SAN DIEGO, Jan. 5, 2015 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage biopharmaceutical company, today reported that enrollment in its pivotal EPIC study of its lead product candidate vepoloxamer (MST-188) in sickle cell disease surpassed the one-third enrollment milestone, ahead of internal projections. The Company remains on-track to complete enrollment by the end of 2015 and, consistent with prior guidance, anticipates reporting top line results in the first quarter of 2016.
"We are extremely pleased to report that, as of today, 130 patients have been randomized to the EPIC study, which is ahead of the enrollment projections we set for ourselves more than a year ago," stated Brian M. Culley, Chief Executive Officer. "We now have opened almost 70 sites in ten countries, with more than 50 of those sites located in the U.S. I am pleased to affirm that we remain on-track to complete enrollment this year, which means we expect to announce top line data in the first quarter of 2016. As there has never been a drug approved for sickle cell patients to treat an ongoing crisis, we are both hopeful and excited for a positive outcome from the EPIC study."
"We have built a sense of camaraderie with the sickle cell medical community and are enjoying a groundswell of momentum that is helping to drive enrollment," added Edwin L. Parsley, D.O., Chief Medical Officer. "Of note, approximately 60% of the sites we have opened in EPIC have enrolled at least one subject and two-thirds of those sites have enrolled two or more subjects. This broad activity indicates that investigators worldwide are excited about the study and are encouraging their patients to participate."
"I am also pleased to highlight that the EPIC study's independent Data and Safety Monitoring Board ("DSMB") has held multiple pre-planned meetings and recommended that the study proceed without any changes," added Dr. Parsley.
Additional milestones anticipated from the Company in 2015 include:
- Reporting data from a repeat-dose nonclinical study of vepoloxamer in heart failure;
- Initiating a Phase 2 clinical study of vepoloxamer in acute decompensated heart failure;
- Initiating enrollment in an open-label EPIC extension study, referred to as EPIC-E, to expand the Company's existing safety database regarding repeat exposure to vepoloxamer;
- Reporting data from a nonclinical study of vepoloxamer in embolic stroke; and
- Reporting data from one or more of the Phase 2a studies of AIR001 in patients suffering heart failure with preserved ejection fraction (HFpEF).
Conference Call Information
Interested parties may access the conference call on Tuesday, January 6, 2015 by dialing (877) 870-4263 from the U.S. and (412) 317-0790 from outside the U.S. and should request the Mast Therapeutics, Inc. Corporate Update Call. The webcast will be available live via the Internet by accessing the Investors section of Mast's website at http://www.masttherapeutics.com/investors/events/. Replays of the webcast will be available on the Company's website for 30 days and a phone replay will be available through January 15, 2015 by dialing (877) 344-7529 from the U.S. and (412) 317-0088 from outside the U.S. and entering conference reference number 10057420.
In March 2014, the Company announced that the United States Adopted Names (USAN) Council assigned "vepoloxamer" as the unique non-proprietary (generic) name for the active pharmaceutical ingredient (API) in MST-188. The Company sought a unique name for its API to clearly identify it as different from non-purified poloxamers. In support of its application, the Company submitted proprietary data showing that drug products containing non-purified poloxamers may have serious toxicity consequences and should not be substituted for or confused with MST-188.
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in San Diego, California. The Company is leveraging the MAST (Molecular Adhesion and Sealant Technology) platform, derived from over two decades of clinical, nonclinical and manufacturing experience with purified and non-purified poloxamers, to develop vepoloxamer (MST-188), its lead product candidate, for serious or life-threatening diseases and conditions typically characterized by impaired microvascular blood flow and damaged cell membranes.
The Company is enrolling subjects in EPIC, a pivotal Phase 3 study of vepoloxamer in sickle cell disease, and in a Phase 2 study to evaluate whether vepoloxamer improves the effectiveness of recombinant tissue plasminogen activator therapy in patients with acute limb ischemia. The Company also is planning to initiate a Phase 2 study of vepoloxamer in patients with acute decompensated heart failure in the first half of 2015. More information can be found on the Company's web site at www.masttherapeutics.com. (Twitter: @MastThera)
Mast Therapeutics™ and the corporate logo are trademarks of Mast Therapeutics, Inc.
Forward Looking Statements
Mast Therapeutics cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that are based on the Company's current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements regarding the EPIC study, including timing of completion of patient enrollment and announcement of data, and relating to anticipated milestones for the Company's other development programs. Among the factors that could cause or contribute to material differences between the Company's actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: delays in the commencement or completion of clinical studies, including as a result of difficulties in obtaining regulatory agency agreement on clinical development plans or clinical study design, opening trial sites, enrolling study subjects, manufacturing sufficient quantities of clinical trial material, being subject to a "clinical hold," and/or suspension or termination of a clinical study, including due to patient safety concerns or lack of funding; the uncertainty of outcomes in ongoing and future studies of the Company's product candidates and the risk that its product candidates, including vepoloxamer, may not demonstrate adequate safety, efficacy or tolerability in one or more such studies; the potential for institutional review boards or the FDA or other regulatory agencies to require additional nonclinical or clinical studies prior to initiation of a planned clinical study of a product candidate; the risk that, even if clinical studies are successful, the FDA or other regulatory agencies may determine they are not sufficient to support a new drug application; the potential that, even if clinical studies of a product candidate in one indication are successful, clinical studies in another indication may not be successful; the Company's reliance on contract research organizations (CROs), contract manufacturing organizations (CMOs), and other third parties to assist in the conduct of important aspects of development of its product candidates, including clinical studies, manufacturing, and regulatory activities for its product candidates, and that such third parties may fail to perform as expected; the Company's ability to obtain additional funding as needed on a timely basis or on acceptable terms, or at all; the potential for the Company to delay, reduce or discontinue current and/or planned development activities, including clinical studies, partner its product candidates at inopportune times or pursue less expensive but higher-risk and/or lower return development paths if it is unable to raise sufficient additional capital as needed; the risk that, even if the Company successfully develops a product candidate in one or more indications, it may not realize commercial success with its products and may never generate revenue sufficient to achieve profitability; the risk that the Company is not able to adequately protect its intellectual property rights relating to the MAST platform and vepoloxamer or AIR001 and prevent competitors from duplicating or developing equivalent versions of its product candidates; and other risks and uncertainties more fully described in the Company's press releases and periodic filings with the Securities and Exchange Commission. The Company's public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. Mast Therapeutics does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date hereof, except as may be required by law.
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