This article contains content that is written like an advertisement .(August 2021) |
Company type | Private |
---|---|
Founded | 1997 |
Headquarters | Woburn, MA |
Products | SIR-Spheres yttrium-90 resin microspheres |
Owner | China Grand Pharmaceutical and Healthcare Holdings Ltd./CDH Genetech, Ltd. |
Number of employees | 1000 |
Website | www.sirtex.com |
Sirtex Medical Limited is a medical device firm that offers radioactive treatment for inoperable liver cancer called SIR-Spheres microspheres. [1] Sirtex was founded in 1997 in Australia and today has offices and production facilities in the U.S., Australia, Germany, and Singapore. Following its acquisition by China Grand Pharmaceutical and CDH Genetech, Sirtex delisted 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. [2]
When SIR-Sphere microspheres are used to treat liver cancer, the treatment is called selective internal radiation therapy (called SIRT). This is a relatively new treatment option for people suffering from inoperable liver cancer. [3] SIR-Spheres are very small radioactive beads about one-third the size of a human hair that are injected into tumours within the liver.
The radioactive microspheres have a half-life of about 64 hours. They are administered by a trained interventional radiologist who specialises 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 is guided into the liver through the femoral artery in the leg up to the tumour 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, with the whole procedure taking about an hour. Most patients are discharged within 24 hours. [4]
Primary liver cancer, also known as hepatocellular carcinoma (HCC), is the most frequent type of liver cancer, accounting for approximately 90% of the primary malignant liver tumours in adults. Liver cancer is the sixth most prevalent malignancy and the third greatest cause of cancer-related deaths worldwide. [5] Every year, around 600,000 instances of liver cancer are diagnosed around the world. This includes around 19,000 in the US, 54,000 in Europe, and 390,000 in China, Korea, and Japan. The incidence of HCC is rising in Asia as chronic infection with Hepatitis B and C becomes more common. Additional risk factors include iron overload, alcoholic cirrhosis and some congenital disorders. Patients with liver cancer had a lower fiver-year survival rate than those with other cancer types. [6]
Colorectal cancer (CRC), often known as colon cancer or large bowel cancer, is the third highest cause of cancer-related deaths in the western world. [7] Each year, an estimated 1.6 million people are diagnosed with the condition around the world. An estimated 50% of CRC patients will develop liver metastases. Sirtex targets metastatic colorectal cancer (mCRC) via SIR-Sphere microspheres. It has been thought that in 30-40% of individuals with severe illness, the liver is the only site of dissemination.
At presentation, 20-25% of patients will have clinically identifiable liver metastases, and up to 50% of all patients develop liver metastases develop liver metastases within three years of primary tumor removal. [8] On average, 25% of patients with metastatic liver disease are eligible for liver resection surgery, which is the only possible cure available to them. [9] The remaining patients are eligible for alternative treatments such as chemotherapy and SIR-Sphere microspheres.
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 (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. [10] At present, this is focused on the three areas listed below.
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 the success of SIRT using standard laboratory tests prior to treatment. [11]
In addition, the global SIRFLOX study, which completed patient recruitment in 2013, will evaluate SIR-Sphere microspheres as a first-line treatment for colorectal liver metastases. [12]
SIR-Sphere microspheres [13] 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 (CMS) currently reimburse SIR-Spheres microspheres under Medicare Code C2616. [14]
SIR-Spheres are covered in Australia by private insurers and reimbursed under Medicare. [15]
In Europe, SIR-Sphere microspheres are regulated under the Active Implantable Medical Device Directive. The product received CE Mark approval in October 2002. [16]
In the UK, patients treated with SIR-Spheres were either self-funded, had private medical insurance, or had the microspheres donated by Sirtex. A small number have been approved by the National Health Service (NHS).[ citation needed ] This is partly due to formal guidance documentation provided by the National Institute for Clinical Excellence (NICE), which questioned the clinical benefits of SIR-Sphere microspheres requiring patient consent. Since 2013, it has been mandatory for NHS organisations in the UK to provide funding for medicines and treatment as recommended by NICE. [17] [18] A favourable review will see the National Health Service pay for treatment across the UK and help reimbursement in other EU countries.
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 for the year ending June 30, 2013. Globally, revenue was $100 million Australian dollars, up 16 percent from 2012, with a 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, the Middle East, and Africa increasing nine percent. Sirtex plans to triple manufacturing capacity in 2014 with new facilities in Germany and the U.S. [19]
Radiation therapy or radiotherapy is a treatment using ionizing radiation, generally provided as part of cancer therapy to either kill or control the growth of malignant cells. It is normally delivered by a linear particle accelerator. Radiation therapy may be curative in a number of types of cancer if they are localized to one area of the body, and have not spread to other parts. It may also be used as part of adjuvant therapy, to prevent tumor recurrence after surgery to remove a primary malignant tumor. Radiation therapy is synergistic with chemotherapy, and has been used before, during, and after chemotherapy in susceptible cancers. The subspecialty of oncology concerned with radiotherapy is called radiation oncology. A physician who practices in this subspecialty is a radiation oncologist.
Radionuclide therapy uses radioactive substances called radiopharmaceuticals to treat medical conditions, particularly cancer. These are introduced into the body by various means and localise to specific locations, organs or tissues depending on their properties and administration routes. This includes anything from a simple compound such as sodium iodide that locates to the thyroid via trapping the iodide ion, to complex biopharmaceuticals such as recombinant antibodies which are attached to radionuclides and seek out specific antigens on cell surfaces.
Brachytherapy is a form of radiation therapy where a sealed radiation source is placed inside or next to the area requiring treatment. Brachy is Greek for short. Brachytherapy is commonly used as an effective treatment for cervical, prostate, breast, esophageal and skin cancer and can also be used to treat tumours in many other body sites. Treatment results have demonstrated that the cancer-cure rates of brachytherapy are either comparable to surgery and external beam radiotherapy (EBRT) or are improved when used in combination with these techniques. Brachytherapy can be used alone or in combination with other therapies such as surgery, EBRT and chemotherapy.
Radiosurgery is surgery using radiation, that is, the destruction of precisely selected areas of tissue using ionizing radiation rather than excision with a blade. Like other forms of radiation therapy, it is usually used to treat cancer. Radiosurgery was originally defined by the Swedish neurosurgeon Lars Leksell as "a single high dose fraction of radiation, stereotactically directed to an intracranial region of interest".
Transcatheter arterial chemoembolization (TACE) is a minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply. Small embolic particles coated with chemotherapeutic drugs are injected selectively through a catheter into an artery directly supplying the tumor. These particles both block the blood supply and induce cytotoxicity, attacking the tumor in several ways.
Sunitinib, sold under the brand name Sutent, is an anti-cancer medication. It is a small-molecule, multi-targeted receptor tyrosine kinase (RTK) inhibitor that was approved by the FDA for the treatment of renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor (GIST) in January 2006. Sunitinib was the first cancer drug simultaneously approved for two different indications.
Neuroendocrine tumors (NETs) are neoplasms that arise from cells of the endocrine (hormonal) and nervous systems. They most commonly occur in the intestine, where they are often called carcinoid tumors, but they are also found in the pancreas, lung, and the rest of the body.
Technetium (99mTc) arcitumomab is a drug used for the diagnostic imaging of colorectal cancers, marketed by Immunomedics. It consists of the Fab' fragment of a monoclonal antibody and a radionuclide, technetium-99m.
TheraSphere is a radiotherapy treatment for hepatocellular carcinoma (HCC) that consists of millions of microscopic, radioactive glass microspheres being infused into the arteries that feed liver tumors. These microspheres then embolize, lodging themselves in the liver's capillaries and bathing the malignancy in high levels of yttrium-90 radiation. It is currently approved as a Humanitarian Device, meaning effectiveness has not been proven, for patients as a neoadjuvant to surgery or transplantation by the U.S. Food and Drug Administration and is being used at a number of clinical centers in the United States.
Medullary thyroid cancer is a form of thyroid carcinoma which originates from the parafollicular cells, which produce the hormone calcitonin. Medullary tumors are the third most common of all thyroid cancers and together make up about 3% of all thyroid cancer cases. MTC was first characterized in 1959.
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. Metastatic tumors in the liver are 20 times more common than primary tumors. In 50% of all cases the primary tumor is of the gastrointestinal tract; other common sites include the breast, ovaries, bronchus and kidney. Patients with Colorectal cancer will develop liver metastases during the disease
Selective internal radiation therapy (SIRT), also known as transarterial radioembolization (TARE), radioembolization or intra-arterial microbrachytherapy is a form of radionuclide therapy used in interventional radiology to treat cancer. It is generally for selected patients with surgically unresectable cancers, especially hepatocellular carcinoma or metastasis to the liver. The treatment involves injecting tiny microspheres of radioactive material into the arteries that supply the tumor, where the spheres lodge in the small vessels of the tumor. Because this treatment combines radiotherapy with embolization, it is also called radioembolization. The chemotherapeutic analogue is called chemoembolization, of which transcatheter arterial chemoembolization (TACE) is the usual form.
In oncology, metastasectomy is the surgical removal of metastases, which are secondary cancerous growths that have spread from cancer originating in another organ in the body.
Biocompatibles International plc was a medical technology company in the field of drug-device combination products. It was acquired by BTG plc in 2010, which was, in turn, acquired by Boston Scientific in 2019.
SIR-Spheres microspheres are used to treat patients with unresectable liver cancer. These are mostly patients with hepatocellular carcinoma (HCC), metastatic colorectal cancer (mCRC), or metastatic neuroendocrine tumours (mNET).
Metastatic breast cancer, also referred to as metastases, advanced breast cancer, secondary tumors, secondaries or stage IV breast cancer, is a stage of breast cancer where the breast cancer cells have spread to distant sites beyond the axillary lymph nodes. There is no cure for metastatic breast cancer; there is no stage after IV.
A brain metastasis is a cancer that has metastasized (spread) to the brain from another location in the body and is therefore considered a secondary brain tumor. The metastasis typically shares a cancer cell type with the original site of the cancer. Metastasis is the most common cause of brain cancer, as primary tumors that originate in the brain are less common. The most common sites of primary cancer which metastasize to the brain are lung, breast, colon, kidney, and skin cancer. Brain metastases can occur months or even years after the original or primary cancer is treated. Brain metastases have a poor prognosis for cure, but modern treatments allow patients to live months and sometimes years after the diagnosis.
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for adults and children with rare and difficult-to-treat cancers. The company is headquartered in Austin, Texas, United States.
Interventional oncology is a subspecialty field of interventional radiology that deals with the diagnosis and treatment of cancer and cancer-related problems using targeted minimally invasive procedures performed under image guidance. Interventional oncology has developed to a separate pillar of modern oncology and it employs X-ray, ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI) to help guide miniaturized instruments to allow targeted and precise treatment of solid tumours located in various organs of the human body, including but not limited to the liver, kidneys, lungs, and bones. Interventional oncology treatments are routinely carried out by interventional radiologists in appropriate settings and facilities.
Radiation lobectomy is a form of radiation therapy used in interventional radiology to treat liver cancer. It is performed in patients that would be surgical candidates for resection, but cannot undergo surgery due to insufficient remaining liver tissue. It consists of injecting small radioactive beads loaded with yttrium-90 into the hepatic artery feeding the hepatic lobe in which the tumor is located. This is done with the intent of inducing growth in the contralateral hepatic lobe, not dissimilarly from portal vein embolization (PVE).