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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 

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.



Exelbine™, or ANX-530 (vinorelbine injectable emulsion), is a novel emulsion formulation of the chemotherapy drug vinorelbine (Navelbine®). We are seeking a partner or outside investor to continue development of the Exelbine program.


ANX-514 (docetaxel for injectable emulsion) is a novel, detergent-free emulsion formulation of the chemotherapy drug docetaxel. We are seeking a partner or outside investor to continue development of the ANX-514 program.

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


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

Schedule 13D and 13G filings submitted since 03/31/2013

  Filing Company Date of
Total Reported
Shares Owned
Shares Reported
on 13F
  Baker Bros LLC 03/31/14 3,000,000 3,000,000
SC 13G SABBY MANAGEMENT, LLC 01/14/2014 4,105,500 3,639,571
SC 13G FRANKLIN RESOURCES INC 07/10/2013 10,987,000 12,000,000
Reported via Event Date Name Ticker Shares * Change % of Portfolio
13F     MSTX      
13F     MSTX      




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
ANX News: Mast Therapeutics Initiates Sub-Study Within Phase 3 EPIC Trial 06/16/2014 08:00:00 AM
#12363   It's accurate Pray. Boston Based Hedge Fund MPM Rhodey Red 10/24/14 08:52:55 AM
#12362   Does not seem right. That would only be pray 10/23/14 04:40:11 PM
#12361   Inst. increases holdings from 525,000 to 2,551,851...huge increase laker2000 10/23/14 10:54:26 AM
#12360   Thanks for posting that Laker 2000!!!! Rhodey Red 10/21/14 07:01:51 PM
#12359   Rhodney here's the reply fromIR laker2000 10/21/14 01:39:25 PM
#12358   Thanks for the thoughts on my new residence. Rhodey Red 10/21/14 05:50:16 AM
#12357   Can you give links concerning the withdraw? As pray 10/20/14 09:46:26 PM
#12356   Absolutely!!!!!! Still holding strong and sleeping very soundly Rhodey Red 10/20/14 07:41:21 PM
#12355   I think $MSTX and $IFUS both might turn Ecomike 10/19/14 02:06:28 AM
#12354   Still holding your position, have not noticed any pray 10/17/14 07:58:26 AM
#12353   EBOLA US MSTX provest 10/16/14 10:07:10 PM
#12352   Depends how long you can wait and your pray 10/15/14 03:03:13 AM
#12351   there are a lot of turds on the okaly 10/14/14 09:45:21 PM
#12350   I've been holding on to this one for moneylover3 10/14/14 09:47:30 AM
#12349   Even if they did with no PR division pray 10/14/14 03:46:56 AM
#12348   No, but I was wondering about that too. Ecomike 10/14/14 12:02:18 AM
#12347   $MSTX hearing might be an EBOLA play? provest 10/13/14 08:55:52 PM
#12346   Actually MSTX has outperformed most other stocks the Ecomike 10/13/14 06:57:09 PM
#12345   This thing gets much lower, going to be kpisme 10/13/14 01:55:01 PM
#12344   Thx, RR. Cicant 10/13/14 05:50:35 AM
#12343   Historically ODD news from the EU comes out Rhodey Red 10/12/14 08:43:58 PM
#12342   MSTX trades one hell of a lot of Ecomike 10/10/14 02:42:20 PM
#12341   No news about orphan status opinion for MST-188 Cicant 10/10/14 11:03:23 AM
#12340   So, about this buyout coming this week. Are The Bread Man 10/08/14 11:11:48 AM
#12339   Mast is presenting this Tuesday at the Bio Rhodey Red 10/05/14 09:42:20 PM
#12338   MSTX:In level two, transactions changed from sell(red) to neutral lecorb 10/03/14 04:34:20 PM
#12337   Cool! I need to get more shares now. The Bread Man 10/03/14 10:09:26 AM
#12336   New medical doctor received 600,000 shares at .59 pray 10/03/14 12:52:55 AM
#12335   In the last 180 min.....range 0,5898 and 0,59 harmsen 10/02/14 03:56:47 PM
#12334   It is a technical issue of chart. At lecorb 10/02/14 03:40:16 PM
#12333   40,100 SHARES BUY @.5899 15:03 +8,575 @.5899 15:12 lecorb 10/02/14 03:35:15 PM
#12332   Buyout next week!100% harmsen 10/02/14 03:21:52 PM
#12331   Volume today 775,871. harmsen 10/02/14 03:20:04 PM
#12330   News is coming,quote 0,5898 and 0,5899. harmsen 10/02/14 03:18:22 PM
#12329   AMERICAN BULLS: STAY LONG, The Delayed Intraday Module lecorb 10/02/14 01:56:27 PM
#12328   Analyst Ratings Network:Price Target: $2.10 (255.93% upside) lecorb 10/02/14 01:11:18 PM
#12327   Mast Therapeutics Announces Appointment Of Chief Medical Officer harmsen 10/02/14 08:06:35 AM
#12326   Yes! harmsen 10/01/14 12:47:10 PM
#12325   Possible buyout? Is it time to start loading? The Bread Man 10/01/14 12:22:42 PM
#12324   Good article, not sure why MAST themselves would pray 10/01/14 11:44:21 AM
#12323   Look, it worked. My negative comment caused this The Bread Man 10/01/14 11:33:06 AM
#12322   This thing's dropping faster than a lead potatoe, The Bread Man 10/01/14 11:04:03 AM
#12321   Why Imminent Orphan Status Designation Will Attract Big LaJollaCA 10/01/14 10:58:28 AM
#12320   No one even noticed it. Instead of price pray 10/01/14 10:54:35 AM
#12319   Good news for MSTX. Rhodey Red 09/26/14 09:12:21 PM
#12318   mstxto present at 2 conferences first week of October biz money 09/23/14 03:21:10 PM
#12317   Two Words .... Pathetic Management. pray 09/19/14 12:43:53 PM
#12316   Doubt it will get to that, .55 maybe. pray 09/16/14 08:47:23 AM
#12315   This keeps dropping you will be able to kpisme 09/15/14 05:45:02 PM
#12314   Daily cycle .... shorts sell 10,000 first hour pray 09/15/14 12:49:59 PM