Rafael Pharmaceuticals Crosses Midpoint of Enrollment to First Interim Analysis in Pivotal Phase 3 Trial (ARMADA 2000) of CPI...
21 Juli 2020 - 3:00PM
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Rafael Pharmaceuticals, Inc. (“Rafael” or the
“Company”), a leader in the growing field of cancer
metabolism-based therapeutics, today announced that it has crossed
the midpoint to its first interim analysis in enrollment for its
pivotal Phase 3 clinical trial (ARMADA 2000) of CPI-613®
(devimistat) for relapsed or refractory acute myeloid leukemia
(AML). The multicenter, open-label, randomized pivotal trial is
evaluating the efficacy and safety of its lead compound devimistat
in combination with high dose cytarabine and mitoxantrone (CHAM) in
older patients.
The Food and Drug Administration (FDA) worked
closely with Rafael to make changes to the protocol to help address
enrollment challenges; the trial protocol modifications
significantly increased patient enrollment.
“The majority of relapsed AML patients will pass
away within five years of diagnosis,” said Sanjeev Luther,
President and CEO of Rafael Pharmaceuticals. “This enrollment
milestone provides hope to these patients, as we work to deliver
more effective treatments to patient populations that have few
viable options. We are deeply appreciative of all of our principal
investigators, patients and caregivers for their continued support
of this trial.”
The global study is currently active across more
than 60 sites in countries including the United States, Canada,
Europe, India, South Korea and Australia. While the COVID-19
pandemic has disrupted many clinical trials, Rafael has expanded
safety protocols to continue enrollment, maintaining the safety and
wellbeing of patients as the company’s foremost priority.
Jorge Cortes, M.D., Director of the Georgia
Cancer Center at Augusta University, is the principal investigator
on this Phase 3 clinical trial. Dr. Cortes developed the rationale
and design of the trial and is supervising the conduct of the
ongoing clinical investigation.
“Actively and safely enrolling patients and
reaching the midpoint to the first interim analysis is an
achievement worth noting, especially given the challenges for
clinical trial enrollment across the globe due to the coronavirus
pandemic,” said Dr. Cortes. “Relapsed or refractory AML remains a
significant challenge for older patients, so it is encouraging to
see enrollment continue to grow.”
About CPI-613® (devimistat) CPI-613®
(devimistat) is a first-in-class clinical lead compound of Rafael,
which targets enzymes that are involved in cancer cell energy
metabolism and are located in the mitochondria of cancer cells.
Devimistat is designed to target the mitochondrial tricarboxylic
acid (TCA) cycle, a process essential to tumor cell multiplication
and survival, selectively in cancer cells. Devimistat substantially
increases the sensitivity of cancer cells to a diverse range of
chemotherapeutic agents. This synergy allows for potential
combinations of devimistat with lower doses of these generally
toxic drugs to be more effective with lower patient’s side effects.
Combination with devimistat represent a diverse range of
opportunities to substantially improve patient’s benefit in many
different cancers. The U.S. Food and Drug Administration (FDA) has
given Rafael approval to initiate pivotal Phase 3 clinical trials
in pancreatic cancer (AVENGER 500) and acute myeloid leukemia
(ARMADA 2000), and has designated devimistat as an orphan drug for
the treatment of pancreatic cancer, acute myeloid leukemia,
myelodysplastic syndrome, peripheral T-cell lymphoma and Burkitt’s
lymphoma. The EMA has granted orphan drug designation to devimistat
for pancreatic cancer and acute myeloid leukemia.
About Rafael Pharmaceuticals, Inc.Rafael
Pharmaceuticals is a leader in the growing field of cancer
metabolism. The company is developing a new, first-in-class
category of metabolic oncology therapeutics that attack
hard-to-treat cancers by targeting the metabolic processes the
disease needs to survive, grow and proliferate. Rafael
Pharmaceuticals’ lead compound, CPI-613® (devimistat), is a highly
selective, well-tolerated and effective anti-cancer agent that is
being evaluated in ongoing and completed Phase 1, 2 and 3 clinical
trials. Devimistat has been granted orphan drug status by the FDA
for the treatment of pancreatic cancer, acute myeloid leukemia
(AML), myelodysplastic syndrome (MDS) and Burkitt’s and peripheral
T-cell lymphomas. The Company's investors include Rafael Holdings,
Inc. (NYSE AMERICAN: RFL). For more information, please visit
www.rafaelpharma.com.
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Rafael Media Contact:Holly Duganrafael@antennagroup.com
(201) 465-8019
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