NEW YORK, Oct. 21 (PRNewswire-FirstCall) — Delcath Systems, Inc. (Nasdaq: DCTH - News), a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced today that its pivotal Phase III Metastatic Melanoma Trial has met its goal of 92 patients and is fully enrolled. This clinical study is evaluating the Delcath PHP System(TM) for the regional delivery of melphalan to the liver to treat patients with metastatic cutaneous and ocular melanoma who have unresectable tumors in the liver.
With the achievement of complete enrollment, the company remains on-track for a FDA submission of its Delcath PHP System(TM) with melphalan in 2010. Trial enrollment will continue for the near-term to include additional patients that have begun the evaluation process and may be eligible to participate.
"We always expected to see the greatest enrollment activity in the second half of the study period as positive word about the Delcath PHP System spread and attracted new patients to the study," said Eamonn Hobbs, President and CEO of Delcath Systems. "We are delighted to have completed enrollment on-plan, and to continue the extremely positive momentum created over the last six months. We have achieved several key, strategic milestones, including the successful review of our Phase III safety data, orphan drug designation for doxorubicin for the treatment of hepatocellular carcinoma, and the additions of David McDonald as Chief Financial Officer and Dr. Krishna Kandarpa as Chief Medical Officer and EVP of Research and Development. We also executed on our plans to build our own manufacturing facility, which we will continue to develop as we focus for the remainder of the year on preparation for our FDA submission, commercialization and international licensing."
OCt. 15 — There was an article that appeared today in one of the leading newspaper titles in China, "The Shanghai Daily." The article states that every year 600,000 people are diagnosed with liver cancer globally and 50% of them are in China. So based on this article, China has 300,000 liver cancer patients a year.
Comapre those 300,000 liver cancer patients in China to an article that also ran today on REUTERS that said: "The latest estimates from the American Cancer Society show that an estimated 22,620 people in the U.S. will be diagnosed with liver cancer in 2009."
That means that China has the potential to be a 10 times bigger market for DCTH than the United States! I think this is extremely important for anyone invested in DCTH. Investors should go back and listen at the MINUTE MARKER (13:55) from Eamon Hobbs recent presentation at the Rodman & Renshaw investment conference. If you take that opportunity you will hear DCTH's CEO say:
1) HOBBS QUOTE:
"We are targeting Asain partners in China, Korea, and Japan ... where the sick livers are."
2) HOBBS QUOTE:
"We expect to partner with Major Pharma Companies in China first ... which will open up a very significant market ... and then we will penetrate the Korean market .... and then ultimately Japan."
I didn't quite understand why DCTH was going outside the US market's first, but after reading the "Shanghai Daily" article it is now as clear as a bright blue sky to me. If DCTH were to obtain just 10% of the China market (300,000 liver cancer patients annually), that 10% market share would still be almost 40% bigger than the entire USA liver cancer market annually. And DCTH management has stated that they believe that the US market alone for liver cancer is a $4 billion opportunity annually. If the US is a $4 BILLION opportunity annually, then is 10% of the China liver cancer mMarket a $5.6 billion opportunity annually?
Even if you cut that $5.6 Billion in half, China is a monster opportunity for DCTH. Commercializing DCTH's products in China first ... that is definately a smart move for DCTH!
Delcath Systems, Inc., a development stage company, develops and manufactures devices to administer high dose chemotherapy and other therapeutic agents directly to diseased organs or regions of the body. It focuses on the development of the Delcath PHP System, a Phase III clinical trial product, which isolates the liver from the patient's general circulatory system and delivers high dose of melphalan hydrochloride or other therapeutic agents directly to the liver. The Delcath PHP System kit includes an arterial infusion catheter, a multi-passageway/double balloon catheter, a blood tubing/extracorporeal filtration circuit, two activated carbon hemoperfusion filters, a return catheter/a thin-walled blood sheath, and a series of introducers and related accessories to properly place the catheters. The company also conducts Phase II clinical trials to test the Delcath PHP System with the drug melphalan against liver cancer/hepatocellular tumors, neuroendocrine and adenocarcinoma tumors that have spread to the liver, and melanomas metastatic to the liver that have received prior regional treatment. It has a collaboration with the National Cancer Institute to develop and evaluate the Delcath PHP System device to deliver high-dose melphalan to patients, and to evaluate the use of additional chemotherapy agents with the Delcath PHP System. Delcath Systems, Inc. was founded in 1988 and is based in New York, New York.
Delcath Systems Inc. (DCTH)
NEW YORK, Oct. 21 (PRNewswire-FirstCall) — Delcath Systems, Inc. (Nasdaq: DCTH - News), a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced today that its pivotal Phase III Metastatic Melanoma Trial has met its goal of 92 patients and is fully enrolled. This clinical study is evaluating the Delcath PHP System(TM) for the regional delivery of melphalan to the liver to treat patients with metastatic cutaneous and ocular melanoma who have unresectable tumors in the liver.
With the achievement of complete enrollment, the company remains on-track for a FDA submission of its Delcath PHP System(TM) with melphalan in 2010. Trial enrollment will continue for the near-term to include additional patients that have begun the evaluation process and may be eligible to participate.
"We always expected to see the greatest enrollment activity in the second half of the study period as positive word about the Delcath PHP System spread and attracted new patients to the study," said Eamonn Hobbs, President and CEO of Delcath Systems. "We are delighted to have completed enrollment on-plan, and to continue the extremely positive momentum created over the last six months. We have achieved several key, strategic milestones, including the successful review of our Phase III safety data, orphan drug designation for doxorubicin for the treatment of hepatocellular carcinoma, and the additions of David McDonald as Chief Financial Officer and Dr. Krishna Kandarpa as Chief Medical Officer and EVP of Research and Development. We also executed on our plans to build our own manufacturing facility, which we will continue to develop as we focus for the remainder of the year on preparation for our FDA submission, commercialization and international licensing."
OCt. 15 — There was an article that appeared today in one of the leading newspaper titles in China, "The Shanghai Daily." The article states that every year 600,000 people are diagnosed with liver cancer globally and 50% of them are in China. So based on this article, China has 300,000 liver cancer patients a year.
Comapre those 300,000 liver cancer patients in China to an article that also ran today on REUTERS that said: "The latest estimates from the American Cancer Society show that an estimated 22,620 people in the U.S. will be diagnosed with liver cancer in 2009."
That means that China has the potential to be a 10 times bigger market for DCTH than the United States! I think this is extremely important for anyone invested in DCTH. Investors should go back and listen at the MINUTE MARKER (13:55) from Eamon Hobbs recent presentation at the Rodman & Renshaw investment conference. If you take that opportunity you will hear DCTH's CEO say:
1) HOBBS QUOTE:
"We are targeting Asain partners in China, Korea, and Japan ... where the sick livers are."
2) HOBBS QUOTE:
"We expect to partner with Major Pharma Companies in China first ... which will open up a very significant market ... and then we will penetrate the Korean market .... and then ultimately Japan."
I didn't quite understand why DCTH was going outside the US market's first, but after reading the "Shanghai Daily" article it is now as clear as a bright blue sky to me. If DCTH were to obtain just 10% of the China market (300,000 liver cancer patients annually), that 10% market share would still be almost 40% bigger than the entire USA liver cancer market annually. And DCTH management has stated that they believe that the US market alone for liver cancer is a $4 billion opportunity annually. If the US is a $4 BILLION opportunity annually, then is 10% of the China liver cancer mMarket a $5.6 billion opportunity annually?
Even if you cut that $5.6 Billion in half, China is a monster opportunity for DCTH. Commercializing DCTH's products in China first ... that is definately a smart move for DCTH!
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Delcath Systems, Inc., a development stage company, develops and manufactures devices to administer high dose chemotherapy and other therapeutic agents directly to diseased organs or regions of the body. It focuses on the development of the Delcath PHP System, a Phase III clinical trial product, which isolates the liver from the patient's general circulatory system and delivers high dose of melphalan hydrochloride or other therapeutic agents directly to the liver. The Delcath PHP System kit includes an arterial infusion catheter, a multi-passageway/double balloon catheter, a blood tubing/extracorporeal filtration circuit, two activated carbon hemoperfusion filters, a return catheter/a thin-walled blood sheath, and a series of introducers and related accessories to properly place the catheters. The company also conducts Phase II clinical trials to test the Delcath PHP System with the drug melphalan against liver cancer/hepatocellular tumors, neuroendocrine and adenocarcinoma tumors that have spread to the liver, and melanomas metastatic to the liver that have received prior regional treatment. It has a collaboration with the National Cancer Institute to develop and evaluate the Delcath PHP System device to deliver high-dose melphalan to patients, and to evaluate the use of additional chemotherapy agents with the Delcath PHP System. Delcath Systems, Inc. was founded in 1988 and is based in New York, New York.
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