Rafael Pharmaceuticals Crosses Enrollment of 150 Patients in Pivotal Phase 3 Trial (ARMADA 2000) of CPI-613® (Devimistat) fo...
March 30 2021 - 9:00AM
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 enrollment of 150 patients in its
Phase 3 clinical trial for patients with relapsed or refractory
acute myeloid leukemia (AML) (ARMADA 2000). The multicenter,
open-label, randomized pivotal trial is assessing the efficacy and
safety of Rafael’s lead compound CPI-613® (devimistat) in
combination with high dose cytarabine and mitoxantrone (CHAM)
compared to high dose cytarabine and mitoxantrone (HAM) therapy in
older patients. The announcement comes on the heels of the
Company’s achievement in receiving FDA fast-track designation for
CPI-613® (devimistat) in the treatment of AML, at the end of 2020.
“Every enrollment is an opportunity for us to
hope for the future of this therapy for very hard-to-treat
cancers,” said Sanjeev Luther, President and CEO
of Rafael Pharmaceuticals. “The pace at which we are enrolling
patients demonstrates the need for more effective AML treatments,
and we have so much appreciation for the caregivers, patients,
primary investigators and Rafael employees who contributed to help
us surpass this important milestone.”
There are currently no standard therapy for AML
patients who suffer a relapse, and the prognosis for older patients
is grim.
“The need for new and novel treatments in AML
continues to grow alongside the estimated incidence rate,” said
Richard Larson, M.D., Director of the Hematologic Malignancies
Program at the University of Chicago Medical Center and a principal
investigator on the Phase 3 clinical trial. “As patients face a
diagnosis with relapsed or refractory AML, the potential of these
treatments is incredibly important.”
“Having Dr. Larson and other leading clinicians
contributing to the enrollment growth of this trial is immensely
helpful,” said Timothy S. Pardee, M.D., Ph.D., Co-Chief Medical
Officer of the Company. “Ultimately, it is these milestones that
will shepherd us towards finding treatment options for patients who
need them most.”
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, peripheral
T-cell lymphomas and soft tissue sarcoma. The Company's investors
include Rafael Holdings, Inc. (NYSE AMERICAN: RFL). For more
information, please visit www.rafaelpharma.com.
Safe Harbor StatementThis press release
contains forward-looking statements. These statements relate to
future events or the company’s future financial performance. In
some cases, you can identify forward-looking statements by
terminology such as "may", "will", "should", "expect", "plan",
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as a representation by the company, or any other person, that such
forward-looking statements will be achieved. The business and
operations of the company are subject to substantial risks which
increase the uncertainty inherent in forward-looking statements. We
undertake no duty to update any of the forward-looking statements,
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In light of the foregoing, readers are cautioned
not to place undue reliance on such forward-looking statements.
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Rafael Media Contact:Diana
Cleinmarkrafael@antennagroup.com(408) 713-1216
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