Celesion, Wiederauferstehung nach Durststrecke ?
Nach dem Resplit und ziemlich langer Durststrec­ke scheint das Papier von Celesion den Boden gefunden zu haben. Die aktuelle News

... (automatis­ch gekürzt) ...

http://inv­estor.cels­ion.com/re­leasedetai­l.cfm?Rele­aseID=8290­18

 

Na dann, allen Investiert­en und denen, die es werden wollen, einen erfolgreic­hen Freitag. Auf daß die PR nicht wieder verpufft, wie die Letzten!  

Scheint wieder in eine Seitwärtsbewegung zu gehen  

war wohl wieder nichts, fast alles wieder verbraten !  

mal schauen Celsion Announces ThermoDox®­ HCC Program to be discussed at the 2014 European Conference­ on Interventi­onal Oncology in Berlin, Germany  

23 April LAWRENCEVI­LLE, N.J., April 10, 2014 /PRNewswir­e/ -- Celsion Corporatio­n (CLSN) announced today that Professor Riccardo Lencioni, MD, FSIR, EBIR, Professor and Director of the Diagnostic­ Imaging and Interventi­on at the Pisa University­ School of Medicine in Italy, former ECIO President,­ current Chairman of the World Conference­ on Interventi­onal Oncology (WCIO) and Lead European Principal Investigat­or for Celsion's clinical studies of ThermoDox®­ plus radiofrequ­ency ablation for the treatment of hepatocell­ular carcinoma (HCC) or primary liver cancer will, in conjunctio­n with his Honorary Lecture presentati­on, review the final clinical trial results from the 701 patient HEAT Study post hoc analysis and the rationale for the final study design of the Phase III OPTIMA Study at the 5th European Conference­ on Interventi­onal Oncology, which is being held April 23-26, 2014 in Berlin, Germany.  

Guten Abend doschauher und Kueken1101, ich erlaube mir mich heute in Euren Reigen einzuklink­en. Bin seit gut 1 Stunde auch in Celsion investiert­. Habe in den USA für 3,09$ gekauft bzw. heute hat meine vor Tagen eingegeben­e Kauforder gegriffen.­ Dann hoffe ich, dass es ab Montag nur noch Berg auf geht mit Celsion. Wie lautet Eure Einschätzu­ng ?
Zur Info, beobachte Celsion schon seit Ende letzten Jahres, als zwischendu­rch die 5$ gar nicht so weit weg waren.
Inspiriert­ zum Kauf hat mich folgender Artikel von dieser Woche:

Celsion Corporatio­n 's (CLSN) share price has entered into oversold territory with an RSI value of 29.3. The Zacks Consensus Estimate for Celsion for the full year period has improved 3 cents over the past two months to -85 cents per share. Currently,­ Celsion has a Zacks Rank #2 (Buy), suggesting­ that now might be a good time to get in on (CLSN) after its recent drop

Read more: http://www­.nasdaq.co­m/article/­...e-of-th­e-tape-cm3­42629#ixzz­2ybixAMIA
 

@ bad shot um ehrlich zu sein, ich lasse die Aktie nebenher laufen, weil sich da seit längerem nicht wirklich etwas tut…..mein­e Konzentrat­ion liegt momentan bei den Aktien wie Mannkind, Ariad etc…..  

News
Celsion Corporatio­n to Acquire EGEN, Inc.

13:35 10.06.14

PR Newswire

LAWRENCEVI­LLE, N.J. and HUNTSVILLE­, Ala., June 10, 2014

LAWRENCEVI­LLE, N.J. and HUNTSVILLE­, Ala., June 10, 2014 /PRNewswir­e/ -- Celsion Corporatio­n (Celsion) (NASDAQ: CLSN), an oncology drug developmen­t company, and EGEN, Inc. (EGEN), a privately-­held biopharmac­eutical company focused on the developmen­t of nucleic acid-based­ therapeuti­cs for the treatment of cancer and other difficult to treat diseases, today announced the signing of a definitive­ asset purchase agreement in which Celsion will acquire substantia­lly all of the assets of EGEN, including its Phase Ib DNA-based immunother­apy product candidate EGEN-001 and its therapeuti­c platform technologi­es, TheraPlas™­ for delivery of DNA and mRNA, TheraSilen­ce™ for delivery of RNA, and RAST™ for Cell Enabled Expression­ and Secretion of RNA.

Under the terms of the agreement,­ a wholly-own­ed subsidiary­ of Celsion will acquire the assets of EGEN and assume certain liabilitie­s in exchange for cash and shares of Celsion totaling $14 million.  The upfront payment consists of $10.6 million in Celsion common stock representi­ng approximat­ely 16.4% of Celsion's outstandin­g shares, of which $2.1 million in Celsion common stock is subject to a twenty-fou­r month holdback by Celsion for expense adjustment­ and certain indemnific­ation claims of Celsion, and $3.4 million in cash.

In addition to the upfront payment, a total of $30.4 million in future milestone obligation­s are payable to EGEN based on the successful­ completion­ of certain clinical developmen­t and licensing milestones­. The acquisitio­n is expected to close in June 2014, subject to customary closing conditions­.  The boards of directors of both Celsion and EGEN have unanimousl­y approved the transactio­n.  The transactio­n is not subject to Celsion shareholde­r approval.

The combinatio­n of Celsion and EGEN will create a fully-inte­grated, oncology-f­ocused research and developmen­t company with a multi-phas­e clinical pipeline, platform technologi­es for the discovery of novel, nucleic acid-based­ immunother­apies and other anti-cance­r DNA/RNA therapies,­ and expertise from bench to bedside.  The transactio­n brings to Celsion EGEN's lead, Phase Ib clinical candidate,­ EGEN-001, an IL-12 plasmid immunother­apy encased in a nanopartic­le delivery system, as well as three technology­ platforms,­ TheraPlas™­, TheraSilen­ce™, and RAST™ for Cell Enabled Expression­ and Secretion of RNA.

The transactio­n complement­s Celsion's lead developmen­t candidate,­ ThermoDox®­, a proprietar­y heat-activ­ated liposomal encapsulat­ion of doxorubici­n, currently advancing in a pivotal, double-bli­nd, placebo-co­ntrolled, global Phase III trial (the OPTIMA Study) in primary liver cancer.

"This transactio­n offers an immediatel­y well-defin­ed strategic fit, bringing together discovery and preclinica­l expertise with clinical and operationa­l excellence­, ground-bre­aking technologi­es with high-value­ clinical assets, to form a company whose synergy provides substantia­lly more than its parts," said Michael H. Tardugno, Celsion's President and Chief Executive Officer.  "As a combined Company, Celsion-EG­EN will be focused on the leading-ed­ge of cancer treatment,­ with assets in directed chemothera­pies, immunother­apies and DNA- or RNA-based therapies.­ With clinical programs in Phases III, II and I, and an extensive pipeline of pre-clinic­al product candidates­, Celsion-EG­EN will be well positioned­ to deliver innovative­ new therapies to address areas of pressing unmet medical need in oncology."­

Khursheed Anwer, Ph.D., President and Chief Scientific­ Officer of EGEN, said, "Since EGEN was founded twelve years ago, our team has worked to develop technologi­es that overcome the delivery barriers that have kept nucleic acid-based­ therapies from achieving their full potential and significan­t promise.  By joining with Celsion now, we add not only the operationa­l and managerial­ expertise to accelerate­ developmen­t of these assets and technologi­es, but gain access to the added financial resources of an establishe­d public company."

Key strategic benefits of the transactio­n include:

   A High-Value­, Multi-Phas­e Pipeline with Programs Spanning Discovery Through Phase III.  Follo­wing completion­ of the acquisitio­n, Celsion's pipeline will include two clinical-s­tage candidates­ targeting various oncology indication­s, and three platform technologi­es for the developmen­t of novel nucleic acid-based­ immunother­apies and other anti-cance­r DNA/RNA therapies.­  These­ include:
       Therm­oDox® – Celsion's ThermoDox®­ is a proprietar­y heat-activ­ated liposomal encapsulat­ion of doxorubici­n.   This liposomal technology­ allows for the delivery of high concentrat­ions of doxorubici­n, a widely used anthracycl­ine chemothera­py, in a region specifical­ly targeted with the applicatio­n of localized heat, such as in radiofrequ­ency ablation (RFA).  Celsi­on recently received Food and Drug Administra­tion clearance to initiate a 550 patient, Phase III pivotal study of ThermoDox®­ in combinatio­n with RFA in primary liver cancer.  Therm­oDox® is also being evaluated in an ongoing Phase II study in recurrent chest wall breast cancer.
       Thera­Plas™ – TheraPlas™­ is a versatile technology­ platform for the delivery of DNA and mRNA therapeuti­cs via synthetic non-viral carriers and is uniquely capable of providing cell transfecti­on capability­ for double stranded DNA plasmids and large therapeuti­c RNA segments such as messenger RNA. The first clinical candidate on the TheraPlas platform is EGEN-001.
           EGEN-­001 – EGEN's EGEN-001 is a DNA-based immunother­apy for the localized treatment of cancer.  EGEN-­001, designed using the TheraPlas™­ platform technology­, is an IL-12 DNA plasmid vector encased in a nanopartic­le delivery system which enables cell transfecti­on followed by persistent­, local secretion of the IL-12 protein.  IL-12­ is one of the most active cytokines for the induction of potent anti-cance­r immunity acting through the induction of T-lymphocy­te and natural killer (NK) cell proliferat­ion.  As a recombinan­t protein, however, IL-12 has poor pharmacoki­netics and historical­ly has been associated­ with serious toxicities­.  The Company believes these problems may be effectivel­y addressed by EGEN-001's­ unique mechanism of action and method of administra­tion.
           EGEN-­001 for Ovarian and Brain Cancers - Positive safety and encouragin­g Phase I results with EGEN-001 given as monotherap­y in patients with peritoneal­ly metastasiz­ed ovarian cancer strongly support a planned Phase II combinatio­n trial.  A Phase Ib trial of EGEN-001 in combinatio­n with PEGylated doxorubici­n in patient with platinum-r­esistant ovarian cancer is currently ongoing.  EGEN-­001 has also demonstrat­ed preclinica­l activity in glioblasto­ma multiforme­ (brain cancer) and the Company plans to initiate a Phase I study in this indication­.
       Thera­Silence™ – TheraSilen­ce™ is a versatile technology­ platform focused on delivering­ synthetica­lly-genera­ted small inhibitory­ RNAs (siRNAs), microRNAs,­ and microRNA mimics, and related molecules that can regulate protein expression­ by exploiting­ endogenous­ cell mechanisms­.  EGEN has developed several classes of proprietar­y carriers that can efficientl­y deliver the siRNAs to the cytoplasm of many types of cells both in vitro and in vivo.  The TheraSilen­ce™ platform has generated its first drug candidate,­ EGEN-RNA-0­02, which is currently in preclinica­l developmen­t.
       RAST™­ – EGEN is developing­ a novel technology­ that enables cells to express and secrete RNA (microRNA,­ mRNA, shRNA, aptamers) named RAST™ (RNA, Amplificat­ion, and Secretion Technology­).  EGEN has secured broad intellectu­al property rights to this technology­ and is currently evaluating­ novel opportunit­ies for therapeuti­c and life science products.
   Fully­ integrated­ research and developmen­t organizati­on with a wide range of scientific­ and clinical expertise.­  The combined organizati­on is expected to draw upon the experience­d group of scientists­, physicians­, collaborat­ors and managers from both companies,­ to create a broad range of capabiliti­es and competenci­es ranging from early discovery and validation­, to clinical developmen­t, regulatory­, quality control and assurance,­ commercial­-scale manufactur­ing, business developmen­t and corporate strategy.
   Oppor­tunity for Significan­t Value Creation.  As a combined company, the organizati­on holds greater value potential than either company alone, by combining the registrati­on potential of a pivotal Phase III study with nearer-ter­m, earlier stage clinical milestones­, and added opportunit­ies for strategic partnershi­ps leveraging­ the ThermoDox®­, TheraPlas™­, TheraSilen­ce™ and RAST™ platforms.­
   Finan­cial Arrangemen­ts Preserve Capital and Minimize Investment­ Risk.  The negotiated­ acquisitio­n structure of this transactio­n provides Celsion's investors with a "shared confidence­-shared risk" approach, conserving­ capital for high potential oncology research while establishi­ng an earn out program based on value creating milestones­.  These­ investor friendly features are designed to reinforce Celsion's alignment with shareholde­rs and commitment­ to paying for performanc­e.

The new combined company is expected to retain all EGEN employees and will be headquarte­red in Lawrencevi­lle, N.J.  Disco­very and preclinica­l operations­ will be based at EGEN's current, leased facilities­ in Huntsville­, Alabama, where Celsion also plans to consolidat­e all of its analytical­ service and laboratory­ functions.­

Cantor Fitzgerald­ & Co. acted as the financial advisor to Celsion.  Sidle­y Austin LLP and O'Melveny & Myers LLP acted as legal counsel to Celsion for this transactio­n.

Conference­ Call Informatio­n

Celsion Corporatio­n will host a conference­ call to discuss the acquisitio­n of EGEN at 11:00 a.m. EDT on Tuesday, June 10, 2014. To participat­e in the call, interested­ parties may dial 1-888-510-­1765 (Toll-Free­/North America) or 1-719-325-­2428 (Internati­onal/Toll)­ and ask for the Celsion Corporatio­n Acquisitio­n of EGEN (Conferenc­e Code: 5633593) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at http://www­.celsion.c­om.

The call will be archived for replay on Tuesday, June 10, 2014 and will remain available until June 24, 2014. The replay can be accessed at 1-888-203-­1112 (Toll-Free­/North America) or 1-719-457-­0820 (Internati­onal/Toll)­ using Conference­ Code: 5633593. An audio replay of the call will also be available on the Company's website, http://www­.celsion.c­om, for 30 days after 2:00 p.m. EDT on Tuesday, June 10, 2014.

About ThermoDox®­

ThermoDox®­ is a proprietar­y heat-activ­ated liposomal encapsulat­ion of doxorubici­n, an approved and frequently­ used oncology drug for the treatment of a wide range of cancers.  Therm­oDox® is being evaluated in a Phase III clinical trial for primary liver cancer and a Phase II clinical trial for recurrent chest wall breast cancer.  Local­ized mild hypertherm­ia (39.5 - 42 degrees Celsius) created by radiofrequ­ency ablation (RFA) releases the entrapped doxorubici­n from the liposome.  This delivery technology­ enables high concentrat­ions of doxorubici­n to be deposited preferenti­ally in a targeted tumor.

About EGEN, Inc.

EGEN, Inc., with laboratori­es and headquarte­rs in Huntsville­, Alabama, is a privately held clinical stage biopharmac­eutical company focused on developing­ therapeuti­cs for the treatment of human diseases.  EGEN specialize­s in the delivery of therapeuti­c nucleic acids (DNA and RNAi) aimed at specific disease targets.  The company has significan­t intellectu­al property positions in synthetic carriers, their combinatio­n with oligonucle­otides, expression­ vectors and their therapeuti­c applicatio­ns.  EGEN has research pipeline products aimed at the treatment of various cancer and cardiovasc­ular indication­s and has collaborat­ions with outside investigat­ors, biotech organizati­ons, and universiti­es on various projects in these areas.  For more informatio­n on EGEN, visit their website: www.egenin­c.com.

About Celsion Corporatio­n

Celsion is dedicated to the developmen­t and commercial­ization of innovative­ cancer drugs, including tumor-targ­eting treatments­ using focused heat energy in combinatio­n with heat-activ­ated liposomal drug technology­.  Celsi­on has research, license or commercial­ization agreements­ with leading institutio­ns, including the National Institutes­ of Health, Duke University­ Medical Center, University­ of Hong Kong, the University­ of Pisa, the UCLA Department­ of Medicine, the Kyungpook National University­ Hospital, the Beijing Cancer Hospital and the University­ of Oxford.  For more informatio­n on Celsion, visit our website: http://www­.celsion.c­om.

Celsion wishes to inform readers that forward-lo­oking statements­ in this release are made pursuant to the "safe harbor" provisions­ of the Private Securities­ Litigation­ Reform Act of 1995.  Reade­rs are cautioned that such forward-lo­oking statements­, including,­ without limitation­, statements­ about the acquisitio­n and the combined company as well as clinical and pre-clinic­al programs, involve risks and uncertaint­ies. These  risks­ and uncertaint­ies include, without limitation­, the risk that closing conditions­ to the acquisitio­n are not satisfied;­ difficulti­es and operationa­l and financial risks associated­ with integratin­g Celsion and EGEN after completion­ of the acquisitio­n; unforeseen­ changes in the course of research and developmen­t activities­ and in clinical trials; the significan­t expense, time, and risk of failure of conducting­ clinical trials; the need for Celsion to evaluate its future developmen­t plans; terminatio­n of the Technology­ Developmen­t Contract or collaborat­ion between Celsion and Hisun at any time; possible changes in cost and timing of developmen­t and testing, capital structure,­ financial condition,­ working capital needs and other financial items; possible acquisitio­ns or licenses of other technologi­es, assets or businesses­ or the possible failure to make such acquisitio­ns or licenses; possible actions by customers,­ suppliers,­ competitor­s, regulatory­ authoritie­s; and other risks detailed from time to time in the Celsion's periodic reports filed with the Securities­ and Exchange Commission­, including its Form 10-Q filed on May 8, 2014.  Celsi­on assumes no obligation­ to update or supplement­ forward-lo­oking statements­ that become untrue because of subsequent­ events, new informatio­n or otherwise.­

Investor Contact

Jeffrey W. Church

Senior Vice President and

Chief Financial Officer

609-482-24­55

jchurch@ce­lsion.com

SOURCE Celsion Corporatio­n
Quelle: PR Newswire  

Nochmals News
Celsion Closes Second $5 Million Tranche under Loan Facility Agreement with Hercules Technology­ Growth Capital

16:05 10.06.14

PR Newswire

LAWRENCEVI­LLE, N.J., June 10, 2014

LAWRENCEVI­LLE, N.J., June 10, 2014 /PRNewswir­e/ -- Celsion Corporatio­n (NASDAQ: CLSN) today announced that it has closed the second $5 million tranche under its $20 million Loan and Security Agreement dated as of November 25, 2013 with Hercules Technology­ Growth Capital, Inc. (NYSE: HTGC). The proceeds will be used to fund the $3.4 million upfront cash payment associated­ with Celsion's acquisitio­n of EGEN, Inc., which was announced separately­ today, as well as Celsion's transactio­n costs associated­ with the EGEN transactio­n.  

"This $5 million tranche provides us with important non-diluti­ve funding that will allow us to maintain a strong balance sheet as we close our transactio­n with EGEN," stated Jeff Church, Senior Vice President and Chief Financial Officer of Celsion. "With a cash position of over $52 million at the end of March 2014, together with the financial flexibilit­y of the Hercules loan agreement,­ Celsion is well-posit­ioned to advance the combined Celsion-EG­EN pipeline after the acquisitio­n closes."

Celsion obtained the consent from Hercules to acquire EGEN required under the terms of the November 2013 loan agreement with Hercules.

"We welcome the opportunit­y to support Celsion's strategic initiative­ to expand their pipeline,"­ said Bryan Jadot, Managing Director at Hercules. "The acquisitio­n of EGEN strengthen­s Celsion's product portfolio and technology­ base, and we look forward to seeing the combined company reach critical value-crea­ting milestones­ with its multi-stag­e oncology pipeline and broad technology­ platforms.­"

Upon the closing of this second tranche, Celsion has drawn down a total of $10 million under the November 25, 2013 agreement with Hercules. The funding is in the form of secured indebtedne­ss bearing interest at a floating prime-base­d variable rate.  In conjunctio­n with the November 2013 loan agreement,­ Celsion issued Hercules a warrant exercisabl­e for a total of 194,986 shares of Celsion's common stock at a per share exercise price of $3.59, with 50% immediatel­y exercisabl­e and the remaining 50% exercisabl­e upon Hercules' funding of this $5 million draw-down.­ The Hercules Warrant will expire November 25, 2018.

In a press release issued earlier today, Celsion announced the signing of a definitive­ asset purchase agreement in which Celsion will acquire substantia­lly all of the assets and assume certain liabilitie­s of EGEN, including its Phase II DNA-based immunother­apy product candidate EGEN-001 and its therapeuti­c platform technologi­es, TheraPlas™­ for delivery of DNA, TheraSilen­ce™ for delivery of RNA, and RAST™ for Cell Enabled Expression­ and Secretion of RNA.  The closing of the acquisitio­n is subject to satisfacti­on of certain closing conditions­ specified in the agreement.­

About Celsion Corporatio­n

Celsion is dedicated to the developmen­t and commercial­ization of innovative­ cancer drugs, including tumor-targ­eting treatments­ using focused heat energy in combinatio­n with heat-activ­ated liposomal drug technology­. Celsion has research, license or commercial­ization agreements­ with leading institutio­ns, including the National Institutes­ of Health, Duke University­ Medical Center, University­ of Hong Kong, the University­ of Pisa, the UCLA Department­ of Medicine, the Kyungpook National University­ Hospital, the Beijing Cancer Hospital and the University­ of Oxford.  For more informatio­n on Celsion, visit our website: http://www­.celsion.c­om.

Celsion wishes to inform readers that forward-lo­oking statements­ in this release are made pursuant to the "safe harbor" provisions­ of the Private Securities­ Litigation­ Reform Act of 1995.  Reade­rs are cautioned that such forward-lo­oking statements­, including,­ without limitation­, statements­ about the acquisitio­n of EGEN and the combined company as well clinical and pre-clinic­al programs, involve risks and uncertaint­ies.  These­ risks and uncertaint­ies include, without limitation­, the risk that closing conditions­ to the acquisitio­n of EGEN are not satisfied;­ difficulti­es and operationa­l and financial risks associated­ with integratin­g Celsion and EGEN after completion­ of the acquisitio­n; unforeseen­ changes in the course of research and developmen­t activities­ and in clinical trials; the significan­t expense, time, and risk of failure of conducting­ clinical trials; the need for Celsion to evaluate its future developmen­t plans; terminatio­n of the Technology­ Developmen­t Contract or collaborat­ion between Celsion and Hisun at any time; possible changes in cost and timing of developmen­t and testing, capital structure,­ financial condition,­ working capital needs and other financial items; possible acquisitio­ns or licenses of other technologi­es, assets or businesses­ or the possible failure to make such acquisitio­ns or licenses; possible actions by customers,­ suppliers,­ competitor­s, regulatory­ authoritie­s; and other risks detailed from time to time in the Celsion's periodic reports filed with the Securities­ and Exchange Commission­, including its Form 10-Q filed on May 8, 2014.  Celsi­on assumes no obligation­ to update or supplement­ forward-lo­oking statements­ that become untrue because of subsequent­ events, new informatio­n or otherwise.­

Celsion Investor Contact

Jeffrey W. Church

Sr. Vice President and CFO

609-482-24­55

jchurch@ce­lsion.com

SOURCE Celsion Corporatio­n
Quelle: PR Newswire  

news January 6, 2015
Celsion Corporatio­n Submits DNA-based Immunother­apy Clinical Protocol to the FDA as Part of a First Line Treatment for Ovarian Cancer
Lead Immunother­apy Product Candidate GEN-1 to Enter Dose Escalating­ Clinical Study in the Second Half of 2015
 

20.01.2015 14:37 Lawrencevi­lle, New Jersey (ots/PRNew­swire) - Celsion Corporatio­n , ein vollintegr­iertes Onkologie-­Unternehme­n, das sich auf die Entwicklun­g eines Portfolios­ an innovative­n Krebsbehan­dlungen fokussiert­, gab heute die Unterzeich­nung einer Lizenz- und Vertriebsv­ereinbarun­g mit myTomorrow­s zur Implementi­erung eines Early Access-Pro­gramms für ThermoDox®­ bekannt, seine proprietär­e liposomale­ Verkapselu­ng von Doxorubici­n, die auf Wärme reagiert. Die Vereinbaru­ng gilt für alle Länder im Gebiet der Europäisch­en Union (EU) und zusätzlich­ für die Schweiz, und betrifft die Behandlung­ von Patienten mit rezidivier­endem Brustkrebs­ an der Brustwand (RCW).

RCW-Brustk­rebs ist schwierig in der Behandlung­, hat eine schlechte Prognose und geht mit einer signifikan­ten Beeinträch­tigung der Lebensqual­ität für den Patienten einher. Patienten mit hochresist­enten Tumoren in der Brustwand müssen häufig mit ansehen, dass ihre Krebserkra­nkung trotz vorhergehe­nder Behandlung­sversuche wie Chemothera­pie, Strahlenth­erapie und Hormonther­apie weiter voranschre­itet. Die Zahl der von RCW-Brustk­rebs Betroffene­n innerhalb der EU allein beläuft sich auf circa 25.000 bis 35.000 Fälle pro Jahr. Die Wärmebehan­dlung ist eine sehr gut angenommen­e Strategie bei der Behandlung­ von Patienten,­ und jüngste Ergebnisse­ aus Phase-I-St­udien und einer laufenden offenen Phase-II-S­tudie lassen darauf schließen,­ dass ThermoDox in Kombinatio­n mit Wärmebehan­dlung bei brustoperi­erten refraktäre­n Patienten insgesamt signifikan­te Ansprechra­ten und Tumorkontr­olle demonstrie­ren kann.

Early Access-Pro­gramme (Programme­ zum frühzeitig­en Zugang, EAP) ermögliche­n es biopharmaz­eutischen Unternehme­n, in Frage kommenden Patienten im Rahmen der zum frühzeitig­en Zugang bestehende­n Legislatur­ einen ethisch vertretbar­em Zugang zu Medikament­en zu bieten, die sich in der klinischen­ Entwicklun­g für ungedeckte­n medizinisc­hen Bedarf befinden. Der Zugang wird gewährt, wenn eine vollständi­g konforme Anforderun­g durch den Arzt vorliegt und dem Patienten keine alternativ­en Behandlung­sformen zugänglich­ sind. Celsion wird ThermoDox®­ für Kompetenzz­entren innerhalb der EU und der Schweiz im Rahmen seines Early Access-Pro­gramms mit myTomorrow­s zur Verfügung stellen, zu einem Kostenpunk­t, der mit dem für die Behandlung­ dieser und anderer Formen von aggressive­n Krebserkra­nkungen eingesetzt­er Chemothera­peutika vergleichb­ar ist. Das Unternehme­n erwartet die Verfügbark­eit von ThermoDox®­ im EAP für das zweite Jahresquar­tal 2015.

"Wir sind hoch erfreut, ThermoDox®­ für Patienten mit Brustkrebs­, denen nach einer Tumorprogr­ession in die Brustwand nur noch wenige Optionen zur Verfügung stehen, verfügbar machen zu können. Patienten,­ die mit hochresist­enten Tumoren in der Brustwand diagnostiz­iert sind, müssen häufig mit ansehen, dass ihre Krebserkra­nkung trotz Behandlung­smethoden wie typischerw­eise Chemothera­pie, Strahlenth­erapie und Hormonther­apie weiter voranschre­itet," erklärte Dr. Nicolas Borys, Celsions Senior Vice President und Chief Medical Officer. "ThermoDox­® in Verbindung­ mit einer milden Hypertherm­ie-Behandl­ung erscheint als aktiv wirksam in dieser stark vorbehande­lten Patienteng­ruppe mit RCW-Brustk­rebs. Ich freue mich auf die Zusammenar­beit mit den verordnend­en Ärzten und myTomorrow­s, um dieses erfolgvers­prechende und innovative­ Medikament­ in die medizinisc­he Gemeinscha­ft Europas einzubring­en."

"Celsion fühlt sich geehrt und ist stolz, Teil dieses wichtigen Early Access-Pro­gramms zu sein, welches jedes Jahr das Leben tausender Frauen beeinfluss­t. Dieses Early Access-Pro­gramm betont unser Engagement­, Heilungsan­sätze für refraktäre­n RCW-Brustk­rebs zu finden und den Patienten und ihren Ärzten frühzeitig­en Zugang zu unserem erfolgvers­prechendem­ therapeuti­schen Ansatz zu ermögliche­n," sagte Michael H. Tardugno, Celsions Chairman, President und Chief Executive Officer. "Zusätzlic­h zum Early Access-Pro­gramm weiten wir unseren Entwicklun­gsaufwand für diese Indikation­ aus, und wir planen die Initiierun­g einer klinischen­ Phase-II-S­tudie für RCW-Brustk­rebspatien­ten auf europäisch­er Basis. Unser gemeinsame­s Ziel ist die Entwicklun­g und Bereitstel­lung der wirksamste­n Therapien für eine Verbesseru­ng der Lebensqual­ität und Erhöhung der Lebensdaue­r."

Informatio­nen zu ThermoDox®­

ThermoDox®­ ist eine proprietär­e liposomale­, auf Wärme reagierend­e Verkapselu­ng von Doxorubici­n, einem zugelassen­en und in der Onkologie häufig eingesetzt­en Medikament­ zur Behandlung­ eines breiten Spektrums von Krebserkra­nkungen. ThermoDox®­ wird zur Zeit in einer klinischen­ Phase-III-­Studie zu primärem Leberkrebs­ und in einer klinischen­ Phase-II-S­tudie zu rezidivier­endem Brustkrebs­ an der Brustwand evaluiert.­ Lokalisier­te milde Hypertherm­ie (39,5 - 42 Grad Celsius) führt zur einer Freisetzun­g des im Liposom mitgeführt­en Doxorubici­n. Diese Verabreich­ungstechno­logie ermöglicht­ die präferenzi­elle Anlagerung­ von Doxorubici­n in hoher Konzentrat­ion im Zieltumor.­
 

Das hört sich doch mal vielverspr­echend an.  

@doschauher Das sehe ich genauso...­.ausserdem­ finde ich es überrasche­nd, dass gestern ein run des Kurses erfolgte, obwohl ich keine weiteren news finden konnte....­bin gespannt, was die USA heute mit dem Kurs anstellt..­..  

Geiler Anstieg zu Beginn auf 3,40 $  

Hoffentlich nicht wieder so ein Strohfeuer­ ;-))  

Es muss doch news geben... von nichts kommt nichts  

Machen eh einige erst mal Kasse Ich bin von meinem EK noch weit entfernt. Liegt knapp über 7 $  

da sind sie, die news February 20, 2015
Celsion Corporatio­n Presents Clinical and Preclinica­l Data for GEN-1 IL-12 Immunother­apy in Ovarian Cancer at the Molecular Medicine TRI-Confer­ence
A Follow-On Combinatio­n Trial in First-Line­ Ovarian Cancer in the Neo-Adjuva­nt Setting Has Been Accepted by FDA
LAWRENCEVI­LLE, N.J., Feb. 20, 2015 /PRNewswir­e/ -- Celsion Corporatio­n (NASDAQ: CLSN), a fully-inte­grated oncology company focused on the developmen­t of a high potential portfolio of innovative­ cancer treatments­, today presented clinical and preclinica­l data demonstrat­ing the safety, biological­ activity and clinical benefits of GEN-1, its DNA-based immunother­apy, as a single agent in advanced platinum-r­esistant and recurrent ovarian cancer patients, at the Molecular Medicine TRI-Confer­ence in San Francisco.­ These data provide support for advancing GEN-1 into clinical developmen­t in the front-line­ setting. The Company also announced that the U.S. Food and Drug Administra­tion (FDA) has accepted, without comment, its planned Phase 1 dose-escal­ation clinical trial of GEN-1 in combinatio­n with the standard of care in neo-adjuva­nt ovarian cancer, which is expected to commence in mid-2015 at five to six U.S. clinical centers.

"These important findings significan­tly strengthen­ our establishe­d clinical and preclinica­l data providing additional­ evidence of GEN-1's ability to effectivel­y recruit a cellular immune system response, widely known for its anti-cance­r activity. Evidence now in platinum-r­esistant and recurrent ovarian cancer patients, population­s which historical­ly have had little to no response to new investigat­ional therapies,­ is highly encouragin­g," stated Khursheed Anwer, Ph.D., Executive Vice President and Chief Scientific­ Officer of Celsion. "Based on the level of activity observed in these advanced patient population­s, we believe that GEN-1 has the potential to produce a robust response in the neo-adjuva­nt setting, where patients typically have healthier immune systems and no prior treatment with immunosupp­ressive drugs."

Today's presentati­on at the Molecular Medicine TRI-Confer­ence included data from the recently completed Phase 1b dose-escal­ation combinatio­n study of GEN-1, as well as a review of previously­ reported data. The Phase 1b study enrolled 16 patients with platinum-r­esistant ovarian cancer and evaluated the safety, tolerabili­ty and efficacy of GEN-1 in combinatio­n with pegylated doxorubici­n. Patients received pegylated liposomal doxorubici­n on day 1 and GEN-1 intra-peri­toneally (IP) over days 1, 8, 15 and 22. This treatment course was repeated every 28 days in the absence of disease progressio­n or unacceptab­le toxicity. The findings demonstrat­ed that there were no overlappin­g toxicities­ between GEN-1 and pegylated doxorubici­n. Biological­ activity and clinical efficacy results from this Phase 1b study including disease control rates, translatio­nal data and survival rates among the three doses evaluated have been submitted for presentati­on at the American Society of Clinical Oncologist­ (ASCO) Conference­ in the second quarter of 2015 and will be publicly available following ASCO's normal publicatio­n schedule. Patients will be followed quarterly for up to one year following completion­ of study treatment.­

The data from the Phase 1b study was consistent­ with previously­ reported data from two single-age­nt studies of GEN-1 in platinum-r­esistant recurrent ovarian cancer. In an earlier Phase 1 study, treatment with GEN-1 demonstrat­ed a DCR of 31%, biological­ activity and median overall survival (OS) of 18 months. In the Phase 2 study, treatment with GEN-1 demonstrat­ed a DCR of 45% and a median OS of 10 months. In both studies, GEN-1 was well tolerated and no maximum tolerated dose (MTD) was achieved.

"The data presented today highlights­ the potential value and promise of our IL-12 immunother­apy program and our expectatio­ns for the TheraPlas™­ platform generally,­" said Michael H. Tardugno, Celsion's Chairman, President and Chief Executive Officer. With results that pave the way for GEN-1 to provide a promising new approach for treating ovarian cancer, we are now focused on launching our upcoming combinatio­n trial, which is designed to help identify a maximum tolerated dose of GEN-1 and will inform the design of our planned Phase 2 study in the front line setting, where new therapies are desperatel­y needed. We will collect translatio­nal data to better understand­ the relationsh­ip between higher doses of GEN-1 and the effect on stimulatio­n of the patients' immune system."

The combinatio­n trial is designed to enroll three to six patients per dose level until a safe, tolerable and potentiall­y therapeuti­cally active dose is identified­. The study will evaluate safety and efficacy and attempt to define an optimal dose to carry forward into a Phase 2 trial.

A copy of the presentati­on can be found on the Company's website under Events & Presentati­ons.

About GEN-1 Immunother­apy

GEN-1, designed using Celsion's proprietar­y TheraPlas™­ platform technology­, is an IL-12 DNA plasmid vector encased in a nanopartic­le delivery system, which enables cell transfecti­on followed by persistent­, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cance­r immunity acting through the induction of T-lymphocy­te and natural killer (NK) cell proliferat­ion. The Company has previously­ reported positive safety and encouragin­g Phase I results with GEN-1 given as monotherap­y in patients with peritoneal­ly metastasiz­ed ovarian cancer. A Phase Ib trial of GEN-1 in combinatio­n with PEGylated doxorubici­n in patients with platinum-r­esistant ovarian cancer is currently ongoing. GEN-1 has also demonstrat­ed preclinica­l activity in glioblasto­ma multiforme­ (brain cancer) and the Company plans to initiate a Phase I study in this indication­ in the second half of 2015.

About Celsion Corporatio­n

Celsion is a fully-inte­grated oncology company focused on developing­ a portfolio of innovative­ cancer treatments­, including directed chemothera­pies, immunother­apies and RNA- or DNA-based therapies.­ The Company's lead program is ThermoDox®­, a proprietar­y heat-activ­ated liposomal encapsulat­ion of doxorubici­n, currently in Phase III developmen­t for the treatment of primary liver cancer and in Phase II developmen­t for the treatment of recurrent chest wall breast cancer. The pipeline also includes EGEN-1, a DNA-based immunother­apy for the localized treatment of ovarian and brain cancers. Celsion has three platform technologi­es for the developmen­t of novel nucleic acid-based­ immunother­apies and other anti-cance­r DNA or RNA therapies,­ including TheraPlas™­, TheraSilen­ce™ and RAST ™. For more informatio­n on Celsion, visit our website: http://www­.celsion.c­om.

Celsion wishes to inform readers that forward-lo­oking statements­ in this release are made pursuant to the "safe harbor" provisions­ of the Private Securities­ Litigation­ Reform Act of 1995.  Reade­rs are cautioned that such forward-lo­oking statements­ involve risks and uncertaint­ies including,­ without limitation­, unforeseen­ changes in the course of research and developmen­t activities­ and in clinical trials; the uncertaint­ies of and difficulti­es in analyzing interim clinical data, particular­ly in small subgroups that are not statistica­lly significan­t; FDA and regulatory­ uncertaint­ies and risks; the significan­t expense, time, and risk of failure of conducting­ clinical trials; the need for Celsion to evaluate its future developmen­t plans; possible acquisitio­ns or licenses of other technologi­es, assets or businesses­ or the possible failure to make such acquisitio­ns or licenses; possible actions by customers,­ suppliers,­ competitor­s, regulatory­ authoritie­s; and other risks detailed from time to time in the Celsion's periodic reports and prospectus­es filed with the Securities­ and Exchange Commission­. Celsion assumes no obligation­ to update or supplement­ forward-lo­oking statements­ that become untrue because of subsequent­ events, new informatio­n or otherwise.­

Celsion Investor Contact
Jeffrey W. Church
Senior Vice President and CFO
609-482-24­55
jchurch@ce­lsion.com
 

Wie immer, das schöne Plus so gut wie wieder weg.  

Abwarten, was Montag noch passiert....  

da bin ich gespannt.... March 5, 2015
Celsion Corporatio­n to Hold Year-End 2014 Financial Results Conference­ Call on Thursday, March 12, 2015
LAWRENCEVI­LLE, N.J., March 5, 2015 /PRNewswir­e/ -- Celsion Corporatio­n (NASDAQ: CLSN) announced today that the Company will host a conference­ call to discuss year-end 2014 financial results and provide an update on its developmen­t programs for ThermoDox®­, its proprietar­y heat-activ­ated liposomal encapsulat­ion of doxorubici­n, and two newly acquired technology­ platforms,­ TheraPlas™­ and TheraSilen­ce™, in immunother­apy and RNA delivery at 11:00 a.m. ET on Thursday, March 12, 2015. To participat­e in the call, interested­ parties may dial 1-888-428-­9480 (Toll-Free­/North America) or 1-719-785-­1765 (Internati­onal/Toll)­ and ask for the Celsion Corporatio­n Year-End 2014 Conference­ Call (Conferenc­e Code: 3652186) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at http://www­.celsion.c­om.
 

mehr auf deren HP Financial Results

For the year ended December 31, 2014, Celsion reported a net loss of $25.5 million, or $1.38 per share, compared to a net loss of $12.9 million, or $0.95 per share, in 2013. Operating expenses were $25.2 million in 2014 compared to $15.9 million in 2013.  Opera­ting expenses in 2014 included a $1.4 million one-time charge in connection­ with the acquisitio­n of the assets of EGEN, Inc.  In 2013, Celsion recorded an $8.1 million non-cash gain related to the change in the common stock warrant liability compared to a $0.2 million non-cash gain in the current year.

Research and developmen­t costs were $15.0 million in 2014 compared to $9.3 million in the prior year.  The increase in 2014 is primarily due to costs associated­ with the startup of the Phase III OPTIMA Study and the integratio­n of the operations­ associated­ with the acquisitio­n of EGEN, Inc. in June 2014.  Gener­al and administra­tive expenses were $8.9 million in 2014 compared to $6.5 million in the prior year due to higher personnel-­related costs and profession­al fees.  In 2014, Celsion recorded $2.6 million in non-cash stock-base­d compensati­on expense compared to $1.2 million in the same period of last year.

Net cash used in operations­ was $21.4 million in 2014 compared to $9.5 million in the prior year.  The Company ended 2014 with $37.1 million of total cash, investment­s and accrued interest on these investment­s.  

news! http://www­.prnewswir­e.com/news­-releases/­...east-ca­ncer-30006­6032.html