February 17, 2012

TheraSphere® Providing Hope to Liver Cancer Patients in Turkey



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.


Gilead Announces Data For Genotype 1 Null Responder Hepatitis C Patients Enrolled In ELECTRON Study



By Business Wire 02/17/12 - 06:01 AM EST

Gilead Sciences, Inc. (NASDAQ:GILD) announced today that the majority of hepatitis C genotype 1 patients with a prior “null” response to an interferon (IFN)-containing regimen enrolled in the ongoing ELECTRON study experienced viral relapse within four weeks of completing 12 weeks of treatment with GS-7977 plus ribavirin (RBV). Ten patients were randomized to this arm of the ELECTRON study and data are available for eight of the 10 patients at this time. Among these eight patients, six have experienced viral relapse. Two patients have not relapsed; however, they have only reached the two week post-treatment time point.

“These data answer an important question about the use of GS-7977 and ribavirin for the treatment of genotype 1 null responder patients, suggesting that additional direct acting antivirals may be necessary to effectively treat this patient population,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. “We will continue to explore a number of therapeutic approaches to address this significant unmet medical need, including combinations with other oral antivirals.”

GS-7977 is a nucleotide analog polymerase inhibitor that is currently being studied for the treatment of chronic hepatitis C. A number of ongoing Phase 2 and Phase 3 studies are evaluating the safety and efficacy of the compound with and without RBV and/or pegylated interferon (Peg-IFN) in patients with genotypes 1-6 who are treatment naïve, treatment experienced, or have had a “null” response to Peg-IFN.

Genotype 2 and 3 data from the ELECTRON study were presented at the 62nd annual meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2011). Data from the genotype 1 null responder arm of the study will be presented at an upcoming scientific conference.

Results from ongoing studies in genotype 1 treatment-naïve patients will be available in the coming months. The first data evaluating GS-7977 plus RBV for 12 weeks in genotype 1 naïve patients will come from an arm of the QUANTUM study with 25 patients at the end of the first quarter of 2012. This will be followed in the second quarter by data from the ELECTRON study involving 25 patients and, early in the third quarter, data on GS-7977 and RBV treatment for 24 weeks from an arm of the QUANTUM study will become available.