AP-001 is a topical delivery system that incorporates interferon alpha-2b in Altum’s patented BiPhasix™ technology. The BiPhasix system uniquely enables efficient delivery of biomolecules across the mucosa.
Interferon alpha-2b is a potent, broad acting anti-viral agent, with established anti-HPV activity. Intron A® is approved for treatment of HPV induced genital warts (condylomata acuminate). Treatment requires intra-lesional injections three times a week. This administration makes it very difficult to use in indications such as HPV-cervical neoplasia, where lesions are not readily visible and the multiple local injections impair patient quality of life on many levels. There is also the cost and inconvenience of repeated healthcare professional visits for the injections. Intron A has therefore not been developed in this indication. Intravenous interferon results in systemic toxicities which precludes its use for treatment of cervical HPV. HPV-cervical dysplasia is a local disease ideally treatment with the local delivery of interferon alpha-2b. The delivery should be easy to use and self-administered at home and safe, without systemic and local side effects). AP-001 is intended to fulfill this need.
AP-001 is a self-administered intra-vaginal cream. It fills the vagina in proximity to the cervix following self- administration. The product’s viscosity prevents vaginal leakage of the cream following administration, thereby allowing prolonged coating the cervix for optimal drug delivery. AP-002 has completed Phase 1 and Phase 2 clinical trials, where it was shown to be active (in cervical neoplasia regression) and safe (no systemic or local side effects). An adaptive design Phase 3 clinical trial in HPV-cervical HSIL patients is projected to be initiated in Q2 2019.