Good call. Followed those guys closer before, then when they hit opposition abroad, I lost interest. Delcath is flying under the radar lately, but... Still watching developments in Germany / UK closely.
CHEMOSAT®Hepatic Delivery System• Approved as Class IIb Medical Device; kit supplied w/o
melphalan• Broad indication for intra-hepatic administration of
melphalan hydrochloride and subsequent filtration of the
venous blood return• 130 commercial procedures performed in 15 leading
cancer centers in the EU• Reimbursement via Individual Funding Requests; NUB
Value 4 Status in Germany• Growing Support for NUB Value 1 Status among
German KOLs; 2015 NUB decision by February 1, 2015• UK Block Grants pending & private pay insurance
Improved device and procedure since prior trials o 130 EU treatments o 20 treatments in US Expanded Access Program and
Compassionate Use cases o Many issues raised at ODAC have not been reported• EU patients report improved QoL• Current device/procedure permitting multiple treatment cycles• Recent scientific presentations at ESSO for OM from 3 centers in
US and EU o University Southampton reported 47% of patients had a partial
response and 16% had a complete response o Moffitt reported 67% of patients had a partial response. In addition,
one patient was reported to have a complete response o Leiden reported 80% of patients had a partial response
16 DELCATH SYSTEMS, INCRisks Observed in Previous Clinical Trials• Risks observed using product and procedure protocol from Previous Clinical
Program• Integrated safety population of patients showed risks associated with
Melphalan/ HDS to include: o 4.1% incidence of deaths due to adverse reactions o 4% incidence of stroke o 2% reported incidence of myocardial infarction in the setting of an incomplete cardiac
risk assessment o a ≥ 70% incidence of grade 4 bone marrow suppression with a median time of
recovery of greater than 1 week o 18% incidence of febrile neutropenia, along with the additive risk of hepatic injury,
severe hemorrhage, and gastrointestinal perforation o Deaths due to certain adverse reactions did not occur again during the
clinical trials following the adoption of related protocol amendments o Reports from treating physicians in US and EU indicate improved safety
profile with improved device and procedure refinements
Let's say, 26 years+
"3 Things to Watch With Delcath Systems
ARTICLE PREVIEW — For full access, register below, it's free
By Sean Williams | More Articles
September 19, 2012 | Comments (0)
Delcath Systems (Nasdaq: DCTH ) is a specialty pharmaceutical and medical device company focused on oncological treatments.
Today, let's look at three things investors should be watching regarding Delcath Systems, as they will provide us with better insight into the company.
1. NDA filing for hepatic Chemosat therapy device with melphalan
After waiting for 24 years (no joke, 24!), it appears that Delcath shareholders finally have a reason to be excited, with the company filing a new drug application with the Food and Drug Administration that encompasses both its revolutionary hepatic Chemosat therapy device that delivers chemotherapy agents directly to the liver via hepatic artery infusion, as well as the cancer-fighting agent it purchased from GlaxoSmithKline (NYSE: GSK ) in 2003, melphalan."
Good man. Happy to see you having some fun. Hope you make some $$. This flies or dies. Place your bets.
They're science focused, obviously not business / marketing focused... I have to agree. What's nice is Germany is picking it up anyway, and the doubling of treatments there isn't insignificant.
New German Hospital
Seems like a new German hospital in Hannover offering Chemosat.
11/4 Press Release.
Using google translate:
Specialists of the Hannover Medical School (MHH) for the first time a new therapy for the treatment of liver tumors have been successfully used in two patients. This is the so-called Chemosaturation. It provides in particular in patients who have no other treatment more responsive the ability to fight the tumor in the liver effective. The minimally invasive method has so far been applied only in a few specialized clinics in Germany.
When Chemosaturation the physician the liver to flood through the artery with a high-dose chemotherapy. During this procedure, the liver is isolated through a second special catheter from the rest of the blood circulation of the body, the liver blood is passed outside of the body by means of special filters. The purified blood then add the doctors again the bloodstream. Characterized the side-effects of the cytostatic agent is less. Patients can go about their everyday habits after a hospital stay of a few days. The Chemosaturation may be for inoperable malignant liver tumors or metastatic tumors that are confined to the liver, used. These include liver metastasis in colorectal cancer (colon cancer), melanoma (skin cancer) or in uveal melanoma in the eye. Also liver tumors can be treated with their own method.
At the MHH the complex intervention of an experienced team of hepatologists, oncologists, radiologists, anesthesiologists and perfusionists is performed. "We are very pleased that the medical team with the Chemosaturation can complement the range of minimally invasive local treatment of tumors in the liver and hope for us from a further appreciation of the MHH as a center of excellence in the treatment of liver tumors," says Professor Dr. Michael Peter Manns , director of the MHH Clinic for Gastr
b8 - Have you ever posted here in the last few years? srosone - What are you doing here, if you don't like it? Short and be happy. Or buy and go long. Simple stuff, Bro.
Anyone with minimal exposure to commercial developments / advances knows that a year is a very short amount of time... The events that have taken place in Germany during 2014 are under-rated.