Sehr gute long Investment Chance
| eröffnet am: | 25.01.13 22:55 von: | berliner-nobody |
| neuester Beitrag: | 14.04.23 16:03 von: | Vassago |
| Anzahl Beiträge: | 142 | |
| Leser gesamt: | 56626 | |
| davon Heute: | 22 | |
bewertet mit 3 Sternen |
||
|
Seite:
1
|
||
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
berliner......
Dies sieht ja richtig gut aus.
Sehr gute Recherche.....
Meinst Du, die kommt die nächsten Tage noch etwas runter?
für q1 2013 gibt es durch den vertrag mit OrbeShield weitere einnahmen.
es gibt nur ca. 12 mio aktien, vergleichbare werte wie PEREGRINE PHARMACEUTICALS sind deutlich mehr wert. ca. 2 us dollar bei bei ca. 132 mio aktien.
das heißt hier nun echtes potenzial.
Was spricht denn dafür. Also für nicht zocker und kleinanleger.
Überlege aber mir fehlt noch der bezug. *denk*
PRINCETON, N.J., Jan. 29, 2013 /PRNewswire via COMTEX/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that its OrbeShieldTM (oral beclomethasone 17,21-dipropionate or oral BDP) development program for the treatment of GI ARS has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA). Soligenix has also previously received Orphan Drug designation from the FDA for oral BDP for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.
Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life- threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for OrbeShieldTM on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of six months.
"There are no FDA approved therapies for the treatment of GI ARS," stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix. "The FDA's action in granting fast track designation is a validation of BDP's potential to address this life-threatening, unmet medical need. We look forward to working closely with the FDA, as well as with the National Institute of Allergy and Infectious Disease (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) to potentially expedite the OrbeShieldTM development program."
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 has the potential to be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that results from high-dose radiation exposure. Therefore, there is an urgent need to develop specific medical countermeasures against the lethal pathophysiological manifestations of radiation-induced GI injury.
About OrbeShieldTM
OrbeShieldTM contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. OrbeShieldTM is formulated for oral administration in GI ARS patients as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract and the other tablet is intended to release 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 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(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. OrbeShieldTM 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
übersetzt mit google
FDA Grants Soligenix Fast Track Designation für OrbeShield (TM) für die Reduktion der Mortalität mit gastrointestinalen akuten Strahlenkrankheit Syndrom (GI ARS) Assoziierte
PRINCETON, NJ, 29. Januar 2013 / PRNewswire / - Soligenix, Inc. (OTCQB: SNGX) (Soligenix oder das Unternehmen), eine Entwicklung, biopharmazeutisches Unternehmen, gab heute bekannt, dass seine OrbeShieldTM (oral Beclometason 17,21 - dipropionate oder mündliche BDP) Entwicklungsprogramm für die Behandlung von GI ARS hat "Fast Track" von der US Food and Drug Administration (FDA) erhalten. Soligenix hat ebenfalls zuvor Orphan Drug von der FDA für die orale BDP erhielten zur Vorbeugung des Todes infolge einer potentiell tödlichen Dosis von Ganzkörperbestrahlung während oder nach einer Bestrahlung Katastrophe.
Fast Track ist eine Bezeichnung, dass die FDA Reserven für ein Medikament soll einen schweren oder lebensbedrohlichen Zustand und eine, die das Potenzial für einen ungedeckten medizinischen Bedarf für den Zustand adressieren zeigt behandeln. Fast-Track-wurde entwickelt, um die Entwicklung erleichtert und beschleunigt die Prüfung neuer Arzneimittel. Zum Beispiel sollte Veranstaltungen rechtfertigen, wird Soligenix Anspruch auf eine New Drug Application (NDA) für OrbeShieldTM auf einer kontinuierlichen Basis vorlegen, erlaubt die FDA Teile der NDA bereits vor dem Eingang der vollständigen Unterwerfung. Zusätzlich NDAs für schnelle Spur Entwicklungsprogramme für gewöhnlich kommen für Priority-Review, die eine verkürzte Zeit für die Prüfung von sechs Monaten vermittelt.
"Es gibt keine von der FDA zugelassenen Therapien zur Behandlung von GI ARS", sagte Christopher J. Schaber, PhD, President & Chief Executive Officer von Soligenix. "Die FDA-Aktion bei der Gewährung Fast-Track ist eine Validierung der BDP das Potenzial, diese lebensbedrohlich, nicht gedeckten medizinischen Bedarf adressieren. Wir freuen uns auf die enge Zusammenarbeit mit der FDA, sowie mit dem National Institute of Allergy and Infectious Disease (NIAID ) und der Biomedical Advanced Research and Development Authority (BARDA) potenziell beschleunigen die OrbeShieldTM Entwicklungsprogramm. "
Über GI ARS
ARS tritt nach toxischen Strahlenbelastung und umfasst mehrere Organsysteme, insbesondere das Knochenmark der GI-Trakt und später die Lunge. Im Falle einer nuklearen Katastrophe oder terroristische Detonation einer Atombombe sind Opfer ausgesetzt> 2 Gy mit einem hohen Risiko für die Entwicklung einer klinisch signifikanten ARS. Exposition gegenüber hohen Dosen von Strahlung von mehr als 10-12 Gy verursacht akute GI Verletzungen, die zum Tod in 5-15 Tagen führen kann. Der GI-Trakt ist hochempfindlich aufgrund der Anforderung für unaufhörlichen Proliferation von Stammzellen und Krypta Herstellung von Schleimhautepithel. Das Ausmaß der Schädigung des Knochenmarks und der GI-Trakt sind die wichtigsten Determinanten des Überlebens nach der Exposition gegenüber TBI. Obwohl die hämatopoetischen Syndrom hat das Potential, durch Knochenmarkstransplantation oder Wachstumsfaktor Verabreichung gerettet werden, gibt es keine etablierte Behandlung oder vorbeugenden Maßnahme zur GI Schäden infolge hochdosierten Strahlenexposition. Daher ist es dringend notwendig ist, bestimmte medizinische Gegenmaßnahmen gegen die tödliche pathophysiologischen Manifestationen der strahleninduzierten GI Verletzungen entwickeln.
Über OrbeShieldTM
OrbeShieldTM enthält BDP, ein hochwirksamer, topisch wirksamen Kortikosteroiden, die eine lokale Wirkung auf entzündete Gewebe hat. OrbeShieldTM ist zur oralen Verabreichung in GI ARS Patienten als einheitliches Produkt aus zwei Tabletten formuliert; eine Tablette soll BDP in den proximalen Abschnitten des GI-Trakts und der andere Tablette freigeben soll BDP in den distalen Abschnitten des Magen freisetzen Trakt. BDP hat in den Vereinigten Staaten und weltweit seit den frühen 1970er Jahren als pharmazeutischen Wirkstoff in Inhalations-Produkte für die Behandlung von Patienten mit allergischer Rhinitis und Asthma vermarktet. Oral BDP kann auch Anwendung bei der Behandlung anderer Erkrankungen, die durch GI schwere Entzündungen wie Morbus Crohn und Strahlenenteritis charakterisiert.
Über Soligenix, Inc.
Soligenix ist eine Entwicklung biopharmazeutisches Unternehmen die Entwicklung von Produkten zu schweren entzündlichen Erkrankungen zu behandeln, wo es bleibt ein ungedeckter medizinischer Bedarf, sowie die Entwicklung von mehreren Biodefense Impfstoffe und Therapeutika. Soligenix entwickelt proprietären Rezepturen der mündlichen BDP (Beclometason 17,21-Dipropionat) für die Prävention / Behandlung von Magen-Darm-Erkrankungen, die durch eine starke Entzündung, einschließlich pädiatrischer Morbus Crohn (SGX203), akute Strahlung Enteritis (SGX201) und chronische Graft-versus-Host gekennzeichnet Krankheit (orBec), sowie die Entwicklung seines neuartigen angeborenen Abwehr Regler (IDR) Technologie SGX942 für die Behandlung von oraler Mukositis.
Durch seine Biodefense Division, wird Soligenix entwickeln Gegenmaßnahmen nach dem Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan 2011-2016 für die Aufnahme in die US-Regierung Strategischen Nationalen Stockpile. Soligenix führendes Biodefense Produkte in der Entwicklung sind ein rekombinanter Subunit-Impfstoff namens RiVax (TM), die zum Schutz gegen die tödliche Auswirkungen der Exposition gegenüber Ricintoxin und VeloThrax (TM), ein Impfstoff gegen Anthrax Exposition zu schützen. RiVax (TM) hat sich gezeigt, dass gut verträglich und immunogen in zwei klinischen Phase-1-Studien an gesunden Freiwilligen. Beide RiVax (TM) und VeloThrax (TM) sind derzeit Gegenstand einer $ 9.400.000 National Institute of Allergy and Infectious Diseases (NIAID) Förderpreis Entwicklung neuer Impfstoff Soligenix die thermische Stabilisierung Technologie ThermoVax (TM) bekannt. Soligenix ist auch die Entwicklung OrbeShield (TM) für die Behandlung von Magen-Darm akuten Strahlenkrankheit Syndrom (GI ARS) unter $ 600.000 NIAID Small Business Innovation Research (SBIR) Zuschuss. OrbeShieldTM zuvor statistisch signifikante präklinische Überleben Ergebnisse in zwei getrennten canine GI ARS Studien des NIH finanziert demonstriert.
Für weitere Informationen bezüglich Soligenix, Inc., besuchen Sie bitte die Website des Unternehmens unter www.soligenix.com.
Diese Pressemitteilung enthält zukunftsgerichtete Aussagen, die Soligenix, Inc. 's aktuelle Erwartungen bezüglich ihrer zukünftigen Ergebnissen, Leistungen, Aussichten und Möglichkeiten anzupassen. Aussagen, die keine historischen Fakten sind, wie "antizipieren", "glauben", "beabsichtigen" oder ähnliche Ausdrücke enthalten, sind zukunftsweisende Aussagen. Diese Aussagen unterliegen einer Reihe von Risiken, Unsicherheiten und andere Faktoren, aufgrund derer die tatsächlichen Ereignisse oder Ergebnisse in zukünftigen Perioden wesentlich von den in ausgedrückt oder impliziert werden, diesen Aussagen abweichen. Soligenix kann nicht versichern, dass es in der Lage sein, erfolgreich zu entwickeln oder Vermarktung von Produkten auf der eigenen Technologie basiert, insbesondere in Anbetracht der erheblichen Unsicherheit in der Entwicklung von Impfstoffen gegen Bioterror Bedrohungen, Herstellung und Durchführung von präklinischen und klinischen Studien von Impfstoffen und Erlangung der behördlichen Genehmigungen, , dass die Produktentwicklung und Kommerzialisierung Bemühungen nicht reduziert oder abgesetzt werden aufgrund von Schwierigkeiten oder Verzögerungen bei der klinischen Studien oder aufgrund mangelnder Fortschritt oder positive Ergebnisse aus Forschung und Entwicklung, dass es in der Lage sein, erfolgreich zu erhalten, weitere Stipendien und Auszeichnungen, halten wird bestehenden Zuschüssen, die abhängig von den Leistungsparametern sind, in allen Biodefense Aufträge mit der US-Regierung oder anderen Ländern geben, oder dass der US-Kongress nicht passieren jede Gesetzgebung, die zusätzliche Finanzierung für das Projekt BioShield Programm würde. Diese und andere Risikofaktoren werden von Zeit zu Zeit in den Einreichungen bei der Securities and Exchange Commission, einschließlich beschrieben, aber nicht beschränkt auf, Soligenix Bericht auf den Formularen 10-Q und 10-K begrenzt. Soweit nicht gesetzlich vorgeschrieben, übernimmt Soligenix keine Verpflichtung zur Aktualisierung oder Überprüfung zukunftsgerichteter Aussagen infolge neuer Informationen oder künftiger Ereignisse weiterzuentwickeln.
SOURCE Soligenix, Inc.
sc.png (verkleinert auf 45%)
PRINCETON, N.J., Feb. 4, 2013 /PRNewswire via COMTEX/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development-stage biopharmaceutical company, announced today the formation of a Medical Advisory Board (MAB) to provide medical/clinical strategic guidance to the Company as it advances the development of SGX942 for the treatment of oral mucositis, a common complication of cancer treatments.
Comprised of cancer supportive care thought leaders with extensive experience in oral mucositis, the MAB will play an important advisory role in the design and conduct of the upcoming Phase 2 clinical study as well as in the design of subsequent clinical studies and associated regulatory interactions with health authorities. The MAB will provide feedback, input and guidance on clinical strategies and their implementation as well as on other critical issues, such as health economics and reimbursement to assist Soligenix in meeting the needs of the oral mucositis patient population.
"Oral mucositis is a significant unmet medical need which ultimately impacts the tolerability of radiation and chemotherapy and therefore the survivability of cancer," stated Stephen T Sonis, DMD, DMSc, Clinical Professor of Oral Medicine at Harvard School of Dental Medicine. "The lack of an effective treatment has frustrated healthcare providers and caused misery for innumerable patients. I'm delighted to be helping to develop SGX942 as I believe it holds significant promise as a mucositis intervention. As an innate defense regulator (IDR), SGX942 directly targets a fundamental biological mechanism which leads to mucosal injury caused by radiation and chemotherapy."
"We are pleased to be able to attract such esteemed and enthusiastic professionals to participate as members of our Medical Advisory Board," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "The initiation of an oral mucositis program marks the first step in the development of our IDR technology platform. We look forward to working with the MAB and initiating a clinical program in 2013."
The MAB Members
Stephen T. Sonis, DMD, DMSc
Dr. Sonis currently serves as Clinical Professor of Oral Medicine at Harvard School of Dental Medicine and Senior Surgeon and Chief, Divisions of Oral Medicine at Brigham and Women's Hospital and the Dana-Farber Cancer Institute, and as Chief Scientific Officer, Biomodels, LLC. He also serves as a consultant to a number of biotechnology and pharmaceutical companies, advising directly on the conduct of clinical trials of oral mucositis. Throughout his career, Dr. Sonis has focused on the biology and clinical significance of cancer regimen-related mucosal toxicities. In particular, Dr. Sonis was pivotal in identifying the crucial role of innate immunity in the generation of severe oral mucositis. The results of his studies have provided treatment targets for biological and pharmaceutical development. Dr. Sonis and his collaborators have identified specific pathways that are critical in toxicity development and have used these to form the basis for models of gene-based risk prediction. Dr. Sonis has published and lectured extensively on the clinical, biological, and health economic aspects of cancer and complications associated with its treatment. He serves on a number of editorial boards, and is a founding member of the International Society of Oral Oncology and the International Academy of Oral Oncology. Dr. Sonis received his Doctor of Dental Medicine (DMD) from Tufts University, his Doctor of Medical Science (DMSc) from Harvard University and was a Knox Fellow at Oxford University.
Dorothy Keefe, MD, FRACP, FRCP
Professor Keefe is Service Director, SA Cancer Services, Professor of Cancer Medicine at the University of Adelaide and a Senior Medical Oncologist at Royal Adelaide Hospital Cancer Centre. She is Head of the Mucositis Research Group in the Hanson Institute, and Immediate Past-President of the Multi-national Association of Supportive Care in Cancer (MASCC). Professor Keefe's research interests include mucositis in its broadest sense, covering patho-biology, epidemiology, prevention and treatment. She has been highly involved in leading the development of evidence-based guidelines for the management of mucositis through MASCC, as well as co-chairing an international, multi-centre study investigating burden of illness and cost of care for patients with mucositis. Professor Keefe graduated in Medicine (Bachelor of Medicine, Bachelor of Surgery; MBBS) from the University of London. She migrated to Australia, where she undertook her Physician Training in General Medicine and Medical Oncology at the Queen Elizabeth Hospital in South Australia. She became a Fellow of the Royal Australasian College of Physicians (FRACP) and later a Fellow of the Royal College of Physicians in London (FRCP). She received her Doctorate of Medicine from the University of Adelaide.
Mark Schubert, DDS, MSD
Dr. Schubert is a Professor in the Department of Oral Medicine, School of Dentistry at the University of Washington and is the Director of Oral Medicine with the Seattle Cancer Care Alliance as well as a Member in the Clinical Research Division at the Fred Hutchinson Cancer Research Center. Dr. Schubert's research interests have focused on the oral complications of cancer and cancer therapy, especially as they relate to hematopoietic cell transplantation. A primary area of interest has been the management of oral mucositis associated with cancer therapy. Research in oral mucositis management has focused on topical anti-infectives (defensins), growth factors and cytokines (KGFs and IL-11), cytoprotective agents (benzydamine, amifostine), and low level lasers therapy. Additional research interests include basic research and management strategies for other oral complications of cancer therapy including salivary gland dysfunction, oral graft-versus-host disease in allogeneic hematopoietic cell transplant recipients, and dental growth and development problems following hematopoietic cell transplant. Additionally, Dr. Schubert has been involved with research related to oral changes and infections in HIV-infected patients. Dr. Schubert received his Doctor of Dental Surgery from the University of Washington, where he completed a residency in Hospital Dentistry, and later received his Masters of Dental Sciences degree from the University of Washington.
About SGX942
SGX94 is an IDR, a new class of short, synthetic peptides that has a novel mechanism of action in that it has simultaneous anti-inflammatory and anti-infective activity. IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation-therapy. SGX94 has demonstrated safety in a Phase 1 clinical study in healthy human volunteers and efficacy in numerous animal disease models including mucositis, colitis, skin infection and other bacterial infections. SGX94 is the subject of an open Investigational New Drug (IND). SGX94 was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada and approximately $40 million has been put towards its development inclusive of government grants.
About Oral Mucositis
Mucositis is the clinical term for damage done to the mucosa by anticancer therapies (e.g., radiation or chemotherapy). It can occur in any mucosal region, but is most commonly associated with the mouth (i.e., oral mucositis), followed by the small intestine. Mucositis affects 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy. Mucositis almost always occurs in patients with head and neck cancer treated with radiation therapy (>80% incidence of severe mucositis) and is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of mucositis depends greatly on the nature of the conditioning regimen used. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes. Direct and indirect consequences of mucositis have been estimated to add ~$18,000 per patient to cancer treatment costs.
The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.
About Soligenix, Inc.
Soligenix is a development 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(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. OrbeShieldTM 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.
http://rt.prnewswire.com/...NEWS_USPR_____PH53129&DateId=20130204
sc.png (verkleinert auf 45%)
sc.png (verkleinert auf 45%)