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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

http://stockcharts.com/h-sc/ui?s=MSTX&p=D&b=9&g=0&id=p36778398928

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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MSTX
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SureTrader
MSTX News: Current Report Filing (8-k) 08/10/2016 09:02:44 AM
MSTX News: Current Report Filing (8-k) 08/09/2016 09:01:26 AM
MSTX News: Mast Therapeutics Reports Second Quarter 2016 Financial Results 08/09/2016 08:00:00 AM
MSTX News: Mast Therapeutics Awarded Small Business Innovation Research Grant From The National Institutes Of Health 08/08/2016 08:00:00 AM
MSTX News: Mast Therapeutics Announces Issuance Of Composition Of Matter Patent Covering Vepoloxamer 08/03/2016 08:00:00 AM
PostSubject
#14206   I don't mind rich dummies!!! as long as trueblue 08/29/16 09:00:35 PM
#14205   Even today, there was decent volume in the brooklyn13 08/29/16 07:20:33 PM
#14204   Yeah, I really don't see the 300%? trueblue 08/29/16 06:55:02 PM
#14203   It's sounds good for you, but I'm brooklyn13 08/29/16 06:26:02 AM
#14202   Interesting to say the least? I bought shares trueblue 08/28/16 11:13:48 PM
#14201   Well, January, actually, so 3 months later, but brooklyn13 08/28/16 10:03:47 PM
#14200   There are over 14,000 2.50 calls a month trueblue 08/28/16 09:53:12 PM
#14199   Ponzi scheme? That must be why there brooklyn13 08/28/16 05:31:10 PM
#14198   IMO Culley printing new shares daily therefore right pray 08/27/16 01:10:02 AM
#14197   Has anyone seen any activity that would lead Kreed32 08/26/16 12:12:40 PM
#14196   Sorry to hear that, I have a few trueblue 08/21/16 07:09:15 PM
#14195   Not so great when back in the day mcp4 08/19/16 09:10:47 PM
#14194   Sold at a dollar. Now waiting for .60's. pray 08/19/16 12:12:57 PM
#14193   Analyst are saying $2.70 price target. I'll stick trueblue 08/17/16 11:27:26 PM
#14192   did you take your blgo profits today? looks blackbandit 08/16/16 11:42:00 PM
#14191   MSTX & BLGO ...MY two cash cows presently. pray 08/15/16 12:00:58 PM
#14190   Analyst are saying $5.00 a share price target! trueblue 08/13/16 10:23:46 PM
#14189   Those ratings are almost always for day traders Kreed32 08/13/16 10:58:20 AM
#14188   And now, Zack's downgrade. Zack's is crap-ola, but WTF? docoroc2 08/13/16 07:46:43 AM
#14187   Today had high volume and big relative increase docoroc2 08/12/16 08:53:45 PM
#14186   * * $MSTX Video Chart 08-12-16 * * ClayTrader 08/12/16 04:47:12 PM
#14185   I'm pretty sure this is the MSTX board WCT 08/12/16 12:34:45 PM
#14181   No RS, one offering, same share structure, no pray 08/10/16 11:18:13 AM
#14176   WHY? Of the 1000's of stocks to choose RNsidersbuying 08/09/16 04:11:01 PM
#14175   $MSTX on the pincher list now. Time BooDog 08/09/16 10:52:55 AM
#14174   While waiting sold half of mstx and bought pray 08/08/16 04:14:03 PM
#14173   It's a nice bone. Every little bit BooDog 08/08/16 01:49:10 PM
#14172   Still if half million, covers half of Hercules loan. pray 08/08/16 11:36:46 AM
#14171   Should be filed in their 8K. I would BooDog 08/08/16 10:39:18 AM
#14170   Never seen a grant where figure is excluded? pray 08/08/16 10:00:54 AM
#14169   I didn't see any dollar amount but I RNsidersbuying 08/08/16 09:50:43 AM
#14168   Anyone know how much is grant announced this pray 08/08/16 09:19:07 AM
#14167   Hope soon .... At least green after 5 pray 08/06/16 12:00:09 PM
#14166   Data on the way. Run up into BooDog 08/04/16 05:51:43 AM
#14165   Pushing a half cent a day loss after pray 08/03/16 01:38:36 PM
#14164   culley flooding the market with shares; clearly okaly 08/03/16 09:57:43 AM
#14163   Patent news... BooDog 08/03/16 08:14:15 AM
#14162   Thanks for the heads up, much appreciated...... I trueblue 08/02/16 09:59:04 PM
#14161   Patent issued this morning BooDog 08/02/16 05:48:48 AM
#14160   Some how the ceo's and others usually make trueblue 08/01/16 05:06:29 PM
#14159   I believe you are viewing that chart upside pray 08/01/16 01:19:18 PM
#14158   Past track record. pray 08/01/16 12:56:22 PM
#14157   Mast Therapeutics Announces Initiation Of Phase 2 Study BooDog 08/01/16 08:27:49 AM
#14156   New to this board, I was wondering trueblue 07/31/16 08:48:08 PM
#14155   Expecting continued moves upward today and tomorrow. Tidal~Gains~!! 07/28/16 08:43:27 AM
#14154   stocktwits.com stocker25 07/27/16 09:17:18 AM
#14153   I have read his posts on stocktwits. I stocker25 07/27/16 09:14:08 AM
#14152   It's clear that the company needs a new stocker25 07/27/16 09:13:12 AM
#14151   It could be, but there are also other stocker25 07/27/16 09:11:26 AM
#14150   http://stocktwits.com/RhodeyRed123 Link Scroll down an Tidal~Gains~!! 07/27/16 09:09:52 AM
PostSubject