Noxopharm announced the U.S. FDA has approved the Investigational New Drug (IND) application for Veyonda for combination treatment with doxorubicin in patients with soft tissue sarcomas.
Veyonda is a suppository dosage form of the small molecule idronoxil, a first-in-class inhibitor of sphingosine-1-phosphate (S1P). By inhibiting the overexpression of S1P-driven pro-survival pathways in solid tumors, idronoxil is designed to sensitize cancer cells to the anti-cancer effects of drugs such as doxorubicin, as well as to radiation.
A phase I trial, CEP-1, demonstrated positive data. CEP-1 was a multi-center, open-label, non-randomized, study in patients with metastatic solid tumors (breast, prostate, lung, ovarian and head & neck). Treatment consisted of monotherapy lead-in followed by up to 6 cycles of Veyonda in combination with lower-dose carboplatin (50% of standard for cycles 1-3, followed by 75% of standard for cycles 4-6). Efficacy assessment included overall response according to RECIST v1.1 criteria. Of the 8 patients (2 in the 400 mg cohort and 6 in the 800 mg cohort) who completed 6 cycles of carboplatin in combination with Veyonda (on days 1-7 of each cycle), 1 patient (in the 800 mg cohort) had a partial response, 5 patients had stable disease (1 patient in the 400 mg cohort and 4 patients in the 800 mg cohort) and 2 patients had progressive disease (1 patient in each dose cohort). Veyonda was well tolerated. One adverse event, anemia, was related to Veyonda.
Two clinical studies are currently underway in Australia. Both studies are enrolling men with metastatic Castrate Resistant Prostate Cancer (mCRPC). DARRT-1 is a multi-center, open-label dose escalation and dose expansion study, and LuPIN is an investigator-initiated trial being led by Professor Louise Emmett at St Vincent’s hospital in Sydney.