Rafael Pharmaceuticals Receives FDA Fast Track Designation for CPI-613® (devimistat) for the Treatment of Pancreatic Cancer
10 November 2020 - 3:00PM
Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader
in the growing field of cancer metabolism-based therapeutics,
announced today that the U.S. Food and Drug Administration (FDA)
has granted Fast Track designation for the Company’s lead compound,
CPI-613® (devimistat), for the treatment of metastatic pancreatic
cancer.
“Receiving Fast Track designation is a significant milestone in
our fight against pancreatic cancer,” said Sanjeev Luther,
President and CEO of Rafael. “This designation further stresses the
severe unmet need in treatment options for this aggressive and
devastating disease. We are truly thankful to the doctors,
researchers, the FDA and all of our supporters who have made this
possible. And most of all, we are grateful to the patients involved
in our trials; the patients are the inspiration and driving force
behind all of our efforts.”
Rafael has continued to reach milestones throughout the year,
including achieving its target enrollment of 500 patients for its
Phase 3 trial for metastatic pancreatic cancer ahead of schedule.
The Company also recently announced that the FDA granted devimistat
Orphan Drug Designation for the treatment of soft tissue
sarcoma.
“Pancreatic cancer is notoriously challenging to treat and long
overdue for a new approach,” said Philip A. Philip, M.D., Ph.D.,
FRCP, Professor of Oncology at the Barbara Ann Karmanos Cancer
Institute at Wayne State University and a medical advisor to
Rafael. “We have remained hopeful throughout our pancreatic cancer
trials, and now with Fast Track designation, our optimism is
further fueled. We believe with this designation, cancer metabolism
is truly being propelled forward, with devimistat at the helm.”
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, Burkitt’s
lymphoma and soft tissue sarcoma. 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.
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Rafael Media Contact:
Vanessa Donohue
rafael@antennagroup.com
(201) 465-8036
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