Mast Therapeutics Presents MST-188 Data at 7Th Annual Sickle Cell Disease Research and Educational Symposium
SAN DIEGO, April 17, 2013 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX) today announced that two posters for its lead product candidate, MST-188, were presented at the 7th Annual Sickle Cell Disease Research & Educational Symposium, currently underway in Miami.
Brian M. Culley, Chief Executive Officer, said: "Increasing evidence suggests that transfusion of 'older' red blood cells (RBC) impairs clinical outcomes as a result of defects resulting from storage or age. An NIH meta-analysis of 21 studies involving more than 400,000 patients reported that transfusion of older versus newer blood was associated with significantly increased risk of death. Since older RBC aggregate more than younger RBC, we hypothesize that increased RBC aggregation following transfusion of older RBC or those with 'storage lesion' impairs blood flow in the microcirculation, where the majority of oxygen and nutrient exchange occur, thereby decreasing tissue perfusion and worsening outcomes."
Mr. Culley continued: "The data presented today show that MST-188 reduced aggregation of both older and younger RBC, with a greater effect on older RBC. If adverse clinical outcomes following transfusion are the result of increased RBC aggregation in the microcirculation, MST-188 may offer an option to improve the efficacy of transfusion. We are conducting additional preclinical studies in this area, with the goal of helping to improve treatment options for the 4.5 million people who, in the U.S. alone, receive a transfusion each year."
- The poster entitled "Is There a Role for a Rheologic Agent in Transfusion?" was presented by R. Martin Emanuele, Ph.D., Senior Vice President, Development
- The poster entitled "Evaluation of Purified Poloxamer 188 in Children (EPIC) – Key Design Considerations" was presented by Santosh J. Vetticaden, Ph.D., M.D., Chief Medical Officer
- The poster presentations are available on the Company's website at http://www.masttherapeutics.com/technology/publications/
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in San Diego, CA. 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 MST-188, its lead product candidate, for serious or life-threatening diseases with significant unmet needs. MST-188 is a cytoprotective, hemorheologic, anti-inflammatory and antithrombotic agent that has potential utility in diseases or conditions characterized by microcirculatory insufficiency (endothelial dysfunction and/or impaired blood flow).
The Company is recruiting subjects in EPIC, a pivotal phase 3 study of MST-188 in sickle cell disease. The Company plans to initiate a phase 2 clinical study of MST-188 in acute limb ischemia, a complication of peripheral arterial disease, in late 2013 or early 2014. More information can be found on the Company's web site at www.masttherapeutics.com.
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 Company's development plans for MST-188, including in sickle cell disease, acute limb ischemia, and blood transfusions, as well as the timing of activities related to those plans, and prospects for MST-188's clinical, regulatory and commercial success. Among the factors that could cause or contribute to material differences between the Company's actual results and expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: the uncertainty of outcomes in ongoing and future nonclinical and clinical studies despite positive results in nonclinical testing and prior clinical studies; the potential for significant delays in the development of MST-188, including due to lack of funding, 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, completing necessary manufacturing process development activities, and being subject to a "clinical hold," or suspension or termination of a clinical study, including due to patient safety concerns; the potential for institutional review boards or the FDA or other regulatory agencies to require additional nonclinical or clinical studies prior to initiation of planned phase 2 clinical studies of MST-188 in any particular indication in which the Company determines to develop MST-188, including acute limb ischemia, which likely would increase the total time and cost of development in the indication; the risk that clinical studies of MST-188 are not successfully executed and/or do not successfully demonstrate its safety or efficacy; 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 risk that even if clinical studies of MST-188 in one indication or jurisdiction are successful, clinical studies in another indication or jurisdiction may not be successful; the potential for unsuccessful nonclinical or clinical studies in one indication or jurisdiction, or by a future partner that may be outside of the Company's control, to adversely affect opportunities for MST-188 in other indications or jurisdictions; 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 MST-188's development, including clinical studies and regulatory activities, and that such third parties may fail to perform as expected; the Company's ability to obtain additional funding 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 MST-188 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 the FDA, the EMA or other regulatory agencies do not grant marketing approval of MST-188, on a timely basis, or at all; the risk that the Company is not able to adequately protect its intellectual property rights relating to the MAST platform and MST‑188 and prevent competitors from duplicating or developing equivalent versions of MST-188; and other risks and uncertainties more fully described in the Company's press releases and periodic filings with the U.S. Securities and Exchange Commission. The Company's public filings with the U.S. 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. the Company 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.
SOURCE Mast Therapeutics, Inc.