SAN DIEGO, April 7, 2014 /PRNewswire/ -- MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced the presentation of new pre-clinical data showing the ability of its lead drug candidate Pracinostat to inhibit bladder cancer cell growth and induce activated transcription factor 3 (ATF-3) expression, a potential marker of tumor response. The data were presented yesterday at the American Association for Cancer Research (AACR) Annual Meeting in San Diego.
"These results are encouraging as they suggest a basis to explore the clinical potential for Pracinostat in solid tumor indications," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "In addition, this represents an important first step toward identifying one or more valuable biomarkers for Pracinostat, which can be included in clinical trials to identify and predict patients who benefit from treatment, not only in bladder cancer, but potentially in other solid tumors as well."
Previous studies have shown that decreased ATF-3 expression is associated with tumor progression and reduced rate of survival in patients with bladder cancer. This study, conducted in collaboration with the Centre for Cancer Research, MIMR-PHI Institute of Medical Research in Melbourne, Australia, demonstrated that ATF-3 expression is reactivated in bladder cancer cells treated with Pracinostat in vitro. In addition, the study showed that Pracinostat treatment induced reactivation of ATF-3 in xenograft tumor samples.
A copy of the poster, entitled "Activated Transcription Factor 3 (ATF-3) Expression is a Potential Marker of Tumor Response to the HDAC Inhibitor Pracinostat," is now available at www.meipharma.com.
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. Pracinostat has been generally well tolerated in more than 200 adult and pediatric patients to date, with readily manageable side effects that are often associated with drugs of this class, including fatigue. In a Phase I dose-escalation trial, Pracinostat demonstrated evidence of single-agent activity in elderly acute myeloid leukemia (AML) patients, including two out of 14 (14%) who achieved a CR, with durable responses persisting 206+ and 362 days, respectively. In addition, results from a pilot Phase II study of Pracinostat in combination with Vidaza® (azacitidine) in patients with advanced myelodysplastic syndrome (MDS) showed an overall response rate of 90% (nine out of 10), including eight patients who achieved either a CR or a CR with incomplete blood count recovery (CRi).
MEI Pharma owns exclusive worldwide rights to Pracinostat.
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 MDS and AML. 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.
 Yuan X, et al. ATF3 Suppresses Metastasis of Bladder Cancer by Regulating Gelsolin-Mediated Remodeling of the Actin Cytoskeleton. Cancer Res. 2013 Jun 15;73(12):3625-37.
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