SAN DIEGO, Oct. 29, 2014 /PRNewswire/ -- MEI Pharma, Inc.
(Nasdaq: MEIP), an oncology company focused on the clinical
development of novel therapies for cancer, announced today that the
first patient has been dosed in the cohort-expansion stage of the
Company's Phase Ib clinical study of investigational drug candidate
ME-344 in combination with topotecan in patients with small cell
lung or ovarian cancer who failed initial therapy.
The cohort expansion comes after the initial stage of the study
confirmed the maximum tolerated dose (MTD) of ME-344 in combination
with topotecan is 10mg/kg, the same dose defined for single agent
use. Now the study will enroll an additional 40 patients into two
cohorts: locally advanced or metastatic small cell lung cancer and
ovarian cancer.
"This milestone represents another important step forward for
the clinical development of ME-344," said Robert D. Mass, MD, Chief Medical Officer of MEI
Pharma. "While we remain focused on our lead drug candidate
Pracinostat, we continue to be very excited by the potential of
this novel mitochondrial inhibitor. ME-344 has shown broad and
potent anti-tumor activity in pre-clinical studies, followed by
promising single-agent activity in the clinic. Now we look forward
to assessing its clinical activity in combination with chemotherapy
and reporting on its progress in the months ahead."
The Phase Ib study is evaluating the combination of intravenous
ME-344 and topotecan (trade name Hycamtin®), a drug
approved by the U.S. Food & Drug Administration for the
treatment of small cell lung, ovarian and cervical cancers.
Following the initial stage of the study, an independent Safety
Committee determined the recommended Phase II dose for continued
testing of ME-344 to be 10 mg/kg in combination with 4 mg/m2 of
topotecan. The combination of ME-344 and topotecan has been
generally well tolerated; the most frequent side effects of the
combination are fatigue and gastrointestinal disturbances.
In October 2013, results from a
Phase I clinical study of ME-344 were presented showing preliminary
evidence of single-agent activity in patients with refractory solid
tumors, including eight of 21 evaluable patients (38%) who achieved
stable disease or better. Notably, one patient with small cell lung
cancer achieved a confirmed partial response and remained on study
for 104 weeks. ME-344 was generally well tolerated in the study at
doses equal to or less than 10 mg/kg delivered on a weekly schedule
for extended durations. Dose limiting toxicities were observed at
both the 15 and 20 mg/kg dose levels, consisting primarily of Grade
3 peripheral neuropathy.
About ME-344
ME-344 is a mitochondrial inhibitor drug candidate derived from
MEI Pharma's isoflavone-based technology platform. In preclinical
studies, ME-344 has been shown to cause cell death in multiple
human tumor cell lines, including ovarian cancer stem cells, by
interfering with mitochondrial energy generation. In April 2013, Ayesha
Alvero, MD, Yale University School of
Medicine, presented data at the American Association for
Cancer Research Annual Meeting showing the ability of ME-344 to
decrease tumor burden and delay recurrence in a pre-clinical in
vivo model of recurrent epithelial ovarian cancer, the most
lethal of all gynecological malignancies.
MEI Pharma owns exclusive worldwide rights to all of its drug
candidates, including ME-344.
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 lead drug candidate is Pracinostat, a potential
best-in-class, oral histone deacetylase (HDAC) inhibitor currently
in development for myelodysplastic syndrome (MDS) and acute myeloid
leukemia (AML). In August 2014, the
Company completed enrollment in a randomized, placebo-controlled
Phase II study of Pracinostat in combination with azacitidine in
patients with previously untreated intermediate-2 or high-risk MDS.
The Company plans to unblind the study and report topline data in
Q1 2015. Preliminary data from an ongoing Phase II study of
Pracinostat plus azacitidine in elderly patients with newly
diagnosed AML showed responses in six of the first nine patients
enrolled in the study (67%), including three patients who achieved
a CR or CRi as their initial response. MEI Pharma is also
developing ME-344, a mitochondrial inhibitor that has shown
preliminary evidence of single-agent activity in a first-in-human
clinical study in patients with refractory solid tumors. In
September 2013, the Company further
expanded its pipeline of drug candidates with the acquisition of
PWT143, a highly selective PI3K delta inhibitor. For more
information, go to www.meipharma.com.
Under U.S. law, a new drug cannot be marketed until it has
been investigated in clinical trials 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 trial 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
patents or proprietary rights and obtain necessary rights to third
party patents and intellectual property to operate our business;
our inability to operate our business without infringing the
patents and proprietary rights of others; general economic
conditions; the failure of any products to gain market acceptance;
our inability to obtain any additional required financing;
technological changes; government regulation; changes in industry
practice; and one-time events. We do not intend to update any of
these factors or to publicly announce the results of any revisions
to these forward-looking statements.
Logo -
http://photos.prnewswire.com/prnh/20140805/133834
SOURCE MEI Pharma, Inc.