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Mast Therapeutics, Inc. (MSTX)

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Mast Therapeutics

About Mast Therapeutics


We are a publicly traded biopharmaceutical company headquartered in San Diego, California.

We are 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, our lead product candidate, for serious or life-threatening diseases with significant unmet needs.

To learn more about our company, please see our Letter from the CEO.



Evaluation of Purified Poloxamer 188 in Children in Crisis (EPIC)
This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Mast Therapeutics, Inc.
Mast Therapeutics, Inc.
Information provided by (Responsible Party):
Mast Therapeutics, Inc. Identifier:
First received: November 27, 2012
Last updated: September 24, 2015
Last verified: September 2015


The purpose of this study is to evaluate whether MST-188 can reduce the duration of vaso-occlusive crisis (VOC) in subjects with sickle cell disease. The study will also evaluate whether MST-188 can reduce the frequency of rehospitalization of subjects due to a recurrence of VOC. Additionally, this study will compare the development of acute chest syndrome during VOC in subjects who receive MST-188 to those who do not receive MST-188.

Condition Intervention Phase
Vaso-occlusive Crisis
Sickle Cell Disease
Drug: Saline
Drug: MST-188
Phase 3
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC): A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of MST-188 (Purified Poloxamer 188) Injection in Subjects With Sickle Cell Disease Experiencing Vaso Occlusive Crisis
Resource links provided by NLM:
Further study details as provided by Mast Therapeutics, Inc.:
Primary Outcome Measures:
  • Reduction of the duration of vaso occlusive crisis (VOC) in subjects with sickle cell disease. [ Time Frame: Study participants will be followed for the duration of hospital stay, an expected average of 4 days ] [ Designated as safety issue: No ]


Secondary Outcome Measures:
  • Re-hospitalization rate for VOC [ Time Frame: Hospital discharge to 14 days post-discharge ] [ Designated as safety issue: No ]
    Occurence of acute chest syndrome [ Time Frame: Randomization to 120 hours after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 388
Study Start Date: May 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MST-188
MST-188 injection administered as a continuous infusion 100 mg/kg for 1 hour followed by 30 mg/kg/hr for up to 48 hours.
Drug: MST-188
Other Name: vepoloxamer
Placebo Comparator: Saline
Saline administered as a continuous infusion for up to 49 hours
Drug: Saline

Ages Eligible for Study:   4 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 4 through 65 years
    Subject has a confirmed diagnosis of HbSS, HbSC, HbSβ+thal, or HbSβ0thal
    Subject is experiencing acute pain typical of vaso-occlusive crisis requiring treatment with parenteral analgesia
    Subject requires hospitalization

Exclusion Criteria:

  • Subject has acute chest syndrome
    Subject's laboratory results indicate inadequate organ function
    Subject is pregnant or nursing an infant
    Subject had a painful crisis requiring hospitalization within the preceding 14 days or has experienced > 5 hospitalizations for VOC in the prior 6 months
    Subject has been transfused within the past 14 days
    Subject is hospitalized for a condition other than VOC
    Subject has complications related to SCD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01737814

Contact: Mast Therapeutics Call Center 1-888-965-1238    

  Show 72 Study Locations
Sponsors and Collaborators
Mast Therapeutics, Inc.
Study Director: Edwin L. Parsley, D.O. Mast Therapeutics, Inc.  
  More Information

No publications provided
Responsible Party: Mast Therapeutics, Inc. Identifier: NCT01737814     History of Changes
Other Study ID Numbers: MST-188-01
Study First Received: November 27, 2012
Last Updated: September 24, 2015
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Committee of Ethics in Research
Dominican Republic: Consejo Nacional de Bioetica en Salud
Jordan: Jordanian Food and Drug Administration
Lebanon: Institutional Review Board
Oman: Academic Accreditation Authority
Panama: Ministry of Health
Spain: Ministerio de Sanidad, Servicios Sociales e Igualdad
Saudi Arabia: Saudi Food and Drug Administration
Turkey: Drug and Medical Device Institution
Jamaica: Ministry of Health

Keywords provided by Mast Therapeutics, Inc.:
sickle cell disease
vaso-occlusive crisis

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies processed this record on December 30, 2015





MST-188 (lead product candidate)

MST-188 (purified poloxamer 188) is an investigational agent that has potential to reduce ischemic tissue injury and end-organ damage by restoring microvascular function, which is compromised in a wide range of serious and life-threatening diseases and conditions. We initially are developing MST-188 as a treatment for complications arising from sickle cell disease.



This page contains Forward Looking Statements.*

AIR001 is a sodium nitrite solution for intermittent inhalation via nebulizer. Nitrite is a direct vasodilator and can be recycled in vivo to form nitric oxide (NO) independent of the classical NO synthase (NOS) pathway. Nitrite mediated NO formation has several beneficial effects, including dilation of blood vessels and reduction of inflammation and undesirable cell growth. Generation of NO from sodium nitrite is not dependent upon endothelial function and is enhanced in the setting of tissue hypoxia and acidosis, conditions in which NOS activity typically is depressed. In early clinical studies, AIR001 demonstrated positive hemodynamic effects with reductions observed in right atrial pressure and pulmonary capillary wedge pressure, as well as improvements in mean pulmonary artery pressures and cardiac output.

We are developing AIR001 for treatment of heart failure with preserved ejection fraction (HFpEF), a condition that affects millions in the U.S. and for which no proven therapeutic agent is available. Numerous lines of evidence suggest that HFpEF is a disease of NO deficiency. We are supporting two institution-sponsored Phase 2a studies in patients with HFpEF to evaluate acute hemodynamic effects of AIR001 and to evaluate its acute effects versus placebo on submaximal oxygen consumption and exercise hemodynamics.

How Does AIR001 Work?


AIR001 Inhalation Solution is sodium nitrite formulated with a phosphate buffer into an inhalation solution. Nitrite is a physiological signaling molecule with roles in intravascular endocrine nitric oxide (NO) production, hypoxic vasodilation, signaling, and cytoprotection after ischemia-reperfusion. Nitrite serves as the largest physiologic reservoir of NO and can be converted to NO independent of NO synthase (NOS) activity.

In experimental models, nitrite use demonstrated improved remodeling both in the pulmonary vasculature and right ventricle. Hemodynamic effects include venodilation with reductions in right atrial pressures, pulmonary and systemic vasodilation with reductions in pulmonary vascular resistance and left atrial pressures, and improved cardiac relaxation. In addition, recent clinical and nonclinical studies have demonstrated that nitrite can stimulate mitochondrial biogenesis and mitochondrial fusion and decrease mitochondrial oxygen consumption through a mechanism distinct from that of NO, which may have utility in treating heart failure.

AIR001 Clinical Data


We obtained the AIR001 program through our acquisition of Aires Pharmaceuticals, Inc. in February 2014. Prior to the acquisition, AIR001 had been tested in more than 120 healthy volunteers and patients with various forms of pulmonary hypertension in three Phase 1 studies and in one Phase 2 study in patients with pulmonary arterial hypertension. While the Phase 2 study was prematurely terminated due to Aires’ capital constraints prior to the acquisition, preliminary data from the study are positive, showing improvements in hemodynamic parameters and in exercise capacity from baseline. There were no treatment-related serious adverse events and methemoglobin levels remained normal (< 1.5%), which distinguishes AIR001 from safety concerns associated with intravenously-administered nitrite.

Data from these early clinical studies support continued clinical development of AIR001. Given the observed hemodynamic improvements of decreased right arterial pressure, decreased pulmonary capillary wedge (or left atrial pressure), as well as improvements in pulmonary vascular resistance and cardiac lusitropic effects, AIR001 may benefit patients with exercise impairment due to heart failure with preserved ejection fraction (HFpEF), for whom these are all desirable effects.


Potential Applications of AIR001

Hemodynamic improvements, improvements in pulmonary artery pressures, and cardiac lusitropic effects observed in earlier studies of AIR001 support AIR001’s potential to benefit patients with heart failure with preserved ejection fraction (HFpEF). We currently are pursuing clinical development of AIR001 for that patient population.

2013 Activities

Event Timing

Initiate tQT/QTc Study Completed

Secure Orphan Designation for MST-188 for SCD in EU Completed

Activate First Site in Phase 3 Study Completed

File New Patent Applications Completed

Dose First Subject in Phase 3 Study Completed

Report data from tQT/QTc Study Q3 Completed and Primary Endpoints Met

Request Orphan Designation for MST-188 for ALI in U.S. Q3 Completed and Designation Granted By FDA

Initiate Nonclinical Proof-of-Concept Study in Heart Failure Q3 Completed and POC Data to be released Q1 '14

2014 Activities

Event Timing

Present Data From Nonclinical Proof-of-Concept Study In Heart Failure  Q1 '14  Data Released 01/06/14'Showed Significant Statistical Improvement"

Initiate Phase 2 Study in ALI Q1 '14 Initiated

Outcome of review of application for Unique Name Designation For Purified Poloxamer 188 From U.S. Adopted Names Counsel Q1 '14 Granted and Named VEPOLOXAMER

Open First Ex-U.S. Clinical Sites in Phase 3 Trial Q1 '14. Initiated and On Schedule

Submit Abstract with Heart Failure Study Biomarker Data to Major Medical Conference Q2 '14

Request Orphan Designation for ALI in EU Q2 '14  Application Submitted

Initiate Nonclinical POC Study in Stroke Q2 '14 Study Initiated

Initiate EPIC Sub-Study Q2 '14 Initiated On Schedule 06/14/14

Report Results from Phase 2 Study of AIR001 in PAH Q3 '14 Positive Top line Data released 9/8/14

Initiate study with Dept of Defense: MST-188 Resuscitation from major trauma '14 CRADA with US Military Initiated Q3 '14

Receive protocol from FDA for Phase 2 Heart Failure Study Q4'14 FDA Approves Heart Failure Study 12/9/14

2015 Event Schedule

Initiate dosing Phase2a study in AIR001 Q1 '15.  INITIATED 2/4/15

Nonclinical Study EMBOLIC STROKE Data Q1 '15:  POSITIVE DATA RELEASED 2/11/15

Report nonclinical data for repeat dose on Vepoloxamer in Heart Failure Q1 '15 POSITIVE DATA RELEASE 03/02/15

Phase 2 Study HEART FAILURE Initiate Enrollment Q2 '15 INITIATED 3/23/15

EPIC EXTENSION STUDY (Repeat Exposure) Initiate Enrollment 1st Half '15 INITIATED 5/26/15 

Phase 2a Study of AIR001 (WHO GROUP 2) in HFpEF Preliminary Data 2nd Half '15

Phase 2 Study Heart Failure Interim Safety Analysis 2nd Half '15



EPIC Top Line Data Q1 2016


Video of Management of Mast Therapeutics $MSTX speaking about MST-188 for Sickle Cell Disease ,orphan drug


Schedule 13D and 13G filings submitted since 09/30/14

  Filing Company Date of
Total Reported
Shares Owned
Shares Reported
on 13F
  Baker Bros LLC 12/31/14 4,774,434 4,774,434
  BVF Inc. 3/31/15 7,241,600 7,241,600!
SC 13G FRANKLIN RESOURCES INC 02/04/15 11,946,100 11,946,100
Reported via Event Date Name Ticker Shares * Change % of Portfolio
13F MPM Asset Management     MSTX 2,551,851    
13F Vanguard Group     MSTX 3,382,483    
13F Proquest Associates                                                                                                                                                                                                      MSTX.                        2,551,851




Contact Information

P: 858-552-0866    F: 858-552-0876
General Inquiries

Investor Relations Contact

Business Development Contact

Careers Contact




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Current Price
Bid Ask Day's Range
MSTX News: Current Report Filing (8-k) 10/19/2016 09:02:04 AM
MSTX News: Mast Therapeutics Announces Agreement With Philips For Supply Of Adaptive Aerosol Delivery System For AIR001 10/17/2016 08:00:00 AM
MSTX News: Mast Therapeutics To Present At 2016 BIO Investor Forum On October 19th 10/13/2016 08:00:00 AM
MSTX News: Could these companies be setting up for a rebound? 10/06/2016 08:00:00 AM
MSTX News: Mast Therapeutics Provides Business Update 09/26/2016 09:00:00 AM
#14957   $MSTX I know for a fact this is ChrisIT 10/21/16 06:55:03 PM
#14956   very few drugs under test for HFpEF. Despite lux1 10/21/16 05:15:55 PM
#14955   Give it time, this will go up. Look ChrisIT 10/21/16 08:36:37 AM
#14954   Big pharma trials in HF: Merck & Bayer. lux1 10/20/16 06:43:38 AM
#14953   We already seeing some after our action anyway stockpro3434 10/19/16 07:04:12 PM
#14952   Conference wasn't bad at all debt is stockpro3434 10/19/16 06:59:41 PM
#14951   In @.0880 for a bet TheKobra 10/19/16 03:47:22 PM
#14950 ChrisIT 10/19/16 02:16:14 PM
#14949   At the moment, we are only 5-7% up StockBull 10/19/16 01:51:01 PM
#14948   Big buys coming in hitting the ask Adam129 10/19/16 12:05:37 PM
#14947   Big day tomorrow stockpro3434 10/18/16 09:20:36 PM
#14946 Can't wait to see ChrisIT 10/18/16 06:30:15 PM
#14945   People stop arguing with one another. I have ChrisIT 10/18/16 06:27:35 PM
#14944   I agree. Why else even bother unless you StockBull 10/18/16 03:50:35 PM
#14943   It could be, but I hope if Culley lux1 10/18/16 02:56:44 PM
#14942   Correction... I was excited about this yesterday, but StockBull 10/18/16 10:35:40 AM
#14941   I'm super excited about it. I hope MSTX StockBull 10/17/16 08:58:24 PM
#14939   Tomorrow after noon will be interesting for Wednesday stockpro3434 10/17/16 05:49:19 PM
#14938   Are you all on ST stocktwits? I am. ChrisIT 10/17/16 04:03:29 PM
#14936   "Our agreement has been extended to include not ChrisIT 10/17/16 02:09:29 PM
#14935   Mast Therapeutics Announces Agreement With Philips For Supply StockBull 10/17/16 01:17:12 PM
#14934 StockBull 10/17/16 11:41:18 AM
#14933   PM looking good!!$$$glta?? omri 10/17/16 08:47:49 AM
#14932   fluffffff mikekrane 10/17/16 08:03:11 AM
#14931   The conference on Wednesday will be the telling ChrisIT 10/16/16 12:48:08 PM
#14930   EPIC, again. What really happened? Trial failed, lux1 10/15/16 09:14:05 AM
#14929   This week will be epic. I have 350,000 ChrisIT 10/15/16 09:08:31 AM
#14928   Agree! People have been saying bottom is in StockBull 10/14/16 04:03:13 PM
#14927   Time for going back up from here stockpro3434 10/14/16 03:45:37 PM
#14926   Now selling has stop stockpro3434 10/14/16 03:44:36 PM
#14925   it can be very very tempting to buy atoz 10/14/16 03:40:51 PM
#14924   Yes you are. This is a falling knife, StockBull 10/14/16 03:36:15 PM
#14923   i am so lucky i didn't average down atoz 10/14/16 03:19:56 PM
#14922   New 52wk low. Relentless selling, just doesn't stop. StockBull 10/14/16 02:49:31 PM
#14921   Here is some info about the BIO Investor StockBull 10/14/16 01:00:01 PM
#14919   unfortunately I have to agree with you. Ceo lux1 10/14/16 12:50:35 PM
#14918   I agree 100% with the concerns you brought StockBull 10/14/16 12:42:52 PM
#14917   Don't let that 400k on bid at .08 StockBull 10/14/16 12:03:59 PM
#14916   I knew they would have to sell for StockBull 10/14/16 11:52:52 AM
#14914   You would think this would start reversing on StockBull 10/14/16 10:46:10 AM
#14913   Addressed but not "acknowledged." Why is it so pray 10/14/16 10:13:48 AM
#14912   That's two different things being addressed versus actually ChrisIT 10/14/16 08:24:42 AM
#14911   The payment has already been addressed... BooDog 10/14/16 08:15:34 AM
#14910   I received an email from mstx yesterday stating ChrisIT 10/14/16 07:13:21 AM
#14909   I hope Ceo Culley reads this,just the point lux1 10/14/16 04:12:22 AM
#14908   Not that it means anything here, because massive StockBull 10/13/16 02:37:59 PM
#14907   Exactly! He should step down like John Stumpf StockBull 10/13/16 02:15:26 PM
#14906   ..the CEO is still working there.This is the problem lux1 10/13/16 10:30:50 AM
#14905   October 19th is the AIR001 confetence in San ChrisIT 10/13/16 10:22:08 AM