The company has innovative drug delivery system to treat incurable metastatic liver cancer. "The pivotal trial results showed that melanoma patients whose cancer had spread to their liver survived for an average of 398 days before dying or having their cancer get worse after treatment with the company's PHP ("Percutaneous Hepatic Perfusion") system. Patients treated with standard drugs survived for an average of 124 days before they died or their tumor growth restarted." 13 months vs. 4 months! Compare with Dendreon Provenge: the patients treated with Provenge lived an average of 4.1 months longer than patients treated with the control.
Delcath Systems Inc (DCTH) expects to finish an application for U.S. review of its cancer drug delivery system in the fourth quarter, which would put it on track for approval by mid-2011, according to the company's chief financial officer.
Strongly recommended for investment in Q II-III 2011. Low risk, high reward
November 7, 2010 by BiotechInvest
DCTH was in my hot watch list since 05/03/10 when I sold it after phase III trial results. I was going to invest in this company again starting from Q II 2011. However, recent company news inspired me to buy it now.
"We initiated our rolling NDA submission to the FDA at the end of April 2010 and expect to complete the NDA application during the fourth quarter of 2010."
"we recently concluded a separate multi-arm Phase II clinical trial of the Delcath system for chemosaturation therapy with melphalan in patients with primary and metastatic liver cancer, stratified into four arms: neuroendocrine tumors (carcinoid and islet cell tumors), hepatocellular carcinoma (primary liver cancer), ocular or cutaneous melanoma (eye or skin cancer who have been previously treated with regional therapy using melphalan), and metastatic adenocarcinoma (glandular cancer). We intend to include the results of our Phase II clinical trial in our NDA submission to the FDA, which we expect to file during the fourth quarter of 2010."
What is this Phase II clinical trial about?
"Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancer"
PURPOSE: This phase II trial is studying how well giving an hepatic arterial infusion of melphalan together with hepatic perfusion works in treating patients with unresectable liver cancer.
DCTH phase III trial was "Hepatic Arterial Infusion With Melphalan Compared With Standard Therapy in Treating Patients With Unresectable Liver Metastases Due to Melanoma"
So, now DCTH are testing the Peripheral Hepatic Perfusion (PHP) on just any liver cancer. If successful this phase II trial will significantly strengthen DCTH NDA submission. The company said that they expect to file NDA during Q IV of 2010 i.e. any time from today. I think that positive phase II trial results together with NDA submission will be very positive events for DCTH price.
December 21, 2010 by BiotechInvest
"Delcath Systems(DCTH_) is supposed to complete the U.S. approval application for its liver tumor Chemosaturation System before the end of the month" i.e. during this week.
I hope it will not induce DCTH sell off on news...
Disclosure: I bought 3k of DCTH today, will keep it before news, may be for long.