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

 

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

 

fast alles wieder verbraten !  

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

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.  

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
 

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…..  

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  

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  

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
 

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.
 

doch mal vielversprechend an.  

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....  

auf 3,40 $  

nicht wieder so ein Strohfeuer ;-))  

von nichts kommt nichts  

Ich bin von meinem EK noch weit entfernt. Liegt knapp über 7 $  

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
 

das schöne Plus so gut wie wieder weg.  

 

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.
 

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.  

http://www.prnewswire.com/news-releases/...east-cancer-300066032.html