Rafael Pharmaceuticals to Present Pancreatic & Biliary Tract Cancer Data on CPI-613® (Devimistat) from its Multicenter, Rand...
June 30 2021 - 8:00AM
Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader
in the growing field of cancer metabolism-based therapeutics, today
announced that data on its lead compound, devimistat, has been
selected for an oral presentation at the 2021 European Society of
Medical Oncology World Gastrointestinal Congress (ESMO), taking
place June 30 through July 3, 2021.
“We are proud to have our primary clinical
investigators present at EMSO to share updates from our ongoing
trials for devimistat in pancreatic and biliary tract cancer, two
hard-to-treat diseases with few treatment options,” said Sanjeev
Luther, President and CEO of Rafael Pharmaceuticals. “Dr. Philip A.
Philip and Dr. Vaibhav Sahai will share important perspectives on
new treatment options from their frontline experience treating
cancer and evaluating devimistat in clinical trials.”
Presentation Details:Session Title:
Gastrointestinal Cancer: Cancer of the Pancreas and Biliary
TractPoster Title: A multicenter, randomized phase 1b/2 study of
gemcitabine and cisplatin with or without CPI-613 as first-line
therapy for patients with advanced unresectable biliary tract
cancer (BilT-04)Date: June 30, 2021Abstract ID: 390Authors: Vaibhav
Sahai, Amy E. Chang, Oxana V. Crysler, David B. Zhen, Muhammad S.
Beg, Kent A. Griffith, Mark M. Zalupski
Session Title: Session I: Cancer of the Pancreas
and Biliary Tract, Q&ADate: July 1, 2021Time: 4:34 PM
(CEST)Speaker: Philip A. Philip
Devimistat’s mechanism of action aims to stunt
the growth of cancer cells, creating an opportunity to increase
survival rates for cancers like pancreatic and biliary tract, which
have historically produced grim outlooks for patients. According to
the Surveillance, Epidemiology, and End Results (SEER) database,
biliary tract cancer has a 5-year relative survival rate of just 9%
across all combined SEER stages (localized, regional and distant).
Pancreatic cancer has a similar profile, with a 5-year relative
survival rate of 10.8%. Patients battling both cancers urgently
need therapeutic options that can improve survival rates.
“Our team is thrilled to have the opportunity to
share updates from our clinical study currently in-progress for the
treatment of biliary cancer, especially at the ESMO GI Congress,”
said Vaibhav Sahai, MBBS, M.S., primary investigator and medical
oncologist at the University of Michigan Rogel Cancer Center in Ann
Arbor, Michigan.
“I’m pleased to share updates on the treatment
of pancreatic cancer. I believe that with each milestone met, we’re
a step closer to discovering potential new treatment options,” said
Dr. Philip, M.D., Ph.D., F.R.C.P, primary investigator and medical
oncologist at the Karmanos Cancer Center in Detroit, Michigan.
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, Soft Tissue
Sarcoma, Burkitt’s lymphoma and biliary cancer. 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 and biliary tract cancer.
The Company's investors include Rafael Holdings, Inc. (NYSE: RFL).
On June 21, 2021, we announced that we have entered into a
merger agreement with Rafael Holdings, Inc., to create a publicly
traded late-stage clinical oncology company focused on cancer
metabolism-based therapeutics. 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",
"anticipate", "believe", "estimate", "predict", "potential" or
"continue", the negative of such terms, or other comparable
terminology. These statements are only predictions. Actual events
or results may differ materially from those in the forward-looking
statements as a result of various important factors. Although we
believe that the expectations reflected in the forward-looking
statements are reasonable, such statements should not be regarded
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,
whether as a result of new information, future events or
otherwise.
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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