2 Final-Studien (Brust & Leberkrebs) Mkap 35 M$

Die Veranstaltung ist nicht in Italien sondern in Budapest/Ungarn, 19./20. Juni 2013.

Infos zur Pipeline:

http://celsion.com/  

was haben führende ärzte laut dem artikel nochmal gesagt?  

http://seekingalpha.com/article/...sion-myths-destroyed?source=nasdaq  

LAWRENCEVILLE, N.J., June 12, 2013 — /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN) today issued the following statement regarding a blog entry posted by Alpha Exposure, Contributor, on Seeking Alpha.com:

"Statements made in Alpha Exposure's blog entry are misleading and require clarification.  

As is common in the biotechnology and pharmaceutical industry, Celsion has conducted a comprehensive post hoc analysis of the data from its Phase III HEAT Study of ThermoDox® in hepatocellular carcinoma (HCC) with its key principal investigators, data experts and liver cancer experts.  This analysis followed the announcement on January 31, 2013, that ThermoDox® in combination with radiofrequency ablation (RFA) did not meet the Study's primary endpoint.  Emerging findings from the HEAT Study post hoc analysis, which has provided important insights regarding the use of ThermoDox® in conjunction with RFA to treat HCC, suggests that ThermoDox® markedly improves progression-free survival (PFS) and overall survival (OS) in patients if their lesions undergo RFA for 45 minutes or more.  These findings apply to HCC lesions from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a sizable subgroup of approximately 300 patients.  In the patient subgroup treated in the ThermoDox arm whose RFA procedure lasted longer than 45 minutes (63% of single lesion patients), overall survival improved by 53% (Hazard Ratio of 0.65 and a Pvalue = 0.105) when compared to the control arm of RFA treatment only.  While the Hazard Ratio reported above should be viewed with caution since the HEAT Study has not reached its median point for overall survival analysis, there is a strong signal which our investigators and data experts consider to be encouraging and sufficient to warrant additional clinical investigation.  These data were presented at a recent medical meeting of interventional oncology by two of Celsion's lead investigators.  Furthermore, the detailed data has been submitted for peer review at upcoming international meetings in liver oncology and interventional oncology.  HEAT Study investigators have agreed to the submission of the HEAT Study results and the post hoc data for peer review.

Celsion is refining the appropriate theoretical models to establish quantitative predictions for the influence of RFA heating time on local tissue concentrations of ThermoDox®.  Empirical studies will then be used to verify the model predictions using appropriate animal studies which are targeted for completion over the summer.  Assuming that our hypothesis is supported by non-clinical studies as well as continued follow-up of patients in the HEAT Study to the overall survival endpoint, we will meet with the U.S. Food and Drug Administration to discuss these findings.  We would plan to propose a regulatory path forward which may include additional clinical studies based on FDA's predictive enrichment guidance.  Furthermore, investigators in the HEAT Study have expressed significant interest in participating in a follow-on clinical trial."

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 involve risks and uncertainties including, without limitation, 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; HEAT Study data is subject to further verification and review by the HEAT Study Data Management Committee; 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 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.

Investor Contact  Jeffrey W. Church  Senior Vice President – Corporate   Strategy and Investor Relations  609-482-2455  jchurch@celsion.com

SOURCE Celsion Corporation  

http://investor.celsion.com/releasedetail.cfm?ReleaseID=771012  

denk da kommt noch was...extra eine News um den Eintrag zu dementieren, das ist ja auch nicht standard...  

 

momentan $ 1, 45  

http://finance.yahoo.com/q?s=CLSN  

http://www.nasdaq.com/press-release/...-19-and-20-2013-20130620-00264


Google Übersetzung:

Celsion die ThermoDox ® HEAT Studienergebnisse auf das Jahr 2013 European Conference on Interventional Oncology (ECIO) in Budapest, Ungarn am 19. Juni Bewertet und 20. Januar 2013
Von PR Newswire,  20. Juni 2013, 08.00.00 EDT
Vote up


Dauer der RFA Verfahren korreliert mit Sinnvolle Clinical Benefit
LAWRENCEVILLE, NJ , 20. Juni 2013 / PRNewswire / - Celsion Corporation (NASDAQ: CLSN ) gab heute bekannt, dass Professor Riccardo Lencioni , MD, FSIR, EBIR 2013 ECIO Programm Co-Präsident und Direktor der Abteilung für Bildgebende Diagnostik und Intervention bei Pisa University School of Medicine in Italien und Lead Europäischen Principal Investigator für die HEAT-Studie bewertet die Ergebnisse der klinischen Studie von der Gesellschaft Phase III HEAT Study darunter Erkenntnisse aus dem HEAT-Studie Post-hoc-Analyse auf das Jahr 2013 European Conference on Interventional Oncology, das ist gehalten von 19. bis 22. Juni 2013 in Budapest , Ungarn. Die aufstrebenden Post-hoc-Ergebnisse deuten darauf hin, dass die Heiz-Zyklen optimiert werden, um deutlich zu verbessern Radiofrequenzablation (RFA), wenn sie mit ThermoDox ® verwendet werden. Die post-hoc-Daten zeigen, dass ThermoDox ® kann Potential für klinisch relevante Verbesserung des progressionsfreien Überlebens (PFS) und das Gesamtüberleben (OS) Ergebnisse liefern. Professor Lencioni machte zwei Präsentationen auf hepatozellulären Karzinoms (HCC) und die damit verbundenen Fortschritte in der interventionellen Management.
Professor Lencioni erste Präsentation mit dem Titel "New Approaches in Interventional Oncology HCC; Ein Update auf Clinical Trials" wurde am gehalten Wednesday, 19. Juni 2013 um 14.30 Uhr (Ortszeit) in Plenarsitzung: Offene Probleme in der Geschäftsführung von Leberkrebs . Diese Präsentation ist Teil eines Joint Symposium der ECIO und dem Internationalen Liver Cancer Association (ILCA). Dieses besondere Ereignis wird von Professor Lencioni (2013 ECIO Programm Co-Vorsitzender) und Dr. Vorsitz Joseph Llovet (ILCA Präsident)
Seine zweite Präsentation mit dem Titel "thermisch empfindlichen Doxorubicin Carriers" wurde am gehalten Thursday, 20. Juni 2013 um 10.30 Uhr New Horizons in der interventionellen Onkologie: (Ortszeit) in Plenarsitzung
"Ich freue mich, diese Post-hoc-Analyse einer großen Untergruppe von Patienten aus der Phase-III-Studie zum HEAT europäischen und internationalen interventionellen Onkologie Gemeinschaft, die unter Angabe kann einen sinnvollen klinischen Nutzen sowohl das progressionsfreie Überleben (PFS) und das Gesamtüberleben präsentieren (OS) bei Patienten, die eine optimierte RFA Verfahren erhalten ", sagte Professor Lencioni. "Es ist wichtig, um die Dauer von Wärme aus dem RFA Verfahren beachten ist ein wichtiger Faktor in einem erfolgreichen klinischen Ergebnisse, wenn sie mit ThermoDox ® kombiniert. Diese Ergebnisse stehen im Einklang mit unserem Verständnis, dass eine erhöhte Durchblutung und damit verbundene Heizzeit wichtige Faktoren sind dafür, dass die hitzeempfindlichen Liposomen aktiviert werden, um hohe Konzentrationen von Doxorubicin in dem Tumor und dem umgebenden Gewebe zu hinterlegen. "
Die Daten aus der Studie HEAT Post-hoc-Analyse von Professor Lencioni dargestellt sind, zeigen, dass ThermoDox ® deutlich verbessert PFS und OS bei Patienten mit einer einzigen Läsion, wenn ihre Läsionen RFA unterziehen für 45 Minuten oder mehr. Diese Erkenntnisse HCC Läsionen unabhängig von ihrer Größe gelten und stellen eine Untergruppe von etwa 300 Patienten bzw. 42% der Patienten in der HEAT-Studie.
In der Untergruppe von Patienten in der ThermoDox ®-Arm, dessen RFA Verfahren dauerte länger als 45 Minuten und wurde innerhalb von 90 Minuten abgeschlossen (40% der einzelnen Läsion Patienten) Gesamtüberleben verbesserte sich um 66% (Hazard-Ratio von 0,602) behandelt werden, wenn die Kontrolle Arm im Vergleich von RFA-Behandlung nur.
In der Untergruppe von Patienten in der ThermoDox ®-Arm, dessen RFA Verfahren dauerte länger als 90 Minuten (23% der einzelnen Läsion Patienten) behandelt, Gesamt-Überleben fast verdoppelt (Hazard-Ratio von 0,508) im Vergleich zu der Kontrollgruppe der RFA-Behandlung nur im Vergleich.
Zusammen zeigen diese beiden Untergruppen klinischen Ergebnisse, die eine 53% ige Verbesserung der Gesamtüberlebenszeit, eine Hazard-Ratio von 0,65, und ein PValue = 0,105 angegeben.
Im Gegensatz dazu zeigte die Untergruppe von Patienten mit ThermoDox ® deren RFA Prozedur dauerte weniger als 45 Minuten Dauer (37% der einzelnen Läsion Patienten) behandelt, dass die Querlenker eine verbesserte Gesamtüberlebenszeit Vorteil hatte, als der ThermoDox ®-Arm verglichen.
Die Hazard Ratios oben berichtet sollte mit Vorsicht betrachtet werden, da sie statistisch nicht signifikant sind und die HEAT-Studie hat nicht seine mittlere Punkt für das Gesamtüberleben Analyse erreicht. Celsion wird nach allen Patienten, die in der HEAT-Studie auf den sekundären Endpunkt Gesamtüberleben weiter und aktualisieren ihre Subgruppenanalyse auf RFA Heizdauer basiert.
Professor Lencioni Präsentation ist auf der Website des Unternehmens unter www.celsion.com unter "News & Investor Info -. Events & Presentations"
Über Celsion Gesellschaft
Celsion ist auf die Entwicklung und Vermarktung von innovativen Krebsmedikamenten, einschließlich Tumor-Targeting-Behandlungen mit Schwerpunkt Wärmeenergie in Kombination mit Wärme-aktivierten liposomalen Wirkstoff-Technologie gewidmet. Celsion hat Forschungs-, Lizenz-oder Kommerzialisierung Vereinbarungen mit führenden Institutionen, darunter die National Institutes of Health, der Duke University Medical Center, University of Hong Kong , der Universität Pisa , der UCLA Department of Medicine, die Kyungpook National University Hospital, die Peking Cancer Hospital und der University of Oxford . Für weitere Informationen über Celsion, besuchen Sie unsere Website: http://www.celsion.com .
Celsion weist den Leser darauf hinweisen, dass zukunftsgerichtete Aussagen in dieser Pressemitteilung sind gemäß den "Safe Harbor"-Bestimmungen des Private Securities Litigation Reform Act von 1995. Die Leser werden gewarnt, dass solche zukunftsgerichteten Aussagen beinhalten Risiken und Unsicherheiten, einschließlich, ohne Einschränkung, unvorhergesehene Änderungen im Verlauf der Forschung und Entwicklung und in klinischen Studien; die erheblichen Kosten, Zeit und Risiko des Scheiterns der Durchführung von klinischen Studien; HEAT Study Daten unterliegen der weiteren Überprüfung und Bewertung durch die Hitze Study Data Management Committee, die Notwendigkeit für Celsion seine zukünftigen Entwicklungspläne bewerten; Beendigung des Technology Development Vertrag oder Zusammenarbeit zwischen Celsion und HISUN jederzeit, mögliche Akquisitionen oder Lizenzen von anderen Technologien , Vermögenswerten oder Unternehmen oder die mögliche Nichteinhaltung solche Zukäufe oder Lizenzen machen, mögliche Aktionen von Kunden, Lieferanten, Wettbewerbern, Behörden und andere Risiken, die von Zeit zu Zeit in die Celsion 's periodischen Berichten und Prospekten bei der Securities and Exchange eingereicht Kommission. Celsion übernimmt keine Verpflichtung zur Aktualisierung oder Ergänzung zukunftsgerichtete Aussagen, die unwahr geworden aufgrund nachfolgender Ereignisse, neue Informationen oder anderweitig.
Ansprechpartner für Investoren Jeffrey W. Kirche Sr. Vice President - Corporate- Strategie und Investor Relations 609-482-2455 jchurch@celsion.com



Read more: http://www.nasdaq.com/press-release/...3-20130620-00264#ixzz2WlMT7LHK  

http://ih.advfn.com/...bol=CLSN&period=0&size=19&volume=1  

wohl noch nicht alle die Meldung gelesen  :)  

http://www.thestreet.com/story/11957437/4/...s-under-10-to-watch.html  

 

es geht dann wieder ganz schnell runter auch !  

 

gemacht  

gut oder schlecht?????  

Celsion Announces Jeffrey W. Church Reappointed to CFO14:05 02.07.13


PR Newswire

LAWRENCEVILLE, N.J., July 2, 2013

LAWRENCEVILLE, N.J., July 2, 2013 /PRNewswire/ -- Celsion Corporation (Nasdaq: CLSN) announced today that Jeffrey W. Church, Senior Vice President, will resume the role of Chief Financial Officer, a position he held prior to his promotion to Senior Vice President in July 2011.  In this position he will retain responsibility for corporate investor relations.  Mr. Church joined Celsion in July 2010 as Vice President and CFO.  Mr. Church's re-appointment will be effective immediately.  Mr. Church has more than 30 years of experience in financial management, the majority of which are as a Chief Financial Officer for publicly traded life science companies.  

This announcement follows the resignation of Gregory Weaver, the Company's Chief Financial Officer who, after 7 years of service to Celsion, will be pursuing other professional opportunities consistent with his extensive experience in commercial and development stage companies.  Mr. Weaver's resignation, which is effective June 30, 2013, includes a transition plan designed to ensure continuity of business operations.

Michael H. Tardugno, Celsion's President and Chief Executive Officer stated, "Greg has made many important contributions to the Company as CFO and during his six years of service as a Board Director.  We thank him for his service and wish him well in the pursuit of his new endeavors.  It's also important to note that the transition of CFO responsibilities is being made to a very capable member of our senior management team, Jeff Church, and that this restructuring is an integral part of the Company's cash conservation plans announced earlier this year.  We maintain our commitment to the efficient use of our financial and human resources as we enter a pivotal time for the Company."  

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 involve risks and uncertainties including, without limitation, 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; 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.

Investor Contact

Jeffrey W. Church

Senior Vice President

609-482-2455

jchurch@celsion.com

SOURCE Celsion Corporation


Quelle: PR Newswire  

 

 

 

Celsion Corporation and Zhejiang Hisun Pharmaceutical Company Sign Memorandum of Understanding for Future Development of ThermoDox® and Other Liposomal Formulations14:35 19.07.13


PR Newswire

LAWRENCEVILLE, N.J. and TAIZHOU CITY, China, July 19, 2013

LAWRENCEVILLE, N.J. and TAIZHOU CITY, China, July 19, 2013 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company and Zhejiang Hisun Pharmaceutical Company Ltd. (SSE Code: 600267), a leading Chinese pharmaceutical company, announced today that they have entered into a Memorandum of Understanding to pursue ongoing collaborations for the continued clinical development of ThermoDox® as well as the technology transfer relating to the commercial manufacture of ThermoDox® for the greater China territory.   In June 2012, Celsion and Hisun signed a long-term commercial supply agreement for the production of ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin. Hisun is one the largest manufacturers of chemotherapy agents globally, including doxorubicin.  In January 2013, a Technology Development Agreement was signed whereby Hisun paid Celsion a non-refundable payment of $5 million in exchange for Celsion providing Hisun with support for its ThermoDox® manufacturing development program.  In addition, the expanded collaboration will focus on next generation liposomal formulation development with the goal of creating safer, more efficacious versions of marketed cancer chemotherapeutics.

Among the key provisions of the Celsion-Hisun collaboration are:

•Hisun will provide Celsion with non-dilutive financing and the investment necessary to complete the technology transfer of its proprietary manufacturing process and the production of registration batches for China;
•Hisun will collaborate with Celsion around the clinical and regulatory approval activities for ThermoDox® as well as other liposomal formations with the China state Food and Drug Administration (SFDA). A local China partner affords Celsion access to accelerated SFDA review and potential regulatory exclusivity for the approved indication; and
•Hisun will be granted a right of first offer for a commercial license to ThermoDox® for the sale and distribution of ThermoDox® in the greater China territory.
"We are delighted with our continuing collaboration with Hisun which serves multiple strategic purposes towards successful ThermoDox® drug development and eventual product launch in the China market, potentially the largest opportunity in the world for ThermoDox®," said Michael H. Tardugno, Celsion's President and Chief Executive Officer.  "Hisun represents an ideal strategic partner due to their regulatory and manufacturing expertise.  We will work very closely with Hisun to accelerate our drug development program in China for ThermoDox® in primary liver cancer and other indications."

Mr. Hua Bai, CEO and Chairman of Hisun, stated, "We are pleased to announce our expanded collaboration with Celsion for the continued development of ThermoDox® to treat HCC to patients in China, the world's largest market.  China is one of the countries with the highest HCC incidence and mortality and, up until now, there has not been any standard of care for treating intermediate HCC in China.  This joint effort will not only focus on ThermoDox for HCC and other indications but will also facilitate the local manufacturing and potential product launch in China, thereby providing physicians with more options for better care and prolonging the survival of patients."  

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. In the HEAT Study, ThermoDox® is administered intravenously in combination with RFA. Localized mild hyperthermia (39.5 - 42 degrees Celsius) created by the RFA releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.

For primary liver cancer, ThermoDox® is being evaluated in a 700 patient global Phase III study at 79 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox® in combination with RFA when compared to patients who receive RFA alone as the control. On January 31, 2013, Celsion announced that ThermoDox® in combination with RFA did not meet the primary endpoint of the HEAT study in patients with hepatocellular carcinoma, also known as primary liver cancer.  Celsion has conducted a comprehensive analysis of the data from the Phase III HEAT Study with key principal investigators, data experts and liver cancer experts.  Emerging data from the HEAT Study post hoc analysis demonstrates that ThermoDox® markedly improves PFS and overall survival in patients if their lesions undergo RFA for 45 minutes or more.  These findings apply to HCC lesions from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a sizable subgroup of approximately 300 patients.

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.

About Zhejiang Hisun Pharmaceutical Company Ltd.

Founded in 1956, the mission for Zhejiang Hisun Pharmaceuticals Co., Ltd. (stock code 600267) hereinafter called "Hisun" is to be persistent in pharmaceutical innovation for humans' well-being.  The company's vision is to become a widely respected global pharmaceutical provider.  It focuses on the integration of pharmaceutical research and development (R&D) with production resources in order to provide its global customers with outstanding products and services.  To date, over 40 of the company's products have passed certification by many regulatory agencies such as the FDA (U.S.), EDQM (EU), TGA (Australia) , and KFDA (Korea) and are sold to more than 30 countries worldwide.

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 significant expense, time, and risk of failure of conducting clinical trials; HEAT Study data is subject to further verification and review by the HEAT Study Data Management Committee; 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 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

Sr. Vice President and CFO

609-482-2455

jchurch@celsion.com

Hisun Investor Contact

Madam Zhang Wei

Stock600267@hisunpharm.com

SOURCE Celsion Corporation


Quelle: PR Newswire