partnership with OctoPlus, a drug delivery and development company based in the Netherlands, for the joint development of a controlled-release formulation of alfa interferon. The product under joint development, Locteron?, combines BLX-883 with OctoPlus' proprietary biodegradable PolyActive? drug delivery technology, and is designed to be a best-in-class therapeutic for patients with chronic hepatitis C.

"The results from the recently completed Phase 1 study of BLX-883 support continued development of this protein," said Jan Turek, Chief Executive Officer of Biolex. "These results are consistent with our expectation that the LEX System has the capability to produce proteins comparable to those produced in traditional expression systems but with substantially lower capital and operating costs. The Phase 1 results make us even more optimistic about the potential of Locteron to offer patients with chronic hepatitis C a more convenient, controlled-release interferon that may be better tolerated than currently available pegylated interferon therapies."

About Biolex Therapeutics

Biolex Therapeutics is developing and commercializing therapeutic proteins based on the LEX SystemSM, its patented expression system that enables the production of hard-to-make proteins and the optimization of monoclonal antibodies.

The Company is developing a proprietary pipeline of products that rely upon known mechanisms of action to provide a reduced risk profile while targeting large, proven pharmaceutical markets. Biolex's lead clinical candidate, Locteron? is being developed as a best-in-class controlled-release interferon alfa for the treatment of hepatitis C.

The Company's second product candidate, BLX-155, is a direct-acting thrombolytic, designed to break up clots in certain diseases such as acute peripheral arterial disease, deep vein thrombosis and catheter occlusion. In addition, the unique capabilities of the LEX System have led to collaborations with Centocor, Medarex and other leading pharmaceutical/biotech companies.

Biolex is a venture capital-backed company located in the Research Triangle region of North Carolina, United States. For additional information, please visit Biolex's web site at http://www.biolex.com

http://www.biolex.com/

Contact:

Michelle Linn, Linnden Communications, 508-419-1555, linnmich@comcast.net.

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