CRANBURY, N.J., March 23, 2017 /PRNewswire/ -- Cornerstone
Pharmaceuticals, Inc., a clinical-stage, oncology-focused
pharmaceutical company, announced a major milestone today.
Following successful End-of-Phase I (EOP1) Type B meetings with the
U.S. Food and Drug Administration (FDA), the Company has been given
a clear clinical and regulatory path forward to conduct pivotal
trials of its lead compound, CPI-613, in patients with acute
myeloid leukemia (AML) and pancreatic cancer.
CPI-613 is Cornerstone Pharmaceuticals' first-in-class
anticancer compound from its proprietary Altered Energy Metabolism
Directed (AEMD) platform. The drug is designed to disrupt the
altered energy production pathways in cancer cells by targeting the
mitochondrial tricarboxylic acid (TCA) cycle, an indispensable
process essential to cell multiplication and survival. The FDA has
designated CPI-613 an orphan drug for the treatment of acute
myeloid leukemia (AML), pancreatic cancer and myelodysplastic
syndromes (MDS).
"Our productive dialogue with the FDA has cleared a path forward
for initiating pivotal trials of CPI-613, which may be sufficient
to support our proposed indications for the treatment of AML and
pancreatic cancer," said Sanjeev
Luther, Chief Operating Officer, Cornerstone
Pharmaceuticals. "The FDA has provided valuable feedback to inform
a design that will enhance the robustness of our trials. This would
allow the Agency to assess them as registrational trials. We are
confident in our ability to meet the FDA's requirements for the
trials, and look forward to continued interaction with the FDA as
the CPI-613 clinical development program advances."
During the EOP1 Type B meetings with the FDA, Cornerstone
Pharmaceuticals presented updated results from Phase I trials of
CPI-613 in patients with AML and pancreatic cancer.
"We believe the Phase II trial in AML can potentially lead to
approval for treatment of a disease that historically has been
extremely difficult to treat," said Jorge
Cortes, M.D., lead investigator of the AML trials and Deputy
Chair and Professor of Medicine in the Department of Leukemia at
The University of Texas MD Anderson
Cancer Center.
"We are encouraged that the FDA has granted us the opportunity
to continue clinical trials in pancreatic cancer, a disease with
large unmet clinical need, and are optimistic that we will continue
to see positive results in advanced pancreatic cancer patients,"
commented Philip A. Philip, M.D.,
Ph.D., F.R.C.P., lead investigator of the pancreatic cancer trials
and Professor of Oncology and Pharmacology, Leader, GI and
Neuroendocrine Oncology, and Vice President of Medical Affairs at
Karmanos Cancer Center, Wayne State
University.
About Cornerstone Pharmaceuticals, Inc.
Cornerstone Pharmaceuticals, Inc. is a clinical-stage,
oncology-focused pharmaceutical company committed to the
development and commercialization of therapies that exploit the
metabolic differences between normal cells and cancer cells.
Cornerstone's primary objective is to develop highly selective and
effective agents with minimal toxic effects on normal cells and
tissues. Cornerstone's first-in-class clinical lead compound,
CPI-613 is being evaluated in multiple Phase I, I/II, and II
clinical studies. The U.S. Food and Drug Administration (FDA) has
designated CPI-613 an orphan drug for the treatment of acute
myeloid leukemia (AML), pancreatic cancer and myelodysplastic
syndromes (MDS). The company's investors include IDT Corporation
(NYSE: IDT). For more information, visit
www.cornerstonepharma.com.
Safe Harbor Statement
This 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.
Contact:
Jacob
Jonas
Public Relations, Cornerstone Pharmaceuticals, Inc.
jacob@cornerstonepharma.com
Kara Golub
JFK Communications, Inc.
609-456-0822
kgolub@jfkhealth.com
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SOURCE Cornerstone Pharmaceuticals, Inc.