Advaxis Announces FDA Clearance Of IND Application For Phase 2 Study Of ADXS-HPV

(RTTNews) - Advaxis Inc. (ADXS) announced the clearance of the Investigational New Drug or IND application by the United States Food and Drug Administration or FDA to conduct a Phase 2 study of ADXS-HPV (ADXS11-001) alone or in combination with Incyte Corp.'s (INCY) investigational oral indoleamine 2,3-dioxygenase 1 or IDO1 inhibitor, epacadostat (INCB24360), for the treatment of Stage I-IIIb human papillomavirus (HPV)-associated cervical cancer.

In February 2015, Advaxis and Incyte reached a non-exclusive clinical trial collaboration agreement to evaluate the combination of ADXS-HPV with epacadostat for the treatment of cervical cancer. The proposed Phase 2 protocol is designed as a multicenter, open-label, preoperative window-study designed to evaluate the safety and efficacy of ADXS-HPV as monotherapy and in combination with epacadostat in approximately 30 patients with Stage I-IIIb human papillomavirus (HPV)-associated cervical cancer. The results will be used to determine whether further clinical development of this combination is warranted.