On February 25, 2020 Noxopharm (ASX: NOX) reported that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for Veyonda for combination treatment with doxorubicin in patients with soft tissue sarcomas (Press release, Noxopharm, FEB 25, 2020, View Source [SID1234554750]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Based on preclinical and clinical data, the FDA’s approval of this IND is validation of the clinical potential of Veyonda," said Noxopharm CMO Gisela Mautner, M.D., Ph.D. "Further, it means that Veyonda has met stringent FDA standards for safety and tolerability."

"While the Company’s resources and energies are primarily focused on bringing a treatment for late-stage prostate cancer to market, this IND grant for a less common cancer type advances that commercial objective," said Noxopharm CEO Graham Kelly, Ph.D. "The recent IND approval process has familiarized the FDA with Veyonda ahead of IND applications for more advanced DARRT and LuPIN study submissions. It also opens the door to Veyonda’s use in the U.S., where patient demand has been growing."

DARRT and LuPIN are ongoing investigations in which combination therapies with Veyonda are exhibiting promising interim results for the treatment of late-stage, progressive prostate cancer resistant to other treatments.

"This IND grant is an important step toward achieving a strategic partnering arrangement," Kelly said. "With the emerging clinical data and growing evidence that Veyonda is a uniquely acting immuno-oncology drug candidate designed to restore immune function to cold tumors, we are confident that the industry will recognize the considerable opportunities in the adjunctive benefits of Veyonda."

Veyonda is a suppository dosage form of 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.