Sirtex Medical Limited is a medical device company, providing radioactive treatment for inoperable

liver cancer Liver cancer (also known as hepatic cancer, primary hepatic cancer, or primary hepatic malignancy) is cancer that starts in the liver. Liver cancer can be primary (starts in liver) or secondary (meaning cancer which has spread from elsewhere to th ...

called SIR-Spheres microspheres. Sirtex was established in 1997 in Australia and currently maintains offices and manufacturing facilities in the U.S., Australia, Germany and Singapore. Following an acquisition by China Grand Pharmaceutical and CDH Genetech, Sirtex de-listed from the Australian Securities Exchange (ASX:SRX) on Monday, September 24, 2018. The company is currently headed by Kevin R. Smith, who was appointed as CEO on October 16, 2019.

How the SIR-Spheres microspheres work

When SIR-Spheres microspheres are used to treat liver cancer, the treatment is called

selective internal radiation therapy Selective internal radiation therapy (SIRT), also known as transarterial radioembolization (TARE), radioembolization or intra-arterial microbrachytherapy is a form of radiation therapy used in interventional radiology to treat cancer. It is general ...

(called SIRT). This is a relatively new treatment option for people suffering inoperable liver cancer. SIR-Spheres are very small radioactive beads about one third the size of a human hair width that are injected into tumors within the liver.

How they are used

The radioactive microspheres have a

half-life Half-life (symbol ) is the time required for a quantity (of substance) to reduce to half of its initial value. The term is commonly used in nuclear physics to describe how quickly unstable atoms undergo radioactive decay or how long stable ato ...

of about 64 hours. They are administered by a trained interventional

radiologist Radiology ( ) is the medical discipline that uses medical imaging to diagnose diseases and guide their treatment, within the bodies of humans and other animals. It began with radiography (which is why its name has a root referring to radiatio ...

who specializes in minimally invasive, targeted treatments. The procedure is usually performed under local sedation. A small incision is made in the patient's groin and a flexible

catheter In medicine, a catheter (/ˈkæθətər/) is a thin tube made from medical grade materials serving a broad range of functions. Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. Cath ...

is guided into the

liver The liver is a major Organ (anatomy), organ only found in vertebrates which performs many essential biological functions such as detoxification of the organism, and the Protein biosynthesis, synthesis of proteins and biochemicals necessary for ...

through the

femoral artery The femoral artery is a large artery in the thigh and the main arterial supply to the thigh and leg. The femoral artery gives off the deep femoral artery or profunda femoris artery and descends along the anteromedial part of the thigh in the fem ...

in the leg up to the tumor sites. The catheter is moved through the hepatic artery and positioned by the interventional radiologist to allow for targeted infusion of the SIR-Spheres microspheres to the site of the tumors. The microspheres take approximately 15 minutes to be infused, the whole procedure taking about one hour. Most patients are discharged within 24 hours.

The medical problem

Primary liver cancer

Primary

, or

hepatocellular carcinoma Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer in adults and is currently the most common cause of death in people with cirrhosis. HCC is the third leading cause of cancer-related deaths worldwide. It occurs in t ...

(HCC) is the most common form of liver cancer, responsible for about 90% of the primary

malignant Malignancy () is the tendency of a medical condition to become progressively worse. Malignancy is most familiar as a characterization of cancer. A ''malignant'' tumor contrasts with a non-cancerous ''benign'' tumor in that a malignancy is not s ...

liver tumors in adults. Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases of liver cancer are diagnosed worldwide each year. This comprises approximately 19,000 in the US, 54,000 in Europe and 390,000 in China, Korea and Japan. The incidence of HCC is increasing due to increased rates of chronic infection with

Hepatitis B Hepatitis B is an infectious disease caused by the ''Hepatitis B virus'' (HBV) that affects the liver; it is a type of viral hepatitis. It can cause both acute and chronic infection. Many people have no symptoms during an initial infection. Fo ...

and

Hepatitis C Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that primarily affects the liver; it is a type of viral hepatitis. During the initial infection people often have mild or no symptoms. Occasionally a fever, dark urine, a ...

in Asia. Other risk factors include iron overload, alcoholic cirrhosis and some congenital disorders. Five-year survival rates for liver cancer patients are low relative to other cancers.

Metastatic colorectal cancer

Colorectal cancer Colorectal cancer (CRC), also known as bowel cancer, colon cancer, or rectal cancer, is the development of cancer from the colon or rectum (parts of the large intestine). Signs and symptoms may include blood in the stool, a change in bowel m ...

(CRC), also called

colon cancer Colorectal cancer (CRC), also known as bowel cancer, colon cancer, or rectal cancer, is the development of cancer from the colon or rectum (parts of the large intestine). Signs and symptoms may include blood in the stool, a change in bowel mo ...

or large bowel cancer, is the third leading cause of cancer-related death in the western world. An estimated 1.6 million people are diagnosed with the disease worldwide every year. An estimated 50% of CRC patients will show liver

metastases Metastasis is a pathogenic agent's spread from an initial or primary site to a different or secondary site within the host's body; the term is typically used when referring to metastasis by a cancerous tumor. The newly pathological sites, then, ...

. It is this form of metastatic colorectal cancer (mCRC) Sirtex targets with SIR-Spheres microspheres. It has been estimated that in 30-40% of patients with advanced disease, the liver is the only site of spread. At presentation, 20-25% of patients will have clinically detectable liver metastases and up to 50% of all patients will develop liver metastases after re-section of the primary tumor within three years of follow up. Of those patients with

metastatic liver disease A liver metastasis is a malignant tumor in the liver that has spread from another organ affected by cancer. The liver is a common site for metastatic disease because of its rich, dual blood supply (the liver receives blood via the hepatic artery a ...

, approximately 25% (on average) are eligible for liver re-section surgery, which represents the only potential cure available to patients. The remainder are eligible for alternative forms of treatment, namely

chemotherapy Chemotherapy (often abbreviated to chemo and sometimes CTX or CTx) is a type of cancer treatment that uses one or more anti-cancer drugs (chemotherapeutic agents or alkylating agents) as part of a standardized chemotherapy regimen. Chemotherap ...

and other technologies including SIR-Spheres microspheres.

Research and development

Sirtex is currently looking at new ways to treat other forms of cancer using the SIR-Spheres technology. This research is taking place at the

Australian National University The Australian National University (ANU) is a public research university located in Canberra, the capital of Australia. Its main campus in Acton encompasses seven teaching and research colleges, in addition to several national academies and ...

(ANU) and several institutions in the US and Europe. Sirtex is also working to develop a new technology that will help improve the treatment and survival of cancer patients. At present this is focused on the three areas listed below. #''Targeted Hyperthermia'' – Preparation for pre-clinical studies started in 2009 with the

in Canberra, the

University of Sydney The University of Sydney (USYD), also known as Sydney University, or informally Sydney Uni, is a public research university located in Sydney, Australia. Founded in 1850, it is the oldest university in Australia and is one of the country's si ...

and other institutions. The aim is to establish if heating tumors will increase the effectiveness of SIR-Spheres. #''Hollow Microspheres'' – Sirtex has exclusive worldwide rights to hollow, biodegradable microsphere technology developed by the

University of New South Wales The University of New South Wales (UNSW), also known as UNSW Sydney, is a public research university based in Sydney, New South Wales, Australia. It is one of the founding members of Group of Eight, a coalition of Australian research-intensive ...

(UNSW). The company is investigating if hollow microspheres can be used to deliver a range of therapeutic agents, including chemotherapy drugs. #''Radioprotector Technology'' – Sirtex and the

Peter MacCallum Cancer Centre The Peter MacCallum Cancer Centre, also known as the Peter MacCallum Cancer Institute and commonly abbreviated as Peter Mac, is an Australian oncology research institute, cancer treatment and professional oncologist training centre located in M ...

in Melbourne have developed a compound that protects healthy skin from the harmful effects of exposure to

radiation In physics, radiation is the emission or transmission of energy in the form of waves or particles through space or through a material medium. This includes: * ''electromagnetic radiation'', such as radio waves, microwaves, infrared, visi ...

. This has potential benefit for a wide range of cancer patients. It could also expand the number of patients able to be treated with SIR-Spheres microspheres. It may also be used to help protect patients with head, breast or neck cancer from external beam radiation during treatment. Results from the largest most comprehensive study to date evaluating SIRT in liver metastases from colorectal cancer were presented at ASCO in 2012, ASCO-GI 2013 and ASCO in 2014. The various subsets of the MORE study, led by Andrew S. Kennedy M.D. Physician in Chief, Radiation Oncology Sarah Cannon Research Institute Nashville Tenn., have demonstrated safety and efficacy as well as the same in treating the elderly. The most recent set of data presented at ASCO in 2014 documented the ability to predict success of SIRT using standard laboratory tests prior to treatment. In addition, the global SIRFLOX study which completed patient recruitment in 2013 will evaluate SIR-Spheres microspheres a first-line treatment for colorectal liver metastases.

Reimbursement

SIR-Spheres microspheres are regulated as a Medical Device. The product was approved for sale in the US in March 2002. The US

Centers for Medicare and Medicaid Services The Centers for Medicare & Medicaid Services (CMS), is a federal agency within the United States Department of Health and Human Services (HHS) that administers the Medicare program and works in partnership with state governments to administer M ...

(CMS) currently reimburse SIR-Spheres microspheres under Medicare Code C2616. SIR-Spheres are covered in Australia by private insurers and reimbursed under Medicare. In Europe, SIR-Spheres microspheres are regulated under the Active Implantable Medical Device Directive. The product received CE Mark approval in October 2002. In the UK, patients treated with SIR-Spheres have been funded by themselves, private medical insurance or had the microspheres donated by Sirtex. A small number have been approved by the

National Health Service The National Health Service (NHS) is the umbrella term for the publicly funded healthcare systems of the United Kingdom (UK). Since 1948, they have been funded out of general taxation. There are three systems which are referred to using the " ...

(NHS). This is partly due to formal guidance documentation provided by the

National Institute for Clinical Excellence The National Institute for Health and Care Excellence (NICE) is an executive non-departmental public body of the Department of Health and Social Care in England that publishes guidelines in four areas: * the use of health technologies withi ...

(NICE) which questioned the clinical benefits of SIR-Spheres microspheres requiring patient consent. Since 2002, it has been a mandatory for NHS organizations in the UK to provide funding for medicines and treatment as recommended by NICE. A favorable review will see the

pay for treatment across the UK and help reimbursement in other EU countries.

Financial Performance

On 3 September 2013, Sirtex announced that dose sales of SIR-Spheres microspheres grew a solid 21 percent with more than 4,750 doses being supplied in the Americas region for the year ending June 30, 2013. Globally, revenue was $100 million Australian dollars, up 16 percent from 2012, with net profit after tax of AU$18 million. Dose sales of SIR-Spheres microspheres grew 19 percent in fiscal year 2013, with Asia Pacific reporting growth of 29 percent and Europe, Middle East and Africa increasing nine percent. Sirtex plans to triple manufacturing capacity in 2014 with new facilities in Germany and the U.S.

References

External links

* {{Authority control Medical technology companies of Australia Radiation therapy Australian companies established in 1997 Companies formerly listed on the Australian Securities Exchange