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2004 Postings, 1002 Tage berliner-nobodySehr gute long Investment Chance

 
  
    #1
3
25.01.13 22:55

 

BARDA Invites Soligenix to Submit Contract Proposal for  Development of OrbeShield(TM) in GI ARS


PRINCETON, N.J.,  Jan. 7, 2013 /PRNewswire via COMTEX/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix  or the Company), a development stage biopharmaceutical company, announced today  that pursuant to review of the Company's white paper on development of  OrbeShield(TM) as a countermeasure for the gastrointestinal effects of acute  radiation syndrome (GI ARS), the Biomedical Advanced Research and Development  Authority (BARDA), Division of Chemical, Biological, Radiological and Nuclear  (CBRN) Medical Countermeasures has informed the Company that after careful  analysis and consideration, it is inviting Soligenix to submit a full proposal  for a potential multi-year, multi-million dollar contract to develop  OrbeShield(TM) from its current level of technical readiness to FDA approval.

Soligenix submitted its white paper entitled "OrbeShield(TM), oral  beclomethasone 17,21-dipropionate (BDP), a candidate broad spectrum therapeutic  countermeasure for GI ARS," to BARDA in response to a Broad Agency Announcement  (BARDA-BAA-12-100-SOL-00011) for advanced research and development of medical  countermeasures for chemical, biological, radiological and nuclear threats.  BARDA is interested in the advanced development and eventual licensure/approval  of effective medical countermeasures that mitigate, treat, affect, delay, or  interrupt the progression of injuries resulting from an acute exposure to  radiation from a radiological/nuclear accident or attack, particularly injuries  associated with ARS.

In a canine model of GI ARS, OrbeShield(TM) demonstrated a statistically  significant survival advantage in animals that received OrbeShield(TM) therapy  up to 24 hours following exposure to lethal doses of total body irradiation  (TBI) when compared with placebo control animals (p=0.04). Median survival post  TBI exposure in the control group was 8 days, compared to 87 days in the  OrbeShield(TM) treated group. A subsequent study to replicate and expand upon  the observations made in the canine model is being initiated and, like the  previous study, is supported by a recent National Institute of Allergy and  Infectious Diseases (NIAID) Small Business Innovation Research (SBIR) grant  award.

"We are very excited by BARDA's invitation to submit a full proposal for  development of OrbeShield(TM) as a medical countermeasure against GI ARS,"  stated Christopher J Schaber, PhD, President & Chief Executive Officer of  Soligenix. "Although there are no guarantees, we believe that we are  well-positioned to receive BARDA support for this indication and that the full  proposal will allow us to further demonstrate the growing body of compelling  scientific evidence supporting OrbeShield(TM)'s potential as a countermeasure  for GI ARS. We intend to submit our proposal to BARDA in February 2013 and look  forward to their response. Meanwhile, we continue to develop OrbeShield(TM)  pursuant to our recent $600,000 SBIR grant supporting further GI ARS canine  studies."

The invitation to submit a proposal is non-binding and the selection of  Soligenix's white paper for submission of a full proposal is not a guarantee of  a BARDA contract. A contract award will require a favorable technical and  scientific review by BARDA followed by negotiation of fair and reasonable  contract terms.

About GI ARS

ARS occurs after toxic radiation exposure and involves several organ systems,  notably the bone marrow the GI tract and later the lungs. In the event of a  nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed  to >2 Gy are at high risk for development of clinically significant ARS.  Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury  which can result in death in 5-15 days. The GI tract is highly sensitive due to  the requirement for incessant proliferation of crypt stem cells and production  of mucosal epithelium. The extent of injury to the bone marrow and the GI tract  are the principal determinants of survival after exposure to TBI. Although the  hematopoietic syndrome can be rescued by bone marrow transplantation or growth  factor administration, there is no established treatment or preventive measure  for the GI damage that occurs after high-dose radiation. Therefore, there is an  urgent need to develop specific medical countermeasures against the lethal  pathophysiological manifestations of radiation-induced GI injury.

About OrbeShield(TM)

OrbeShield(TM) is formulated for oral administration in GI ARS patients as a  single product consisting of two tablets; one tablet releases BDP in the  proximal portions of the GI tract and the other tablet releases BDP in the  distal portions of the GI tract. BDP has been marketed in the United States and  worldwide since the early 1970s as the active pharmaceutical ingredient in  inhalation products for the treatment of patients with allergic rhinitis and  asthma. Oral BDP may also have application in treating other GI disorders  characterized by severe inflammation such as Crohn's disease and radiation  enteritis.

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing  products to treat serious gastrointestinal diseases where there remains an unmet  medical need, as well as developing several biodefense vaccines and  therapeutics. Soligenix is developing proprietary formulations of oral BDP  (beclomethasone 17.21-dipropionate) for the prevention/treatment of  gastrointestinal disorders characterized by severe inflammation, including  pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and  chronic Graft-versus-Host disease (orBec�), as well as SGX942 for the treatment  of oral mucositis.

Through its BioDefense Division, Soligenix is developing countermeasures  pursuant to the Biomedical Advanced Research and Development Authority (BARDA)  Strategic Plan of 2011-2016 for inclusion in the US government's Strategic  National Stockpile. Soligenix's lead biodefense products in development are a  recombinant subunit vaccine called RiVax(TM), which is designed to protect  against the lethal effects of exposure to ricin toxin and VeloThrax(TM), a  vaccine against anthrax exposure. RiVax(TM) has been shown to be well tolerated  and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both  RiVax(TM) and VeloThrax(TM) are currently the subject of a $9.4 million National  Institute of Allergy and Infectious Diseases (NIAID) grant supporting  development of Soligenix's new vaccine heat stabilization technology known as  ThermoVax(TM). Soligenix is also developing OrbeShield(TM) for the treatment of  gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small  Business Innovation Research (SBIR) grant. OrbeShield(TM) has previously  demonstrated statistically significant preclinical survival results in two  separate canine GI ARS studies funded by the NIH.

For further information regarding Soligenix, Inc., please visit the Company's  website at www.soligenix.com.

This press release contains forward-looking statements that reflect  Soligenix, Inc.'s current expectations about its future results, performance,  prospects and opportunities. Statements that are not historical facts, such as  "anticipates," "believes," "intends," or similar expressions, are  forward-looking statements. These statements are subject to a number of risks,  uncertainties and other factors that could cause actual events or results in  future periods to differ materially from what is expressed in, or implied by,  these statements. Soligenix cannot assure you that it will be able to  successfully develop or commercialize products based on its technology,  particularly in light of the significant uncertainty inherent in developing  vaccines against bioterror threats, manufacturing and conducting preclinical and  clinical trials of vaccines, and obtaining regulatory approvals, that product  development and commercialization efforts will not be reduced or discontinued  due to difficulties or delays in clinical trials or due to lack of progress or  positive results from research and development efforts, that it will be able to  successfully obtain any further grants and awards, maintain its existing grants  which are subject to performance, enter into any biodefense procurement  contracts with the US Government or other countries, or that the US Congress may  not pass any legislation that would provide additional funding for the Project  BioShield program. These and other risk factors are described from time to time  in filings with the Securities and Exchange Commission, including, but not  limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law,  Soligenix assumes no obligation to update or revise any forward-looking  statements as a result of new information or future events.

SOURCE Soligenix, Inc.

 

 

www.prnewswire.com  Copyright (C) 2013 PR Newswire. All rights reserved

-0-

 

KEYWORD:          New Jersey INDUSTRY KEYWORD: HEA                   MTC                   PHA SUBJECT CODE:     CON

 

 

Also das ist meine erste Thread Eröffung :)

mit der News oben begann mein interesse, erst scheute ich mich daran zu glauben, aber nun bin ich investiert!  Ich sehe nach dem kontinuierlichen Kursanstieg gute Chancen.

Es ist kein Zock!!

Pusherblätter gibt es stand heute kaum, der Wert, ist gänzlich ruhig.

Aktienanzahl stand heute Aktienanzahl 11,16 Mio.

Period  Ending Sep 30, 2012 Jun 30, 2012 Mar 31, 2012 Dec 31, 2011
Total Revenue 932 763 647 653
Cost of Revenue 762 616 557 550
Gross Profit 170 147 91 104

Operating Expenses

Research and  Development 371 501 877 1,044
Sales, General  and Admin. 559 627 655 568
Non-Recurring Items - - - -
Other - - - -
Operating Income (760) (982) (1,441) (1,508)

Income From Continuing Operations

Add'l  Income/Expense Items 1 2 2 2
Earnings Before Interest and Tax (759) (980) (1,439) (1,506)
Interest Expense - - - -
Earnings Before  Tax (759) (980) (1,439) (1,506)
Income Tax - - - -
Minority  Interest - - - -
Equity Earnings  Unconsolidated Subsidiary - - - -
Net  Income Cont. Operations (759) (980) (1,439) (932)

Non Recurring Events

Discontinued  Operations - - - -
Extraordinary  Items - - - -
Effect of  Accounting Changes - - - -
Other Items - - - -
Net Income (759) (980) (1,439) (932)
Preferred Stock and Other Adjustments - - - -
Net  Income Applicable to Common Shareholders (759) (980) (1,439) (932)

http://www.otcmarkets.com/stock/SNGX/financials

 

Ich persönlich bin sehr gespannt auf die Zahlen aus Q4

Desweiteren erwarte ich ein uplisting zur Nasdaq in küze

Wednesday, 23. Januar 2013
Chris Schaber, Präsident & CEO von Soligenix (OTC: SNGX) erzählt Proactiveinvestors dass die Firmenphilosophie, um das Geschäft zu wachsen, mit Regierung und staatliche Unterstützung, soweit möglich. Mit, was Chris sagt, ist ein erfahrenes Management-Team und Vorstand will das Unternehmen, um voranzukommen mit der Investment-Community und auch an einem gewissen Punkt, sollten Sie eine vollständige Nasdaq Auflistung.
www.youtube.com/watch?feature=player_embedded&v=qpY_RCiVNsc

ich hoffe das mit dem video funktioniert :)

ich freu mich über eine sachliche offene Disskusion

 
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58 Postings ausgeblendet.

1968 Postings, 4073 Tage HiGhLiFEordentlich, mal schaun ob

 
  
    #60
19.09.13 20:47
auch hierzulande etwas Volumen reinkommt, ist schon schade als Alleinunterhalter bei sonem geilen Wert  

1968 Postings, 4073 Tage HiGhLiFEweiter steigen bitte

 
  
    #61
20.09.13 20:55

1968 Postings, 4073 Tage HiGhLiFEda stehen sie die 2$

 
  
    #62
20.09.13 22:31

1968 Postings, 4073 Tage HiGhLiFEhier geht die Post ab...

 
  
    #63
24.09.13 21:08

1968 Postings, 4073 Tage HiGhLiFEUS Gesundheitsministerium ist dabei...

 
  
    #64
24.09.13 21:10
mit 26,3 Mio$.
Soligenix Awarded BARDA Contract Valued up to $26.3 Million for Advanced Development of OrbeShield? in GI ARS
Date : 09/19/2013 @ 7:15AM
Source : PR Newswire (US)
Stock : Soligenix, Inc. (SNGX)
Quote : 2.2  0.18 (8.91%) @ 2:53PM
                    §
Soligenix Awarded BARDA Contract Valued up to $26.3 Million for Advanced Development of OrbeShield? in GI ARS
Print
Soligenix, Inc. (OTCBB:SNGX)
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1 Month : From Aug 2013 to Sep 2013
Click Here for more Soligenix, Inc. Charts.

PRINCETON, N.J., Sept. 19, 2013 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense medical countermeasures (MCMs) where there remains an unmet medical need, announced today that it has been awarded a contract valued at up to $26.3 million by the US Department of Health and Human Service's Biomedical Advanced Research and Development Authority (BARDA). The contract is for the advanced preclinical and manufacturing development of OrbeShield? (oral beclomethasone 17,21-dipropionate or oral BDP) as a MCM for the treatment of gastrointestinal acute radiation syndrome (GI ARS).

The potential five year contract contains a two year base period, with two contract options that would extend the contract an additional three years. The total award will support the preclinical and manufacturing development activities necessary to successfully navigate and complete the FDA approval process for use of OrbeShield? to treat GI ARS.

"Securing a highly competitive BARDA contract provides important recognition as to the innovative quality and potential therapeutic impact of our technology," stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix.  "This contract award provides the comprehensive funding necessary to continue development of OrbeShield? while building upon the growing body of compelling scientific evidence supporting its use as a potential MCM for GI ARS.  We thank BARDA for their support and look forward to collaborating closely with them as we advance this technology."

About GI ARS

ARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow the GI tract and later the lungs.   In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to >2 Gy are at high risk for development of clinically significant ARS. Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury which can result in death in 5-15 days.  The GI tract is highly sensitive due to the requirement for incessant proliferation of crypt stem cells and production of mucosal epithelium. The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to TBI.  Although the hematopoietic syndrome can be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that occurs after high-dose radiation. Therefore, there is an urgent need to develop specific MCMs against the lethal pathophysiological manifestations of radiation-induced GI injury.

About OrbeShield?

OrbeShield? is formulated for oral administration in GI ARS patients as a single product consisting of two tablets; one tablet releases BDP in the proximal portions of the GI tract and the other tablet releases BDP in the distal portions of the GI tract.  BDP has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. To date, oral BDP has been safely administered to more than 350 human subjects in multiple clinical studies.  Oral BDP is also being developed in other GI disorders characterized by severe inflammation such as pediatric Crohn's disease, radiation enteritis and chronic Graft-versus-Host disease (cGVHD).

The FDA has cleared the Investigational New Drug (IND) application for OrbeShield? for the mitigation of morbidity and mortality associated with GI ARS.  OrbeShield? has also been granted Orphan Drug and Fast Track designations by the FDA for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

About BARDA

The Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services, provides an integrated, systematic approach to the development and procurement of critical products needed for public health emergencies. In collaboration with the National Institutes of Health, Department of Homeland Security, and other federal agencies, BARDA plays a key role in the government's efforts to develop MCMs needed to prevent or mitigate potential health effects from exposure to chemical, biological, radiological and nuclear (CBRN) agents and other terrorist threats. Support for OrbeShield? product development is being provided under a CBRN program to advance technologies and products to treat acute radiation syndrome (ARS).  Funding for BARDA's MCM development programs is authorized under the Pandemic and All Hazards Preparedness Act of 2006 (PAHPA) and reauthorized under the Pandemic and All Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). Additional MCM programs are funded by BARDA under the Project BioShield Act of 2004.

About Soligenix, Inc.

Soligenix is a clinical stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis.  

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's lead biodefense products in development are a recombinant subunit vaccine called RiVax?, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax?, a vaccine against anthrax exposure. RiVax? has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax? and VeloThrax? are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax?.  Soligenix is also developing OrbeShield? for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield? has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIAID.  Recently, Soligenix announced a worldwide exclusive collaboration with Intrexon Corporation that will focus on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

SOURCE Soligenix, Inc.
 

1968 Postings, 4073 Tage HiGhLiFEseekingalpha Artikel...

 
  
    #65
24.09.13 21:11

2004 Postings, 1002 Tage berliner-nobodyso, ich meld mich auch mal wieder

 
  
    #67
25.09.13 09:41
die 2 dollar könnten nun endlich durch sein, gestern mit neuem allzeithoch auf tagesschluss ... Das wird spannend  

1968 Postings, 4073 Tage HiGhLiFENews!

 
  
    #68
25.09.13 13:29
Soligenix Awarded NIAID Contract Valued up to $6.4 Million for the Development of OrbeShield? in GI ARS
PR NewswirePress Release: Soligenix, Inc. ? 27 minutes ago

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      SNGX      2.15      
§
PRINCETON, N.J., Sept. 25, 2013 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense medical countermeasures (MCMs) where there remains an unmet medical need, announced today that it has been awarded a contract valued at up to $6.4 million by the US Department of Health and Human Service's National Institutes of Health (NIH) (specifically funded by the National Institute of Allergy and Infectious Diseases or NIAID). The contract is for the advanced preclinical development of OrbeShield? (oral beclomethasone 17,21-dipropionate or oral BDP) as a MCM for the treatment of gastrointestinal acute radiation syndrome (GI ARS).

The potential three year contract contains a one year base period, with two contract options that would extend the contract an additional year each. The total award will support the development activities necessary to evaluate OrbeShield? as a potential MCM to treat GI ARS.

"Securing this highly competitive NIH contract provides further recognition as to the innovative quality and potential therapeutic impact of our technology," stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix.  "This contract award, in addition to the BARDA contract award recently received, has the potential to provide the necessary funding to advance the development of OrbeShield? while building upon the scientific evidence supporting its use as a potential MCM for GI ARS.  We thank NIAID for their past and present support and look forward to collaborating closely with them as we advance this technology."

About GI ARS
ARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow the GI tract and later the lungs.   In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to >2 Gy are at high risk for development of clinically significant ARS. Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury which can result in death in 5-15 days.  The GI tract is highly sensitive due to the requirement for incessant proliferation of crypt stem cells and production of mucosal epithelium. The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to TBI.  Although the hematopoietic syndrome can be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that occurs after high-dose radiation. Therefore, there is an urgent need to develop specific MCMs against the lethal pathophysiological manifestations of radiation-induced GI injury.

About OrbeShield?
OrbeShield? is formulated for oral administration in GI ARS patients as a single product consisting of two tablets; one tablet releases BDP in the proximal portions of the GI tract and the other tablet releases BDP in the distal portions of the GI tract.  BDP has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. To date, oral BDP has been safely administered to more than 350 human subjects in multiple clinical studies.  Oral BDP is also being developed in other GI disorders characterized by severe inflammation such as pediatric Crohn's disease, radiation enteritis and chronic Graft-versus-Host disease (cGVHD).

The FDA has cleared the Investigational New Drug (IND) application for OrbeShield? for the mitigation of morbidity and mortality associated with GI ARS.  OrbeShield? has also been granted Orphan Drug and Fast Track designations by the FDA for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.  In addition, OrbeShield? was recently awarded a contract valued up to $26.3M by the US Department of Health and Human Service's Biomedical Advanced Research and Development Authority (BARDA).

About NIAID
The National Institute of Allergy and Infectious Diseases conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the US and around the world.

About Soligenix, Inc.
Soligenix is a clinical stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis.  

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's lead biodefense products in development are a recombinant subunit vaccine called RiVax?, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax?, a vaccine against anthrax exposure. RiVax? has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax? and VeloThrax? are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax?.  Soligenix is also developing OrbeShield? for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract award valued up to $26.3M and a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield? has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID.  Recently, Soligenix announced a worldwide exclusive collaboration with Intrexon Corporation that will focus on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.  

1968 Postings, 4073 Tage HiGhLiFEjetzt schon über 30 Mio.$ Cash...

 
  
    #69
25.09.13 13:31
von Regierungsorganisationen innerhalb weniger Tage, das ist schon Hammer für sone kleine Biotechfirma.  

2004 Postings, 1002 Tage berliner-nobodyda geht noch mehr

 
  
    #70
1
25.09.13 16:21
einfach long gehen, wenn die großen etwas abhaben springt sie richtig  

1968 Postings, 4073 Tage HiGhLiFEparty geht weiter...

 
  
    #71
25.09.13 21:45
oder sie fängt besser gesagt erst an bei diesen glänzenden Aussichten.  

1968 Postings, 4073 Tage HiGhLiFE2 mal Cash in einer Woche...

 
  
    #72
25.09.13 22:01
Soligenix: A Huge Win for Two Contracts within One Week
Zacks Small Cap ResearchBy Zacks Small Cap Research | Zacks Small Cap Research ? 7 hours ago

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By Grant Zeng, CFA

Another Government Contract Award for Soligenix

On Sept. 25, 2013, Soligenix, Inc. (OTC BB:SNGX) announced that it has been awarded a contract valued at up to $6.4 million by the US Department of Health and Human Service's National Institutes of Health (NIH) (specifically funded by the National Institute of Allergy and Infectious Diseases or NIAID).

The NIAID contract is awarded for the advanced preclinical development of OrbeShield? (oral beclomethasone 17,21-dipropionate or oral BDP) as a biodefense medical countermeasure (MCM) for the treatment of gastrointestinal acute radiation syndrome (GI ARS).

This is a contract for three years which contains a one year base period, with two contract options that would extend the contract an additional year each. The total award will support the development activities necessary to evaluate OrbeShield? as a potential MCM to treat GI ARS.

This is the second government contract Soligenix secured within one week. Last week, Soligenix was awarded a $26.3 million contract by the US Department of Health and Human Service?s Biomedical Advanced Research and Development Authority (BARDA). Both contracts are awarded for the advanced preclinical and manufacturing development of OrbeShield? as a biodefense medical countermeasures (MCMs) for the treatment of gastrointestinal acute radiation syndrome (GI ARS).

The contracts are a huge win for Soligenix in our view. It not only provides non-dilutive funding for the development of the OrbeShield program for GI ARS, but more importantly validates the technology the company has developed over the years related to OrbeShield. Securing a highly competitive government contract provides important recognition as to the innovative quality and potential therapeutic impact of OrbeShield.

The total award will support the preclinical and manufacturing development activities necessary to successfully navigate and complete the FDA approval process for use of OrbeShield? to treat GI ARS.

OrbeShield Advantages

OrbeShield? is an oral immediate and delayed release BDP formulation that is being developed for the treatment of GI ARS (gastrointestinal acute radiation syndrome). OrbeShield in GI ARS has FDA Fast Track and Orphan Drug designations.

The GI tract is highly sensitive to ionizing radiation and the destruction of epithelial tissue is one of the first effects of radiation exposure. The rapid loss of epithelial cells leads to inflammation and infection that are often the primary cause of death in acute radiation injury. This is the same type of toxicity that occurs in Soligenix?s acute radiation enteritis clinical program with SGX201. As a result, there is a dual avenue of development for Soligenix, and OrbeShield? is potentially a ?dual use? compound, a desirable characteristic which is a specific priority of Biomedical Advanced Research and Development Authority (BARDA) for ARS and other medical countermeasure indications.

In preclinical studies, OrbeShield? has demonstrated positive results in a canine GI ARS model which indicate that dogs treated with OrbeShield? demonstrated statistically significant (p=0.04) improvement in survival with dosing at either 2 hours or 24 hours after exposure to lethal doses of total body irradiation (TBI) when compared to control dogs. The median survival was 100 days (p=0.04) when canines were treated 2 hours post exposure, 87 days (p=0.048) when canines were treated 24 hours post exposure. OrbeShield? appears to significantly mitigate the damage to the GI epithelium caused by exposure to high doses of radiation.

Soligenix plans to conduct a follow-on replication dog study in 1H14 with results available also in 1H14. The FDA has cleared the IND application for OrbeShield? for the mitigation of morbidity and mortality associated with GI ARS.

OrbeShield has other advantages beyond the efficacy seen in the canine model to date:


·         OrbeShield is an oral formulation, as opposed to injectable like many of the other biodefense vaccines and therapeutics; therefore, if a catastrophic event was to occur, the general population could dose themselves without the need for medical personnel to administer;

·         OrbeShield has demonstrated excellent safety profile in about 350 human subjects with the company?s oral BDP formulation;

·         cGMP Manufacturing process already at large commercial scale to produce sufficient quantities of OrbeShield, as needed.

Furthermore, Soligenix?s OrbeShield is being developed under specific FDA regulatory guidelines called the ?Animal Rule.? The Animal Rule provides that under certain circumstances, where it is unethical or not feasible to conduct human efficacy studies, the FDA may grant marketing approval based on adequate and well-controlled animal studies when the results of those studies establish that the drug is reasonably likely to produce clinical benefit in humans. Demonstration of the product's safety in humans is still required.

We think the ?Animal Rule? means a lot for Soligenix, because this can accelerate the development of OrbeShield and other vaccines. Once approved by the FDA, Soligenix will have the opportunity to negotiate a stock-pile contract with the US government.  These stock-pile or procurement contracts have been very lucrative for other companies supplying similar drugs to the US government.

A copy of the latest research report can be downloaded here >>  Soligenix Report

Please visit SCR.Zacks.com for additional information on our research and coverage universe, and Subscribe to receive our articles and reports emailed directly to you each morning.  

1968 Postings, 4073 Tage HiGhLiFEknacken wir heut die 2,50$?

 
  
    #73
26.09.13 13:13

1968 Postings, 4073 Tage HiGhLiFEsehr hohes Volumen heute,...

 
  
    #74
26.09.13 22:34
da haben wohl einige die Möglichkeit genutzt nochmal nachzukaufen oder halt Gewinne mitzunehmen.

Wir bleiben aber weiter dabei und warten auf den nächsten Hammer, als da wären Rivax und Pedriatic Crohns Disease.  

1968 Postings, 4073 Tage HiGhLiFEweitere Investoren für SNGX

 
  
    #75
21.11.13 14:24

Soligenix Announces Initial $600,000 Investment and up to $10.6 Million Common Stock Purchase Agreement with Lincoln Park Capital Fund, LLC
PR Newswire
Soligenix, Inc. 1 hour ago

PRINCETON, N.J., Nov. 21, 2013 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today that it signed a stock purchase agreement with Lincoln Park Capital Fund, LLC (LPC) providing an initial investment in Soligenix of $600,000 and the availability of additional periodic investments up to $10.0 million over a 36 month term.

Upon execution of the agreement, the Company received an investment of $600,000 in exchange for the issuance of 285,714 shares of the Company's common stock to LPC.  The per share purchase price of $2.10 was equal to the closing price of the Common Stock on the day prior to the execution of the agreement.   At its sole discretion, Soligenix has the right to sell to LPC up to an additional $10.0 million of its common stock, in amounts as described in the agreement and subject to certain conditions, which include the effectiveness of a registration statement with the U.S. Securities and Exchange Commission covering the sale of the shares that may be issued to LPC. The purchase price of the shares will be based on prevailing market prices of Soligenix's shares immediately preceding the notice of a sale without any fixed discount.  Soligenix controls the timing and amount of any future investment and LPC is obligated to make such purchases, if and when the Company decides in accordance with the stock purchase agreement.  Additionally, there are no upper price limit restrictions, negative covenants or any restrictions on the Company's future financing activities. Soligenix can terminate the agreement at any time without any monetary cost or penalty.  LPC has also agreed not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Company's shares of common stock.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "LPC has years of experience investing in life sciences companies, including technologies that address orphan indications, and we are pleased to have them as investors in the Company."  Dr. Schaber continued, "The ability to raise capital at or near market prices enhances our potential to pursue strategic alliances in a very efficient and opportunistic manner while staying committed to advancing our Phase 2 studies with SGX942 for the treatment of oral mucositis in head and neck cancer and SGX203 for the treatment of pediatric Crohn's disease."  

About Lincoln Park Capital

Lincoln Park Capital (LPC) is an institutional investor headquartered in Chicago, Illinois.   LPC's experienced professionals manage a portfolio of investments in public and private entities.  These investments are in a wide range of companies and industries emphasizing life sciences, specialty financing, energy and technology.  LPC's investments range from multiyear financial commitments to fund growth to special situation financings to long-term strategic capital offering companies certainty, flexibility and consistency.  For more information, visit www.lpcfunds.com

About Soligenix, Inc.

Soligenix is a clinical stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis.  

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's lead biodefense products in development are a recombinant subunit vaccine called RiVax?, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax?, a vaccine against anthrax exposure. RiVax? has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax? and VeloThrax? are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax?.  Soligenix is also developing OrbeShield? for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract award valued up to $26.3 million and a NIAID contract award valued up to $6.4 million. OrbeShield? has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID.  Recently, Soligenix announced a worldwide exclusive collaboration with Intrexon Corporation that will focus on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.  

1968 Postings, 4073 Tage HiGhLiFEsollte heute wieder laufen

 
  
    #76
21.11.13 14:24

1968 Postings, 4073 Tage HiGhLiFE10 Gründe long zu bleiben...

 
  
    #77
05.12.13 11:41

1968 Postings, 4073 Tage HiGhLiFEschöner Anstieg heut

 
  
    #78
14.01.14 18:27

1968 Postings, 4073 Tage HiGhLiFEnochmal 750.000$ Cash

 
  
    #79
16.01.14 15:41

Soligenix Receives $750,000 in Non-Dilutive Financing from New Jersey's Technology Business Tax Certificate Transfer Program
Receipt of Proceeds increases January Cash Position to Approximately $6.6 million
PR Newswire
Soligenix, Inc. 2 hours ago

PRINCETON, N.J., Jan. 16, 2014 /PRNewswire/ -- Soligenix, Inc. (SNGX)  (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well a developing several biodefense vaccines and therapeutics, announced today that it has recently received approximately $750,000, net of transaction costs, in non-dilutive financing via the State of New Jersey's Technology Business Tax Certificate Transfer Program (the Program).

This Program enables approved, unprofitable biotechnology businesses to sell their unused Net Operating Loss Carryovers (NOLs) and unused Research and Development (R&D) Tax Credits to unaffiliated, profitable corporate taxpayers in the State of New Jersey. This allows biotechnology businesses with NOLs to turn their tax losses and credits into cash proceeds to fund more R&D, buy equipment and/or facilities, or cover other allowable expenditures. The New Jersey Economic Development Authority (NJEDA) determines eligibility for the Program, the New Jersey Division of Taxation determines the value of the available tax benefits (NOLs and R&D Tax Credits), and the New Jersey Commission on Science and Technology evaluates the technology and its viability. The state of New Jersey was the originator of this Program and the first state to implement and fund it.

"As we are always looking for non-dilutive ways to fund our company, we are once again very pleased with NJEDA's decision to approve our application in this year's program," stated Christopher J. Schaber, PhD, President and CEO of Soligenix. "This NOL funding is a nice addition to other non-dilutive funding we have recently been awarded from BARDA and NIAID.  We are very thankful for New Jersey's continued support of its biotechnology industry."

About Soligenix, Inc.

Soligenix is a clinical stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis.  

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's biodefense products in development are a recombinant subunit vaccine called RiVax?, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax?, a vaccine against anthrax exposure. RiVax? has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax? and VeloThrax? are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax?.  Soligenix is also developing OrbeShield? for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract award valued up to $26.3 million and a NIAID contract award valued up to $6.4 million. OrbeShield? has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID.  Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (XON) focused on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

CONTACT: Joe Warusz, CPA, Acting Chief Financial Officer, (609) 538-8200, www.soligenix.com, Soligenix, Inc.
29 Emmons Drive, Suite C-10
Princeton, NJ 08540  

1968 Postings, 4073 Tage HiGhLiFEBiotech mit Non Dilutive Funding

 
  
    #80
16.01.14 22:28

1968 Postings, 4073 Tage HiGhLiFEüber 30 Mio Cash

 
  
    #81
16.01.14 22:31
von BARDA, NIAID und NJ Tax Programm in den letzten Monaten.
Marketcap bei 40 Mio, ein Witz hoch 10.  

1968 Postings, 4073 Tage HiGhLiFEKaufempfehlung!

 
  
    #82
20.03.14 11:27

Vista Partners Initiates Coverage on Soligenix, Inc. (Ticker: SNGX); $5.50 Price Target
Marketwired
Vista Partners LLC March 18, 2014 9:00 AM

SAN FRANCISCO, CA--(Marketwired - Mar 18, 2014) - Vista Partners announced today that it has initiated coverage on Soligenix, Inc. (OTCBB: SNGX) with a twelve-month price target of $5.50. Soligenix, Inc. is a New Jersey based clinical stage biopharmaceutical company committed to developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases. Ross Silver, Principal Analyst at Vista Partners, stated, "Soligenix has signed an exclusive worldwide collaboration deal with Intrexon Corporation ($2.9B mkt cap) (NYSE: XON) to develop a novel passive immunotherapy for Melioidosis. Melioidosis, also known as Bp, is an often deadly infectious disease caused by the bacterium, Burkholderia pseudomallei, with some symptoms similar to those of the flu and pneumonia. Melioidosis occurs in many different places around the globe, currently however it is of greatest concern in southeast-Asia and northern Australia, where public officials see it as a major threat to the health of the population." Mr. Silver continues, "The Company also has an exclusive commercial collaboration with SciClone Pharmaceuticals ($250M mkt cap) (NASDAQ: SCLN) in China for SGX942 in the treatment of oral mucositis." Mr. Silver concludes, "The Company boasts a diverse pipeline with nine prospective drug candidates. The science behind the Company's prospective therapies has been and continues to be validated by a number of significant, important and influential entities such as government organizations and major pharmaceutical companies. To date the Company has been awarded approximately $40M mainly through BARDA, NIH and FDA grants/contracts. The Company has up to approximately $34 million in active government contract and grant funding still available to support its associated research programs through 2018."

To download a FREE copy of the Soligenix, Inc. research report, please visit http://www.vistapglobal.com and click the "download research" icon to gain access to the report.

About Vista Partners:
Vista Partners LLC, founded in 2005, is a Registered Investment Advisor in the States of California and Oregon. The firm's professional staff has backgrounds in finance, corporate communications and investment banking. Vista focuses on investing globally across all market sectors. Vista also provides investment considerations on publicly traded companies through a platform of stock research reports, newsletters, company specific webpages and daily commentary. The platform of products is meant to serve as potential tools for investors to learn about investment considerations. It is Vista's mission to provide investors with tools that may enable them to make profitable investment decisions with the goal to deliver investment considerations that outperform small, mid and large cap equity indexes.

Please follow us on Twitter @VistaPResearch & Facebook at Vista-Partners to receive updates, thoughts and ideas about and our coverage universe of companies and more.

Disclaimer & Disclosure:
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Contact:  

1968 Postings, 4073 Tage HiGhLiFEsieht wieder gut aus

 
  
    #83
18.07.14 20:48
nach der langen Konsolidierung gehts endlich wieder rauf  

1968 Postings, 4073 Tage HiGhLiFE24,7 Mio. Contract

 
  
    #84
23.09.14 08:08

Soligenix Awarded NIAID Contract Valued up to $24.7 Million for the Development of Heat Stable RiVax? Vaccine
PR Newswire
Soligenix, Inc. September 19, 2014 7:00 AM

PRINCETON, N.J., Sept. 19, 2014 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that it has been awarded a contract valued at up to $24.7 million inclusive of options by the US Department of Health and Human Service's National Institutes of Health (NIH) (specifically funded by the National Institute of Allergy and Infectious Diseases or NIAID).  The objectives of the contract are to advance the development of Soligenix's thermostabilization technology, ThermoVax?, combined with the company's ricin toxin vaccine, Rivax?, as a medical countermeasure (MCM) to prevent the effects of ricin exposure.

The contract contains a 16 month base period providing financial support of approximately $5.8 million, followed by several contract options that would extend the contract award for up to six years. If all contract options are exercised, the total award will support the preclinical, manufacturing and clinical development activities necessary to advance heat stable RiVax? with the US Food and Drug Administration (FDA).

"Securing this highly competitive NIAID contract provides further recognition as to the innovative quality and potential impact of both our vaccine and thermostabilization technologies," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  "With this new contract award, the Company now has up to $57 million in NIAID and BARDA funding to advance the biodefense business segment.  We thank NIAID for their past and present support and look forward to collaborating closely with them as we advance RiVax? development towards potential FDA licensure and procurement for the national stockpile."

This is Soligenix's third awarded federal contract.  Soligenix's gastrointestinal acute radiation syndrome (GI ARS) program is supported by contract awards from both the Biomedical Advanced Research Development Authority (BARDA) and NIAID, totaling up to approximately $32 million to support the development of OrbeShield? as a MCM for GI ARS.

About Ricin Toxin

Ricin toxin is a plant toxin thought to be a bioterror threat because of its stability and high potency as well as the large worldwide reservoir created as a by-product of castor oil production. Ricin comes in many forms like powder, mist, or pellet. Ricin can also be dissolved in water and other liquids.  It is so powerful of a poison that the US Centers for Disease Control (CDC) estimate the lethal dose in humans is about the size of a grain of salt. Exposure to ricin results in local tissue necrosis and general organ failure leading to death within several days of exposure and is especially toxic when inhaled.  Ricin is a ribosome inactivating protein (RIP) and a potent member of the AB family of toxins.  Ricin inactivates the ribosomes in cells making them unable to produce proteins needed to survive and reproduce.  When ribosomes are inactivated, cells die.

There are currently no effective means to prevent the effects of ricin poisoning.  The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used in rapid deployment scenarios in the event of a biological attack.  

About RiVax?

RiVax? is Soligenix's proprietary recombinant subunit vaccine developed to protect against exposure to ricin toxin.  With RiVax?, Soligenix is a world leader in the area of ricin toxin vaccine research.

RiVax? contains a genetically altered version of RTA chain containing two mutations that inactivate the toxicity of the ricin molecule.  A Phase 1A clinical trial was conducted with a formulation of RiVax? that did not contain an adjuvant.  This trial revealed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers. The adjuvant-free formulation of RiVax? induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals.  To increase the longevity and magnitude of toxin neutralizing antibodies, RiVax? was formulated with an adjuvant of aluminum salts (known colloquially as Alum) for a Phase 1B clinical trial.  Alum is an adjuvant that is used in many human vaccines, including most vaccines used in infants. The results of the Phase 1B study indicated that Alum-adjuvanted RiVax? was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax?. In preclinical animal studies, the Alum formulation of RiVax? also induced higher titers and longer lasting antibodies than the adjuvant-free vaccine.

The development of RiVax? has been sponsored through a series of grants from both NIAID and the US Food and Drug Administration (FDA), which were granted to Soligenix and to University of Texas Southwestern (UTSW) where the vaccine originated. To date, Soligenix and Dr. Ellen Vitetta and colleagues at UTSW have collectively received approximately $25 million in grant funding from NIAID for development of RiVax? and related vaccine technologies. RiVax? would potentially be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack.

About ThermoVax?

ThermoVax? is a technology that is designed to eliminate the standard cold chain production, distribution and storage logistics required for most vaccines. Cold chain requirements add considerable cost to the production and storage of current conventional vaccines.  According to the Biopharma Cold Chain Sourcebook of 2010, 98% of all vaccines (with a total value of $20.6 billion) require shipment through cold chain.  Elimination of the cold chain would also enhance the utility of these vaccines for emerging markets and for other applications requiring but lacking reliable cold chain capabilities.  Further, the World Health Organization (WHO) reports that 50% of all global vaccine doses are wasted because they are not kept within required temperature ranges.  NIAID has also highlighted the priority of technologies for biodefense vaccines that focus on broad spectrum approaches including vaccine adjuvants and temperature stabilization for long shelf life, rapid onset of immunity, and surge capacity for production.  For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the utilization of ThermoVax? has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines in emergency situations.

The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations.  RiVax? is extremely labile in liquid form requiring careful management under refrigerated conditions at 4 degrees Celsius (39 degrees Fahrenheit).  By employing ThermoVax? during their final formulation, it is possible to produce stable and potent vaccines that are capable of withstanding temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year.

The underlying technology has been developed by Drs. John Carpenter and Theodore Randolph at the University of Colorado. The vaccine technology has been developed to date in collaboration with SRI International, the University of Kansas, the Wadsworth Center of the New York State Department of Health, and the Tulane National Primate Research Center under the sponsorship of the cooperative grant from NIAID.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201). Soligenix is also advancing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis and SGX301, its novel first-in-class photodynamic technology utilizing synthetic hypericin with safe visible light, for the treatment of cutaneous T-cell lymphoma.  

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's biodefense products in development are a recombinant subunit vaccine called RiVax?, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax?, a vaccine against anthrax exposure.  RiVax? has demonstrated statistically significant preclinical survival results in a lethal aerosol exposure non-human primate model, and has also been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers.  Both RiVax? and VeloThrax? are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax?.  Soligenix is also developing OrbeShield? for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract award valued up to $26.3 million and a NIAID contract award valued up to $6.4 million.  OrbeShield? has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID.  Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (XON) focused on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.  

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