ImmunotherapywithLeukocyteInterleukin,InjectionforHuman.pptVIP

Immunotherapy with Leukocyte Interleukin, Injection for Human Papilloma Virus (HPV) Induced Cervical Dysplasia In HIV Patients Taylor G1,2, Ely L1, Wolff T2, Davis C1,2, Ioffe O1, Talor E3, Khanna N2, Redfield R1,2, and Tramont E4. Institute of Human Virology, Baltimore, MD1; University of Maryland, Baltimore, MD2 CEL-SCI Corporation, Vienna, VA3 and NIAID, Bethesda, MD4 ABSTRACT HPV causes greater than 90% of pre-cancerous cervical lesions leading to cervical cancer. Co- infection with HPV in HIV-infected patients is common and cervical cancer is considered an AIDS defining illness. Local immune responses associated with inflammation can clear cervical HPV infection. Therefore, we hypothesized that local immunity with Leukocyte Interleukin, Injection (MultikineTM) a natural mixture of pro-inflammatory cytokines and chemokines [containing: IL-2, IL- 1?, IFN-gamma, TNF-alpha, GM-CSF, among others], can improve and/or cure HPV-induced cervical disease. Preliminary results from this on-going Phase I, dose-escalating study, in which 200 IU (as IL- 2) [lowest dose tested] was administered by endocervical/perilesional injections 16-20 times over a 6 week period to 5 dually infected (HPV/HIV) patient volunteers with moderate to severe cervical dysplasia. All of the patient volunteers tolerated the injections well and without any associated serious adverse reactions. Five out of five patient volunteers had clinical improvement by colposcopic visualization; 3/4 had no evidence of residual dysplasia on punch biopsy 7-8 weeks after the final injection. Biopsies on the remaining patient volunteer had no change in the histopathology. One patient was lost to follow-up. Quantitative HPV PCR data are pending. Leukocyte Interleukin, Injection did not increase peripheral blood HIV levels by PCR. Dose-ranging studies are proceeding. A pivotal trial is in the planning stage. . HPV-ASSOCIATED CONDITIONS Skin warts Anogenital warts Cervi