Epicyte Pharmaceutical Advances Production of Human HIV Antibodies in Plants.

Business Editors & Health/Medical Writers

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SAN DIEGO--(BUSINESS WIRE)--Jan. 28, 2003

San Diego Biopharmaceutical Company Takes Antibody Production from

Cell Culture to Plants to Prevent HIV Transmission

Epicyte Pharmaceutical, Inc., a San Diego biopharmaceutical company focused on the discovery and development of human monoclonal antibodies, today announced that it is growing the first greenhouse plant lines to yield an antibody product for the prevention of HIV, an illness that infects 900,000 people in the U.S. but that experts predict could infect 25 million in India and 15 million in China by the end of this decade. The HIV plantibodies were developed as part of a National Institutes of Health Advanced Technology SBIR award.

"HIV infection rates clearly represent a global health threat of frightening magnitude," said Kevin Whaley, Epicyte's Director of antibody discovery. "The current high drug production costs and capacity constraints have been one of the biggest challenges. But Epicyte's Plantibodies(TM) technology has the potential to break the production bottleneck and reduce production costs by 50 percent or more."

Epicyte plans to produce three human IgA antibodies in plants: 2G12, 4E10 and 2F5, all of which bind HIV envelope proteins that are critical in the infectious pathway. These antibodies were developed and licensed to Epicyte by Dr. Hermann Katinger, head of the Institute of Applied Microbiology at Vienna's University of Natural Resources and Applied Life Sciences.

"These antibodies have the potential to neutralize a diverse array of HIV types and could have a dramatic effect on HIV prevention," said Dr. Katinger. "These antibodies together with Epicyte's progress on perfecting its production methods make the possibility of a preventative product very encouraging."

Epicyte is slated to become the first U.S. company to enter Phase I clinical trials with a human herpes antibody produced in plants. The company plans to begin trials this year with HX8, a treatment for herpes simplex virus, which infects 50 million people in the U.S. alone. In May 2002, Epicyte also announced that it had seeded a corn crop with R-19, an antibody to treat respiratory syncytial virus (RSV).

Epicyte has been awarded three grants from the National Institute of Allergy and Infectious Diseases to apply the company's proprietary technology for the cost-effective, large-scale production of antibodies and hybrid antibodies to block the transmission of HIV. Successful completion of two of the $600,000 phase I grants offers Epicyte the opportunity to apply for a phase II support that may include $3 million in clinical trials. The grants are a nondiluting investment in the development of pipeline products.

About 40,000 new HIV infections occur in the U.S. every year, according to the Centers for Disease Control. From the beginning of the epidemic through December 2000, the CDC reported 448,060 deaths. Twenty years into the AIDS epidemic, 40 million people are living with HIV globally, and 25 million have died. If many countries continue to respond ineffectively, in the next 20 years close to 70 million people will die because of AIDS, according to a 2002 report by the U.N.

Epicyte has broad and exclusive commercial rights to a U.S. patent claiming any transgenic plant that expresses any antibody, including human monoclonal antibodies. This technology allows Epicyte to produce large quantities of antibodies at substantially reduced capital and manufacturing costs.

About Epicyte

Epicyte Pharmaceutical Inc. is a biopharmaceutical company focused on the discovery and development of therapeutics to treat inflammatory and infectious diseases. The company's proprietary technology for producing antibodies in plants allows Epicyte to address an unmet need -- making antibody treatments for common infectious diseases in large enough quantities for widespread use. High production costs associated with traditional methods for producing antibodies have limited their use as a disease treatment. Epicyte's technology for growing antibodies in plants is scalable and cost effective. For additional information, visit www.epicyte.com.