The Center for Special Immunology (CSI) has filed aninvestigational new drug (IND) application with FDA to conducta Phase I trial of a lymphocyte replacement therapy forpatients with late-stage AIDS.

CSI announced the filing on Tuesday, saying its ImmuneReconstitution Cell Transfer Therapy utilizes monthly infusionsof licensed human intravenous globulin followed by closelymatched peripheral blood lymphocytes from an HIV-negativedonor who is usually a close relative. Patients will bemaintained on anti-retroviral and prophylactic therapy againstopportunistic infections.

William Reiter, chairman and chief executive officer of CSI'sparent company, Health Professionals Inc., told BioWorld that a19-patient pilot study showed that patients could repeatedlyreceive cells from the same donor without developingantibodies to the cells. The study also found that graft vs. hostdisease was minor -- consisting of fever, lymph node swelling,diarrhea and muscle aches -- and self-limited.

Last August, FDA approved a limited IND to permit CSI and itsaffiliated physicians to continue the therapy in patientspreviously enrolled in the pilot program.

CSI of Fort Lauderdale, Fla., owns and operates a network ofresearch and primary care facilities, and conducts clinical trialsin cooperation with pharmaceutical and biotechnologycompanies. Physicians affiliated with CSI developed theimmune reconstitution therapy. Reiter said a number ofcompanies have expressed interest in the therapy, but CSI isretaining the treatment until it is further developed.

Reiter noted that CSI originally used hyperimmune globulinfrom HIV-infected individuals (HIVIG), but is now usingregular immune globulin. He said HIVIG is obtained from asmall pool of HIV-positive people, whereas thousands of peoplecontribute to the pool of regular immune globulin. Reiter saidthat with the larger pool of donors, one is more likely to obtaina broader spectrum of antibodies against a greater number ofpathogens.

-- Brenda Sandburg News Editor

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