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MEI Pharma Advances Clinical Study Of Mitochondrial Inhibitor ME-344 In Small Cell Lung And Ovarian Cancers

MTD Confirmed in Combination with Topotecan, First Patient Dosed in Cohort Expansion

Oct 29, 2014

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.

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SOURCE MEI Pharma, Inc.

For further information: Pete De Spain, Vice President, Investor Relations & Corporate Communications, 858-792-3729, pdespain@meipharma.com


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