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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.

Investors

http://www.masttherapeutics.com/investors/

 

Evaluation of Purified Poloxamer 188 in Children in Crisis (EPIC)

https://clinicaltrials.gov/show/NCT01737814
This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Mast Therapeutics, Inc.
Sponsor:
Mast Therapeutics, Inc.
Information provided by (Responsible Party):
Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01737814
First received: November 27, 2012
Last updated: September 24, 2015
Last verified: September 2015
 

  Purpose

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

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

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 ClinicalTrials.gov identifier: NCT01737814

Contacts
       
Contact: Mast Therapeutics CT.gov Call Center 1-888-965-1238    

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

No publications provided
 
   
Responsible Party: Mast Therapeutics, Inc.
ClinicalTrials.gov 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
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies

ClinicalTrials.gov processed this record on December 30, 2015

 

Technology

 

Hematology

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.

AIR001

 

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 STUDY COMPLETE ENROLLMENT Q4 '15

2016 EVENTS

EPIC Top Line Data Q1 2016







 

Video of Management of Mast Therapeutics $MSTX speaking about MST-188 for Sickle Cell Disease ,orphan drug 
http://www.youtube.com/watch?v=eI7inPOiyZM&feature=youtu.be 
http://www.masttherapeutics.com/wp-content/uploads/2013/04/EPIC-An-Ongoing-Pivotal-Phase-3-Study-in-Patients-with-Sickle-Cell-Disease-Aug-21-2013.




 

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

  Filing Company Date of
Filing
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



 

                                                                       






http://stockcharts.com/h-sc/ui?s=MSTX&p=D&b=2&g=0&id=p32395513381

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http://stockcharts.com/freecharts/gallery.html?MSTX

                                                       

Contact Information

P: 858-552-0866    F: 858-552-0876
General Inquiries
info@mastthera.com

Investor Relations Contact
ir@mastthera.com

Business Development Contact
busdev@mastthera.com

Careers Contact
hr@mastthera.com

 

                                                                                                 

                                                                                                                                                 

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SureTrader
MSTX News: Results of Vepoloxamer Nonclinical Studies in Advanced Heart Failure Presented at European Society of Cardiology 3rd World Co... 05/23/2016 08:00:00 AM
MSTX News: Notice of Effectiveness (effect) 05/17/2016 06:01:31 AM
MSTX News: Notice of Effectiveness (effect) 05/17/2016 06:00:53 AM
MSTX News: Positive Interim Results From Second Phase 2a Study Of AIR001 In Patients With Heart Failure With Preserved Ejection Fraction... 05/16/2016 08:00:00 AM
MSTX News: Prospectus Filed Pursuant to Rule 424(b)(3) (424b3) 05/16/2016 07:42:09 AM
PostSubject
#13948  Sticky Note Institutional ownership update: alexander77 05/17/16 10:49:36 AM
#13841  Sticky Note Targets are set for April into June for BooDog 03/15/16 06:38:54 PM
#13952   they are talking about commercialisation at the national lux1 05/26/16 07:16:07 AM
#13951   Squeeze! Last Price 0.34 BooDog 05/26/16 06:26:03 AM
#13950   I see good things happening here so I kpisme 05/19/16 02:56:19 PM
#13949   That's low considering they did an offering of hboss 05/19/16 03:59:37 AM
#13948   Institutional ownership update: alexander77 05/17/16 10:49:36 AM
#13947   Thanks!Why Phase 3 on sickle cell will meet alexander77 05/16/16 02:55:15 PM
#13946   Nice write up for EPIC... BooDog 05/16/16 01:39:49 PM
#13945   I don't understand if this is good news Jack766 05/16/16 09:08:05 AM
#13944   POSITIVE INTERIM RESULTS FROM SECOND PHASE 2A STUDY Cicant 05/16/16 08:59:59 AM
#13943   Study which shows Vepoloxamer is statistically efficient alexander77 05/15/16 05:48:48 PM
#13942   Thinking we're very close to seeing data. BooDog 05/15/16 09:47:50 AM
#13941   I am back in. Reason: I am 100 alexander77 05/14/16 03:19:55 PM
#13940   You mentioned you were out. Are you TheSaint09 05/14/16 03:08:23 PM
#13939   "What Adam Feuerstein really said about MSTX phase alexander77 05/14/16 02:18:17 PM
#13938   You may start buying now alexander77 05/13/16 03:48:48 PM
#13937   I am out. Read my pitch to see why. alexander77 05/13/16 05:24:39 AM
#13936   This and ENDO, my two bio-hopefuls. pray 05/12/16 12:53:01 PM
#13935   Thanks pray. :-) Looking forward to data soon. BooDog 05/12/16 12:07:16 PM
#13934   You are right, been a risk for years. pray 05/12/16 12:04:42 PM
#13933   Exactly what make this such a powerful risk BooDog 05/12/16 11:58:04 AM
#13932   Not personal, about integrity. Countless deception by Cully. pray 05/12/16 11:55:24 AM
#13931   As stated, I am still waiting for Mr. pray 05/12/16 11:45:58 AM
#13930   When MSTX was ANX the same was done pray 05/12/16 11:42:03 AM
#13929   I'm thinking soon considering the press we're seeing BooDog 05/12/16 10:55:31 AM
#13928   Importantly, vepoloxamer has the potential to become the RNsidersbuying 05/12/16 08:40:35 AM
#13927   Mstx pre-market high $.39 crazy Jack766 05/12/16 07:50:30 AM
#13926   Pray, I'm just curious since I am new to TheSaint09 05/10/16 09:01:41 PM
#13925   Clearly why he filed this... BooDog 05/10/16 11:16:16 AM
#13924   The one thing Culley does well is "manipulate." pray 05/10/16 10:43:14 AM
#13923   So, if that is the case based on TheSaint09 05/10/16 08:00:24 AM
#13922   Hope it is a success, but look at pray 05/09/16 09:50:24 PM
#13921   Or it could be the trial is an Valensio 05/09/16 07:30:51 PM
#13920   Hate to burst your bubble but you must pray 05/09/16 05:39:24 PM
#13919   That is great news in addition to the TheSaint09 05/07/16 11:09:29 PM
#13918   Thanks Alex! That is great! Jim BooDog 05/07/16 06:48:33 AM
#13917   More great news:'The Company is filing this Post-Effective alexander77 05/06/16 06:09:24 PM
#13916   $MSTX Daily and Weekly Ichimoku Chart http://s $Pistol Pete$ 05/05/16 10:58:27 AM
#13915   Mstx akamaii 05/04/16 04:17:39 PM
#13914   i see the inmates have taken over... okaly 05/04/16 01:39:46 AM
#13913   UKER....... seachops 05/03/16 11:27:20 PM
#13912   LOOKY HERE ^ seachops 05/03/16 11:18:07 PM
#13911   ;)no no seachops 05/03/16 11:15:56 PM
#13910   hopefully not bill c seachops 05/03/16 11:12:18 PM
#13909   Bill's comming seachops 05/03/16 11:07:16 PM
#13908   .50$ cent handle soon seachops 05/03/16 10:57:08 PM
#13907   I grabed quit a few today... seachops 05/03/16 08:48:53 PM
#13906   Look Up ^ seachops 05/03/16 08:31:56 PM
#13905   Looks good. I put my alerts out around BooDog 05/03/16 08:24:12 PM
#13904   Should be a go this time... seachops 05/03/16 08:14:38 PM
#13903   More action in the premarket in the last Jack766 05/02/16 09:08:56 AM
PostSubject