Rafael Pharmaceuticals Receives Approvals to Open Trial Sites in India and Canada for Pivotal Phase 3 Trial (ARMADA 2000) of ...
23 Aprile 2020 - 3:00PM
Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader
in the growing field of cancer metabolism-based therapeutics, today
announced that the Central Drugs Standard Control Organization
(CDSCO), the national regulatory body for Indian pharmaceuticals
and medical devices, granted approval for the opening of sites in
India for the company’s Phase 3 clinical trial in the treatment of
acute myeloid leukemia (AML). The company has also received
approval by Health Canada to open sites for the trial in Canada.
ARMADA 2000 is a multicenter, open-label,
randomized pivotal trial for evaluating the efficacy and safety of
Rafael’s lead compound CPI-613® (devimistat) in combination with
high dose cytarabine and mitoxantrone (CHAM) compared with high
dose cytarabine and mitoxantrone (HAM) in older patients (50
years-old and older) with relapsed or refractory AML.
“This week, we recognized AML World Awareness
Day, when the world joins forces to address the importance of
supporting and advocating for better treatments for AML patients,”
said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals.
“But at Rafael, this is our mission every single day. With over 50
activated sites, including sites in the United States, Europe,
Australia and South Korea, we are continuing to expand the trial in
order to ultimately deliver more effective treatments. We are now
bringing our trial into India, with its population of more than 1.3
billion people, as well as to Canada, to address the significant
unmet needs for AML treatments in these markets.”
In light of the COVID-19 pandemic, the sites
will not immediately be open for patient enrollment. Rafael will
stay in close contact with the trial sites and local health
officials to determine when patients can begin enrolling safely.
The safety and wellbeing of patients is Rafael’s foremost
priority.
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.
Safe Harbor StatementThis press
release contains forward-looking statements. These statements
relate to future events or the company’s future financial
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statements by terminology such as "may", "will", "should",
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Actual events or results may differ materially from those in the
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forward-looking statements are reasonable, such statements should
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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:Holly
Duganrafael@antennagroup.com(201) 465-8019
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