MEI Pharma Receives Orphan Status For Lead Drug Candidate Pracinostat For Treatment Of Acute Myeloid Leukemia

  MEI Pharma Receives Orphan Status For Lead Drug Candidate Pracinostat For
                     Treatment Of Acute Myeloid Leukemia

PR Newswire

SAN DIEGO, Feb. 28, 2014

SAN DIEGO, Feb. 28, 2014 /PRNewswire/ --MEI Pharma, Inc. (Nasdaq: MEIP), an
oncology company focused on the clinical development of novel therapies for
cancer, announced today that the U.S. Food and Drug Administration (FDA) has
granted orphan drug designation to the Company's investigational drug
Pracinostat for the treatment of acute myeloid leukemia (AML).

(Logo: http://photos.prnewswire.com/prnh/20120628/LA32362LOGO)

"We are very pleased to receive this orphan drug designation," said Daniel P.
Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "AML is a
particularly devastating cancer for which there are currently few broadly
effective treatments. Through development of Pracinostat, we hope to address
this significant unmet medical need."

The FDA's Orphan Drug Designation program provides orphan status to drugs
defined as those intended for the safe and effective treatment, diagnosis or
prevention of rare diseases that affect fewer than 200,000 people in the U.S.
Orphan designation qualifies the sponsor of the drug for certain development
incentives, including tax credits for qualified clinical testing, prescription
drug user fee exemptions and seven-year marketing exclusivity upon FDA
approval.

About Pracinostat

Pracinostat is an orally available histone deacetylase (HDAC) inhibitor that
has been tested in a number of Phase I and Phase II clinical trials in
advanced hematologic disorders and solid tumor indications in both adult and
pediatric patients. Pracinostat has been generally well tolerated in more than
200 patients to date, with readily manageable side effects that are often
associated with drugs of this class, such as fatigue. In a Phase I
dose-escalation trial, Pracinostat demonstrated evidence of single-agent
activity in elderly AML patients, including two out of 14 (14%) who achieved a
complete remission (CR), with durable responses persisting 206+ and 362 days,
respectively. MEI Pharma is currently conducting a Phase II clinical trial of
Pracinostat in combination with Vidaza in elderly patients with newly
diagnosed AML. Preliminary data from the open-label trial is anticipated by
December 2014.

MEI Pharma owns exclusive worldwide rights to Pracinostat.

About AML

Acute myeloid leukemia (also known as acute myelogenous leukemia) is the most
common acute leukemia affecting adults, and its incidence is expected to
increase as the population ages. The American Cancer Society estimates about
14,590 new cases of AML per year in the U.S., with an average age of about 66.
Treatment options for AML remain virtually unchanged over the past 30 years.
Front line treatment consists primarily of chemotherapy, while the National
Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology
recommend Vidaza^® (azacitidine) or Dacogen^® (decitabine) as low intensity
treatment options for AML patients over the age of 60 who are unsuited for
induction chemotherapy.

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 HDAC inhibitor
currently being developed for myelodysplastic syndrome (MDS) and AML. Results
from a pilot Phase II clinical trial of Pracinostat in combination with Vidaza
in patients with advanced MDS showed an overall response rate of 90% (nine of
10). Data from three ongoing Phase II clinical trials of Pracinostat are
expected by the end of 2014. 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, including eight of 21 evaluable patients (38%) who achieved stable
disease or better. In September 2013, the Company further expanded its
pipeline of drug candidates with the acquisition of PWT143, a highly selective
PI3-kinase 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.

SOURCE MEI Pharma, Inc.

Website: http://www.meipharma.com
Contact: Pete De Spain, Sr. Director, Investor Relations & Corporate
Communications, (858) 792-3729, pdespain@meipharma.com
 
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