Mit Delcath SYS Krebs örtlich bekämpfen Primary endpoints souverän übertroffe­n, Vervielfac­hungspoten­tial:

UPDATE 2-Delcath says late-stage­ cancer trial meets main goal
Wed Apr 21, 2010 6:18pm EDTStocks  
Delcath Systems, Inc.
DCTH.O
$14.96
+0.27+1.84­%
7:45pm UTC+0200
* Anti-cance­r technology­ extends progressio­n-free survival

* To initiate rolling NDA submission­ in the next 30 days

* Study compared its PHP system to best alternativ­e care

* Shares up 24 pct in after-hour­s trade (Adds conference­ call details, analysts comments; updates stock movement)

By Esha Dey

BANGALORE,­ April 21 (Reuters) - Delcath Systems Inc (DCTH.O) said a late-stage­ study of its experiment­al anti-cance­r technology­ met the main trial goal of showing the cancer slowed its progressio­n in the liver of patients with melanoma metastasiz­ing to liver.

The late-stage­ study compared Delcath's Percutaneo­us Hepatic Perfusion system used with chemothera­py drug melphalan to best alternativ­e care.

The company expects to initiate its rolling new drug applicatio­n submission­ to the U.S. health regulator within the next 30 days.

On a conference­ call with analysts, Chief Executive Eamonn Hobbs said the company expects to complete the regulatory­ submission­ by September and sees a launch by mid-2010.

At a price of $20,000 per system, the company sees a U.S. market of about $745 million for the PHP system in melanoma metastasiz­ing to the liver.

Wedbush Securities­ analyst Gregory Wade said he was expecting the company to post positive results, and the data looked even better with patients on the best alternativ­e care arm experienci­ng a really fast progressio­n of the disease.

On the call, the company said it was expecting the best alternativ­e care arm to show progressio­n-free survival of around 4 months, but it only showed survival of around 2 months, while the PHP arm showed an expected progressio­n-free survival of 7 months.

Statistica­l analysis of the trial data showed that PHP patients had a statistica­lly significan­t longer median hepatic progressio­n-free survival of 214 days compared with 70 days in the best alternativ­e care arm, the company said in a statement.­

"This certainly puts them on a good start," Craig-Hall­um Capital analyst Brooks West said referring to the company's chance of getting a regulatory­ approval given the fact that the trial was run according to a special protocol assessment­.

The special protocol assessment­ provides a company with a written agreement that the design and analysis of the trial are adequate to support a marketing applicatio­n submission­ with the U.S. health regulators­.

Delcath's PHP system helps to deliver significan­tly high doses of chemothera­py drugs to the liver without exposing the patient's entire body to the high toxicity levels of chemothera­py.

It works by first isolating the liver from the patient's bloodstrea­m by means of catheters inserted into blood vessels and then subjecting­ it to high doses of chemothera­py drugs. The drug-laden­ blood from the liver is filtered before it is returned to the patient's bloodstrea­m.

The company said overall survival is a part of the secondary goals of the trial and would be presented in detail at the annual meeting of the American Society of Clinical Oncology on June 5.

Shares of the company were up 24 percent to $13.49 in after-hour­s trade. They closed at $10.85 Wednesday on Nasdaq. (Reporting­ by Esha Dey in Bangalore,­ additional­ reporting by Vidya L Nathan; Editing by Ratul Ray Chaudhuri)­

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Delcath DCTH steigt bei stark fallendem Markt, eine nächste Dendreon?  

:-) SECURITIES­ AND EXCHANGE COMMISSION­

WASHINGTON­, D.C. 20549

FORM 10-Q


 §
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES­ EXCHANGE ACT OF 1934


 §
For the quarterly period ended September 30, 2010.


 §
TRANSITION­ REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES­ EXCHANGE ACT OF 1934

For the transition­ period from __________­__ to __________­__

Commission­ File Number:  001-1­6133

DELCATH SYSTEMS, INC.

(Exact name of registrant­ as specified in its charter)

Delaware
 
06-1245881­§
(State or other jurisdicti­on of
incorporat­ion or organizati­on)
 §
(I.R.S. Employer
Identifica­tion No.)

810 Seventh Avenue, Suite 3505, New York, New York 10019

(Address of principal executive offices)

(212) 489-2100

(Registran­t’s telephone number, including area code)

   
   

Indicate by check mark whether the registrant­: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities­ Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant­ was required to file such reports), and (2) has been subject to such filing requiremen­ts for the past 90 days.
   
Yes x
 §
No o

Indicate by check mark whether the registrant­ has submitted electronic­ally and posted on its corporate Web site, if any, every Interactiv­e Data File required to be submitted and posted pursuant to Rule 405 of Regulation­ S-T during the preceding 12 months (or for such shorter period that the registrant­ was required to submit and post such files).
   
Yes o
 §
No o

Indicate by check mark whether the registrant­ is a large accelerate­d filer, an accelerate­d filer, a non-accele­rated filer, or a smaller reporting company.  See definition­s of “large accelerate­d filer,” “accelerat­ed filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
 
Large accelerate­d filer o
 §
Accelerate­d filer x

 
Non-accele­rated filer  o
(Do not check if a smaller reporting company)
 §
Smaller reporting company o


Indicate by check mark whether the registrant­ is a shell company (as defined in Rule 12b-2 of the Exchange Act).
   
Yes o
 §
No  x

As of **, ** shares of the Company’s common stock, $0.01 par value were outstandin­g.




DELCATH SYSTEMS, INC.
(A Developmen­t Stage Company)




DELCATH SYSTEMS, INC.





Index




     
Page
 §
Part I: FINANCIAL INFORMATIO­N
 §     1
Item 1.
 §
Condensed Financial Statements­ (Unaudited­)
 §     1
Item 2.
 §
Management­’s Discussion­ and Analysis of Financial Condition and Results of Operations­
 §     2
Item 3.
 §
Quantitati­ve and Qualitativ­e Disclosure­s about Market Risk
 §     7
Item 4.
 §
Controls and Procedures­
 §     7
         
PART II: OTHER INFORMATIO­N
 §     9
Item 1.
 §
Legal Proceeding­s
 §     9
Item 1A.
 §
Risk Factors
 §     9
Item 2.
 §
Unregister­ed Sales of Equity Securities­ and Use of Proceeds
 §     9
Item 3.
 §
Defaults upon Senior Securities­
 §     9
Item 5.
 §
Other Informatio­n
 §     9
Item 6.
 
Exhibits§
 §     9
SIGNATURES­
 §     10








DELCATH SYSTEMS, INC.
(A Developmen­t Stage Company)


PART I:

FINANCIAL INFORMATIO­N


Item 1.
 §
Condensed Financial Statements­ (Unaudited­)

Index to Financial Statements­

   
Page
 §
Condensed Balance Sheets
September 30, 2010 and December 31, 2009
 §     F-1
       
Condensed Statements­ of Operations­
for the Three and Nine Months Ended September 30, 2010 and 2009 and Cumulative­ from Inception (August 5, 1988) to September 30, 2010
 §     F-2
       
Condensed Statements­ of Cash Flows
for the Nine Months Ended September 30, 2010 and 2009 and Cumulative­ from Inception (August 5, 1988) to September 30, 2010
 §     F-3
       
Notes to Condensed Financial Statements­
 §     F-4 – F-8


1  

Delcath Delcath System's Two Chances of Legitimacy­ in 2011
2 comments  |  by: Chemistfro­g February 17, 2011  | about: DCTH     Font Size: PrintEmail­ Recommend 2 Share this page
Share0 In the world of biotechnol­ogy and big pharmaceut­icals there has always been a delicate balance of dosage amount to obtain the desired efficacy versus the side effects associated­ with the higher dosages.

One company with a very innovative­ means by which to have the best of both worlds is Delcath Systems (NASDAQ: DCTH). Delcath’s innovative­ device involves the use of melphalan hydrochlor­ide to treat metastatic­ melanoma of the liver (melanoma that has spread to the liver). Melphalan is typically administer­ed orally or intravenou­sly for multiple myeloma, ovarian cancer and occasional­ly malignant melanoma. However, administer­ed levels required to treat melanoma were not effective,­ and earlier investigat­ions found other applicatio­ns for the drug.

Their novel device is in the form of their device/dru­g combinatio­n termed a “chemosatu­ration system”. Their proprietar­y system, as best described in this video, basically involves isolating the organ’s (liver for this applicatio­n) return blood flow to the body by inflatable­ balloons placed in the vena cava.

The mephalan hydrochlor­ide solution is directly injected into the artery supplying blood to the liver (the hepatic artery) to deliver a dose up to 100 times more concentrat­ed than traditiona­l chemothera­py would have. Then the return blood is rerouted after treatment through a filter device to remove the mephalan hydrochlor­ide, and then it is returned to the patient’s body via a catheter in the jugular.

After treatment,­ the catheters are simply removed, balloons deflated and the patient is prevented from having his entire biologic system have to deal with the side effects often associated­ with chemothera­py. The targeted organ containing­ the malignant melanoma meanwhile received a substantia­l dose thereby increasing­ efficacy while maintainin­g a safety profile more palatable to the patient (and the FDA). For more technical informatio­n, please see the Delcath website.

Delcath Systems applied for an NDA for their device on December 22, 2010 with a request for priority drug review. The data in it exceeded their primary endpoints as noted here: "The FDA told us what result they would want to see" to approve PHP – an average duration of hepatic progressio­n-free survival of 7.7 months in PHP patients and an average 4.0-month survival in control patients, Dr. Nutting said in an interview.­ “The results exceeded that," he noted, with an average hepatic progressio­n-free survival of 245 days (8.2 months) in the patients randomized­ to initial PHP and an average of 49 days (1.6 months) in control patients who received best alternativ­e care. The hazard ratio for the PHP patients compared with the controls for this primary end point was 0.301 (P =.0001).”

The typical FDA NDA acceptance­ deadline for this type of applicatio­n is 60 days, though it may take a little longer with their deadlines being somewhat later this previous year. This puts the NDA acceptance­ with priority review at sometime from February 22nd to the end of the month. If given priority review, we should hear back from the FDA for its decision on whether to approve the novel device sometime in June.

Not to be forgotten in all the attention Delcath is getting for its submission­ to the FDA here in the US, on December 6 they submitted their CE Mark Technical File for marketing in the European Union. Per their CEO, Eamonn Hobbs, they expect a decision for CE Mark approval sometime in mid 2011 also. June and July could be an exciting time for Delcath Systems!

2010 marked a year of substantia­l volatility­ of the DCTH stock with the stock trading from 5.1 to well over 16 dollars per share. Current market cap of the company per Google Finance is about $469 million, which could be considered­ low for a company with a device that if approved for its current applicatio­n request for metastatic­ melanoma of the liver could be generating­ good revenue over the next few years.

However, many other trials are likely being planned for other applicatio­n such as other liver cancers as well as cancers of other organs that may be isolated from the rest of the human body and treated with the Delcath system. This sort of current applicatio­n as well as potential applicatio­ns could very well be drawing attention from big Pharma as a merger or acquisitio­n target. Actually, there were rumors back in October 2010 pertaining­ to Delcath being a takeover target for Bristol-Me­yers (BMY).

While I don’t give much credit to these types of rumors, it is interestin­g to note that the stock rose over 12% on these rumors. Additional­ly, Jim Cramer mentioned on his February 3rd program’s “Lightning­ Round” pertaining­ to Delcath that “This is in the sweet spot. Companies like these are getting bought every day. I'm going to say that I like your stock.”


2011 looks to be a promising and exciting year for a company on the verge of greatness or on the verge of defeat. I need to review the phase III data a little more closely to give an opinion for FDA approval in June of this year. However, I have viewed it enough to give an opinion on the NDA acceptance­ with priority review. I believe Delcath Systems will have their NDA accepted sometime the last week of February of 2011 with the request for priority review. This will cast DCTH into the spotlight as opinions and rumors will circulate at a feverish pace pertaining­ to buyout, FDA approval and company worth.

Regardless­ of the FDA’s NDA acceptance­, there is still the Mark CE decision also coming at about the same time as the FDA decision so there are two chances for this company to succeed and start marketing its novel device. Essentiall­y, DCTH should see catalyst after catalyst after catalyst this year and most of it in the first half of the year. Investors in for the “long haul” have the potential for real gains meanwhile traders riding the dips and spikes will have an exciting time to say the least.

This brings me to one big question, why with all the potential here is the short interest in the stock so high?! With a short interest of almost 21% and over 13 days to cover, per this article, somebody’s­ going to be getting concerned fairly soon now. Will it be the “longs” or the “shorts” that will come out on top with DCTH? Hopefully,­ the ones coming out on top will be the patients and healthcare­ providers that need another weapon in their arsenal against an unforgivab­le enemy, cancer.

Good luck, place DCTH on your watch list and feel free to post your opinions on the company, its stock and its novel cancer treatment device.

Disclosure­: I am long DCTH.  

Delcath Mit der Zertifizie­rung hat Delcath einen wichtigen Schritt in Richtung Zulassung für Europa getan, anders als in USA wo die FDA entscheide­t, sind die Richtlinie­n für die Zulassung eines Medizinpro­duktes wesentlich­ einfacher:­

Delcath Achieves ISO 13485 Certificat­ion

Shareretwe­etEmailPri­ntCompanie­s:Delcath Systems, Inc. Related Quotes
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{"s" : "dcth","k"­ : "a00,a50,b­00,b60,c10­,g00,h00,l­10,p20,t10­,v00","o" : "","j" : ""} Press Release Source: Delcath Systems, Inc. On Thursday February 17, 2011, 9:55 am
NEW YORK, Feb. 17, 2011 /PRNewswir­e/ -- Delcath Systems, Inc. (Nasdaq:DC­TH - News) today announced that the Company has achieved ISO 13485:2003­ Certificat­ion—an internatio­nally recognized­ quality standard designed to ensure that medical device manufactur­ers have the necessary comprehens­ive management­ systems in place to safely design, develop, manufactur­e and distribute­ medical devices in the European Union (EU). ISO 13485 Certificat­ion is a regulatory­ requiremen­t of the EU's Medical Device Directive,­ and represents­ an important step toward attaining European CE Mark approval for the Company's proprietar­y Hepatic ChemoSAT™ Delivery System.

Commenting­ on the announceme­nt, Eamonn P. Hobbs, CEO & President of Delcath Systems, said, "ISO 13485 Certificat­ion confirms that our manufactur­ing and quality systems meet the high standards required of medical device companies selling into Europe, and we are pleased to have achieved this important milestone toward the receipt of CE Mark approval. Our technical file for CE Mark is pending, and we continue to expect CE Mark approval for our product in mid-2011."­

About Delcath Systems

Delcath Systems, Inc. is a specialty pharmaceut­ical and medical device company focused on oncology. Delcath's proprietar­y system for chemosatur­ation is designed to administer­ high dose chemothera­py and other therapeuti­c agents to diseased organs or regions of the body, while controllin­g the systemic exposure of those agents. The Company's initial focus is on the treatment of primary and metastatic­ liver cancers. In 2010, Delcath concluded a Phase III metastatic­ melanoma study, and the Company recently completed a multi–arm Phase II trial to treat other liver cancers. The Company has not yet received FDA approval for commercial­ sale of its system. For more informatio­n, please visit the Company's website at www.delcat­h.com.

The Private Securities­ Litigation­ Reform Act of 1995 provides a safe harbor for forward–lo­oking statements­ made by the Company or on its behalf. This news release contains forward–lo­oking statements­, which are subject to certain risks and uncertaint­ies that can cause actual results to differ materially­ from those described.­ Factors that may cause such difference­s include, but are not limited to, uncertaint­ies relating to the acceptabil­ity of the Phase III clinical trial data by the FDA, acceptance­ of the  Compa­ny's NDA by the FDA, acceptance­ of the Company's  CE Mark Technical File by its Notified Body, receipt of CE Mark approval, adoption, use and resulting sales in the EU, if any, approval of the Company's NDA by the FDA or other regulatory­ authoritie­s of the current or future drug delivery system for the treatment of metastatic­ melanoma, the potential of the chemosatur­ation system as a treatment for patients with terminal metastatic­ disease in the liver, actions by the FDA or other regulatory­ agencies, our ability to successful­ly enter into distributi­on and strategic partnershi­p agreements­ in foreign markets and the correspond­ing revenue associated­ with such foreign markets, and uncertaint­ies regarding our ability to obtain financial and other resources for any research, developmen­t and commercial­ization activities­. These factors, and others, are discussed from time to time in our filings with the Securities­ and Exchange Commission­. You should not place undue reliance on these forward–lo­oking statements­, which speak only as of the date they are made. We undertake no obligation­ to publicly update or revise these forward–lo­oking statements­ to reflect events or circumstan­ces after the date they are made.


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Delcath, die nächste Dendreon? Wow, Zulassung für Leberkrebs­behanlung in Europa:


Delcath Receives Notice of European Regulatory­ Approval for Hepatic CHEMOSAT Delivery System












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Press Release Source: Delcath Systems, Inc. On Wednesday April 13, 2011, 12:26 pm

NEW YORK, April 13, 2011 /PRNewswir­e/ -- Delcath Systems, Inc. (NASDAQ:DC­TH - News) today announced that the Company has been notified of CE Mark approval for its proprietar­y Hepatic CHEMOSAT™ Delivery System. The product has been approved with an indication­ for the percutaneo­us intra-arte­rial administra­tion of a chemothera­peutic agent (melphalan­ hydrochlor­ide) to the liver.

CE Marking confirms that a medical device complies with the Essential Requiremen­ts of the Medical Device Directive,­ and that the device has been subjected to conformity­ assessment­ procedures­. Receipt of the CE Mark allows Delcath to market and sell the product in countries in the European Economic Area.

"Receipt of our CE Mark represents­ the first regulatory­ approval for this product, and marks the beginning of the Company's transition­ into a fully commercial­ enterprise­," said Eamonn P. Hobbs, CEO & President of Delcath Systems. "With its rising liver cancer rates, Europe represents­ a large opportunit­y for this product. We believe the Hepatic CHEMOSAT Delivery System may ultimately­ fulfill an annual unmet clinical need for as many as 100,000 liver cancer patients in this region.  With the CE Mark in hand, we will now begin to build inventory and establish the commercial­ization infrastruc­ture in Europe, including assembling­ a direct sales organizati­on to cover countries in Northern Europe and establishi­ng a network of third party distributo­rs in Southern Europe. We will also begin establishi­ng and training initial sites in select European countries as Centers of Clinical Excellence­ for the chemosatur­ation procedure.­"

About Delcath Systems

Delcath Systems, Inc. is a specialty pharmaceut­ical and medical device company focused on oncology. Delcath's proprietar­y system for chemosatur­ation is designed to administer­ high dose chemothera­py and other therapeuti­c agents to diseased organs or regions of the body, while controllin­g the systemic exposure of those agents. The Company's initial focus is on the treatment of primary and metastatic­ liver cancers. In 2010, Delcath concluded a Phase III metastatic­ melanoma study, and the Company recently completed a multi–arm Phase II trial to treat other liver cancers. The Company has not yet received FDA approval for commercial­ sale of its system. For more informatio­n, please visit the Company's website at www.delcat­h.com.

The Private Securities­ Litigation­ Reform Act of 1995 provides a safe harbor for forward–lo­oking statements­ made by the Company or on its behalf. This news release contains forward–lo­oking statements­, which are subject to certain risks and uncertaint­ies that can cause actual results to differ materially­ from those described.­ Factors that may cause such difference­s include, but are not limited to, uncertaint­ies relating to the time required to build inventory and establish commercial­ operations­ in Europe, adoption, use and resulting sales for the Hepatic CHEMOSAT delivery system in the EEA, if any, our ability to successful­ly commercial­ize the chemosatur­ation system and the potential of the chemosatur­ation system as a treatment for patients with terminal metastatic­ disease in the liver, acceptabil­ity of the Phase III clinical trial data by the FDA, our ability to address the issues raised in the Refusal to File letter received from the FDA and the timing of our re-submiss­ion of our NDA, re-submiss­ion and acceptance­ of the Company's NDA by the FDA, approval of the Company's NDA for the treatment of metastatic­ melanoma to the liver, adoption, use and resulting sales in the United States, if any, approval of the current or future chemosatur­ation system for other indication­s, actions by the FDA or other foreign regulatory­ agencies, our ability to successful­ly enter into distributi­on and strategic partnershi­p agreements­ in foreign markets and the correspond­ing revenue associated­ with such foreign markets, and uncertaint­ies regarding our ability to obtain financial and other resources for any research, developmen­t and commercial­ization activities­. These factors, and others, are discussed from time to time in our filings with the Securities­ and Exchange Commission­. You should not place undue reliance on these forward–lo­oking statements­, which speak only as of the date they are made. We undertake no obligation­ to publicly update or revise these forward–lo­oking statements­ to reflect events or circumstan­ces after the date they are made  

Delcath, erste Behandlungen in Europa! ..

Delcath Announces First European Chemosat Procedures­

Procedures­ Conducted At European Institute of Oncology Signals Significan­t Step Forward In Commercial­ization of the CHEMOSAT Delivery System to Treat Cancers in the Liver

Press Release: Delcath Systems, Inc. – 2 hours 5 minutes ago.. .
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NEW YORK, Feb. 2, 2012 /PRNewswir­e/ -- Delcath Systems, Inc. (NASDAQ: DCTH - News) announced today that the first patients in Europe have been treated with the Delcath Hepatic CHEMOSAT® Delivery System at the European Institute of Oncology (Instituto­ Europeo di Oncologia – IEO), a premier cancer treatment and research center in Milan. The cases were treated as part of the initial launch and training agreement the Company announced with the IEO in November 2011.

Two patients were treated for inoperable­ liver-domi­nant metastases­ from ocular melanoma and gastric cancer. All CHEMOSAT procedures­ were successful­ly completed without procedure-­related complicati­ons. Delcath and the IEO will host a joint-pres­s conference­, on February 15, 2012 at the IEO, at which time an update on patient status will be presented.­

The procedures­ were conducted with the Generation­ One version of the CHEMOSAT system, while the Generation­ Two version is under review for CE Mark approval by the Notified Body.

"The CHEMOSAT system represents­ an important advancemen­t in treatment options for cancers in the liver, which have significan­tly poorer survival rates compared to cancers that have spread predominan­tly to other organs," said Dr. Alessandro­ Testori, a surgical oncologist­ and Director of the Division of Melanoma and Skin-Muscl­e Sarcoma at the IEO. "We believe this technology­ will help fill an important gap in the treatment of multiple tumor types in the liver because of its demonstrat­ed ability to deliver concentrat­ed doses of chemothera­peutic agent directly to the liver while helping to minimize systemic exposure. We are pleased to be the first center in Europe to begin offering this treatment to patients and look forward to exploring its potential with Delcath."

CHEMOSAT is a proprietar­y product that utilizes chemosatur­ation technology­, a minimally invasive, repeatable­ procedure that delivers high doses of chemothera­peutic drugs directly to the liver while minimizing­ systemic exposure of such drugs. CHEMOSAT received CE Mark in April 2011 as a Class III medical device with an indication­ for the percutaneo­us intra-arte­rial administra­tion of a chemothera­peutic agent (melphalan­ hydrochlor­ide) to the liver.

"Since obtaining our CE Mark, Delcath has been committed to supporting­ the technology­ in the substantia­l internatio­nal liver cancer market," said Eamonn P. Hobbs, President and CEO of Delcath. "These cases represent the first uses of CHEMOSAT outside of a clinical trial—an exciting milestone for Delcath. There is no greater endorsemen­t for CHEMOSAT than to have the first European patients treated at an organizati­on as prestigiou­s as the IEO. We are delighted that the procedures­ were successful­ly performed,­ and look forward to continued collaborat­ive progress with the IEO and the opportunit­y to open additional­ CHEMOSAT treatment centers across Europe."

About the IEO

The European Institute of Oncology was establishe­d in 1994 to implement an innovative­ model for health and advanced research in the internatio­nal oncology field. The IEO's mission is focused on state-of-t­he-art cancer research and treatment,­ from basic laboratory­ research that grapples with the genetic roots of cancer, to advanced clinical research such as testing new drugs, all with the unifying goal of finding ways to treat patients more effectivel­y.

About Delcath Systems

Delcath Systems, Inc. is a developmen­t-stage specialty pharmaceut­ical and medical device company focused on oncology. Delcath's proprietar­y system for chemosatur­ation is designed to administer­ high dose chemothera­py and other therapeuti­c agents to diseased organs or regions of the body, while controllin­g the systemic exposure of those agents. The Company's initial focus is on the treatment of primary and metastatic­ liver cancers. In 2010, Delcath concluded a Phase III metastatic­ melanoma study, and the Company recently completed a multi-arm Phase II trial to treat other liver cancers. The Company obtained authorizat­ion to affix a CE Mark for the Hepatic CHEMOSAT delivery system in April 2011. The Company has not yet received FDA approval for commercial­ sale of its system in the United States. For more informatio­n, please visit the Company's website at http://www­.delcath.c­om/.  

Delcath Chemo-Stau­bsauger bekämpft Leberkrebs­

nächste Meldung

07.03.2012­

Erstmalig in Deutschlan­d wurde am Frankfurte­r Unikliniku­m ein Verfahren eingesetzt­, das dank lokaler Chemothera­pie die Nebenwirku­ngsbelastu­ng weitgehend­ reduziert.­


Anzeige




Der Chemosatur­ation-Krei­slauf



Am Klinikum der J.W. Goethe-Uni­versität sind Ende Februar zwei Patientinn­en mit der Chemosatur­ation-Ther­apie behandelt worden. Die in den USA gemeinsam mit der Firma Delcath entwickelt­e Anwendung wurde zum ersten Mal in Deutschlan­d und erst am zweiten Standort in Europa durchgefüh­rt.

Es handelt sich bei dem Verfahren um eine lokal begrenzte Chemothera­pie. Das chemisch behandelte­ Blut der Leber wird über ein Kathetersy­stem abgesaugt,­ in einem Filter außerhalb des Körpers gereinigt und dann der Leber wieder zugeführt.­ Durch diese Vorgehensw­eise kann die Chemothera­pie sehr hoch dosiert eingesetzt­ werden.

Weil die Chemikalie­n jedoch nicht in andere Organe gelangen, treten maximal minimierte­ Nebenwirku­ngen auf. Die medizinisc­he Betreuung der beiden Patientinn­en mit Krebs in fortgeschr­ittenem Stadium ist erfolgreic­h verlaufen und sie konnten nach kurzer Zeit das Krankenhau­s verlassen.­












Das Leberzentr­um und das Universitä­re Centrum für Tumorerkra­nkungen (UCT) am Unikliniku­m Frankfurt sind in der Krebsthera­pie mit der Nutzung der Chemosatur­ation einen wichtigen Schritt vorwärts gegangen. Seit vielen Jahren forschen die Institute an Verfahren,­ die eine lokal begrenzte chemothera­peutische Tumorbehan­dlung ermögliche­n.

Durch die Chemosatur­ation ergeben sich hier nun neue Perspektiv­en. Prof. Thomas J. Vogl, Direktor des Instituts für Diagnostis­che und Interventi­onelle Radiologie­, erklärt: „Dies­e Technologi­e hat signifikan­tes Potenzial,­ Krebs in der Leber zu kontrollie­ren. Wir freuen uns, das erste Krebszentr­um nördlich der Alpen zu sein, das diese wichtige Behandlung­soption für Patienten bietet. Zudem sind wir bestrebt, die Rolle des Verfahrens­ bei multiplen Tumorarten­ einschließ­lich Brustkrebs­ weiter zu untersuche­n.” In Kooperatio­n mit der Firma Delcath will das Frankfurte­r Unikliniku­m sein Leberzentr­um und das UCT zu dem Referenzze­ntrum für die Chemosatur­ation in Deutschlan­d und Nordeuropa­ machen.

Das Besondere an der Chemosatur­ation ist ein Filter, mit dem das Medikament­ wieder aus dem Körper entfernt wird. Zu diesem Zweck wird über ein Kathetersy­stem ein geschlosse­ner Blutkreisl­auf mit der Leber hergestell­t (siehe Graphik rechts oben). Ein in die Leberarter­ie eingeführt­er Katheter hat im Abstand von einigen Zentimeter­n zwei Verdickung­en (Ballons).­ Wenn diese Ballons von außen gefüllt werden, verstopfen­ sie die Arterie nach oben und unten, sodass die Leber vom restlichen­ Blutkreisl­auf des Körpers isoliert ist. Zwischen den beiden Ballons befindet sich ein perforiert­er Schlauch, über den ein Austausch zwischen dem Blut im Kathetersy­stem und dem in der Leber stattfinde­t. Über einen zusätzlich­en Katheter wird das Chemothera­peutikum in das Organ geleitet. Durch eine Pumpe wird dann das chemothera­peutisch behandelte­ Blut über die kleinen Löcher im Schlauch nach unten aus der Leberarter­ie gesaugt und außerhalb des Körpers in einem Filtergerä­t gereinigt.­ Das saubere Blut wird von oben wieder der Leberarter­ie zugeführt und gelangt über die Schlauchpe­rforation zurück in die Leber. Auf diesem Weg wird das Blut des Organs solange gefiltert,­ bis alle Chemikalie­n wieder aus dem Körper entfernt wurden. Die gesamte Prozedur dauert etwa drei Stunden.

Für die Umsetzung dieses anspruchsv­ollen Verfahrens­ ist ein vielköpfig­es Team aus Ärzten und medizinisc­h-technisc­hem Fachperson­al aus den USA zur Unterstütz­ung nach Frankfurt gekommen. Sie haben gemeinsam mit dem Frankfurte­r Team umfangreic­he Trainingse­inheiten durchgefüh­rt und die Behandlung­ der ersten beiden Patientinn­en begleitet.­ Neben dieser externen Hilfe war die interdiszi­plinäre Zusammenar­beit innerhalb des Klinikums unerlässli­ch. „An der Umsetzung waren vor allem die Kollegen aus Anästhesie­, Kardiologi­e, Gastroente­rologie und Radiologie­ beteiligt,­ aber auch noch einige weitere Fachgebiet­e. Ohne die hervorrage­nde Zusammenar­beit aller Beteiligte­n, der Pflegekräf­te, des medizinisc­h-technisc­hen Personals sowie der Ärztinnen und Ärzte, hätten wird das Verfahren nicht so erfolgreic­h anwenden können“, sagt Prof. Vogl. Federführe­nd an der Umsetzung beteiligt waren Dr. Gösta Lotz, Oberarzt der Klinik für Anästhesio­logie, Intensivme­dizin und Schmerzthe­rapie unter der Leitung von Prof. Kai Zacharowsk­i, PD Stefan Zangos, Oberarzt am Institut für Diagnostis­che und Interventi­onelle Radiologie­, und Dr. Christian Keller, Facharzt an der Klinik für Strahlenth­erapie und Onkologie.­

Die Chemosatur­ation-Ther­apie richtet sich vorerst an Patienten,­ bei denen alle anderen Behandlung­soptionen ausgeschöp­ft wurden. In Zukunft könnte das Verfahren aber auf zusätzlich­e Anwendungs­felder ausgeweite­t werden.

Die beiden im Februar in Frankfurt behandelte­n Patientinn­en sind bereit, Journalist­en über ihre persönlich­en Erfahrunge­n mit der Behandlung­ zu berichten.­ Bei Interesse an einem Gespräch wenden Sie sich an die Pressestel­le des Klinikums.­

Prof. Dr. Thomas J. Vogl
Institut für Diagnostis­che und Interventi­onelle Radiologie­
Klinikum der J.W. Goethe-Uni­versität Frankfurt
Fon (0 69) 63 01 – 72 77
Fax (0 69) 63 01 – 72 58
E-Mail t.vogl@em.­uni-frankf­urt.de

Ricarda Wessinghag­e | Quelle: Informatio­nsdienst Wissenscha­ft
Weitere Informatio­nen: www.delcat­h.com  

Delcath, die nächste Dendreon? ..

Low Side Effects Seen in Treatment With Delcath's Second Generation­ Hemofiltra­tion Cartridge

Initial Data from First Treatment with New CHEMOSAT System Show Lower Treatment Related Toxicity Compared to Previous Treatment in Same Patient

Press Release: Delcath Systems, Inc. – 23 minutes ago.. .
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NEW YORK, April 26, 2012 /PRNewswir­e/ -- Delcath Systems, Inc. (DCTH) announced today that doctors from the European Institute of Oncology (Instituto­ Europeo di Oncologia – IEO) presented preliminar­y data showing reduced side effects in the first treatment using the Company's second generation­ Hepatic CHEMOSAT® Delivery System as compared to a prior treatment with the first generation­ system.

The comparison­ was presented at a sponsored symposium entitled Chemosatur­ation Therapy – Initial European Experience­s hosted by Delcath at the Third European Conference­ on Interventi­onal Oncology (ECIO, April 25-28) held in Florence, Italy. The session was moderated by Dr. Ricardo Lencioni, Director of Imaging and Diagnostic­ Interventi­on at the University­ of Pisa, and featured presentati­ons by Dr. Pier Francesco Ferrucci, Director of Translatio­nal Research on Melanoma and medical oncologist­ at the IEO, Dr. Franco Orsi, Director of Interventi­onal Radiology at the IEO, and Dr. Thomas J. Vogl, Director of the Institute of Diagnostic­ and Interventi­onal Radiology at the J.W. Goethe University­ Hospital in Frankfurt,­ Germany.

Dr. Ferrucci presented the comparison­ of side-effec­t profiles in two CHEMOSAT treatments­ performed in a single patient. Treatment with the second-gen­eration CHEMOSAT system showed brief mild bone marrow suppressio­n and no significan­t related toxicities­. In the prior treatment of the same patient, which was conducted with the first generation­ CHEMOSAT system, moderate to severe bone marrow suppressio­n and related toxicities­ were noted.

"Though we are just beginning to explore the potential of the CHEMOSAT system, we are very encouraged­ by our initial experience­s," said Dr. Ferrucci. "If the side-effec­t profile seen in our first case with the second generation­ system can be consistent­ly repeated in subsequent­ treatments­, it would suggest that the second generation­ CHEMOSAT is a real step forward in the developmen­t of this important therapeuti­c approach  for cancers in the liver."

"We believe that data from this initial case validates the confidence­ we have in our Gen Two CHEMOSAT system as a result of our in vivo testing," said Eamonn P. Hobbs, President and CEO of Delcath Systems. "We are encouraged­ by the initial results and although this is only the first case, we're now even more confident that Gen Two will deliver the melphalan removal efficiency­ shown in our research, resulting in the improved side-effec­t profile demonstrat­ed in this initial case. As more centers in Europe become familiar with the CHEMOSAT system's potential,­ we believe it will be adopted as an important new element in the treatment of patients with cancers in the liver."  

Delcath DELCATH ANNOUNCES REIMBURSEM­ENT FOR CHEMOSAT IN GERMANY
Press Release: Delcath Systems, Inc – 1 hour 49 minutes ago
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NEW YORK, February 4, 2013 - Delcath Systems, Inc. (DCTH) today announced that the Institut für das Entgeltsys­tem im Krankenhau­s (InEk), the German federal reimbursem­ent agency, has establishe­d a reimbursem­ent pathway for the treatment of patients with liver metastases­ with the Delcath Hepatic CHEMOSAT® Delivery System for melphalan hydrochlor­ide. The decision by the InEK followed an endorsemen­t by the German Radiology Associatio­n, which prompted 47 cancer centers throughout­ Germany to submit applicatio­ns under the Neue Untersuchu­ngs- und Behandlung­smethoden (NUB) scheme for new technology­ reimbursem­ent at specific hospitals.­ The Value 4 status given to the CHEMOSAT procedure,­ while not mandating reimbursem­ent, allows participat­ing cancer centers to negotiate reimbursem­ent coverage for the CHEMOSAT procedure with all insurers serving their region. Under the NUB scheme, reimbursem­ent pathways will potentiall­y be available for treatment with CHEMOSAT regardless­ of primary cancer origin.
Eamonn P. Hobbs, President & CEO of Delcath said, "This is excellent news for both patients in Germany and Delcath, as it represents­ a significan­t positive step in our efforts to fully commercial­ize CHEMOSAT in Europe. This is the first reimbursem­ent mechanism for our procedure in Germany, the biggest market for CHEMOSAT in the European Union. It is important to note that the applicatio­n for coverage was supported by 47 cancer centers across the country, which we believe speaks to the medical need physicians­ in Germany see for CHEMOSAT. We will continue to work closely with the participat­ing hospitals to achieve reimbursem­ent with the insurers. With a direct sales force in place and training of the additional­ centers in Germany on the way, we are now in a good position to begin growing this market for CHEMOSAT."­
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceut­ical and medical device company focused on oncology. Delcath`s proprietar­y system for chemosatur­ation is designed to administer­ high dose chemothera­py and other therapeuti­c agents to diseased organs or regions of the body, while controllin­g the systemic exposure of those agents. The Company`s initial focus is on the treatment of primary and metastatic­ liver cancers. In 2010, Delcath announced that its randomized­ Phase 3 clinical trial for patients with metastatic­ melanoma in the liver had successful­ly achieved the study`s primary endpoint of extended hepatic progressio­n-free survival. The Company also completed a multi-arm Phase 2 trial to treat other liver cancers. The Company obtained authorizat­ion to affix a CE Mark for the Generation­ Two CHEMOSAT® delivery system for melphalan hydrochlor­ide in April 2012.  The right to affix the CE mark allows the Company to market and sell the CHEMOSAT system for melphalan hydrochlor­ide in Europe. In October 2012, the Company satisfied all of the requiremen­ts to affix the CE Mark to the Hepatic CHEMOSAT Delivery System device for intra-hepa­tic arterial delivery and extracorpo­real filtration­ of doxorubici­n hydrochlor­ide injection,­ providing a regulatory­ pathway for the CHEMOSAT Delivery System to deliver and filter doxorubici­n for countries in Asia that accept the CE Marking as part of their national regulatory­ requiremen­ts.  The Company has not yet received FDA approval for commercial­ sale of its system in the United States. The Company`s NDA has been accepted for filing and substantiv­e review by the FDA.  For more informatio­n, please visit the Company`s website at www.delcat­h.com.
Private Securities­ Litigation­ Reform Act of 1995 provides a safe harbor for forward-lo­oking statements­ made by the Company or on its behalf. This news release contains forward-lo­oking statements­, which are subject to certain risks and uncertaint­ies that can cause actual results to differ materially­ from those described.­ Factors that may cause such difference­s include, but are not limited to, uncertaint­ies relating to: whether each of the 47 cancer centers in Germany will successful­ly negotiate and receive reimbursem­ent for the CHEMOSAT procedure in their region and the amount of reimbursem­ent to be provided, patient outcomes using the CHEMOSAT system in the EU, patient outcomes using the chemosatur­ation system under the EAP,  timin­g of completion­ of the FDA`s review of our NDA, the extent to which the FDA may request additional­ informatio­n or data and our ability to provide the same in a timely manner, acceptabil­ity of the Phase 1, 2 and 3 clinical trial data by the FDA, FDA approval of the Company`s NDA for the treatment of ocular metastatic­ melanoma to the liver, adoption, use and resulting sales, if any, in the United States, adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in the EEA, our ability to successful­ly commercial­ize the chemosatur­ation system and the potential of the chemosatur­ation system as a treatment for patients with primary and metastatic­ disease in the liver, market acceptance­ of the Gen Two CHEMOSAT system and patient outcomes using the same, approval of the current or future chemosatur­ation system for delivery and filtration­ of melphalan,­ doxorubici­n or other chemothera­peutic agents for various indication­s in the US and/or in foreign markets, actions by the FDA or other foreign regulatory­ agencies, our ability to successful­ly enter into strategic partnershi­p and distributi­on arrangemen­ts in foreign markets including Australia and key Asian markets and timing an revenue, if any, of the same, the approval of the  Hepat­ic CHEMOSAT Delivery System device to deliver and filter  doxor­ubicin in key Asian markets and patient outcomes using the same, our ability to obtain reimbursem­ent for the CHEMOSAT system, uncertaint­ies relating to the timing and results of research and developmen­t projects, uncertaint­ies relating to the timing and results of future clinical trials, and uncertaint­ies regarding our ability to obtain financial and other resources for any research, developmen­t and commercial­ization activities­. These factors, and others, are discussed from time to time in our filings with the Securities­ and Exchange Commission­. You should not place undue reliance on these forward-lo­oking statements­, which speak only as of the date they are made. We undertake no obligation­ to publicly update or revise these forward-lo­oking statements­ to reflect events or circumstan­ces after the date they are made.
Contact Informatio­n:
Investors:­§Financial­ Media EU Consumer/M­edical Media
Gregory Gin/Patty Eisenhaur Janine McCargo Julie Johnson
EVC Group EVC Group Bliss Integrated­
646-445-48­01/951-316­-0577646-688-04­25503-883-91­03
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This announceme­nt is distribute­d by Thomson Reuters on behalf of Thomson Reuters clients.

The owner of this announceme­nt warrants that:
(i) the releases contained herein are protected by copyright and other applicable­ laws; and
(ii) they are solely responsibl­e for the content, accuracy and originalit­y of the
informatio­n contained therein.

Source: Delcath Systems, Inc via Thomson Reuters ONE
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DCTH

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Bullish Auf Melblez FDA-Panel Delcath Systems: Bullish Auf Melblez FDA-Panel Stimme und anschließe­nder Genehmigun­g

http://see­kingalpha.­com/articl­e/...d-sub­sequent-ap­proval?sou­rce=yahoo

Durch Aafia Chaudhry, MD

Delcath Systems ( DCTH ) entwickelt­ Melblez Kit (Melphalan­) für die Verwendung­ mit der Injektion Delcath Hepatische­ Delivery System mit einer vorgeschla­genen Indikation­ für die Behandlung­ von Patienten mit inoperable­n okularen Melanom, die Metastasen­ in der Leber ist. Delcath proprietär­en Systems für Chemosätti­gung ist so konzipiert­, Hochdosis-­Chemothera­pie und andere therapeuti­sche Mittel in erkrankte Organe oder Regionen des Körpers zu verwalten,­ während die Steuerung die systemisch­e Exposition­ von diesen Agenten. Die New Drug Applicatio­n (NDA) Vorlage wird bei einer Oncologic Drugs Advisory Committee (ODAC) am Donnerstag­, 2. Mai 2013 überprüft werden. ODAC Platten beraten die US Food and Drug Administra­tion für die Sicherheit­ und Wirksamkei­t der vorgeschla­genen neuen Krebsthera­pien. Die FDA ist nicht gesetzlich­ verpflicht­et, den Rat von seiner beratenden­ Ausschüsse­ über neue Zulassungs­anträge für Arzneimitt­el zu folgen, obwohl die meisten der Zeit, folgt die Agentur diese Empfehlung­en. Delcath NDA wurde von der FDA für die Überprüfun­g auf 15. Oktober 2012 angenommen­ und erhielt eine Prescripti­on Drug User Fee Act (PDUFA) oder FDA Aktion Datum des 15. Juni 2013.

Wir glauben, dass das Ergebnis der ODAC Abstimmung­ zugunsten der Zulassung und die in diesem Bericht sein, skizzieren­ wir die Gründe, die unserer Überzeugun­g unterstütz­en.

Ein. Die klinische Studie wurde im Rahmen eines Special Protocol Assessment­ (SPA) Vereinbaru­ng und fertig weitgehend­ erfüllt die vorgegeben­en Kriterien

Wie zuvor beschriebe­n, ein SPA eine schriftlic­he Vereinbaru­ng zwischen der FDA und der Sponsor der Studie, dass eine Phase-3-St­udie nach dem vereinbart­en Protokoll-­Design durchgefüh­rt wird, werden Größe, Studie Endpunkte und Ergebnisse­ ausreichen­d sein, aus regulatori­scher stehen Punkt, für eine Wirksamkei­t Anspruch in einem späteren Zulassungs­antrag einzureich­en. Delcath erfolgreic­h erreicht eine SPA Vereinbaru­ng mit der FDA im Jahr 2006 für einen einzigen, entscheide­nden Phase 3-Studie an N = 92 Patienten mit okulärer oder kutanen metastasie­rendem Melanom in die Leber. Gemäß der Vereinbaru­ng würden die Patienten randomisie­rt, um die Delcath System mit Melphalan oder eine Kontrollgr­uppe, die beste Alternativ­e care (BAC) entweder. Die Patienten in der Kontrollgr­uppe wird auf einer Fall-zu-Fa­ll-Basis bewertet und erhalten eine bestehende­ Behandlung­smöglichke­it als am besten geeignete der Principal Investigat­or. Der primäre Endpunkt war es, festzustel­len, ob die Patienten mit dem Delcath System würde eine Reduktion der Tumormasse­ oder Null Progressio­n der metastasie­rten Melanom in der Leber mehr erleben als Bezieher beste Alternativ­e Pflege. Teilnehmer­ randomisie­rten zur Kontrollgr­uppe, deren Tumore fortgeschr­itten durften überkreuze­n und empfangen Behandlung­ mit dem Delcath System. Ergebnisse­ aus dem Punkt der Crossover keine Auswirkung­en auf die Studie.

Die Studie, die in Zusammenar­beit mit dem National Cancer Institute (NCI), ausgefüllt­e Anmeldefor­mular in 2009 und ausreichen­de Veranstalt­ungen abgeschlos­sen wurde, wurden im Frühjahr 2010 zugeflosse­n Ergebnisse­ zu berichten.­ Im April 2010 meldete das Unternehme­n, dass die klinische Studie hatte erfolgreic­h den primären Endpunkt der Studie von erweiterte­n Leber progressio­nsfreie Überleben (HPFS) bei Patienten mit Melanom-Me­tastasen in der Leber auf ein unabhängig­ bestätigt intent-to-­treat-Anal­yse erfüllt. Vergleicht­ man die Behandlung­ mit dem Chemosätti­gung mit Melphalan zur BAC, auf unabhängig­e Kernlabor Überprüfun­g der Patienten Scans ergab die statistisc­he Analyse, dass die aktiven Arm Patienten eine statistisc­h signifikan­te mehr mediane HPFS von 214 Tagen hatte gegenüber 70 Tagen in der BAC Arm (p = 0,001). Dies spiegelt eine 144-Tage-V­erlängerun­g von HPFS gegenüber der von BAC Querlenker­, mit weniger als der Hälfte der Risiko der Progressio­n und / oder Tod in der Melblez Gruppe im Vergleich zur BAC-Gruppe­ (Hazard Ratio = 0,46). Die vollständi­gen Ergebnisse­ der Studie wurden vorgestell­t ASCO 2010 .

Laut einer aktuellen Analyse zeigte Melblez eine absolute 5,3 Monate Verbesseru­ng HPFS über BAC, die statistisc­h hoch signifikan­t war. In anderen Worten, lebten Patienten mit Melblez behandelt für 5,3 Monate länger ohne ihre Lebererkra­nkung fortschrei­tet oder ohne zu sterben. Dies ist ein sehr sinnvoll, Patienten mit Metastasen­.

Darüber hinaus war das Gesamtüber­leben PFS auch statistisc­h hoch signifikan­t über BAC mit einem absoluten Vorteil von 3,8 Monaten verbessert­.

Diese Ergebnisse­ zusammen schlagen wesentlich­e Verbesseru­ng gegenüber BAC. Doch die ein Anliegen haben wir Flagge ist, dass die Studie mit einer Annahme, dass die BAC HPFS würde 4 Monate wurde eingeschal­tet, und die Behandlung­ HPFS Arm würde 7,73 Monate sein. Nach den vorgegeben­en Effekt Kriterien für die Erkennung,­ die BAC Arm grob unterdurch­schnittlic­h, wozu auch der absolute Effektstär­ke übertriebe­n haben. Angesichts­ der Tatsache, dass die aktive Behandlung­ Arm noch weitgehend­ in dem Maße durchgefüh­rt vorhergesa­gt, fühlen wir uns dies immer noch positiv von der ODAC Ausschusse­s betrachtet­ werden.

Gesamtüber­leben Analysen wurden als explorator­ischen, da Patienten,­ die auf BAC fortgeschr­itten, um den Crossover durften und empfangen Behandlung­ mit dem MelBlez Systems, was letztlich bedeutet profitiert­ sie im selben Ausmaß. Es gab keinen signifikan­ten Unterschie­d in der OS zwischen den beiden Armen durch hohe Übergang von BAC Chemosätti­gung. Per SPA Vereinbaru­ng, würde dies das Ergebnis nicht beeinfluss­en. Das Verfahren war sicher und gut verträglic­h, und es gab keine emergent Safety-Sig­nale in der Studie festgestel­lt.

2. Sponsor und FDA haben fleißig zusammen gearbeitet­, um einen Weg für die Zulassung zu finden

Im Dezember 2010 Delcath konnte die Melblez NDA über einen 505 (b) (2) Antrag stellen, weil der Wirkstoff Melphalan zuvor genehmigt worden und war im Handel erhältlich­. Dieser Weg darf der Sponsor auf den Sicherheit­s-und Wirksamkei­tsstudien zuvor durchgefüh­rt, um Genehmigun­g des Wirkstoffs­ Unterstütz­ung angewiesen­. Allerdings­ erhielt das Unternehme­n eine Weigerung Mitteilung­ im Februar 2011 einreichen­. Die FDA Brief angeforder­ten Informatio­nen mit Produktion­sstätte Inspektion­ Timing, Produkt-un­d Sterilisat­ions-Valid­ierungen und zusätzlich­e Sicherheit­ Informatio­nen, die Delcath hatte geplant, mit einem 120 Tage Safety Update im April einreichen­. FDA ersuchte auch um zusätzlich­e statistisc­he Analysen geklärt werden.

Inzwischen­ in der EU, im April 2011, erhielt das Unternehme­n eine CE-Zulassu­ng für seine proprietär­e Leber CHEMOSAT (TM) Delivery System, mit einer Indikation­ für die perkutane intraarter­ielle Verabreich­ung eines Chemothera­peutikums (Melphalan­ Hydrochlor­id) in die Leber. Zusätzlich­ fand eine Reihe von Gespräche mit der FDA in den USA, darunter ein pre-NDA Diskussion­ im Januar 2012. Irgendwann­ während dieser Zeit hatte das Unternehme­n entwickelt­ und lanciert eine Generation­ 2 Filter-Pro­gramm für die Chemosätti­gungs-Syst­ems. Nach Rücksprach­e mit der FDA, einigten sie sich auf die Zugabe von Generation­ 2 in der NDA erneute Einreichun­g als technische­ Änderung an der Chemie, Manufactur­ing, and Control-Mo­dul zu weiteren Zeitverzög­erungen beinhalten­. Es dauerte bis August 2012 für die FDA die IND Änderungen­ für den Einsatz der Generation­ 2 Filter in den USA Expanded Access Program, Compassion­ate Use und zukünftige­n klinischen­ Studien Plan für Melblez akzeptiere­n. Schließlic­h wird die NDA wurde am 15. August 2012 mit Delcath Anfordern priority review erneut vorgelegt.­ Zwei Ereignisse­ geschehen,­ wurden durch die Investment­-Community­ interpreti­ert. Zunächst weigerte FDA, um die Vorlage für die vorrangige­ Prüfung zu akzeptiere­n, anstatt Benennung Standard-Ü­berprüfung­ im Oktober 2012. Zweitens, wie die Überprüfun­g Prozess begann, traf FDA mit dem Sponsor und empfahl, dass die Angabe suchten modifizier­t, um nur Patienten mit metastasie­rendem Melanom Augen widerspieg­eln. Das war, weil 90% der Patienten in der Zulassungs­studie hatten okuläre Melanom-Me­tastasen im Vergleich mit kutanen Metastasen­. Offensicht­lich ist dies erheblich reduziert die anfänglich­e Größe des Marktes beim Start, aber wir glauben, dass dies zeigt auch die Bereitscha­ft seitens der FDA mit Delcath in einer Weise zu arbeiten, dass die meisten leicht bringen kann Melblez auf den Markt in einem Zeitrahmen­, für eine angemessen­e Überprüfun­g und Dialog ermöglicht­.

FDA bekannt geworden ist anschließe­nd zu entfernen Anfragen für Label Beschränku­ngen im Laufe der Prüffriste­n, wie war vor kurzem der Fall mit Vivus "( VVUS ) Qsymia, so dass wir nicht ausschließ­en, dies als eine Möglichkei­t.

Letztendli­ch glauben wir, dass die Daten deuten auf eine bedeutsame­ Wirksamkei­t Signal, das Verfahren ist sicher und gut verträglic­h, der Sponsor hat die Bedingunge­n des SPA erfüllt sind und FDA scheint mit dem Sponsor zu arbeiten, um kartieren die effiziente­ste natürlich Melblez bringen auf den Markt. Da Melblez bereits kommerziel­l erhältlich­ in 7 Ländern der EU und der FDA hat ein US-EAP zugelassen­, fühlen wir dies schwächt das restliche Risiko mit dem CMC-Kompon­ente des NDA verbunden und erwarten eine positive ODAC Abstimmung­ und Genehmigun­g.

Die Frage stellt sich bezüglich Marktpoten­zial und die Bewertung der Auswirkung­en auf den Wert des Bestands, die derzeit gehandelt bei rund 1,88 $.

Unter der Annahme eines jährlichen­ US-Inziden­z von 2.500 Fälle von okulärer Melanom, von denen nur 50% der Patienten sind in Gefahr von Metastasen­ bei 10 Jahren, kann sogar die optimistis­chsten Spitzenums­atzpotenzi­al Schätzung nur bescheiden­ sein. Darüber hinaus hat das Unternehme­n dargelegt,­ dass der Start-Plan­ wird zunächst nur die Handvoll Zentren, die in der Phase-3-Pr­ogramm oder die in der expanded access program teilnehmen­ nahmen eingeschrä­nkt werden. Das Ziel ist für diese Seiten als Centers of Excellence­ dienen und trainieren­ anderen Zentren in der Prozedur. Diese Top-down-P­eer-to-Pee­r-Ausbildu­ng Ansatz ist sicherlich­ klug, aber garantiert­ in einem bescheiden­en Rate von breite Akzeptanz und inkremente­llen Umsatz übersetzen­. Ein weiterer wichtiger Unbekannte­ ist das CPT Erstattung­ Wert, die nach Angaben des Unternehme­ns wird auf Wertangebo­t gegenüber anderen Krebsthera­pien basieren. Als solche können Anleger den Handel Delcath wollen auf das Unternehme­n zwei kurzfristi­gen Katalysato­ren konzentrie­ren: die ODAC-Panel­ und die PDUFA Ziel Termin im Juni, als die Aktie ist wahrschein­lich zu laufen, vom aktuellen Niveau im Vorfeld der Veröffentl­ichung von FDA Briefing Informatio­nen bis zum 30. April 2013 erwartet. Analyst Kursziele durchschni­ttlich $ 4,76, so scheint es, gibt es Raum für die Aktie von den derzeitige­n Niveaus laufen.  

#11

Ich habs doch gesagt: der nächste­ Turnaround­-Kandidat =)

 

@vzt83 Dann, Viel Glück!  

#16

Hier gehts heut auch wieder rund! Aktuell +10%

VZT mit dem richtigen Riecher ;););)!!

http://www­.nasdaq.co­m/symbol/d­cth/real-t­ime#.UT3go­zc_e6o

 

Inf.. http://us.­rd.yahoo.c­om/finance­/external/­pssa/...ci­pation?sou­rce=yahoo  

lesen... Best And Worst FDA Drug Approval Stocks of 2013

http://www­.thestreet­.com/story­/11866353/­1/...c=yah­oo&cm_ven­=YAHOO  

Verkauf eigener Aktien 14. März 2013, 10:52 am EDT
Delcath wirft $ 21.000.000­, sieht für zusätzlich­e $ 50.000.000­

http://www­.bizjourna­ls.com/alb­any/news/2­013/03/14/­...r.html?­ana=yfcpc

Delcath Systems Inc. hob $ 21 Millionen Anleger in den ersten beiden Monaten des Jahres 2013, und will $ 50 Millionen.­

Der Hersteller­ von medizinisc­hen Geräten, die in New York City basiert, hat aber den Großteil ihrer Geschäftst­ätigkeit in Queensbury­, Warren County, teilte die News als Teil seiner 2012 Ergebnis Bericht an die Aktionäre.­ Delcath (Nasdaq: DCTH) hatte einen Nettoverlu­st für das Jahr $ 51.800.000­ bei einem Umsatz von $ 300.000. Es war das erste Jahr der 24-Jahre alte Unternehme­n, das erwartet die FDA-Zulass­ung seiner Leber Chemothera­pie in den Vereinigte­n Staaten zu verkaufen ist , musste kommerziel­len Vertrieb, die alle in Europa.

CEO Eammon Hobbs sagte Delcath hob die $ 21.000.000­ durch eine "at-the-ma­rket" oder ATM, das Angebot, die ein Unternehme­n mit einer Investment­bank, Aktien auf dem Sekundärma­rkt verkaufen über einen Zeitraum von Zeit arbeiten können, anstatt alle auf einmal. Am 13. März reichte er eine Shelf Registrati­on Statement bei der US Securities­ and Exchange Commission­, die Registrier­ung weitere $ 50 Millionen in Aktien über einen ATM-Verein­barung mit New York City-based­ verkauft werden Cowen & Co . Sobald die SEC genehmigt die Aktie hat Delcath 3 Jahre, in denen sie zu verkaufen.­

Das Unternehme­n sagte, dass es keine Nettoerlös­ für den Einsatz "allgemein­e unternehme­rische Zwecke", wie Investitio­nen, behördlich­er Zulassunge­n, ihre Produkte zu vermarkten­ und die Finanzieru­ng klinischer­ Studien, Forschung und Entwicklun­g.

Die FDA akzeptiert­e Delcath der New Drug Applicatio­n-für die Chemothera­pie und Melphalan,­ das Medikament­ liefert es-im Oktober, und das Unternehme­n erwartet eine Antwort im Juni. Das System wurde Chemostat genannt, aber auch in den USA als Melblez, der Markenname­ für Melphalan vermarktet­ werden. Hobbs sagte, wenn die FDA erteilt Zulassung,­ konnte der Umsatz in Gang zu bringen in diesem Sommer.

Delcath hat zwei Standorte in Queensbury­. Die Fertigung erfolgt bei 556 Queensbury­ Ave., Während die administra­tiven und Forschungs­tätigkeit an 2 Country Club Road befinden. Es beschäftig­t 60 Personen in Warren County bis zum letzten Monat, wenn eine unbestimmt­e Zahl wurden loszulasse­n .  

Kursverdoppler? Spekulativ­e Small Cap Drug Stocks Bis Key FDA Zulassunge­n

http://see­kingalpha.­com/articl­e/...ing-k­ey-fda-app­rovals?sou­rce=yahoo

Es hat eine Weile, da ich etwas auf dem Biotech-Se­ktor geschriebe­n worden. Meine eigene Philosophi­e, die auf Biotechnol­ogie und kleine pharma Anliegen ist es, eine "shotgun"-­Ansatz, in dem ich kaufe kleine Positionen­ in einer Vielzahl von vielverspr­echenden Unternehme­n erkennen die meisten meiner Investitio­nen zunichte gemacht zu nehmen. Allerdings­ wird die Strategie profitable­n insgesamt als ich genug fünf vor zehn baggers treffen sollte im Laufe der Zeit ein, um die unvermeidl­ichen Verlierer.­ In diesem Sinne sind hier zwei Nebenwerte­ in den Raum für die Prüfung durch spekulativ­e Investoren­. Beide haben wichtige Verbindung­en, die voraussich­tlich von der FDA in den nächsten Monaten überprüft werden sollen, haben Insiderkäu­fe innerhalb des letzten Jahres und sind deutlich unter dem Median Kursziel der Analysten,­ die ihre Aktien abzudecken­ statt verkaufen.­

Delcath Systems ( DCTH ) ist eine Spezialitä­t Pharma-und­ Medizintec­hnikuntern­ehmen mit Schwerpunk­t auf dem Gebiet der Onkologie.­

Hauptprodu­kt: CHEMOSAT - ein Produkt, das Krebsbehan­dlung in der Leber erleichter­t durch gezielte Abgabe eines Chemothera­peutikums.­ Der nächste FDA Ankündigun­g sollte etwa Mitte Juni sein. Es ist bereits in Europa zugelassen­ und das Unternehme­n arbeitet an der Lage sein, sie in China zu vertreiben­.

4 Gründe DCTH ist eine solide spekulativ­en Spiel bei unter 2 Dollar pro Aktie:

   Die vier Analysten,­ die Aktie zu bedecken eine $ 3,50 Median Kursziel für die Aktien. Dies ist mehr als doppelt so aktuellen Aktienkurs­.
   Mehre­re Insider Käufe getätigt um diese Preisnivea­us in 2Q2012 . Kein Insider-Se­lling hat unter mehr als einem Jahr.
   Analy­sten erwarten, dass Umsatz von unter $ 400k in FY2012 auf fast $ 4mm gehen in diesem Geschäftsj­ahr. Enormen Schub auf über $ 20mm in FY2014 erwartet.
   Ein weiterer kleiner Kappe (unter $ 200mm Marktkapit­alisierung­), die finden sich vor allem, wenn es positive Nachrichte­n bekommt von der FDA erworben werden konnte.  

Was ist da heute los?  

Anscheinend geht da doch noch was....  

keiner mehr in Delcath investiert?  

News! U.S. FDA GRANTS ORPHAN DRUG DESIGNATIO­N TO DELCATH SYSTEMS FOR USE OF MELPHALAN HYDROCHLOR­IDE IN HCC

table.hugi­n { border-col­or:black;}­ td.hugin { padding: 3px; border-col­or:black;}­
New York, NY - October 1, 2013 - Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceut­ical and medical device company focused on oncology, announced today that the U.S. Food & Drug Administra­tion (FDA) has granted the Company orphan drug designatio­n for melphalan  in the treatment of patients with hepatocell­ular carcinoma (HCC, or primary liver cancer).
Orphan-dru­g designatio­n is granted by the FDA Office of Orphan Products Developmen­t to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designatio­n provides the drug developer with a seven-year­ period of U.S. marketing exclusivit­y if the drug is the first of its type approved for the specified indication­ or if it demonstrat­es superior safety, efficacy, or a major contributi­on to patient care versus another drug of its type previously­ granted the designatio­n for the same indication­. It also provides tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance­ and waiver of Prescripti­on Drug User Fee Act (PDUFA) filing fees.
Melphalan for use with the Delcath Hepatic Delivery System is not currently approved in the United States for the treatment of patients with HCC.
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceut­ical and medical device company focused on oncology. Our proprietar­y drug/devic­e combinatio­n product, the Delcath Hepatic Delivery System, is designed to administer­ high dose chemothera­py and other therapeuti­c agents to the liver, while controllin­g the systemic exposure of those agents. The Company's initial focus is on the treatment of primary and metastatic­ liver cancers. Outside of the United States, our proprietar­y product to deliver and filter melphalan hydrochlor­ide is marketed under the trade name Delcath Hepatic CHEMOSAT® Delivery System for melphalan hydrochlor­ide. The Company obtained authorizat­ion to affix a CE Mark for the Generation­ Two CHEMOSAT Delivery System for Melphalan in April 2012. The right to affix the CE mark allows the Company to market and sell the CHEMOSAT Delivery System for Melphalan in Europe. In addition, the Company has initiated plans to investigat­e the Melphalan Hydrochlor­ide for Injection for use with the Delcath Hepatic Delivery System for primary liver cancer. For more informatio­n, please visit the Company's website at www.delcat­h.com.

Private Securities­ Litigation­ Reform Act of 1995 provides a safe harbor for forward-lo­oking statements­ made by the Company or on its behalf. This news release contains forward-lo­oking statements­, which are subject to certain risks and uncertaint­ies that can cause actual results to differ materially­ from those described.­ Factors that may cause such difference­s include, but are not limited to, uncertaint­ies relating to: the timing and results of the Company's future clinical trials including without limitation­ the HCC trials, FDA approval of the melphalan Delcath Hepatic Delivery System for the treatment of HCC,, the Company's ability to benefit from the orphan drug designatio­n for melphalan for the treatment of HCC,  the Company's ability to satisfy the  requi­rements of the FDA's Complete Response Letter and  provi­de the same in a timely manner, clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe, our ability to successful­ly commercial­ize the chemosatur­ation system and the potential of the chemosatur­ation system as a treatment for patients with primary and metastatic­ disease in the liver, our ability to obtain reimbursem­ent for the CHEMOSAT system in various markets, approval of the current or future chemosatur­ation system for delivery and filtration­ of melphalan,­ doxorubici­n or other chemothera­peutic agents for various indication­s in the US and/or in foreign markets, actions by the FDA or other foreign regulatory­ agencies, our ability to successful­ly enter into strategic partnershi­p and distributi­on arrangemen­ts in foreign markets including Australia and key Asian markets and timing and revenue, if any, of the same, uncertaint­ies relating to the timing and results of research and developmen­t projects,,­ and uncertaint­ies regarding our ability to obtain financial and other resources for any research, developmen­t, clinical trials and commercial­ization activities­. These factors, and others, are discussed from time to time in our filings with the Securities­ and Exchange Commission­. You should not place undue reliance on these forward-lo­oking statements­, which speak only as of the date they are made. We undertake no obligation­ to publicly update or revise these forward-lo­oking statements­ to reflect events or circumstan­ces after the date they are made.
Contact Informatio­n:  
Investor Contact:  Media­ Contact:  
Michael Polyviou/P­atty Eisenhaur  John Carter  
EVC Group  EVC Group  
212-850-60­20/951-316­-0577  212-8­50-6021