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Mast Therapeutics, Inc. (MSTX)

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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 MST-188, our lead product candidate, for serious or life-threatening diseases with significant unmet needs.


http://wsw.com/webcast/cowen16/MSTX/  Webcast from Cowen Healthcare Conference 03/03/14

http://www.masttherapeutics.com/wp-content/uploads/2012/09/MastThera_CorpPres_07.09.2013.pdf


http://www.media-server.com/m/p/to9vgb8uhttp://www.media-server.com/m/p/to9vgb8u  Piper Jaffray Healthcare Conference 12/03/13 : 30 minute audio presentation by CEO B. Culley  NEW

http://www.masttherapeutics.com/wp-content/uploads/2012/09/MastThera_CorpPres_10.08.2013.pdf    12th Annual Bio-Investor Conference 10/08/13: 32 page PDF NEW

http://www.masttherapeutics.com/company/ceo-blog/ 
Blog Update from CEO B. Culley 12/12/13  NEW

http://www.masttherapeutics.com/investors/news/?releaseid=1887966  Data From Proof of Concept Study in Heart Failure 
01/06/13


2015 Biotech Conference Presentation Slides: January 12th 2015.  http://www.sec.gov/Archives/edgar/data/1160308/000119312515007330/d850231dex991.htm


ClinicalTrials.gov

 
A service of the U.S. National Institutes of Health

 

  • Make bi

 

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

This study is currently recruiting participants.
Verified July 2013 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: July 22, 2013
Last verified: July 2013

The purpose of this study is to evaluate whether ANX-188 can reduce the duration of vaso-occlusive crisis (VOC) in subjects with sickle cell disease. The study will also evaluate whether ANX-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 ANX-188 to those who do not receive ANX-188.


Condition Intervention Phase
Vaso-occlusive Crisis
Sickle Cell Disease
Drug: ANX-188
Drug: Saline
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 Children in Crisis (EPIC): A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of ANX-188 (Purified Poloxamer 188) Injection in Children 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: ANX-188
ANX-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: ANX-188
Placebo Comparator: Saline
Saline administered as a continuous infusion for up to 49 hours
Drug: Saline

 

 
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737814

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

 
Responsible Party: Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01737814     History of Changes
Other Study ID Numbers: ANX-188-01
Study First Received: November 27, 2012
Last Updated: July 22, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 25, 2013

 

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.

 

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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Wiki
MSTX News: Current Report Filing (8-k) 08/21/2015 04:34:37 PM
MSTX News: Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) 08/21/2015 04:34:08 PM
MSTX News: Notice of Effectiveness (effect) 08/20/2015 06:01:29 AM
MSTX News: Securities Registration: Employee Benefit Plan (s-8) 08/12/2015 04:47:40 PM
MSTX News: Securities Registration Statement (simplified Form) (s-3/a) 08/12/2015 04:42:29 PM
PostSubject
#13116  Sticky Note Upcoming Catalysts: Blinkx90 08/29/15 12:50:48 PM
#13125   Not passing on this puppy. Just need to BooDog 09/01/15 12:43:41 PM
#13124   Saw about four posts Sunday, all gone? Anything pray 09/01/15 10:17:16 AM
#13118   Excellent post blinks and pretty much along with BooDog 08/29/15 05:19:38 PM
#13117   If 100-200% on the low end of expectations Rhodey Red 08/29/15 02:03:56 PM
#13116   Upcoming Catalysts: Blinkx90 08/29/15 12:50:48 PM
#13115   I posted this on SA: Blinkx90 08/29/15 12:47:09 PM
#13114   A $1 - $1.50 on positve data would First Blood 08/29/15 07:20:00 AM
#13113   Initial breakout of PPS on positive top/bottom line Rhodey Red 08/29/15 06:09:35 AM
#13112   Dog - What is your guesstimate on the First Blood 08/29/15 02:07:42 AM
#13111   I've got a hunch that this pig is First Blood 08/28/15 11:44:51 PM
#13110   I have a hunch that they are BooDog 08/28/15 05:30:57 AM
#13109   Pray does go on a bit, that's for First Blood 08/27/15 07:59:59 PM
#13108   Has this ever had a better environment to okaly 08/27/15 07:13:08 PM
#13106   Hate to always be right but …. Class …. pray 08/27/15 11:56:36 AM
#13104   It would be a great to back up pray 08/27/15 11:39:15 AM
#13103   "Doubt it; MSTX is the only company with Blinkx90 08/27/15 11:19:53 AM
#13102   Doubt it; MSTX is the only company with pray 08/27/15 10:31:02 AM
#13101   No offense taken, no melting here because I pray 08/27/15 10:29:02 AM
#13099   4th Annual SCD CONF Blinkx90 08/27/15 07:29:49 AM
#13096   Pray, you are a blatant outright lying POS Rhodey Red 08/26/15 02:16:09 PM
#13095   You are correct, the server had a "reverse pray 08/26/15 12:21:20 PM
#13093   My comment to the SA piece: Blinkx90 08/26/15 07:34:20 AM
#13092   Another positive piece from Brett Jensen: http://stks.co/j31tI Rhodey Red 08/25/15 09:24:48 PM
#13091   looks like a server fail on the hosting side. okaly 08/25/15 11:30:13 AM
#13090   Sorry but again you mis-read me. pray 08/25/15 10:18:59 AM
#13089   You will be out once you are break Blinkx90 08/25/15 10:02:57 AM
#13088   My, My .... amazing how callus some can pray 08/25/15 10:00:35 AM
#13087   Mast's website been down for a few hours, Blinkx90 08/25/15 09:28:27 AM
#13086   "I feel any investor reading that PR seeing Blinkx90 08/25/15 07:19:41 AM
#13085   Rhodey, not a seasoned investor as yourself, nor pray 08/24/15 09:49:01 AM
#13084   RR, you have explained this all so well. Bx3 08/23/15 10:24:31 PM
#13083   Pray, you clearly know the difference between a Rhodey Red 08/23/15 09:18:05 AM
#13082   No freaking out here .... pray 08/22/15 11:17:03 PM
#13081   Everything is correct..the only misunderstanding you were having Rhodey Red 08/22/15 11:01:26 PM
#13080   Maybe I am misunderstanding this but when a pray 08/22/15 10:26:43 PM
#13079   Pray, c'mon man...this isn't an offering. It's 100% Rhodey Red 08/22/15 12:33:25 PM
#13078   "Never Said A Word About Another Offering Last Blinkx90 08/22/15 07:40:50 AM
#13077   Never Said A Word About Another Offering Last pray 08/21/15 10:36:09 PM
#13076   One other thought .... pray 08/19/15 09:22:31 AM
#13075   They may not know MSTX is in the pray 08/18/15 03:47:14 PM
#13074   Blinkx90, we cant be discouraged by this type Bx3 08/18/15 02:57:04 PM
#13073   Not a mention of Mast, amazing. Blinkx90 08/18/15 11:59:49 AM
#13072   My point was if successful promote it. If pray 08/17/15 12:01:14 PM
#13071   BTW, if you can ever get your hands Blinkx90 08/17/15 07:19:55 AM
#13070   I was impressed. Very much looking forward BooDog 08/17/15 07:13:47 AM
#13069   Michael Higgins - Roth Capital Partners Blinkx90 08/17/15 07:04:28 AM
#13068   Blink, curious: what do you expect them to kld2 08/16/15 12:02:47 PM
#13067   "Why have successful tests and not share results? Blinkx90 08/16/15 10:46:16 AM
#13066   Bx3, I misinterpreted your post. My apologies. You kld2 08/16/15 04:06:22 AM
#13065   Hello kid2. I had been following the long Bx3 08/15/15 01:25:51 PM
PostSubject