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Hi Sam do you have a timeframe?
only ask your soul no one is all-knowing
no, it's depending on how corrupt the management is
sure but not only 0.1 is not the target
NEW YORK, Jan. 09, 2018 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announces that results of a multi-center retrospective analysis of Delcath’s PHP® Therapy have been published in the peer-reviewed Journal of Surgical Oncology. The study, Percutaneous Hepatic Perfusion with Melphalan in Uveal Melanoma: A Safe and Effective Treatment Modality in an Orphan Disease, was conducted by researchers from Moffitt Cancer Center (Moffitt) in Tampa, FL and the University Hospital Southampton (UHS) in the United Kingdom. The retrospective analysis of outcomes in 51 patients with liver metastases from ocular melanoma represents the largest data set compilation on the use of PHP Therapy in this tumor type outside of a clinical trial setting.
Patients in the study were treated at the two centers between December 2008 and October 2016. Patients received up to four PHP treatments at UHS and up to six PHP treatments at Moffitt. All patients received at least one PHP treatment, the median number of treatments per patient was two, and a total of 134 PHP treatments had been administered.
Results showed that of the 51 treated patients, 22 (43.1%) showed a partial response, 3 (5.9%) showed a complete response, and 17 (33.3%) had stable disease. The six-month overall and hepatic disease control rates were 64.7% and 70.6% respectively. Survival analysis showed median overall survival of 15.3 months at the time of data cut off. One year overall survival was 64.6%.
Safety analysis showed that 19 patients (37.5%) had Grade 3 or 4 non-hematologic toxicity. Cardiovascular toxicity was seen in 17.6% of patients, a rate comparable to the company’s prior Phase 3 study. Further to implementation of the Gen 2 filter along with prophylactic use of growth factors, severe neutropenia was seen in 16 (31.3%) patients as opposed to 60 (85.7%) patients in the prior Phase 3 trial. Most significantly, as compared to the prior Phase 3, there were no treatment related deaths. Researchers stated that PHP Therapy “can be safely employed in appropriately selected ocular melanoma patients in institutions with appropriate expertise.”
The study authors further concluded that “results clearly demonstrate that PHP Therapy appears to be an effective means of obtaining rapid intrahepatic disease control, and is a sensible option in patients with predominant liver disease.” Researchers said their results support the use of PHP Therapy in an integrated approach to the management of metastatic ocular melanoma, and looked to the company’s Phase 3 FOCUS Trial to further quantify the benefit and optimize treatment strategies for these patients.
Commenting on the announcement, Jennifer K. Simpson, Ph.D., President and CEO of Delcath Systems, said, “gathered over a period of 8 years, this retrospective two-center study represents the most robust data demonstrating a durable response, manageable side effects and a trend toward prolonged survival in this patient population since our prior Phase 3 trial. These data provide confidence that our Phase 3 FOCUS Trial can confirm these findings and produce the evidence necessary to support an application for a labeled indication in this tumor type.”
PHP Therapy with Melphalan/HDS was developed by Delcath Systems as a targeted, whole organ therapy for the liver. It is commercially available as a device in Europe, where it is marketed as CHEMOSAT®. The system has not been approved by the U.S. Food and Drug Administration, and is undergoing Phase 3 clinical testing in the U.S. as an investigational product.
NEW YORK, Jan. 10, 2018 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announces that it has concluded a modification agreement with the U.S. Food and Drug Administration (FDA) for its Phase 3 clinical trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with hepatic dominant ocular melanoma (The FOCUS Trial). The modification agreement revises the FOCUS trial’s eligibility criteria to permit a greater extent of extra-hepatic disease by removing the size restriction, number and location of extra-hepatic lesions, in conjunction with a treatment plan for the extra-hepatic metastases.
Commenting on the announcement, Jennifer K. Simpson, Ph.D., President and CEO of Delcath Systems, “We requested this protocol modification to improve patient access to this important clinical trial for appropriately selected and managed patients. In an ultra-orphan indication like ocular melanoma, striking the appropriate balance between eligibility criteria and patient access can be a challenge. We are pleased that the FDA agreed to this modification, and hope that once approved by the institutional review boards of our participating clinical trial sites, that this modification will help accelerate enrollment in this registrational trial.”
PHP Therapy with Melphalan/HDS was developed by Delcath Systems as a targeted, whole organ therapy for the liver. It is commercially available as a device in Europe, where it is marketed as CHEMOSAT®. The system has not been approved by the U.S. Food and Drug Administration, and is undergoing Phase 3 clinical testing in the U.S. as an investigational product.
I hope you will never see Antichrist called Satan
Trade very low in Europe. Are there reasons?
Frankfurt ist nicht so doll
The Americans = self clorification, the American Indians, slave trade, Korean war, Vietnam war, Iraq war, ... did you ever read a book about the WWII ?
yes, buy a pig in a poke
shutdown the USA...
tomorrow, from whom do you know?
0.1 - 0.25 a small joke nothing to earning money.
perhaps its about the culture
in two ore more months
much higher means $1 in my opinion
hopefully this time really good news
what do you know and from whom
at 0.01
is conectisys still existing?
DCTH a barrel burst
yes, killing my time
Me too but in Frankfurt the trade is very low
Yes, everything is possible and nobody knows why.
Are you German?
Why are you still in?
Rather than no trade
What happened between 01. and 21. June last year? Why did the share increase from $7 to $93. Due to manipulation or hard facts?
Perhaps could happen again.
Sure, this stock is like Conectisys
Yes, hopefuly 0.01 and then ...
Unfortunately for Europeans it is not possible to purchase this share via Nasdaq. Trading forbidden.
Yes, corruption and always want money from the EU
Yes,as Conctisys
thanks a lot
which ratio hat the split? 1:30
to 0.25 ??
You are right. I'm waiting
TOPS is falling down like Conectisys