February 12, 2010
How to make $$ on the upcoming Binary Event for Delcath Systems.
On February 9, 2010 Decalth Systems announced that they have began data analysis of their phase III trial (PHP™). If the trial is successful and meets it’s endpoints they believe that they will be on their way to an FDA approval. The data should be analyzed sometime in March with an expected NDA filing for April, 2010.
The CEO of Delcath Systems, Eamonn Hobbs stated that he is very confident that Phase III will meet it’s endpoint. The main objective of Phase III is to improve progression free survival---(Just means you continue to exist without further spreading of cancers) of patients with matastatic melanoma ocular or cutanous to the liver--(this just means the cancer begins in the eye or on the skin and spreads to the liver) treated with the Delcath PHP System VS patients in the control arm. Cancer often begins in the eye (Ocular) or on the skin (Melanoma) and can quickly spread to vital organs, such as the liver and lungs.
The second objective is to demonstrate a statistically significant improvement in the hepatic progression free survival--acronym is (HPFS). This objective in short just says that the Decalth PHP™ System will significantly increase survival rates without further progression of cancer. Evaluation will be based on duration of response and of course the over all survival.
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What to expect with Delcath’s stock price:
I would surmise that the stock will gradually begin to make an upwards trend for the rest of February into March when Delcath is expected to release results of this binary event.
This is based off of how other Pharmaceutical stocks behave prior to a major binary event. I would expect Delcath, with it’s low float and fairly high institutional ownership to make a run to the $6.00 mark. If the results are meet their endpoints then DCTH should be off to the races.
This is one of the ways that I make quick money in the Biopharm’s. I do a lot of research of upcoming binary events and get in early before the crowds. A recent example is GNVC. They are also expected to come out with results of TNFerade, which I was observing GNVC for about a year now and I bought shares at $1.00 a share as I knew it would at least double, which it. The momentum of this stock was stalled by an IPO offering to raise some cash, but I expect the momentum to continue with GNVC after the dust has settled over that.
Just another example was with VVUS. I knew that they were going to have a binary news event on Qnexa and the news was positive. I bought the stock at $3.89 and sold over $8.00 a share; I am well aware that it went all the way to around $12.50, but the shares I have now are freebies.
This is just one way to make money on biopharm’s. I usually sell half of my shares directly prior to the news release as I usually hold “free shares” by then anyway, due to increase of stock price by 100%. This unquestionably lightens the “worry load” if the news is negative. I have already made my money and am riding the stock with free shares, so the rest is frosting on the cake.
I believe there is some good money to be made from DCTH for the next few weeks, but if you do invest this way---you will have to observe the stock daily to get a good idea to when the news release will occur.
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Phase III summary:
The 92 patient, randomized, multi-center, Phase III study commenced patient enrollment in February 2006. Patients were randomly assigned to receive treatments with ultra-high doses of the chemotherapeutic drug melphalan infused directly into the liver via the Delcath PHP System(TM) or to a control group, where they were provided with best alternative care (BAC). BAC included alternative regional or systemic therapies. Patients assigned to the Delcath arm were eligible to receive up to six cycles of treatment at approximately four to six week intervals. Patients randomized to the non-PHP arm were permitted to cross-over into the Delcath arm at documentation of hepatic disease progression.
The study's primary objective was to demonstrate a statistically significant improvement in the hepatic progression free survival (HPFS) of patients with metastatic melanoma (ocular or cutaneous) to the liver treated with the Delcath PHP System(TM) versus patients in the control arm. Secondary endpoints include response rate, duration of response and overall survival.
About Delcath Systems
Decalth Systems focuses on the development of the Delcath PHP System, (PHP™) a Phase III clinical trial product, which isolates the liver from the patient’s general circulatory system and delivers high dose of melphalan hydrochloride VS Doxorubicin or other therapeutic agents directly to the liver. In short; the Delcath PHP™ System just focuses on the Liver instead as the common chemo agents that run throughout the entire body. When chemotherapy is distributed throughout the entire body it kills and damages many healthy cells. So Delcath wants to isolate the chemo to one organ and at time…in this case, the liver.
Other Trials with Delcath Systems:
Decalth has a collaboration with the National Cancer Institute to develop and evaluate the Delcath System PHP™ 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.
This is a positive and a back up plan. The potential is here for DCTH.
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.
Note: Delcath’s main competitor right now is Celsion. Celsion is definitely on my watch list as they have a low float and someday the stock will explode. Do your DD and you to stay on the right side of a trade. Their main drug in phase III is Thermodox.
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****L@@k at this post from Bigfry_52 on Yahoo Finance. A Wall Street Journal Article summarizing Delcath. A terrific find! Click Here.
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