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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)
After reading this article, people also read:
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
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 Achieves ISO 13485 Certification
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DCTH 11.19 +0.24
{"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 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 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/.
nächste Meldung
07.03.2012
Erstmalig in Deutschland wurde am Frankfurter Uniklinikum ein Verfahren eingesetzt, das dank lokaler Chemotherapie die Nebenwirkungsbelastung weitgehend reduziert.
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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
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
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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."
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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Imo der nächste Turnaround-Kandidat bis Ende April! Werde mir Montag im Laufe des Tages 'ne Posi gönnen!
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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.
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http://www.thestreet.com/story/11866353/1/...c=yahoo&cm_ven=YAHOO
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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 .
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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.
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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