SAN DIEGO, Feb. 13, 2018 /PRNewswire/ -- MEI Pharma,
Inc. (NASDAQ: MEIP), an oncology company focused on the clinical
development of novel therapies for cancer, today announced that a
planned interim review of data supports continuation of its
multicenter, investigator sponsored, study evaluating ME-344, a
novel mitochondrial inhibitor, in patients with HER2-negative
breast cancer. The interim study data show that ME-344 was
generally well-tolerated and, consistent with previous preclinical
data, demonstrate the potential to reverse resistance to
antiangiogenic therapy. Based on the interim results, it was
determined that completion of enrollment of the clinical study of
ME-344 in combination with bevacizumab (marketed as Avastin®) is
warranted.
"The interim data are very encouraging and I look forward to an
opportunity to present the results at a medical meeting later this
year," stated the study principal investigator, Miguel Quintela-Fandino, M.D., Ph.D., Director
of the Clinical Research Program, Centro Nacional De
Investigaciones Oncologicas, Madrid,
Spain.
Dr. Quintela-Fandino continued: "These preliminary data are
consistent with our previously published preclinical studies and it
is our hope that the data from the current clinical study will help
advance our understanding of the escape pathways utilized by tumors
against antiangiogenic agents. The therapeutic opportunity that is
available to exploit the adaptive mechanisms of tumors via
mitochondrial inhibition is quite novel and I am very excited to
continue the trial and further explore the promising utility of
ME-344 in combination with antiangiogenic therapeutics."
Inhibition of mitochondrial adenosine triphosphate (ATP) with
drug candidates such as ME-344 may have significant potential in
combination with antiangiogenic agents. Antiangiogenics are widely
used biologic agents in oncology, but acquired resistance to
antiangiogenics is a major problem in cancer therapeutics.
Antiangiogenics reduce the rate of glycolysis as a mechanism to
block tumor growth, however sustained tumor growth may be achieved
via a shift to an alternative metabolic energy source such as
mitochondrial ATP*. In such cases of tumor plasticity in the
presence of treatment with antiangiogenics, targeting the
alternative metabolic source would open an important therapeutic
opportunity.
About the Study
The study is a multicenter,
investigator sponsored, randomized, open label, clinical trial
evaluating ME-344 in a total of 40 patients with HER2-negative
breast cancer in combination with the VEGF inhibitor bevacizumab
(marketed as Avastin®). Patients are randomized one-to-one to
either ME-344 plus Avastin or saline plus Avastin. The primary
efficacy endpoint is inhibition of cell proliferation as measured
by Ki-67 reductions. The interim data review was predefined to take
place after 20 patients were randomized.
About ME-344
ME-344 is a novel, tumor selective,
isoflavone-derived mitochondrial inhibitor drug candidate. It
directly targets the OXPHOS complex 1**, a pathway involved in the
production of adenosine triphosphate, or ATP, in the mitochondria.
Treatment of tumor cells with ME-344 results in a rapid loss of ATP
and cancer cell death. ME-344 has demonstrated evidence of single
agent activity against refractory solid tumors in a Phase 1
study.***
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a
San Diego-based oncology company
focused on the clinical development of novel therapies for cancer.
The Company's portfolio of drug candidates includes pracinostat, an
oral HDAC inhibitor that is partnered with Helsinn Healthcare, SA.
Pracinostat has been granted Breakthrough Therapy Designation from
the U.S. Food and Drug Administration for use in combination with
azacitidine for the treatment of patients with newly diagnosed
acute myeloid leukemia (AML) who are unfit for intensive
chemotherapy. Pracinostat is also being developed in combination
with azacitidine for the treatment of patients with high and very
high-risk myelodysplastic syndrome (MDS) (NCT03151304). MEI
Pharma's clinical development pipeline also includes ME-401, a
highly differentiated oral PI3K delta inhibitor currently in a
Phase 1b study in patients with
relapsed/refractory CLL or follicular lymphoma, and voruciclib, an
oral, selective CDK inhibitor shown to suppress MCL1, a known
mechanism of resistance to BCL2 inhibitors. The Company is also
developing ME-344, a novel mitochondrial inhibitor currently in an
investigator-sponsored study in combination with bevacizumab for
the treatment of HER2-negative breast cancer. Pracinostat, ME-401,
ME-344 and voruciclib are investigational agents and are not
approved for use in the U.S. For more information, please visit
www.meipharma.com.
References
* Cell Reports. 2016 June
21;15:2705-2718
** Am J Cancer Res. 2015 Jan 15:5(2):689-701.
***
Cancer. 2015 APR 1;121(7):
1056-63.
Under U.S. law, a new drug cannot be marketed until it has
been investigated in clinical studies and approved by the FDA as
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