A-007: IMMUNE MODULATION OF HPV - CERVICAL CANCER

DESCRIPTION: (Applicant's Description) 4,4'-Dihydroxybenzophenone-2,4-dinitrophenylhydrazone (A-007) has recently completed a Phase I clinical trial in advanced cancer with minimal toxicity and objective responses noted. Preliminary observations suggest that A-007 is able to stimulate lymphocyte mobilization when applied topically to normal skin, as well as, to metastatic cutaneous lesions. The specific objectives of this Phase I study will be to document A-007's ability to stimulate lymphocyte migration/activation in cancers associated with immunodeficiency related infections. A-007's functional groups will be modified to maximize pharmacophore activities. All new hydrazones, as well as, A-007 will be assayed in vitro/in vivo for lymphocyte stimulation properties. These studies will be expanded for use as a stimulant of local cervical immunity in a simian immunodeficiency virus (SIV) monkey model and as local treatment for young females with HPV-associated cervical cancers. PROPOSED COMMERCIAL APPLICATION: 4,4'-Dihydroxybenzophenone-2, 4-dinitrophenylhydrazone (A-007) is showing lymphocyte stimulation and anticancer activities in clinical trials. A new agent with anticancer/immune modulation activity in HPV associated cervical cancer would have wide use as a single agent or in combinations therapy.