The FDA has given the Center for Special Immunology (CSI) thego-ahead to begin a Phase I trial of its cell-transfer therapy inlate-stage AIDS patients, the Fort Lauderdale, Fla., companyannounced Monday. The six-month, open-label safety andtolerance study will look for transfusion reactions, graft-vs.-host disease (GvHD) and other toxicities in 50 patients with Tcell counts under 100 cells/ml.

CSI, which is owned by Health Professional Inc., is developing abio-therapy under which AIDS patients are given monthlyinfusions of human immune globulin followed by cross-matched peripheral blood lymphocytes from closely related,HIV-negative relatives. Patients are also maintained onretroviral therapy and prophylactic therapy againstopportunistic infections.

William Reiter, chairman and chief executive officer of HealthProfessionals and director of research at CSI, told BioWorld thatthe company is essentially continuing a "clinical salvage" pilotstudy in pre-terminal AIDS patients that began last August.That trial did not require FDA approval because it wasessentially an experimental medical procedure, he explained.The company decided to pursue formal FDA approval throughan investigational new drug (IND) application after FDA'sCenter for Biologics Evaluation and Research indicated that itmight expand its regulatory scope to include certain bio-therapies. CSI filed an IND for the procedure last December.

During its pilot study, CSI found that AIDS patients were ableto receive repeated transfusions of cells from relatives, whichCSI calls haplomatched cells, without developing antibodies tothe cells and with only minor symptoms of GvHD. Reiterexplained that the therapy appears to actually take advantageof AIDS' ravaging effect on the immune system. The companyattributes lack of antibody development in patients to immunesuppression caused by the disease.

The company's IND protocol differs from its pilot trial, Reitersaid, in that the company will use commercially licensedhuman immune globulin instead of hyper-immune globulinderived from HIV-positive patients (HIVIG).

CSI is funding the study itself. It owns and operates a networkof research and primary-care facilities, and conducts clinicaltrials in cooperation with pharmaceutical and biotechnologycompanies. The company keeps a detailed data base of clinicalinformation on its patients, Reiter explained, so it is able toquickly prepare for participation in clinical trials with apotential partner. CSI has been involved in experimental AIDStherapies since its inception in 1986, he added.

-- Karl A. Thiel Business Editor

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