Rafael Holdings (RFL) Announces CPI-613 Did Not Meet Primary Endpoints in Phase 3 Trial

October 28, 2021 7:02 AM EDT

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Rafael Holdings, Inc., (NYSE: RFL), a holding company focused on developing novel cancer metabolism therapeutics through its Barer Institute, investment in Rafael Pharmaceuticals, Inc. (“Rafael Pharmaceuticals”) as well as other investments in early-stage ventures, today announced that the AVENGER 500 Phase 3 clinical trial for CPI-613® (devimistat), Rafael Pharmaceuticals’ lead product candidate, did not meet its primary endpoint of significant improvement in overall survival in patients with metastatic adenocarcinoma of the pancreas.

In this multi-national Phase 3 randomized clinical trial, 528 patients with metastatic adenocarcinoma of the pancreas who had no prior therapy were randomized to receive either devimistat in combination with modified FOLFIRINOX (mFFX) in the treatment arm or FOLFIRINOX (FFX) alone in the control arm. Devimistat given with mFFX did not significantly improve overall survival (HR=0.95, p=0.66) compared to FFX alone. The median overall survival in the treatment arm was 11.1 months, compared to 11.7 months in the control arm.

Devimistat is also being evaluated in a multi-national Phase 3 randomized clinical trial, ARMADA 2000, in patients with relapsed or refractory acute myeloid leukemia (AML). Following a pre-specified interim analysis, the independent data monitoring committee has recommended the trial be stopped due to lack of efficacy.

“We are disappointed by the results of these two Phase 3 clinical trials with devimistat. We plan to work in collaboration with Rafael Pharmaceuticals to further evaluate the data,” said Ameet Mallik, CEO, Rafael Holdings, Inc. “We would like to thank the patients, families, and investigators for their participation in the AVENGER 500 and ARMADA 2000 trials.”

Conference Call Information:

Date: Thursday, October 28, 2021

Time: 8:00 a.m. ET

Domestic Dial-in Number: (800) 547-0089

International Dial-in Number: (214) 989-7192

Conference ID: 4670624

Live Webcast: accessible from the Company's website at https://rafaelholdings.com under Events and Presentations or with this link: https://edge.media-server.com/mmc/p/izzdnghf.

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