MEI Pharma Announces Fast Track Designation Granted by U.S. FDA for ME-401 For the Treatment of Adult Patients with Relapsed or Refractory Follicular Lymphoma
Mar 31, 2020
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SAN DIEGO, March 31, 2020 /PRNewswire/ -- MEI Pharma, Inc. (NASDAQ: MEIP ) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today announced that the U.S. Food and Drug Administration (FDA ) granted Fast Track designation to ME-401, MEI's investigational selective oral inhibitor of phosphatidylinositol 3-kinase ("PI3K") delta for the treatment of adult Patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies. MEI is currently conducting TIDAL (Trials of PI3K DeltA in Non-Hodgkin's Lymphoma), a Phase 2 trial evaluating ME-401 in patients with relapsed or refractory follicular lymphoma ("FL"). TIDAL is intended to support an accelerated approval marketing application with the FDA. "We are pleased to report that we have received Fast Track designation for ME-401. This designation holds several important advantages to expedite the development and regulatory review of ME-401 as we work diligently to deliver it as a new potential treatment option for patients and their physicians," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We remain very encouraged by the maturing body of ME-401 clinical data, and we are excited to continue expanding the opportunity that ME-401 holds to provide a meaningful impact in the treatment of B-cell malignances." About Fast Track
Fast Track is an FDA program intended to facilitate the development and review of new drugs to address unmet medical needs for the treatment of serious or life-threatening conditions so that a product may get approved and therefore can reach the market expeditiously. To qualify for Fast Track designation, a drug must address an unmet medical need, demonstrated by nonclinical or clinical data, in a serious condition, and show some advantage over any available therapy, such as:
Having an improved effect on serious outcome(s) of the condition
Providing comparable efficacy while avoiding serious toxicity that occurs with the available therapy or avoiding less serious toxicity that is common and causes discontinuation of treatment of the serious condition
Features of fast track designation include:
Actions to expedite a drug's development and review by frequent interactions with FDA
A rolling review process in which a Sponsor, in agreement with FDA, may submit portions of its New Drug Application (NDA) in advance of submission of a complete application. However, actual review of submitted portions may not commence until an application is complete. The FDA review clock starts upon receipt of a complete application. Fast track designated products are eligible for consideration of priority review if supported by clinical data at the time of NDA submission. About ME-401
ME-401 is an oral, once-daily, selective phosphatidylinositol 3-kinase (PI3K) delta inhibitor in clinical development for the treatment of B-cell malignancies. MEI owns worldwide rights in all geographies except Japan, which we licensed to Kyowa Kirin Company in 2018. MEI is currently conducting TIDAL (Trials of PI3K DeltA in Non-Hodgkin's Lymphoma), a Phase 2 clinical trial evaluating ME-401 as a monotherapy for the treatment of adults with relapsed or refractory follicular lymphoma ("FL") after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. Subject to the results, upon completion of the Phase 2 clinical trial, we are planning a submission with the FDA to support an accelerated approval of a marketing application under 21 CFR Part 314.500, Subpart H.
In addition to TIDAL, MEI is also conducting a multi-arm, open-label, Phase 1b dose escalation and expansion trial evaluating ME-401 as a monotherapy and in combination with other therapies such as Rituxan or agents such as Zanubrutinib in patients with relapsed or refractory B-cell malignancies. About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP ) is a late-stage pharmaceutical company focused on developing potential new therapies for cancer. Our portfolio of drug candidates contains four clinical-stage assets, including one candidate in an ongoing global registration trial and another candidate in a Phase 2 clinical trial which may support an accelerated approval marketing application with the U.S. Food and Drug Administration. Each of our pipeline candidates leverages a different mechanism of action with the objective of developing therapeutic options that are: (1) differentiated, (2) address unmet medical needs and (3) deliver improved benefit to patients either as standalone treatments or in combination with other therapeutic options. 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 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.