Rafael Pharmaceuticals Achieves Target Enrollment of 500 Patients in Pivotal Phase 3 Trial (AVENGER 500) of CPI-613 ®️ (de...
06 8월 2020 - 10:00PM
Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader
in the growing field of cancer metabolism-based therapeutics,
announced today that it has reached its target enrollment of 500
patients in its pivotal Phase 3 clinical trial for metastatic
pancreatic cancer (AVENGER 500), which is evaluating the efficacy
and safety of Rafael’s lead compound CPI-613®️ (devimistat) in
combination with modified FOLFIRINOX (mFFX) as first-line therapy.
The global study will remain open for a short while longer and
continue to enroll additional patients.
“The speed at which we were able to fully enroll the Phase 3
trial, even amid the coronavirus pandemic, is demonstrative of
pancreatic cancer patients’ needs for new and more effective
treatment options for this devastating disease,” said Sanjeev
Luther, President and CEO of Rafael. “This achievement is only
possible because of the unwavering dedication and commitment of the
Rafael and Covance teams, study investigators, hospital staff at
the trial sites, patients and their families. We are also grateful
to the FDA for working closely with us to ensure the continued safe
enrollment of patients during the pandemic.”
AVENGER 500 is one of the largest Phase 3 clinical trials
currently open in metastatic pancreatic cancer, taking place in 75
sites around the globe in countries including the United States,
South Korea, Israel, Belgium, France and Germany, among
others.
“Devimistat has revived our hope in cancer metabolism,” said
Philip A. Philip, M.D., Professor of Oncology at the Barbara Ann
Karmanos Cancer Institute at Wayne State University, and principal
investigator of the trial. “Earlier phase trials of devimistat have
demonstrated promising results. We are very hopeful for positive
results, as we begin to compile and assess the Phase 3
data.”
“Metastatic pancreatic cancer is one of the most difficult
diseases to treat,” said Timothy S. Pardee, M.D., Ph.D., Co-Chief
Medical Officer of the Company. “Creating a trial to successfully
evaluate the efficacy of devimistat while maintaining the highest
level of patient safety was our top priority when designing the
trial.”
“Indeed, this is a major milestone for our company,” said Howard
Jonas, Chairman of Rafael. “But more importantly, we are hopeful
that this may serve as a significant milestone for the thousands of
pancreatic cancer patients worldwide who oftentimes have a poor
prognosis with few treatment options currently available to
them.”
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 represents 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: RFL). For more
information, please visit www.rafaelpharma.com.
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Rafael Media Contact:
Taylor Mullins
rafael@antennagroup.com
(773) 280-8061
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