Showing posts with label TheraSphere®. Show all posts
Showing posts with label TheraSphere®. Show all posts

July 31, 2013

TheraSphere® Recommended by the National Institute for Health and Care Excellence (NICE) for the Treatment of Primary and Secondary Liver Cancer

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LONDON, July 30, 2013 /PRNewswire/ --

BTG plc (LSE: BTG), the specialist healthcare company, today announces that the National Institute for Health and Care Excellence (NICE) has issued guidance recommending the use of Selective Internal Radiation Therapy (SIRT)(1), which includes TheraSphere®, for patients with liver cancer across the NHS. The guidance supports the use of this innovative treatment for patients with primary hepatocellular carcinoma as well as for those with intrahepatic cholangiocarcinoma(2) and follows the previous recommendation for its use in patients with colorectal cancer liver metastases(3).

The NHS in England is currently preparing guidelines on how SIRT should be used as a treatment option for patients with liver cancer, including those with colorectal cancer liver metastases and cholangiocarcinoma, after recently issuing an interim policy on how this therapy should be funded(4). It is anticipated that this latest NICE guidance will result in a similar evaluation for patients with primary liver cancer. "NICE's guidance further highlights the growing acceptance and understanding of radioembolization in the treatment of liver cancer," said Peter Pattison, General Manager TheraSphere®. "With over 4,000 new liver cancer cases diagnosed annually in the UK(5), this new guidance will potentially provide patients with access to a broader range of treatment options."

Pattison added: "With many countries looking to the UK for direction on their own reimbursement decisions and processes, this guidance should lead to greater awareness amongst physicians and patients and may also prompt similar guidance in other geographies. In addition to increasing liver cancer treatment options for physicians and patients in the UK, this guidance will assist BTG as we continue to explore other reimbursement opportunities in various regions across the world."

About TheraSphere®

TheraSphere is a form of radioembolization therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive yttrium-90 (Y-90). The product is injected by physicians into the artery of the patient's liver through a catheter, which allows for a high dose of radiation to be delivered directly to the tumour via blood flow thereby limiting the damage to surrounding healthy tissue and side effects to the patients.

TheraSphere is used in the European Union and in Canada for the treatment of hepatic neoplasia in patients who have appropriately positioned arterial catheters. Since its introduction in Europe, more than 1,000 patients have been treated with TheraSphere.

Common side effects include mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the flu. Some patients experience some loss of appetite and temporary changes in several blood tests. For details on rare or more severe side effects, please refer to the TheraSphere package insert/instructions for use at http://www.nordion.com/therasphere.

  1. National Institute of Care Excellence. IPG460 Selective internal radiation therapy for primary hepatocellular carcinoma: guidance. London. 24 July 2013.
  2. National Institute of Care Excellence. IPG459. Selective internal radiation therapy for primary cholangiocarcinoma. London.  24 July 2013.
  3. National Institute of Care Excellence. IPG401. Selective internal radiation therapy for non-resectable colorectal metastases of the liver: guidance. London. July 2012 (updates May 2013).
  4. NHS England. Interim Clinical Commissioning Policy Statement: Selective Internal Radiotherapy (SIRT). June 2013.
  5. http://www.cancerresearchuk.org/cancer-info/cancerstats/types/liver/

About BTG

BTG is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and varicose veins. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programmes and products to develop and market to specialist physicians. For further information about BTG please visit our website at http://www.btgplc.com.

For further information please contact:

BTG
Andy Burrows, Director of Investor Relations
+44(0)20-7575-1741; Mobile: +44(0)7990-530605

FTI Consulting
Ben Atwell/Simon Conway
+44(0)20-7831-3113

SOURCE BTG plc

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April 24, 2012

Nordion Announces Europe-Focused Phase III Clinical Trial for TheraSphere® Liver Cancer Treatment

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PRESS RELEASE

April 24, 2012, 1:00 a.m. EDT

OTTAWA, April 24, 2012 /PRNewswire via COMTEX/ -- Study to evaluate and compare safety and efficacy of TheraSphere® vs. sorafenib in hepatocellular carcinoma patients with portal vein thrombosis

Nordion Inc.,a leading provider of products and services for the prevention, diagnosis and treatment of disease, today announced an additional randomized, multi-centre Phase III clinical trial for TheraSphere®, Nordion's yttrium-90 (Y-90) glass microsphere treatment for liver cancer.

The YES-P trial will be focused primarily in Europe, with additional locations to be identified globally, and is targeting enrolment of about 350 patients at approximately 24 sites. The trial will further evaluate the safety and efficacy of TheraSphere® in the treatment of patients with portal vein thrombosis (PVT) associated with unresectable hepatocellular carcinoma (HCC), the most common form of primary liver cancer.

PVT, a complication in which a clot forms in one of the blood vessels feeding the liver, occurs in approximately 30 to 40% of HCC cases. The presence of PVT is a contraindication for most embolic therapies, but TheraSphere® represents a safe alternative.

"Nordion is excited to directly address the important question of whether TheraSphere® can extend the lives of this sub-group of HCC patients, where typical life expectancy remains unacceptably low," said Mason Ross, MD, Nordion's Vice President of Medical Affairs. "YES-P is our first major clinical trial that will be primarily conducted in Europe, thus supporting our commitment to increase our global clinical research footprint while building on the knowledge of how TheraSphere® may improve survival compared to sorafenib."

The trial will follow a two-armed design. In one arm, patients will undergo Y-90 radioembolization treatment with TheraSphere®, while patients in the other arm will receive sorafenib.

In the last 13 months, Nordion has also announced two additional Phase III clinical trials for TheraSphere®: STOP-HCC, involving patients with HCC, and EPOCH, involving patients with colorectal cancer whose disease has metastasized to the liver.

About TheraSphere®

TheraSphere® is a liver cancer therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive Y-90. The product is injected by physicians into the artery of the patient's liver through a catheter, which allows the treatment to be delivered directly to the tumour via blood flow.

TheraSphere® is used in the European Union and in Canada for the treatment of hepatic neoplasia in patients who have appropriately positioned arterial catheters.

In the US, TheraSphere® is used to treat patients with HCC who can have placement of appropriately positioned hepatic arterial catheters, and can be used as a bridge to surgery or transplantation in these patients. It is also indicated for the treatment of HCC patients with partial or branch portal vein thrombosis or occlusion when clinical evaluation warrants the treatment. TheraSphere® is approved by the U.S. Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE). HDE approvals are based on demonstrated safety and probable clinical benefit. However, effectiveness of the indication for use has not been established.

Common side effects include mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the flu. Some patients experience some loss of appetite and temporary changes in several blood tests. For details on rare or more severe side effects, please refer to the TheraSphere® package insert/instructions for use at www.nordion.com/therasphere .

About Nordion Inc.

Nordion Inc.is a global health science company that provides market-leading products used for the prevention, diagnosis and treatment of disease. We are a leading provider of medical isotopes, targeted therapies and sterilization technologies that benefit the lives of millions of people in more than 60 countries around the world. Our products are used daily by pharmaceutical and biotechnology companies, medical-device manufacturers, hospitals, clinics and research laboratories. Nordion has more than 500 highly skilled employees in three locations. Find out more at www.nordion.com and follow us at http://twitter.com/NordionInc .

SOURCE Nordion Inc.

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March 23, 2012

March 23, 2012, 8:00 a.m. EDT Nordion to Launch Improved Physician Tools for TheraSphere® Liver Cancer Treatment at SIR Annual Scientific Meeting 2012

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PRESS RELEASE

March 23, 2012, 8:00 a.m. EDT

OTTAWA, March 23, 2012 /PRNewswire via COMTEX/ -- Company will also present expert speakers and introduce new iPad app

Nordion Inc. ,a leading provider of products and services for the prevention, diagnosis and treatment of disease, will be attending the Society for Interventional Radiologists (SIR) Annual Scientific Meeting 2012, taking place March 24-29 in San Francisco. The company will introduce several new or updated physician education tools and resources for TheraSphere®, Nordion's Y-90 microsphere treatment for liver cancer.

"With more than 5,000 physicians, scientists and healthcare professionals in attendance, SIR represents one of the most important annual medical meetings Nordion attends," says Peter Covitz, Nordion Senior Vice President, Innovation. "SIR provides an opportunity to connect directly with our key users, share the latest information about TheraSphere, listen to feedback, and respond to questions firsthand."

Nordion representatives will be at Booth #1234 to talk about TheraSphere. The company will host two "Eat and Be Educated" learning sessions at the booth:

Sunday, March 25, 12:15pm How TheraSphere Y-90 Glass Microspheres Fits in Our Treatment Algorithm Matthew Johnson, MD Professor of Radiology and Surgery Indiana University School of Medicine Indianapolis, IN

Tuesday March 27, 12:15pm TheraSphere Multi-Vessel Delivery Siddharth Padia, MD Assistant Professor, Interventional Radiologist University of Washington - Harbourview Medical Center Seattle, WA

Each session will be followed by a Nordion presentation on how to start a TheraSphere program.

Other Nordion TheraSphere activities at SIR include:

Launch of the:

New custom dose feature in Europe and Canada*

Updated Treatment Window Illustrator tool to assist physicians with dose selection

New animated video demonstrating how TheraSphere works

Preview of the upcoming TheraSphere iPad app

Participation in SIR's Residents in Training program

* Nordion has filed a request with the Food and Drug Administration for approval of the custom dose feature in the United States.

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 (Y-90). The product is injected by physicians into the artery of the patient's liver through a catheter, which allows the treatment to be delivered directly to the tumour via blood flow.

In the US, TheraSphere is used to treat patients with unresectable hepatocellular carcinoma (HCC), the most common form of primary liver cancer, and can be used as a bridge to surgery or transplantation in these patients. It is also indicated for the treatment of HCC patients with portal vein thrombosis (PVT). TheraSphere is approved by the U.S. Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE). HDE approvals are based on demonstrated safety and probable clinical benefit. However, effectiveness of the indication for use has not been established.

TheraSphere® is used in the European Union and in Canada for the treatment of hepatic neoplasia in patients who have appropriately positioned arterial catheters.

Common side effects include mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the flu. Some patients experience some loss of appetite and temporary changes in several blood tests. For details on rare or more severe side effects, please refer to the TheraSphere package insert/instructions for use at www.nordion.com/therasphere .

About Nordion Inc. Nordion Inc. is a global health science company that provides market-leading products used for the prevention, diagnosis and treatment of disease. We are a leading provider of medical isotopes, targeted therapies and sterilization technologies that benefit the lives of millions of people in more than 60 countries around the world. Our products are used daily by pharmaceutical and biotechnology companies, medical-device manufacturers, hospitals, clinics and research laboratories. Nordion has more than 500 highly skilled employees in three locations. Find out more at www.nordion.com  and follow us at http://twitter.com/NordionInc  .

SOURCE Nordion Inc.

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February 22, 2012

Top Liver Cancer Specialists Gather in Denver, Colorado for TheraSphere® Summit

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PRESS RELEASE

Feb. 22, 2012, 8:00 a.m. EST

OTTAWA, Feb. 22, 2012 /PRNewswire via COMTEX/ -- Nordion providing training, discussion forum for advanced users of radioactive glass microsphere treatment

Nordion Inc. a leading provider of products and services for the prevention, diagnosis and treatment of disease, is pleased to present the fourth TheraSphere Summit for Advanced Users, taking place February 24 in Denver, Colorado.

Nordion has invited over 100 interdisciplinary liver cancer specialists from hospitals and universities across the U.S. and Canada to attend the Summit. Moderated by Dr. Riad Salem, a world-renowned expert in interventional radiology and liver cancer treatment, the full-day program is a master class for experienced users of the innovative TheraSphere device, a radioactive glass microsphere treatment for hepatocellular carcinoma (HCC), a form of primary liver cancer.

"The TheraSphere Summit is for physicians who are already familiar with the device but want to improve their knowledge and hone their skills to better serve their patients," said Dr. Salem, Professor of Radiology, Medicine and Surgery and Director, Interventional Oncology at Northwestern University in Chicago. "It's an opportunity for them to gain insight from highly respected specialists representing a wide range of disciplines and experience."

Attendees will hear presentations about the latest techniques, research findings and case studies. The user community will also have a chance to share their feedback on every aspect of TheraSphere, from training programs to clinical support services, with senior members of the Nordion team.

"Hosting these sessions for our advanced users demonstrates Nordion's commitment to driving excellence within the TheraSphere brand," said Kevin Brooks, Nordion's Senior Vice President of Sales and Marketing. "These physicians are on the front lines of the fight against liver cancer, and we want to make sure they are armed with the best training and most up to date information available."

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 (Y-90). The product is injected by physicians into the artery of the patient's liver through a catheter, which allows the treatment to be delivered directly to the tumour via blood flow.

TheraSphere is used to treat patients with unresectable hepatocellular carcinoma (HCC) and can be used as a bridge to surgery or transplantation in these patients. It is also indicated for the treatment of HCC patients with portal vein thrombosis (PVT). Patients will typically receive 1.8 treatments over their lifetime. TheraSphere is approved by the U.S Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE). HDE approvals are based on demonstrated safety and probable clinical benefit. However, effectiveness of the indication for use has not been established.

Common side effects include mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the flu. Some patients experience some loss of appetite and temporary changes in several blood tests. For details on rare or more severe side effects, please refer to the TheraSphere package insert at www.nordion.com/therasphere .

About Nordion Inc. Nordion Inc. is a global health science company that provides market-leading products used for the prevention, diagnosis and treatment of disease. We are a leading provider of medical isotopes, targeted therapies and sterilization technologies that benefit the lives of millions of people in more than 60 countries around the world. Our products are used daily by pharmaceutical and biotechnology companies, medical-device manufacturers, hospitals, clinics and research laboratories. Nordion has more than 500 highly skilled employees in three locations. Find out more at www.nordion.com and follow us at http://twitter.com/NordionInc .

SOURCE Nordion Inc.

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February 17, 2012

TheraSphere® Providing Hope to Liver Cancer Patients in Turkey

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PRESS RELEASE

Feb. 17, 2012, 12:27 a.m. EST

ISTANBUL, Turkey, Feb. 17, 2012 /PRNewswire via COMTEX/ -- Leading Istanbul hospital will host news conference to educate public about a safe, well-tolerated and innovative treatment

Nordion Inc. a leading provider of products and services to the global health science market, today celebrated the first anniversary of the market introduction of TheraSphere1, an innovative radioembolic liver cancer therapy, in the Republic of Turkey. The first treatment was administered in Ankara in December 2010. Since then, more than 80 patients have undergone the treatment in more than a half-dozen private and public hospitals across the country.

TheraSphere, available in 16 countries around the world, is a targeted liver cancer therapy consisting of millions of tiny glass beads, each smaller than the diameter of a human hair, containing yttrium-90 (Y-90). In Turkey, it is approved to treat both hepatocellular carcinoma (HCC), a form of primary liver cancer, and metastatic liver cancer (cancer that has spread to the liver from another point of origin).

To mark the anniversary, a news conference is being held today at Acibadem Maslak Hospital, a state-of-the-art private hospital in Istanbul with a strong specialization in cancer treatment. Physicians and Nordion representatives will provide information and demonstrations on how radioembolic therapy works, how it is administered, and what patients undergoing treatment can expect.

Dr. Riad Salem, Professor of Radiology, Medicine and Surgery and Director, Interventional Oncology at Northwestern University in Chicago, is attending the news conference and will present the point of view of a doctor who has been a long-standing researcher and clinician applying this treatment in patients with liver cancer.

"This novel treatment allows me to target radiation directly at the tumour from inside the body, and limits damage to the healthy surrounding tissue," said Dr. Salem. "The procedure can be performed in about one hour, the patients often go home the same day, and studies have shown that side effects are usually not as severe as with other treatments. Quality of life and comfort are very important to patients with this disease and to their families."

According to GLOBOCAN, the World Health Organization (WHO)'s agency for cancer data and research, more than 1,090 new cases of primary liver cancer were diagnosed in men and women in Turkey in 2008, with approximately 1,050 deaths from primary liver cancer that same year. In addition, approximately 60 percent of colorectal cancer (CRC) patients will develop liver metastases, and more than 7,200 new cases of CRC were diagnosed in Turkey in 2008.

"Nordion made a strategic decision to launch TheraSphere in Turkey last year and our commercial efforts, together with those of our Turkish distributor, Eczacibasi Monrol Nuclear Products, mean more physicians in the region are aware and now have access to this innovative treatment, to the benefit of their patients," said Kevin Brooks, Nordion's Senior Vice President of Sales and Marketing. "The clinical adoption we have seen in Turkey over the past 12 months supports our decision to expand into this market, and clearly demonstrates a strong clinical interest in TheraSphere."

The therapy is currently available at the following hospitals in Turkey:

Istanbul University Cerrahpasa Medicine Faculty (Istanbul)

Hacettepe University (Ankara)

Gazi University (Ankara)

American Hospital (Istanbul)

Istanbul Memorial Hospital (Istanbul)

Acibadem Maslak Hospital (Istanbul)

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. Nordion is approved (CE Mark) in Europe to distribute TheraSphere for treatment of hepatic neoplasia. 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 Eugène Marquis in Rennes, France; and Istituto Tumori in Milan, Italy. In the U.S., TheraSphere is currently approved by the U.S Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE) for treatment of unresectable hepatocellular carcinoma (HCC). TheraSphere has some common side effects, including mild to moderate fatigue, pain and nausea. 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 more information on TheraSphere, please visit www.nordion.com/TheraSphere .

About Nordion Inc. Nordion Inc. is a global health science company that provides market-leading products used for the prevention, diagnosis and treatment of disease. We are a leading provider of medical isotopes, targeted therapies and sterilization technologies that benefit the lives of millions of people in more than 60 countries around the world. Our products are used daily by pharmaceutical and biotechnology companies, medical-device manufacturers, hospitals, clinics and research laboratories. Nordion has more than 500 highly skilled employees in three locations. Find out more at www.nordion.com and follow us at http://twitter.com/NordionInc .

1 TheraSphere is a trademark of Theragenics Corporation used under license by Nordion (Canada) Inc. Please note that TheraSphere is an unregistered trademark in Turkey.

SOURCE Nordion Inc.

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