CELL THERAPY SHRINKS TUMORS IN EARLY TRIALApplied Immune Sciences Inc. (AIS) presented research onThursday at the Ninth International Conference on AIDS inBerlin showing that its cell therapy can reduce AIDS patients'tumors.
In an extended Phase I safety trial at Miami VeteransAdministration Hospital, investigator Nancy Klimas has beenadministering activated CD8 cells to 10 HIV-positive patientswho have Kaposi's sarcoma (KS) tumors.
The so-called killer T cells are isolated with the company'sCELLector device and expanded with interleukin-2 (IL-2). Thecells are then activated with the chemical phytohemaglutininand reinfused.
Activated CD8 cells can stop HIV from multiplying andeliminate cells infected with HIV.
Eight of Klimas' patients had received enough infusions to beevaluated for the presentation on Thursday. Of those, fourpatients had their tumors shrink by at least 50 percent.
The study involves five cell infusions over five months,accompanied by short courses of low dose infusions of IL-2, animmune system protein that supports the activity of theinfused cells.
In an initial safety study of six other patients with varioussymptoms, all six completely recovered from some AIDSmanifestations, and others showed significant improvement.
-- Two hairy leukaplakia mouth conditions were resolved and athird patient improved.
-- Both of the KS patients improved.
-- All five fungal infections cleared up.
-- Three patients gained weight.
These unexpected signs of the therapy's benefit during a trialdesigned to merely test safety spurred the investigators tostudy the 10 additional KS patients.
One of the most graphic indications of improvement in the firstgroup, Klimas wrote in a supplement to the April 1992 issue ofSeminars in Hematology, was seen in a man whose KS hadcaused elephantine legs. The KS tumors regressed 70 percent,and the leg swelling came down in three days. After not beingable to even wear shoes for more than six months, the man"was able to go dancing," she wrote.
In the KS patients currently under study, she said, "most of thepatients we are treating are in an advanced stage, and mosthave not been responsive to previous anti-tumor treatments.The bottom line is that this trial was to ascertain the safety ofthe treatment, and that has been demonstrated."
A Phase II study of similar design is under way at SanFrancisco General Hospital through a grant from AIS(NASDAQ:AISX) of Santa Clara, Calif., which announced a $113million pact last week with Rhone-Poulenc Rorer to establish aglobal network of cell therapy centers and collaborate on celland gene therapies. -- Nancy Garcia
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