New European Study Shows TheraSphere(R) Prolongs Liver Cancer Survival Rates
Patient Case Studies and Technical Considerations to be Presented by a Leading Interventional Radiologist and Nuclear Medicine Physician at the EANM 2010
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OTTAWA, Canada, Oct 07, 2010 (BUSINESS WIRE) -- MDS Nordion, a leading provider of products and services to the global health science market, today announced that the first large European study using Yttrium-90 (Y-90) glass microspheres has been published on the use of TheraSphere(R), an innovative radioembolisation therapy for the localised treatment of patients with advanced hepatocellular carcinoma (HCC) or primary liver cancer. The publication, which currently can be viewed online and is expected to appear in the November 2010 edition of Hepatology, concludes that radioembolisation with TheraSphere(R) is both safe and effective, and states that the overall survival rate is similar to that found in another recently published large study analysing Y-90 glass microspheres for the treatment of HCC.(1)
In line with this announcement, MDS Nordion will attend the European Association of Nuclear Medicine 2010 conference in Vienna, 9 to 13 October, booth X14-15, where a leading interventional radiologist and nuclear medicine physician (a co-author of the study) will discuss their experiences with the therapy and the options it offers liver cancer patients.
Conducted at MDS Nordion's European Centre of Excellence in Essen, Germany, the study involved 108 patients, none of whom were eligible for conventional locoregional therapies. Patients achieved a median overall survival of 16.4 months with minimal damage to the surrounding healthy tissue, even in patients with advanced liver cirrhosis or portal vein thrombosis. No lung or visceral toxicity was observed. The most frequently observed adverse event was a transient fatigue-syndrome.
Philip Hilgard, MD, hepatologist and lead author of the paper says, "The outcomes of this study were not unexpected, but it was extremely important for us to be able to substantiate and verify the treatment here in Europe. We feel confident that the publication of our study will help towards giving more patients access to this advanced therapy." The full study, entitled "Radioembolisation with Yttrium-90 Glass Microspheres in Hepatocellular Carcinoma: European Experience on Safety and long term Survival" is available online here.
Peter Covitz, Ph.D., Senior Vice President, Innovation, MDS Nordion, comments, "The patient outcomes reported in this study substantiate our belief that TheraSphere offers an important therapy option for advanced liver cancer patients. We look forward to working with more patients and oncologists to further advance the quality of liver cancer treatment in Europe."
Nadine Piorkowsky, President of the European Liver Patients Association (ELPA) adds, "Radioactive microspheres that can be targeted directly to the tumour via the arteries are a major scientific breakthrough for interventional oncology. We encourage further studies that will improve patient outcomes."
At MDS Nordion's booth at this year's EANM conference, there will be unique and educational presentations that will provide an overview of radioembolisation using Y-90 for liver cancer patients, including:
Dr Riad Salem, Professor of Radiology, Medicine and Surgery and Director of Interventional Oncology in the Department of Radiology at Northwestern University, has been leading a number of TheraSphere studies in the U.S. He will present on specific case studies and experiences.
Spokespeople available for interviews relating to the study:
Dr. Philip Hilgard, Associate Professor of Medicine and Head of Department for Internal Medicine and Gastroenterology at the Academic Teaching Hospital Evangelisches Krankenhaus in Mulheim/Ruhr, Germany. Prof. Dr. med. Gerald Antoch, Director of the Institute of Radiology at the University Hospital Dusseldorf.
In-person interviews will be available with the following at EANM:
Dr Riad Salem Tom Burnett, Vice President Global Sales, MDS Nordion
EANM booth location: Booth X14-15
About Primary Liver Cancer About 50,000 cases of liver cancer are diagnosed each year in the European Union, with 31,000 of those cases in Germany, Italy, Austria, UK and France, according to the European Cancer Observatory (2008). Approximately, 600,000 cases are diagnosed each year globally. The most common form of primary liver cancer is hepatocellular carcinoma. Hepatocellular carcinoma is the fifth most common form of cancer in the world and is increasing globally due to an increase in the incidence of hepatitis.
About TheraSphere TheraSphere is a liver cancer therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive yttrium-90. The product is injected by physicians into the main artery of the patient's liver through a catheter, which allows the treatment to be delivered directly to the tumour via blood vessels.
TheraSphere treatment can generally be administered on an outpatient basis and does not usually require an overnight hospital stay. MDS Nordion is approved (CE Mark) in Europe to distribute TheraSphere for treatment of hepatic neoplasia. MDS Nordion established a European TheraSphere Centre of Excellence in Essen, Germany to train and educate oncology professionals on the use of this innovative cancer treatment. In addition, there are multiple treatment centres across Europe, including the BCLC Group Hospital Clinic in Barcelona, Spain; Centre Eugene Marquis in Rennes, France; and Istituto Tumori in Milan, Italy.
TheraSphere treatment has some common side effects, including mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the common flu. Some patients will experience some loss of appetite and temporary changes in several blood tests. For details on the rarer side effects, please refer to the Instructions for Use on our website at www.mdsnordion.com/TheraSphere.
About MDS Inc. MDS Inc. /quotes/comstock/11t!e:mds (CA:MDS 10.24, +0.08, +0.79%) /quotes/comstock/13*!mdz/quotes/nls/mdz (MDZ 10.14, +0.14, +1.40%) is a global health science company that provides market-leading products and services used for the prevention, diagnosis and treatment of disease. We are a leading provider of innovative technologies for use in medical imaging and radiotherapeutics, and sterilization technologies benefiting the lives of millions of people in more than 65 countries around the world. Our products and services are used daily by pharmaceutical and biotechnology companies, medical-device manufacturers, hospitals, clinics and research laboratories. MDS has more than 600 highly skilled employees in four locations. Find out more at http://www.mdsnordion.com/.
(1) Gastroenterology 2010; 138: 52-64.
SOURCE: MDS
Celsion Receives Positive FDA Guidance For Its New Drug Application For ThermoDox® To Treat Primary Liver Cancer
COLUMBIA, Md., Oct. 4 /PRNewswire/ — Celsion Corporation , a leading oncology drug development company, announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) that the requirements for non-clinical studies have been met for the New Drug Application (NDA) of ThermoDox.
The FDA has provided written guidance that the Company is not required to conduct any additional non-clinical pharmacology, safety pharmacology and general toxicology studies assuming the results of current studies are adequate. The results of these current studies will be reviewed at the time of NDA submission. This agreement takes advantage of an NDA application known as a 505(b)2 which allows a company to reference existing data regarding doxorubicin and other liposomal drugs currently approved by the FDA.
As previously announced, the FDA has granted Fast Track Development for the Company’s 600 patient pivotal Phase III clinical trial (the HEAT study) of its investigational drug, ThermoDox®, in combination with radiofrequency ablation (RFA), The Fast Track Development Program provides for expedited regulatory review including frequent interactions between the FDA. Celsion is eligible to submit its NDA on a rolling basis and review sections of the NDA with the FDA in advance of submitting the complete submission. The HEAT study is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
“We are very pleased with the FDA’s continued willingness to work closely with the Company to identify the most expeditious regulatory pathway forward for ThermoDox® in HCC, a life threatening disorder,” stated Mr. Michael H. Tardugno, Celsion’s President and Chief Executive Officer. ”Our past consultation with the FDA regarding Chemistry Manufacturing and Controls (CMC) has permitted Celsion to implement and validate process improvements to its manufacturing methods used to produce ThermoDox at commercial scale.”
About ThermoDox® and the Phase III HEAT Study
ThermoDox® is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers. In the HEAT study, ThermoDox is administered intravenously in combination with RFA. A thermal zone created by the RFA releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially at the targeted tumor.
For primary liver cancer, ThermoDox® is being evaluated in a 600 patient global Phase III study at 75 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox in combination with RFA when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival (PFS) with a secondary confirmatory endpoint of overall survival. A pre-planned, interim efficacy analysis will be performed by an independent Data Monitoring Committee when enrollment in the trial is complete and 50 percent of the PFS events are realized in the study population. Additional information on the Company’s ThermoDox® clinical studies may be found at http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.clinicaltrials.gov&esheet=5908100&lan=en_US&anchor=http%3A%2F%2Fwww.clinicaltrials.gov&index=3
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About Primary Liver Cancer
Primary liver cancer is one of the most deadly forms of cancer and ranks as the fifth most common solid tumor cancer. The incidence of primary liver cancer is approximately 20,000 cases per year in the United States and has a worldwide incidence of approximately 650,000 cases, due to the high prevalence of Hepatitis B and C in developing countries. The standard first line treatment for liver cancer is surgical resection of the tumor; however 80% to 90% of patients are ineligible for surgery. Radio frequency ablation (RFA) has increasingly become the standard of care for non-resectable liver tumors, but the treatment becomes less effective for larger tumors. There are few non-surgical therapeutic treatment options available as radiation therapy and chemotherapy are largely ineffective in the treatment of primary liver cancer.
About Celsion
Celsion is a leading oncology company dedicated to the development and commercialization of innovative cancer drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. Celsion has research, license, or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, and the North Shore Long Island Jewish Health System. For more information on Celsion, visit our website: http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.celsion.com&esheet=5908100&lan=en_US&anchor=http%3A%2F%2Fwww.celsion.com&index=4.
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Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company’s periodic reports filed with the Securities and Exchange Commission.
Liver Cancer in HCVHepatitis C Virus and Hepatocellular Carcinoma
Industry news Financial Times Sep 2, 2010 Can-Fite BioPharma Ltd. (TASE:CFBI) has completed the recruitment of patients for the Phase I/II clinical trial of its CF102 drug for the treatment of liver cancer, after the safety committee reviewed the interim results and gave the go-ahead to continue the trial. The second stage of the trial will test the safety and efficiency of CF102 in higher dosages than in the first stage.
Company news NewsRX Aug 4, 2010
Can-Fite drug CF102 significantly decreased viral load of HCV in 3 Patients with Liver Cancer. July 25, 2010
CF102
CAN-FITE
A drug discovery boutique
By Karin Kloosterman June 08, 2010
It may take four more years before one of its drug targets come to market, but Israeli biotech drug developer Can-Fite BioPharma is making steady clinical progress on a number of lead compounds that could revolutionize the treatment of a wide range of diseases from arthritis to liver cancer.
The company's drug discovery program is based on research by Can-Fite's CEO, Prof. Pnina Fishman, who discovered that the Gi protein associated A3 adenosine receptor (A3AR) is present in inflammatory and cancer cells, but not in healthy ones. Based on this finding, she built a drug discovery platform on two molecules - the CF101 and the CF102.
CF101has shown to be effective against inflammatory diseases such as psoriasis, dry eye syndrome, glaucoma, and rheumatoid arthritis, and is now in Phase II clinical trials - Phase III being the final test stage before the drugs can be approved by the US Food and Drug Administration. Japanese company, Seikagaku, has licensed the CF101 drug discovery platform to treat arthritis for $20 million plus royalties.
Both compounds are in middle to advanced stages of clinical development for a number of indications. Tests for rheumatoid arthritis and glaucoma are about to start Phase IIb studies in Israel, Fishman remarks. Commenting on the news last year that CF101 failed clinical studies in arthritis, she points out that there were three studies. "One of them in arthritis failed when carried out in combination with the drug methotrexate. It was because of the combination," she tells ISRAEL21c.
Ready for market in four years
Meanwhile Can-Fite's second compound, CF102, is now being tested in two Phase I/II studies, one against hepatocellular carcinoma, or liver cancer, and in patients with liver damage caused by the hepatitis C virus.
Natural History Of HCV
Like pancreatic cancer, the disease which Patrick Swayze succumbed to last year, a diagnosis of liver cancer can be as good as a death sentence, Fishman agrees. The current therapy option, Nexavar, is only marginally effective at slightly extending the life of someone diagnosed with the disease. "This is the only drug, and it prolongs the life of patients for seven to 12 weeks," Fishman asserts. Asked whether Can-Fite's CF102 will improve the prognosis, she responds: "I don't like to say better or less, because it's not fair to the company and the patients, but our investigators are happy."Both Can-Fite's CF101 and CF102 are non-toxic in humans and can be taken orally as a pill and both appear to have excellent clinical prospects. Based on clinical results and progress, Fishman estimates that two drugs indications of CF101, for treatment of psoriasis and dry eye, could be ready to market as soon as four years from now.
"Our molecules are related. It's the same family of compounds that bind to and activate a specific target, present only on the cell surface of pathological cells - on inflammatory cells and cancer and not present on normal body cells. We have a good safety profile because our drug will bind only to diseased cells," she explains.
New indications for eye disorders are in sight Based in Kiryat Matalon near Petah Tikva in central Israel, Can-Fite has recently announced that it has filed a patent with the United States National Institutes of Health (the NIH) to treat yet another sight disorder called uveitis, which is a sight-threatening disease. The researchers are aiming for this new indication of CF101 to join their two other ophthalmic applications - for treating glaucoma and dry eye syndrome.
There is no specific treatment for uveitis, currently treated with steroids and systemic immunosuppressive therapy. Afflicting the inner layer of the middle eye, this inflammatory disorder is the root cause of 10 percent of all blindness cases in the US.
Working under a Material-Transfer Cooperative Research and Development Agreement (M-CRADA) with the NIH, Can-Fite has completed animal studies which demonstrate the efficacy of its lead molecule, CF101, for treating autoimmune uveitis.Can-Fite was founded in 2000 by Fishman, who was then a researcher at the Rabin Medical Center, and patent attorney Dr. Ilan Cohn. The company, which is traded on the Tel Aviv Stock Exchange where it hopes to raise more funds, employs 14 people, 12 in Israel and two in the US through a Boston office. Money raised from venture capital equals about $20 million, not including $30m. raised in public funds.
"We don't see Can-Fite as a company that markets our compounds," says Fishman. "We hope to form strategic alliances, with the CF101 and CF102 compounds, and have big companies out-license them, so that we can work together on Phase III trials - as a discovery boutique," she says, mentioning the support of her partners, Dr. Ken A. Jacobson from the NIH, and Leyden University in the Netherlands, as key to the company's success.
Source
The common liver cancer symptoms are:
1. Abdominal pain: Intense abdominal pain in the upper right or the centre of the abdomen is the most common liver cancer symptom. There could be a pain and discomfort in the right shoulder too, which is called as referred pain. This pain is due to the enlarged liver which stimulates the nerves beneath the diaphragm and goes up to the shoulder.
2. Weight Loss: unexplained and continuous weight loss and loss in appetite is another liver cancer symptom. There is a feeling of fullness even after a person eats a small meal.
3. Fever: unusual fever is again a warning sign of the liver cancer symptom.
4. There is a sudden appearance of ascites (abdominal fluid and swelling) in the patients suffering from liver cancer in the peritoneal cavity. This is a fluid which collects around the liver and intestines. This is due to the damage of the liver which produces less blood protein and the space between the two layers of the tissue in the abdomen. This upsets the fluid balance in the body.
5. Jaundice (skin turns yellow and eyes become white), skin becomes itchy. This is caused when the bile duct is blocked and builds up in the bloodstream.
6. Vomiting occasionally and nausea, shortness of breath and cough. This is due to the enlargement of the liver and the pressure on the stomach which might cause a person to feel sick due to the toxins that build up in the body because of the damage of the liver.
7. Liver becomes enlarged i.e; a lump is formed on the right hand side below the rib cage.
8. Weakness and feeling fatigued or feeling tired very easily. 9. Pale stools and urine is dark colored.10. Recurrence of fever which is high followed by sweating.
More advanced liver cancer symptoms are seen when the cancer has spread to the other organs of the body.
1. In the advanced stages the liver cancer might spread to the other tissues in the body, or also it may pass through the blood vessels to the other parts of the body. This invades the veins that drain the liver and may cause blockage in the veins, resulting in the congestion of the liver. This is especially caused when the liver has cancer cells.
2. If the tumor gets ruptured, there may be an internal bleeding.
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3. Tumors which arise in the liver itself are called as hepatomas. Liver becomes tender and the doctor might feel that tenderness while examining.
4. Another liver cancer symptom is feet and legs swell. Breasts in men might also swell.
5. Cancer cells if block the lymphatic system then, the excessive fluid is not drained off through urine and the fluid may accumulate.
6. Increase in sleepiness.
7. Feeling anemic (decrease in the number of red blood cells) is another possible symptom of liver cancer.
8. Clotting of blood and bruises on the skin.
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