Delcath Systems, Inc. (DCTH)

Oncology Corporate Profile

Stock Performance

0.0405
-0.0002

3 Month Stock History Chart

HQ Location

810 Seventh Avenue, Suite 3505
New York, NY 10019

Company Description

Delcath Systems, Inc. is at the forefront of regional treatment of cancer with a promising therapy to shrink tumors in the liver. Delcath's Percutaneous Hepatic Perfusion (PHP™) technology allows physicians to deliver significantly higher doses of anti-cancer drugs to the liver without exposing the patient's entire body to those same potent levels of drug. PHP™ is an investigational treatment currently undergoing testing in Phase III and Phase II clinical trials.

Website: http://www.delcath.com/index.php

This company does not have any commercial products
  • Brand
  • Generic
  • Investigational
Brand / Product Class Area of Study Phase Partnership
The Delcath systemdrug delivery platform1st line metastatic Melanoma in the LiverIII
The Delcath systemdrug delivery platformHepatocellular carcinoma (HCC)II

View additional information on product candidates here »

Source: http://www.delcath.com

Recent News Headlines

FDA Accepts For Review Supplemental New Drug Application for XTANDI® (enzalutamide) Capsules in Metastatic Castration-resistant Prostate Cancer with Data from Head-to-Head Studies of Enzalutamide Versus Bicalutamide

2/23/2016 07:01 am

(Astellas) Feb 22, 2016 - Astellas Pharma Inc. and Medivation, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) that they have submitted for XTANDI® (enzalutamide) capsules in metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the Phase 2 TERRAIN and STRIVE studies, to update the relevant clinical sections within the current indication.

Delcath Announces Beginning Of Patient Enrollment In Phase 3 Focus Trial

2/10/2016 05:41 pm

(StreetInsider) Feb 10, 2016 - Delcath Systems, Inc., a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announces that patient enrollment has begun in the Company's Phase 3 clinical trial: "A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma" (the FOCUS Trial).

Delcath Announces Initiation Of Phase 3 Trial Of Melphalan/HDS System For Treatment Of Hepatic Dominant Ocular Melanoma

1/20/2016 06:00 pm

(StreetInsider) Jan 20, 2016 - Delcath Systems, Inc., a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announces the initiation of a Phase 3 clinical trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) for the treatment of patients with hepatic dominant ocular melanoma (OM).

Delcath Announces First Patient Treated In ICC Cohort Of Global Phase 2 HCC Trial Program

10/15/2015 04:53 pm

(Delcath Systems) Oct 15, 2015 - Delcath Systems, Inc. announces that the first treatment with the Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT) has been performed in the intrahepatic cholangiocarcinoma (ICC) cohort of the Company's global Phase 2 clinical trial program for treatment of patients with unresectable hepatocellular carcinoma (primary liver cancer or HCC) and ICC.

Ultrasound, MRI Comparable for Cervical Cancer Staging

9/1/2015 12:00 pm

(Monthly Prescribing Reference/HealthDay News) Sept 1, 2015 - Transvaginal sonography (TVS), performed by a dedicated gynecologic radiologist, is comparable to magnetic resonance imaging (MRI) for diagnosing and staging local cervical cancer, according to a study published online Aug. 21 in the Journal of Clinical Ultrasound.

Precision Medicine, Linked To DNA, Still Too Often Misses

9/1/2015 11:05 am

(Boston Globe/STAT) Aug 29, 2015 - Contrary to its name, precision medicine is often inexact, which means that for some patients, it will offer false hope rather than a cure.

What to Watch for After Skin Cancer

9/1/2015 11:05 am

(Wall Street Journal/The Informed Patient) Aug 31, 2015 - Skin cancer is afflicting more people, and research shows patients who have had non-melanoma skin cancers are at increased risk of recurrence.

Two in Three Childhood Cancer Survivors Suffer Long-Term Side Effects

9/1/2015 11:05 am

(American Cancer Society) Aug 31, 2015 – Two in three survivors of childhood cancer endure debilitating side effects and late effects from their cancer treatment that cause significant suffering throughout their lives, a sobering message as the nation observes Childhood Cancer Awareness Month in September.

Men with Low-Risk Prostate Cancer in Active Surveillance Program Not Likely to Succumb to the Disease, Study Shows

9/1/2015 11:05 am

(Johns Hopkins) Aug 31, 2015 - Men with relatively unaggressive prostate tumors and whose disease is carefully monitored by urologists are unlikely to develop metastatic prostate cancer or die of their cancers, according to results of a study by researchers at the Brady Urological Institute at Johns Hopkins, who analyzed survival statistics up to 15 years.

Modified CAR T Cells Can Preferentially Target Cancer Cells and Spare Normal Cells

9/1/2015 11:05 am

(AACR) Sept 1, 2015 - Engineering chimeric antigen receptor (CAR) T cells to lower their affinity for the protein epithelial growth factor receptor (EGFR) made the cells preferentially recognize and eliminate tumor cells that have high amounts of EGFR while sparing normal cells that have lower amounts of the protein, according to a preclinical study.

Newly Engineered CAR T Cells Can Better Discriminate Between Cancer and Normal Cells

9/1/2015 11:05 am

(AACR) Sept 1, 2015 - A new development in engineering chimeric antigen receptor (CAR) T cells, called affinity tuning, can make the CAR T cells spare normal cells and better recognize and attack cancer cells, which may help lower the toxicity associated with this type of immunotherapy when used against solid tumors, according to a preclinical study.

Physicians' Peers Influence Use of New Cancer Tx Modalities

9/1/2015 11:05 am

(Physician’s Briefing/HealthDay News) Aug 31, 2015 - Physicians whose peers were early adopters of brachytherapy for the treatment of women with early-stage breast cancer are more likely to adopt the therapy themselves, according to a study published in the Aug. 15 issue of Cancer.

New Guidelines For Cancer Doctors Aim To Make Sense Of Gene Tests

9/1/2015 11:04 am

(Reuters) Aug 31, 2015 - The American Society of Clinical Oncology (ASCO) has issued guidelines on how cancer doctors should approach the use of new genetic tests that screen for multiple cancer genes at the same time, including counseling patients about genes whose contribution to cancer is still poorly understood.

Novartis Gets EU Approval For Skin Cancer Drugs

9/1/2015 11:04 am

(MarketWatch/Dow Jones Newswires) Sept 1, 2015 - European regulators have approved Novartis AG's tafinlar and mekinist for treating patients with an aggressive type of skin cancer, the company said Tuesday.

Bristol-Myers Myeloma Drug Accepted for Priority Review

9/1/2015 11:04 am

(Wall Street Journal) Sept 1, 2015 - Bristol-Myers Squibb Co.’s Empliciti drug, used to treat multiple myeloma, has been accepted by the U.S. Food and Drug Administration for priority review.

Novartis Receives EU Approval for Tafinlar® and Mekinist®, First Combination Approved For Patients With Aggressive Form Of Melanoma

9/1/2015 07:04 am

(MarketWatch) Sept 1, 2015 - Novartis today announced that the European Commission has approved the combination of Tafinlar® (dabrafenib) and Mekinist® (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

U.S. Food and Drug Administration Accepts for Priority Review the Biologics License Application for Empliciti (elotuzumab) for the Treatment of Multiple Myeloma in Patients Who Have Received One or More Prior Therapies

9/1/2015 07:04 am

(Bristol-Myers) Sept 1, 2015 - Bristol-Myers Squibb Company and AbbVie today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for Empliciti (elotuzumab), an investigational Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody, for the treatment of multiple myeloma as combination therapy in patients who have received one or more prior therapies.

ASCO Releases Updated Policy Statement on Genetic and Genomic Testing for Cancer Susceptibility

9/1/2015 07:04 am

(ASCO) Aug 31, 2015 - The American Society of Clinical Oncology (ASCO) today issued an updated policy statement on genetic and genomic testing for cancer susceptibility.

Mayo Researchers Examine Risk Factors and Patient Outcomes Associated with Colorectal Cancer Operations, Identify Benchmarks

8/31/2015 12:00 pm

(Mayo Clinic) Aug 31, 2015 - Experts continue to debate whether surgical resection of primary tumors and metastatic tumors should be performed at the same time (synchronously) or in separate operations (sequentially).

Delcath Gets FDA Orphan Drug Status For Melphalan to Treat Cholangiocarcinoma

7/21/2015 04:57 pm

(Pharmaceutical Business Review) July 21, 2015 - US-based Delcath Systems has received orphan drug designation from the US Food and Drug Administration's (FDA) Office of Orphan Products Development (OOPD) for melphalan to treat cholangiocarcinoma.

Positive Data With Delcath's CHEMOSAT Highlighted at ASCO 2015

5/29/2015 07:25 pm

(Yahoo! Finance) May 29, 2015 - Delcath Systems, Inc., a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announces that results of a large, European single-center experience of the treatment of uveal melanoma patients with hepatic metastases with the Delcath Hepatic CHEMOSAT® Delivery System, were highlighted in an on-line abstract at ASCO 2015.

ASCO Launches Online Medicare Oncology Payment Model Resources

4/27/2015 12:01 pm

(ASCO in Action) Apr 24, 2015 - ASCO has launched an online resource page aimed at helping members—and the broader oncology community—to evaluate the Center for Medicare and Medicaid Innovation's (CMMI) Oncology Care Model (OCM), decide whether to participate in the model, and guide practices through the application process.

21% Medicare Cut Becomes Reality Unless Senators Repeal SGR Next Week

4/8/2015 12:02 pm

(ASCO in Action) Apr 7, 2015 - Physicians and Medicare beneficiaries across the country are in limbo and facing a 21 percent cut in Medicare reimbursement following inaction to repeal the SGR formula by the Senate on the Medicare Access and CHIP Reauthorization Act of 2015 (H.R. 2).

Delcath Adds New U.S. Center To Global Phase 2 Hepatocellular Carcinoma Program

4/7/2015 05:50 pm

(MarketWatch) Apr 7, 2015 - Delcath Systems, Inc. announces the expansion of its global Phase 2 program for the treatment of patients with unresectable hepatocellular carcinoma (HCC) or primary liver cancer. Montefiore Medical Center in the Bronx, New York has joined the U.S. Phase 2 HCC study and is now open for patient enrollment.

'Kickback' Flak: Sanofi's Caseload Grows Bigger

12/7/2014 06:05 pm

(CNBC) Dec 5, 2014 - More than two years after paying $109 million to settle claims related to allegedly providing arthritis drug samples to doctors as kickbacks, pharma giant Sanofi has yet to sign a corporate integrity agreement with federal health regulators that was expected to follow that settlement.

Delcath Commences U.S. Phase 2 Study of Melphalan Hepatic Delivery System in Primary Liver Cancer

10/3/2014 03:49 pm

(Delcath) Oct 2, 2014 - Delcath Systems, Inc. today announced the opening of its United States (U.S.) Clinical Development Program for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC) or primary liver cancer.

Huntsman Cancer Institute Receives Funding to Establish a National Clinical Trials Network Site

7/18/2014 06:02 am

(HCI/U of U) July 17, 2014 - A team of physician-researchers from Huntsman Cancer Institute (HCI) at the University of Utah (U of U) will receive nearly $3.6 million over the next five years in a cooperative agreement with the National Institutes of Health (NIH) to establish a Network Lead Academic Participating Site (NLAPS).

Bacteria’s Role in Bowel Cancer

3/4/2014 11:04 am

(The Scientist) Mar 3, 2014 - Changes to the microbial composition of the gut can drastically alter the development of certain bowel tumors, according to a study published today (March 3) in The Journal of Experimental Medicine.

Delcath Changing Focus on Cancer-Fighting System

11/7/2013 06:05 pm

(The Post Star [Glens Falls, NY]) Nov 6, 2013 - In a filing with the Securities and Exchange Commission Wednesday, Delcath said it is finishing plans to start a new clinical study of its Melphalan Hepatic Delivery System, also called “Chemosat” and “Melblez Kit.”

Delcath Changing Focus on Cancer-Fighting System

11/7/2013 12:00 pm

(The Post Star [Glens Falls, NY]) Nov 6, 2013 - In a filing with the Securities and Exchange Commission Wednesday, Delcath said it is finishing plans to start a new clinical study of its Melphalan Hepatic Delivery System, also called “Chemosat” and “Melblez Kit.”

Delcath Systems Eliminates 33% of Workforce

10/4/2013 04:10 pm

(Morningstar/Benzinga) Oct 4, 2013 - Delcath Systems, Inc. announced today that as part of its efforts to increase operating efficiencies, the Company has completed a strategic reorganization under which it has eliminated 21 positions, or approximately 33% of its global workforce.

Delcath Systems Eliminates 33% of Workforce

10/4/2013 11:01 am

(Morningstar/Benzinga) Oct 4, 2013 - Delcath Systems, Inc. announced today that as part of its efforts to increase operating efficiencies, the Company has completed a strategic reorganization under which it has eliminated 21 positions, or approximately 33% of its global workforce.

Delcath Gets Special FDA Designation for Therapy

10/2/2013 04:27 pm

(BloombergBusinessweek/Associated Press) Oct 1, 2013 - Shares of Delcath Systems Inc. jumped in after hours trading Tuesday after the medical device and drugmaker said it received preferential regulatory status for its experimental treatment for liver cancer.

Delcath Gets Special FDA Designation for Therapy

10/2/2013 11:02 am

(BloombergBusinessweek/Associated Press) Oct 1, 2013 - Shares of Delcath Systems Inc. jumped in after hours trading Tuesday after the medical device and drugmaker said it received preferential regulatory status for its experimental treatment for liver cancer.

FDA Rejects Delcath's Cancer Therapy, Asks for More Trials

9/13/2013 11:35 am

(Reuters) Sep 13, 2013 - Delcath Systems Inc said the U.S. Food and Drug Administration rejected its cancer therapy, and asked for more trials, more than four months after a panel of U.S. advisers recommended against its approval.

FDA Rejects Delcath's Cancer Therapy, Asks for More Trials

9/13/2013 06:03 am

(Reuters) Sep 13, 2013 - Delcath Systems Inc said the U.S. Food and Drug Administration rejected its cancer therapy, and asked for more trials, more than four months after a panel of U.S. advisers recommended against its approval.