United Press International - Friday, 6 July 2001

Wake Forest School of Medicine researcher Louis Kucera, who pioneered the technique, has formed a partnership with Wake Forest and the University of North Carolina at Chapel Hill to further develop new combination drug products using the delivery system.

The new combinations will enable chemotherapy and antiviral agents to be delivered by mouth instead of intravenously, said Ross Read, chief executive officer of the new company, Kucera Pharmaceuticals, in Winston-Salem. Kucera, a professor of microbiology and immunology, already holds five U.S. patents and has several pending patents in relation to his research at Wake Forest. The university and UNC have licensed those patents to the new company, Read said.

"This technology is applicable to drug delivery not only for treatment of HIV infections but also for cancer and other diseases," he told United Press International. "We are developing new strategies for treating not only cancer, AIDS and hepatitis, but also central nervous system diseases like Alzheimer's and Parkinson's."

The key to the new company is the drug delivery system using a new class of phospholipids, which the company calls pro-drug carriers. Phospholipids, considered the "backbone" of cells, are a major component of plasma membranes. Their properties are biologically significant because the phosphate group is hydrophilic - meaning it attracts water -- and the lipid component is hydrophobic - meaning it repels water -- giving them polarity in an aqueous environment such as plasma. In 1988, Kucera demonstrated that certain phospholipids were active against HIV in human white blood cells and that when one specific phospholipid was combined with the potent AIDS/HIV drug AZT, it has several advantages over AZT by itself.

"The combination markedly reduced the toxicity of AZT," said Read. "And it preferentially targeted lymphoid tissue and the brain, which serve as reservoirs for HIV infection." The combination already has gone through phase I and phase II clinical trials, he noted.

The new company is exploring with a major drug company partner using a similar technique to target hepatitis B and C and combine the delivery system with cancer drugs.

"Since the phospholipids target the lymphoid system and cross the blood-brain barrier, they might be especially helpful against lymphomas, leukemias and brain tumors," he said. "The drugs go right to the cell, so not only are they more potent, they do not interact with organs like the liver and kidneys and therefore they are less toxic." Once they get inside the cells, a specialized enzyme "cleans" the drugs from the delivery system lipids and they are released at the infection or tumor site.

"It's a brand new way to deliver these drugs by mouth," said Dr. Ellis Roberts, a bioengineering researcher at the University of Washington in Seattle. "This will help to improve our understanding of the transport of specific agents to cancer and infection sites, providing new knowledge for the design of better and safer delivery."

"Finding an ideal carrier system is half the battle," Roberts told UPI. "Current systems are often difficult to produce, and may target only a few cells or offer merely a temporary effect."

(Reported by UPI Medical Writer Kurt Samson in Washington.)

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