A New Phase 1 Study Began to Evaluate Rafael Pharmaceuticals’ Lead Compound CPI-613®️ (devimistat) for Patients With Pan...
20 Ottobre 2020 - 3:00PM
Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader
in the growing field of cancer metabolism-based therapeutics
announced today its partner Ono Pharmaceutical Co., Ltd. (“Ono”), a
pharmaceutical company committed to creating innovative medicines,
has begun a Phase 1 study in Japan for patients with pancreatic
cancer. The multicenter, open-label study is evaluating the
efficacy and safety of Rafael’s lead compound, CPI-613®️
(devimistat), labeled as ONO-7912 in Japan, in combination with
modified FOLFIRINOX (mFFX) in patients with pancreatic cancer
refractory or intolerance to chemotherapy including gemcitabine.
This announcement comes on the heels of Rafael reaching its
target enrollment of 500 patients in its global Phase 3 trial.
“After achieving the milestone of enrolling 500
patients in our global Phase 3 trial, we believe the natural next
step is to work with Ono Pharmaceutical to bring the treatment to
the Japanese market,” said Sanjeev Luther, President and Chief
Executive Officer of Rafael Pharmaceuticals. “Sadly, in Japan,
patients with pancreatic cancer have the lowest survival rates. We
are hopeful that bringing our trial to this market will allow us to
help bridge the gap in survival rates and help more people around
the globe.”
In June 2019, the Company announced an
out-licensing agreement with Japan-based Ono Pharmaceutical to
further develop and commercialize devimistat. Ono will work with
Rafael in supporting the trial through lending its deep expertise
in the region.
“We continue to see the incidence and death
rates of pancreatic cancer increase worldwide,” said Philip A.
Philip, M.D.,Ph.D., F.R.C.P., Professor of Oncology at the
Barbara Ann Karmanos Cancer Institute at Wayne State University,
and principal investigator of the global Phase 3 trial. “While
pancreatic cancer remains a hard-to-treat disease, we refuse to
believe it is an impossible feat. We are eager to bring hope to
those living in Japan and continue to remain hopeful around
positive outcomes for the trial.”
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 AMERICAN: RFL). For more information, please visit
www.rafaelpharma.com.
Safe Harbor StatementThis press release
contains forward-looking statements. These statements relate to
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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:
Vanessa Donohue
rafael@antennagroup.com
(201) 465-8036
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