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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.  Webcast from Cowen Healthcare Conference 03/03/14  Piper Jaffray Healthcare Conference 12/03/13 : 30 minute audio presentation by CEO B. Culley  NEW    12th Annual Bio-Investor Conference 10/08/13: 32 page PDF NEW 
Blog Update from CEO B. Culley 12/12/13  NEW  Data From Proof of Concept Study in Heart Failure 

2015 Biotech Conference Presentation Slides: January 12th 2015.

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


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

This study is currently recruiting participants.
Verified July 2013 by Mast Therapeutics, Inc.
Mast Therapeutics, Inc.
Information provided by (Responsible Party):
Mast Therapeutics, Inc. Identifier:
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 identifier: NCT01737814

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

Responsible Party: Mast Therapeutics, Inc. 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
Hematologic Diseases
Genetic Diseases, Inborn processed this record on July 25, 2013





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




Phase 2 Study Acute Limb Ischemia COMPLETE ENROLLMENT 2nd Half '16


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) 06/25/2015 08:02:07 AM
MSTX News: Current Report Filing (8-k) 06/16/2015 04:11:56 PM
MSTX News: Statement of Changes in Beneficial Ownership (4) 06/12/2015 05:45:46 PM
MSTX News: Statement of Changes in Beneficial Ownership (4) 06/12/2015 05:19:06 PM
MSTX News: Statement of Changes in Beneficial Ownership (4) 06/12/2015 05:17:48 PM
#12913   Flipper rebuy time @ .453 RNsidersbuying 06/29/15 01:28:00 PM
#12912   MSTX dropped another 18% in June alone. With pray 06/29/15 09:16:25 AM
#12911   NIH SCD Forum June 25-26. Rhodey Red 06/27/15 11:19:01 PM
#12910   Looks to be triggering some S/L's. Swing BooDog 06/24/15 03:59:22 PM
#12909   Thanks for the reply, but my point was pray 06/23/15 10:43:46 AM
#12908   Nice looking tightening and consolidating going on here, SPM555 06/19/15 12:01:38 PM
#12907 Rhodey Red 06/17/15 08:11:57 PM
#12906   so thats 20 million more shares to dilute? okaly 06/16/15 06:35:33 PM
#12905 Rhodey Red 06/16/15 06:02:32 PM
#12904   Holding the pennant line. See if it can BooDog 06/16/15 11:08:51 AM
#12903   Pray, You know how options work buddy...nothing is given Rhodey Red 06/15/15 06:07:50 AM
#12902   Hope they somehow point out that the nearly pray 06/12/15 10:16:51 PM
#12901   New Form 4 filings released today. Rhodey Red 06/12/15 06:30:19 PM
#12900   Don't look like to me it could hit iSwat22 06/09/15 09:51:23 AM
#12899   Yes, but running backwards. If you check calendar, pray 06/08/15 11:23:52 AM
#12898   A lot selling this morning iSwat22 06/08/15 10:22:45 AM
#12897   He meant run back to the 40s. LOL at14tao 06/08/15 10:06:50 AM
#12896   We're waitin' wodehouse 06/08/15 10:05:01 AM
#12895   Ready for run today iSwat22 06/08/15 08:01:30 AM
#12894   From the chart looks like it will bounce up iSwat22 06/07/15 05:58:19 PM
#12893   Why? wodehouse 06/07/15 05:57:00 PM
#12892   IMO looks like it will bounce up tomorrow iSwat22 06/07/15 05:16:21 PM
#12891   From Bloomberg: Rhodey Red 05/31/15 09:04:33 PM
#12890   Mast has plenty of cash on hand to Rhodey Red 05/30/15 08:29:26 AM
#12889   Any thoughts on the 19 millions OS and db 05/29/15 09:39:46 AM
#12888 Rhodey Red 05/28/15 07:33:20 PM
#12887 Rhodey Red 05/28/15 06:21:14 PM
#12885   Not going to help until positive tests. Pathetic pray 05/26/15 10:47:07 AM
#12884 Rhodey Red 05/26/15 08:10:39 AM
#12883 Rhodey Red 05/20/15 01:24:52 PM
#12882   Absolutely Pray. Every updated version of the Corporate Rhodey Red 05/20/15 07:37:29 AM
#12881   Entering the flip window yet again. Anyone else BooDog 05/19/15 06:26:49 PM
#12880   Agree, excellent update. As a non scientist I BooDog 05/19/15 08:43:21 AM
#12879 Got to admit, the chart pray 05/19/15 08:29:08 AM
#12878   Keeps flirting with the 200dma. Volume would BooDog 05/15/15 08:25:27 AM
#12877   Pathetic ..... Even on a day stocks up pray 05/14/15 07:49:10 PM
#12876   Thanks Rhodey! eom BooDog 05/12/15 09:08:32 PM
#12875   New CEO blog post uploaded to Mast Site: Rhodey Red 05/12/15 08:45:42 PM
#12874   Love to see a 8-15 point run to pray 05/08/15 10:44:16 AM
#12873   Lot of shorts still out there. Could run monkeyfrog 05/08/15 10:23:00 AM
#12872   Nice to see some consistent up swings. pray 05/08/15 10:12:58 AM
#12871   Anyone know what is up with the after Citrati 05/05/15 04:44:57 PM
#12870   Not one iota concerned Okaly. That is a Rhodey Red 05/04/15 08:23:29 PM
#12869   So what's your specific concern and where are monkeyfrog 05/04/15 08:12:18 PM
#12868   anyone concerned about this? im seeing okaly 05/04/15 07:56:56 PM
#12867   Showing some power zone potential imo. BooDog 05/04/15 12:10:58 PM
#12866   Can be difficult to read. Charts point to pray 05/04/15 10:42:42 AM
#12865   Why is the stock price dogging it??? tmeier 05/04/15 08:54:16 AM
#12864   MSTX chart.... hogfan2 05/01/15 11:53:28 AM
#12863   Absolutely Hog!!!! We might fade a bit EOD Rhodey Red 05/01/15 11:42:47 AM