MENLO PARK, Calif. -- A second group of AIDS patients inMiami on Monday started a cell therapy that produced startlingresults against AIDS-related complications in a small Phase Istudy.
The ex vivo cell therapy, developed by Applied ImmuneSciences Inc., will be used with 10 patients. The company isalso pursuing cell therapy applications for treating bonemarrow transplantation and cancer.
The second study is technically still a Phase I trial, according toJerry Ford, AIS's manager of public relations and investorrelations. "They (the researchers) obviously decided there areno toxicity problems at the dosage they used," Ford said. Theonly side effect experienced by the patients was mildnervousness caused by interleukin-2, which is used in theprocedure, he said.
"The speed and extent of the successes during the Phase Istudies surprised the investigators a bit," said Thomas B.Okarma, AIS president. Results from the first study, whichended in April, showed that each of six patients had completelyrecovered from at least some AIDS-related complications andshowed significant improvement in others.
AIS stock (NASDAQ:AISX) gained $1.75 a share on Monday,closing at $16.25.
The previous Phase I trial involved three cases of hairyleukoplakia, two cases of Kaposi's sarcoma (KS) and severalfungus infections (cadidiasis and pityriasis versicolor). Two ofthe three leukoplakia cases were resolved, the company said.Both KS cases showed improvement, and all four cases ofcandidiasis and the one case of pityriasis versicolor wereresolved.
Study results, along with another Phase I study conducted inPittsburgh, were summarized in a supplement to the Apriledition of the Seminars in Hematology journal.
AIS's procedure begins with the withdrawal of white bloodcells from the body by leukapheresis. From these cells areextracted a specific set of immune system cells known as CD8-plus, or killer T-cells. The purified CD8-plus cells are thencultured, where they are treated for 14 to 22 days withinterleukin-2 and phytohemaglutinin, a chemical agent thatactivates the cells.
The now numerous and activated CD8-plus cells are thenreinfused into the patient. Ford said the cells work by seekingout HIV-infected cells and destroying them. Other infectionsare attacked as well. Ford said it is too early to tell what kindof an impact the therapy may have, but that the goal is toincrease the length and quality of life of AIDS patients. HStevePayne
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