SAN DIEGO, May 31, 2017 /PRNewswire/ --
-Independent Safety Review Committee Finds No Dose
Limiting Toxicities, Declares Minimum Biologically Effective Dose,
Recommends Dose Escalation
-Full Data to be Submitted for Presentation at Upcoming
Scientific Meeting
MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on
the clinical development of novel therapies for cancer, today
announced that an independent Safety Review Committee completed its
pre-specified review of the first cohort of six evaluable patients
in a Phase Ib, open-label, dose-escalation study of the Company's
investigational drug candidate ME-401, a potent and selective oral
PI3K delta inhibitor, in relapsed/refractory chronic lymphocytic
leukemia (CLL) and follicular lymphoma.
Based on its review of the safety and efficacy data, the Safety
Review Committee declared a minimum biologically effective dose
(mBED) for ME-401 at the starting dose of 60 mg and recommended
escalation to a 120 mg dose cohort. According to the study
protocol, the mBED is defined as a dose that is safe and achieves a
response in at least three of six patients. Response assessments
are based on criteria of the International Workshop on Chronic
Lymphocytic Leukemia for patients with CLL or the Lugano
Classification for patients with follicular lymphoma. Response is
initially assessed after 8 weeks of therapy.
To date, all six patients have been on study for a minimum of 10
weeks (range, 10-28 weeks). There have been no reports of ALT/AST
elevations, colitis or pneumonitis, events commonly reported with
other drugs in this class. One patient in the study experienced
grade 3 neutropenia that was considered related to study drug. All
other adverse events reported were grades 1 or 2. No patients have
discontinued due to adverse events. Full data will be submitted for
presentation at an upcoming scientific meeting.
"Given the high bar we have placed on the ME-401 program, we are
very pleased with the early safety and efficacy data from this
study," said Daniel P. Gold, Ph.D.,
President and Chief Executive Officer of MEI Pharma. "PI3K delta
inhibitors have demonstrated clear activity in the treatment of CLL
and follicular lymphoma, but at the expense of well-defined and
substantial toxicities. We believe this provides an opportunity for
a highly differentiated drug that is both effective and safe. Now
we look forward to demonstrating the therapeutic index of ME-401
across multiple dose cohorts and presenting detailed results later
this year."
ME-401 is a highly differentiated oral PI3K delta inhibitor that
has a distinct chemical structure from other drugs in its class,
including the approved drug idelalisib (marketed as
Zydelig®). Results from a Phase I first-in-human study
of ME-401 showed levels of drug exposure that support the potential
for an improved therapeutic window compared to idelalisib, with a
half-life that supports once-daily dosing.
The ongoing Phase Ib study is designed to determine the minimum
biologically effective dose, maximally tolerated dose, dose
limiting toxicities and recommended Phase 2 dose of ME-401 while
evaluating its safety, efficacy and pharmacokinetics. The study,
which opened for enrollment in September
2016, is expected to enroll up to 84 patients at
approximately 10 sites. Additional information regarding the
study, including inclusion and exclusion criteria, is available at
www.clinicaltrials.gov (identifier: NCT02914938).
About ME-401
ME-401 (formerly PWT143) is an orally bioavailable, potent and
selective inhibitor of phosphatidylinositol 3 kinase (PI3K) delta,
a molecular target that has been shown to play a critical role in
the proliferation and survival of certain hematologic cancer cells.
Results from a first-in-human, single ascending dose clinical study
of ME-401 in healthy volunteers were presented at the American
Association for Cancer Research Annual Meeting in April 2016. The data demonstrated on-target
activity at very low plasma concentrations and suggest that ME-401
has a superior pharmacokinetic and pharmacodynamic profile compared
to idelalisib. The U.S. Food and Drug Administration approved an
Investigational New Drug application for ME-401 in B-cell
malignancies in March 2016.
MEI Pharma owns exclusive worldwide rights to ME-401.
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 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. MEI
Pharma's clinical development pipeline also includes ME-401, a
highly differentiated oral PI3K delta inhibitor currently in a
Phase Ib study in patients with relapsed/refractory CLL or
follicular lymphoma. 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 and ME-344 are
investigational agents and are not approved for use in the U.S. For
more information, please visit www.meipharma.com.
Under U.S. law, a new drug cannot be marketed until it has
been investigated in clinical studies and approved by the FDA as
being safe and effective for the intended use. Statements included
in this press release that are not historical in nature are
"forward-looking statements" within the meaning of the "safe
harbor" provisions of the Private Securities Litigation Reform Act
of 1995. You should be aware that our actual results could differ
materially from those contained in the forward-looking statements,
which are based on management's current expectations and are
subject to a number of risks and uncertainties, including, but not
limited to, our failure to successfully commercialize our product
candidates; costs and delays in the development and/or FDA
approval, or the failure to obtain such approval, of our product
candidates; uncertainties or differences in interpretation in
clinical study results; our inability to maintain or enter into,
and the risks resulting from our dependence upon, collaboration or
contractual arrangements necessary for the development,
manufacture, commercialization, marketing, sales and distribution
of any products; competitive factors; our inability to protect our
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our inability to operate our business without infringing the
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our inability to obtain any additional required financing;
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to these forward-looking statements.
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SOURCE MEI Pharma, Inc.