Applied Immune Sciences Inc. (AIS) announced Tuesday thatthe Recombinant DNA Advisory Committee (RAC) of theNational Institutes of Health has approved a protocol utilizingcell selection technology and gene therapy designed to enhancechemotherapy tolerance for breast cancer patients.
The protocol, which uses a multiple drug resistance (MDR)gene-carrying virus to protect the immune system's stem cells,will be used in a clinical study to be conducted by KarenAntman and Charles Hesdorfer at Columbia University Collegeof Physicians and Surgeons in New York. The study will alsoinclude patients who have ovarian cancer and brain tumors,AIS said.
AIS is sponsoring the trial and is providing its AIS Cellectorcell-selection technology that has the ability to separatehematopoietic stem cells (CD34+ cells) from the bone marrowfor gene therapy. Cancer cells are simultaneously purged.
The key to the treatment's success, said AIS of Santa Clara,Calif., is the introduction of the gene-carrying virus into theselected CD34+ bone marrow stem cells prior to reinfusion viabone marrow transplantation. The MDR gene should enhancethe cells' tolerance of the effects of chemotherapy, allowingpatients to be given higher doses than usual with fewer sideeffects.
Genetix Pharmaceuticals Inc. of New York developed the MDRgene therapy technology for cancer treatment and is supplyingthe gene for the study. AIS made an equity investment inGenetix in January.
AIS's stock (NASDAQ:AISX) was up $1.25 a share on Tuesday,closing at $21.
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