Schering-Plough Corporation (NYSE: SGP) announced that the European Commission and the US FDA both approved the intravenous (IV) formulation of temozolomide as an alternative to the already approved oral form of the drug. Temozolomide is marketed as TEMODAL(R) in the EU and as TEMODAR(R) in the US. The EU Commission Decision was based on the positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) in November 2008. On January 22, 2009, the Commission approved a sachet packaging presentation for TEMODAL Capsules. This new presentation provides greater patient convenience and flexibility. On February 17, 2009, the Commission approved an IV formulation of TEMODAL. On February 27, 2009, Schering-Plough received approval from the US FDA for the TEMODAR IV formulation.

TEMODAL is a chemotherapy agent approved in the EU for treatment of patients with newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and subsequently as monotherapy, and for patients with malignant gliomas, such as GBM or anaplastic astrocytoma (AA), showing recurrence or progression after standard therapy. In the US, TEMODAR is approved for the treatment of adult patients with newly diagnosed GBM concomitantly with radiotherapy and then as maintenance treatment, as well as for refractory AA, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.

“TEMODAR is a well recognized, effective treatment for patients with newly diagnosed GBM. The newly approved IV formulation of TEMODAR provides patients with an important alternative method of administration, and the European TEMODAL sachet presentation offers flexibility and a convenient alternative form of packaging,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. “These two new options recognize Schering-Plough’s commitment to providing effective treatments in a variety of presentations for specific patient needs and patient convenience.”

About Malignant Gliomas

The worldwide incidence rate of primary malignant brain and central nervous system tumors, using the world standard population, is 3.7 per 100,000 person in males and 2.6 per 100,000 person in females(1). The most common type of primary malignant brain tumors are gliomas, with AA and GBM being the most common and among the most serious types.

About temozolomide

In addition to the new presentations, TEMODAL (temozolomide), a cytotoxic agent, is currently approved in oral form as 5mg, 20mg, 100mg, 140mg, 180mg and 250mg capsules in Europe. Cytotoxic agents are designed to impact the replication of cells that divide rapidly, such as those in tumors.

TEMODAL was initially approved in the EU in 1999 for the treatment of patients with malignant glioma, such as GBM or AA, showing recurrence or progression after standard therapy. In June 2005, TEMODAL received marketing approval in the EU for the treatment of patients with newly diagnosed GBM concomitantly with radiotherapy and subsequently as monotherapy treatment. The TEMODAL IV formulation approved by the EU Commission was developed for cancer patients who are unable to take TEMODAL Capsules and has shown bioequivalence to the oral product. The sachet packaging presentation for TEMODAL Capsules was created to provide greater patient convenience and flexibility.

TEMODAR capsules (temozolomide) received accelerated approval from the US Food and Drug Administration (FDA) for adult patients with refractory AA in 1999 and full approval in March 2005 for refractory AA, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine, and for the treatment of newly diagnosed GBM concomitantly with radiotherapy and then as maintenance treatment.

Important Information Regarding US Labeling for TEMODAR and TEMODAR Intravenous Formulation

TEMODAR(R) (temozolomide) is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. TEMODAR is indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.

TEMODAR(R) is contraindicated in patients who have a history of hypersensitivity (such as urticaria, allergic reaction including anaphylaxis, toxic epidermal necrolysis and Stevens-Johnson syndrome) to any of its components, or to DTIC.

Patients treated with TEMODAR(R) Capsules may experience myelosuppression including prolonged pancytopenia, which may result in aplastic anemia, which in some cases has resulted in a fatal outcome. In some cases, exposure to concomitant medications associated with aplastic anemia including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim complicates assessment. Geriatric patients and women have been shown in clinical trials to have a higher risk of developing myelosuppression. Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, have also been observed.

Prophylaxis against Pneumocystis carinii pneumonia is required for all patients receiving concomitant TEMODAR(R) and radiotherapy for the 42-day regimen. There may be a higher occurrence of PCP when temozolomide is administered during a longer dosing regimen. However, all patients receiving temozolomide, particularly patients receiving steroids, should be observed closely for the development of PCP regardless of the regimen.

TEMODAR(R) can cause fetal harm when administered to a pregnant woman. In nursing women, a decision should be made whether to discontinue nursing or to discontinue TEMODAR(R), taking into account the importance of the drug to the mother. The safety and effectiveness of TEMODAR(R) in children have not been established.

As bioequivalence between TEMODAR Capsules and TEMODAR for Injection has been established only when TEMODAR for Injection was given over 90 minutes, infusion over a shorter or longer period of time may result in suboptimal dosing. Additionally, the possibility of an increase in infusion related adverse reactions cannot be ruled out.

TEMODAR(R) Capsules should not be opened or chewed. If capsules are accidentally opened or damaged, rigorous precautions should be taken with the capsule contents to avoid inhalation or contact with the skin or mucous membranes.

Caution should be exercised when administered to those with severe hepatic or renal impairment.

In newly diagnosed patients with glioblastoma multiforme, the adverse event profile was similar in patients <65 years of age and those greater than or equal to 65 years.

In newly diagnosed glioblastoma multiforme the most common adverse reactions in clinical studies in the Concomitant Phase (Radiotherapy + TEMODAR(R)) and the Maintenance Phase (TEMODAR(R) alone), respectively, were alopecia 69%, 55%; fatigue 54%, 61%; nausea 36%, 49%; vomiting 20%, 29%; anorexia 19%, 27%; headache 19%, 23%; rash 19%, 13%; constipation 18%, 22%; with the following important adverse events also reported: convulsions 6%, 11% and thrombocytopenia 4%; 8%. Of these adverse events, those grade greater than or equal to 3 in clinical studies in the Concomitant Phase (Radiotherapy + TEMODAR) and the Maintenance Phase (TEMODAR alone), respectively, were fatigue 7%, 9%; nausea 1%, 1%; vomiting <1%, 2%; anorexia 1%, 1%; headache 2%, 4%; constipation 1%, 0%; convulsions 3%, 3%; thrombocytopenia 3%, 4%.

In the newly diagnosed GBM population, when laboratory abnormalities and adverse events were combined, Grade 3 or 4 neutropenia occurred in 8% and Grade 3 or 4 platelet abnormalities including thrombocytopenic events occurred in 14% of patients treated with temozolomide.

Most common adverse reactions in the trial in AA patients overall and Grade 3/4, respectively, were: nausea 53%, 10%; vomiting 42%, 6%; headache 41%, 6%; fatigue 34%, 4%; constipation 33%, 1%; convulsions 23%, 5%; with the following important adverse events also reported: hemiparesis 18%, 6%; asthenia 13%, 6%.

Adverse hematologic effects (Grade 3 to 4) in the AA trial in adults were lymphopenia (55%); platelets (19%); neutrophils (14%); WBC (11%); and hemoglobin (4%).

7% and 9.5% of patients over age 70 experienced Grade 4 neutropenia or thrombocytopenia in the first cycle, respectively. For patients less than or equal to age 70, 7% and 5.5% experienced Grade 4 neutropenia or thrombocytopenia in the first cycle, respectively.

Adverse reactions reported from intravenous formulation studies that were not reported in TEMODAR capsule studies were: pain, irritation, pruritus, warmth, swelling, and erythema at infusion site as well as the following adverse reactions: petechiae and hematoma.

About Schering Plough

Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription, animal health and consumer health care products. Schering-Plough’s vision is to “Earn Trust, Every Day” with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to TEMODAL and the potential market for TEMODAL. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough’s forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough’s Securities and Exchange Commission filings, including Item 1A. “Risk Factors” in the 2008 10-K, filed February 27, 2009.

Also Included In: Neurology / Neuroscience; Regulatory Affairs / Drug Approvals; Clinical Trials / Drug Trials

Countless people have heard the phrase, “You have lung cancer,” but only 50 can say they’ve completed a new treatment at Temple University that doubles their chances of surviving the deadly disease – and without the conventional radiation regimen or surgery. Doctors in the Radiation Oncology Department say the technique, stereotactic body radiotherapy, or SBRT, not only improves a person’s odds of surviving early stage lung cancer, but may reduce the need for future surgeries.

“This is a big trend in radiation oncology for early stage lung cancer patients who either can’t undergo surgery or refuse it,” says Curtis Miyamoto, M.D., chair and professor of the Department of Radiation Oncology at the School of Medicine. “With the success of this technique, we’re now questioning whether we’ll even be doing surgeries on these patients in the future.”

Treating lung cancer with conventional radiation is a burdensome process. Patients receive radiation therapy, which kills the cancerous cells and shrinks tumors, five days a week for six to seven weeks. The travel alone can be a hardship for patients not living in the city.

In contrast, SBRT requires only three to eight treatments, not 35. Once malignancy is confirmed through a PET CT scan or biopsy, treatments can begin. Patients are placed in an immobilizing body frame to reduce movement so that doctors can focus radiation on the tumor while reducing exposure of healthy tissue. Although both traditional treatments and SBRT methods involve radiation, SBRT administers large, highly precise doses instead of multiple smaller doses.

But perhaps the most important advantage of SBRT is its effectiveness: Patients who refuse or cannot receive conventional treatments for their lung cancer face a median survival range of nine months. For those who undergo SBRT, the median survival range is more than 32 months. And depending on the size and seriousness of the tumor, the two-year disease free survival, or cure rate through SBRT increases to approximately 81 percent and can reach up to 98 percent, according to findings in the International Journal of Radiation OncologyBiologyPhysics. The cure rate with conventional radiation is closer to 35 percent; SBRT doubles the odds of surviving early stage lung cancer and can actually cure at least half of the patients.

“Such high survival rates are equivalent to other techniques, like invasive surgery, but you don’t have to go under the knife,” says Miyamoto. “I think the big thing the patient notices is it’s all done very quickly and the results are impressive.”

That’s welcome news to Americans considering lung cancer is the second most diagnosed cancer in men and women (after prostate and breast, respectively), but it is the number one cause of death from cancer every year in both men and women, according to statistics from LungCancer.org.

Notes:

Miyamoto will present information on SBRT this June before the Asociacion Latinoamericana de Terapia Radiante Oncologica, or ALATRO, which represents Spanish- and Portuguese-speaking radiation oncologists who treat approximately 500 million people outside the United States.

Cancer is a class of diseases characterized by out-of-control cell growth. There are over 100 different types of cancer, and each is classified by the type of cell that is initially affected.

Cancer harms the body when damaged cells divide uncontrollably to form lumps or masses of tissue called tumors (except in the case of leukemia where cancer prohibits normal blood function by abnormal cell division in the blood stream). Tumors can grow and interfere with the digestive, nervous, and circulatory systems, and they can release hormones that alter body function. Tumors that stay in one spot and demonstrate limited growth are generally considered to be benign.

More dangerous, or malignant, tumors form when two things occur:

1. a cancerous cell manages to move throughout the body using the blood or lymph systems, destroying healthy tissue in a process called invasion
2. that cell manages to divide and grow, making new blood vessels to feed itself in a process called angiogenesis.

When a tumor successfully spreads to other parts of the body and grows, invading and destroying other healthy tissues, it is said to have metastasized. This process itself is called metastasis, and the result is a serious condition that is very difficult to treat.

In 2007, cancer claimed the lives of about 7.6 million people in the world. Physicians and researchers who specialize in the study, diagnosis, treatment, and prevention of cancer are called oncologists.

What causes cancer?

Cancer is ultimately the result of cells that uncontrollably grow and do not die. Normal cells in the body follow an orderly path of growth, division, and death. Programmed cell death is called apoptosis, and when this process breaks down, cancer begins to form. Unlike regular cells, cancer cells do not experience programmatic death and instead continue to grow and divide. This leads to a mass of abnormal cells that grows out of control.

What is cancer? – Video

A short, 3D, animated introduction to cancer. This was originally created by BioDigital Systems and used in the Stand Up 2 Cancer telethon.

3D Medical Animation – What is Cancer?

Genes – the DNA type

Cells can experience uncontrolled growth if there are damages or mutations to DNA, and therefore, damage to the genes involved in cell division. Four key types of gene are responsible for the cell division process: oncogenes tell cells when to divide, tumor suppressor genes tell cells when not to divide, suicide genes control apoptosis and tell the cell to kill itself if something goes wrong, and DNA-repair genes instruct a cell to repair damaged DNA.

Cancer occurs when a cell’s gene mutations make the cell unable to correct DNA damage and unable to commit suicide. Similarly, cancer is a result of mutations that inhibit oncogene and tumor suppressor gene function, leading to uncontrollable cell growth.

Carcinogens

Carcinogens are a class of substances that are directly responsible for damaging DNA, promoting or aiding cancer. Tobacco, asbestos, arsenic, radiation such as gamma and x-rays, the sun, and compounds in car exhaust fumes are all examples of carcinogens. When our bodies are exposed to carcinogens, free radicals are formed that try to steal electrons from other molecules in the body. Theses free radicals damage cells and affect their ability to function normally.

Genes – the family type

Cancer can be the result of a genetic predisposition that is inherited from family members. It is possible to be born with certain genetic mutations or a fault in a gene that makes one statistically more likely to develop cancer later in life.

Other medical factors
As we age, there is an increase in the number of possible cancer-causing mutations in our DNA. This makes age an important risk factor for cancer. Several viruses have also been linked to cancer such as: human papillomavirus (a cause of cervical cancer), hepatitis B and C (causes of liver cancer), and Epstein-Barr virus (a cause of some childhood cancers). Human immunodeficiency virus (HIV) – and anything else that suppresses or weakens the immune system – inhibits the body’s ability to fight infections and increases the chance of developing cancer.

What are the symptoms of cancer?

Cancer symptoms are quite varied and depend on where the cancer is located, where it has spread, and how big the tumor is. Some cancers can be felt or seen through the skin – a lump on the breast or testicle can be an indicator of cancer in those locations. Skin cancer (melanoma) is often noted by a change in a wart or mole on the skin. Some oral cancers present white patches inside the mouth or white spots on the tongue.

Other cancers have symptoms that are less physically apparent. Some brain tumors tend to present symptoms early in the disease as they affect important cognitive functions. Pancreas cancers are usually too small to cause symptoms until they cause pain by pushing against nearby nerves or interfere with liver function to cause a yellowing of the skin and eyes called jaundice. Symptoms also can be created as a tumor grows and pushes against organs and blood vessels. For example, colon cancers lead to symptoms such as constipation, diarrhea, and changes in stool size. Bladder or prostate cancers cause changes in bladder function such as more frequent or infrequent urination.

As cancer cells use the body’s energy and interfere with normal hormone function, it is possible to present symptoms such as fever, fatigue, excessive sweating, anemia, and unexplained weight loss. However, these symptoms are common in several other maladies as well. For example, coughing and hoarseness can point to lung or throat cancer as well as several other conditions.

When cancer spreads, or metastasizes, additional symptoms can present themselves in the newly affected area. Swollen or enlarged lymph nodes are common and likely to be present early. If cancer spreads to the brain, patients may experience vertigo, headaches, or seizures. Spreading to the lungs may cause coughing and shortness of breath. In addition, the liver may become enlarged and cause jaundice and bones can become painful, brittle, and break easily. Symptoms of metastasis ultimately depend on the location to which the cancer has spread.

How is cancer classified?

There are five broad groups that are used to classify cancer.

1. Carcinomas are characterized by cells that cover internal and external parts of the body such as lung, breast, and colon cancer.
2. Sarcomas are characterized by cells that are located in bone, cartilage, fat, connective tissue, muscle, and other supportive tissues.
3. Lymphomas are cancers that begin in the lymph nodes and immune system tissues.
4. Leukemias are cancers that begin in the bone marrow and often accumulate in the bloodstream.
5. Adenomas are cancers that arise in the thyroid, the pituitary gland, the adrenal gland, and other glandular tissues.

Cancers are often referred to by terms that contain a prefix related to the cell type in which the cancer originated and a suffix such as -sarcoma, -carcinoma, or just -oma. Common prefixes include:

* Adeno- = gland
* Chondro- = cartilage
* Erythro- = red blood cell
* Hemangio- = blood vessels
* Hepato- = liver
* Lipo- = fat
* Lympho- = white blood cell
* Melano- = pigment cell
* Myelo- = bone marrow
* Myo- = muscle
* Osteo- = bone
* Uro- = bladder
* Retino- = eye
* Neuro- = brain

How is cancer diagnosed and staged?

Early detection of cancer can greatly improve the odds of successful treatment and survival. Physicians use information from symptoms and several other procedures to diagnose cancer. Imaging techniques such as X-rays, CT scans, MRI scans, PET scans, and ultrasound scans are used regularly in order to detect where a tumor is located and what organs may be affected by it. Doctors may also conduct an endoscopy, which is a procedure that uses a thin tube with a camera and light at one end, to look for abnormalities inside the body.

Extracting cancer cells and looking at them under a microscope is the only absolute way to diagnose cancer. This procedure is called a biopsy. Other types of molecular diagnostic tests are frequently employed as well. Physicians will analyze your body’s sugars, fats, proteins, and DNA at the molecular level. For example, cancerous prostate cells release a higher level of a chemical called PSA (prostate-specific antigen) into the bloodstream that can be detected by a blood test. Molecular diagnostics, biopsies, and imaging techniques are all used together to diagnose cancer.

After a diagnosis is made, doctors find out how far the cancer has spread and determine the stage of the cancer. The stage determines which choices will be available for treatment and informs prognoses. The most common cancer staging method is called the TNM system. T (1-4) indicates the size and direct extent of the primary tumor, N (0-3) indicates the degree to which the cancer has spread to nearby lymph nodes, and M (0-1) indicates whether the cancer has metastasized to other organs in the body. A small tumor that has not spread to lymph nodes or distant organs may be staged as (T1, N0, M0), for example.

TNM descriptions then lead to a simpler categorization of stages, from 0 to 4, where lower numbers indicate that the cancer has spread less. While most Stage 1 tumors are curable, most Stage 4 tumors are inoperable or untreatable.

How is cancer treated?

Cancer treatment depends on the type of cancer, the stage of the cancer (how much it has spread), age, health status, and additional personal characteristics. There is no single treatment for cancer, and patients often receive a combination of therapies and palliative care. Treatments usually fall into one of the following categories: surgery, radiation, chemotherapy, immunotherapy, hormone therapy, or gene therapy.

Surgery

Surgery is the oldest known treatment for cancer. If a cancer has not metastasized, it is possible to completely cure a patient by surgically removing the cancer from the body. This is often seen in the removal of the prostate or a breast or testicle. After the disease has spread, however, it is nearly impossible to remove all of the cancer cells. Surgery may also be instrumental in helping to control symptoms such as bowel obstruction or spinal cord compression.

Radiation
Radiation treatment, also known as radiotherapy, destroys cancer by focusing high-energy rays on the cancer cells. This causes damage to the molecules that make up the cancer cells and leads them to commit suicide. Radiotherapy utilizes high-energy gamma-rays that are emitted from metals such as radium or high-energy x-rays that are created in a special machine. Early radiation treatments caused severe side-effects because the energy beams would damage normal, healthy tissue, but technologies have improved so that beams can be more accurately targeted. Radiotherapy is used as a standalone treatment to shrink a tumor or destroy cancer cells (including those associated with leukemia and lymphoma), and it is also used in combination with other cancer treatments.

Chemotherapy

Chemotherapy utilizes chemicals that interfere with the cell division process – damaging proteins or DNA – so that cancer cells will commit suicide. These treatments target any rapidly dividing cells (not necessarily just cancer cells), but normal cells usually can recover from any chemical-induced damage while cancer cells cannot. Chemotherapy is generally used to treat cancer that has spread or metastasized because the medicines travel throughout the entire body. It is a necessary treatment for some forms of leukemia and lymphoma. Chemotherapy treatment occurs in cycles so the body has time to heal between doses. However, there are still common side effects such as hair loss, nausea, fatigue, and vomiting. Combination therapies often include multiple types of chemotherapy or chemotherapy combined with other treatment options.

Immunotherapy

Immunotherapy aims to get the body’s immune system to fight the tumor. Local immunotherapy injects a treatment into an affected area, for example, to cause inflammation that causes a tumor to shrink. Systemic immunotherapy treats the whole body by administering an agent such as the protein interferon alpha that can shrink tumors. Immunotherapy can also be considered non-specific if it improves cancer-fighting abilities by stimulating the entire immune system, and it can be considered targeted if the treatment specifically tells the immune system to destroy cancer cells. These therapies are relatively young, but researchers have had success with treatments that introduce antibodies to the body that inhibit the growth of breast cancer cells. Bone marrow transplantation (hematopoetic stem cell transplantation) can also be considered immunotherapy because the donor’s immune cells will often attack the tumor or cancer cells that are present in the host.

Hormone therapy

Several cancers have been linked to some types of hormones, most notably breast and prostate cancer. Hormone therapy is designed to alter hormone production in the body so that cancer cells stop growing or are killed completely. Breast cancer hormone therapies often focus on reducing estrogen levels (a common drug for this is tamoxifen) and prostate cancer hormone therapies often focus on reducing testosterone levels. In addition, some leukemia and lymphoma cases can be treated with the hormone cortisone.

Gene therapy

The goal of gene therapy is to replace damaged genes with ones that work to address a root cause of cancer: damage to DNA. For example, researchers are trying to replace the damaged gene that signals cells to stop dividing (the p53 gene) with a copy of a working gene. Other gene-based therapies focus on further damaging cancer cell DNA to the point where the cell commits suicide. Gene therapy is a very young field and has not yet resulted in any successful treatments.

How can cancer be prevented?

Cancers that are closely linked to certain behaviors are the easiest to prevent. For example, choosing not to smoke tobacco or drink alcohol significantly lower the risk of several types of cancer – most notably lung, throat, mouth, and liver cancer. Even if you are a current tobacco user, quitting can still greatly reduce your chances of getting cancer.

Skin cancer can be prevented by staying in the shade, protecting yourself with a hat and shirt when in the sun, and using sunscreen. Diet is also an important part of cancer prevention since what we eat has been linked to the disease. Physicians recommend diets that are low in fat and rich in fresh fruits and vegetables and whole grains.

Certain vaccinations have been associated with the prevention of some cancers. For example, many women receive a vaccination for the human papillomavirus because of the virus’s relationship with cervical cancer. Hepatitis B vaccines prevent the hepatitis B virus, which can cause liver cancer.

Some cancer prevention is based on systematic screening in order to detect small irregularities or tumors as early as possible even if there are no clear symptoms present. Breast self-examination, mammograms, testicular self-examination, and Pap smears are common screening methods for various cancers.

How to eat to prevent cancer – Video

A guide to some everyday foods that contain nutrients that may help reduce your risk of getting cancer. Video by Howcast.

How To Eat To Prevent Cancer

Cancer / Oncology news

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Varian Medical Systems (NYSE: VAR) has received FDA 510(k) clearance for a new proton scanning dose algorithm that offers clinicians greater control over how proton beams are used to target tumors and other abnormalities. The new algorithm, which has been incorporated into Varian’s Eclipse treatment planning software, makes it possible to plan for intensity modulated proton therapy by optimizing dose distributions in three dimensions in order to protect surrounding healthy tissues.

This proton scanning technique improves on current proton delivery methods that require a therapist to enter and exit the treatment room numerous times throughout a treatment to adjust physical compensators for processing proton beams. “With proton scanning and intensity-modulation, this cumbersome process can be completely eliminated,” said Jeff Amacker, Varian’s business manager for treatment planning products.

Proton Therapy

Proton therapy uses a particle accelerator to generate a beam of protons and deposit them accurately within tumors while sparing adjacent healthy tissues and organs. Unlike the more common photon radiotherapy, with beams that pass all the way through the patient’s body, proton therapy beams can be designed to stop and distribute most of their radiation dose at the depth of the tumor. This makes it possible to improve certain cancer treatments by protecting more healthy tissue and thus reduce short- and long-term side effects in cases where surrounding healthy tissues are particularly sensitive to radiation. Radiation oncology experts estimate that about 10 percent of the patients can benefit from having all or some of their treatment with protons.

Eclipse Multi-Functionality

With the addition of the proton scanning dose algorithm, Eclipse, the fastest, most versatile and widely-used radiotherapy treatment planning system in use today, continues to expand on its functionality as a single system for state-of-the-art proton, photon, electron, and brachytherapy treatment planning. Within the Eclipse planning environment, clinicians can combine and compare plans for any and all of these treatment approaches, to arrive at an optimal strategy for helping each and every patient.

About Varian Medical Systems

Varian Medical Systems, Inc., of Palo Alto, California, is the world’s leading manufacturer of medical devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, proton therapy, and brachytherapy. The company supplies informatics software for managing comprehensive cancer clinics, radiotherapy centers and medical oncology practices. Varian is a premier supplier of tubes and digital detectors for X-ray imaging in medical, scientific, and industrial applications and also supplies X-ray imaging products for cargo screening and industrial inspection. Varian Medical Systems employs approximately 4,500 people who are located at manufacturing sites in North America and Europe and in its 60 sales and support offices around the world. For more information, visit http://www.varian.com/

Forward Looking Statements

Statements in this press release regarding future business, events, plans, objectives, expectations, estimates, and other similar matters, including, but not limited to, statements using the terms “can” and “makes it possible to” constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements contained in this press release are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated, including, but not limited to, the risks described in the company’s Annual Report on Form 10-K and other reports filed from time to time by the Company with the Securities and Exchange Commission. These forward-looking statements represent the Company’s judgment as of the date of this press release. The Company assumes no obligation to update or revise these forward-looking statements because of new information, future events, or otherwise.

Varian Medical Systems

Uranium has been refined in Port Hope, Ontario, since the early 1930s. In 2007, the Port Hope Community Health Concerns Committee (PHCHCC) analyzed samples, taken from residents, to assess the radiation exposure of individuals living in the area.

Health Canada’s analysis of the results from the study show that the uranium concentrations in the samples of nine Port Hope residents are within the range of natural levels and that these levels pose no health hazard. This interpretation differs from that of the PHCHCC.

The results of the study are also consistent with those of Health Canada, which continues to monitor uranium in the environment and in workers who are residents of the Port Hope area. In all of these measurements the concentrations fall within the natural range of values found in other communities in Canada.

The major health effect associated with uranium exposure is kidney damage. This effect only occurs at high concentrations, hundreds to thousands times greater than the low levels found to date in Port Hope.

In March of 2001, the Government of Canada began a 10-year, $260-million initiative to develop a long-term management solution for the situation in Port Hope. The Low Level Radioactive Waste Management Office of Atomic Energy of Canada Limited is managing this initiative.

Health Canada officials will assess the full report from the Committee when they receive it and will continue to work to protect the health and safety of Port Hope residents.

Health Canada

Concerns over possible radiation effects of CT scans detailed in a report last Thursday in the New England Journal of Medicine should not scare people away from getting medically needed CT scans, as the scans play a critical role in saving the lives of thousands of people every day, according to an official with the American Association of Physicists in Medicine (AAPM).

In a statement issued last Friday, Dr. John M. Boone, chairman of AAPM’s science council, says that the “science community remains divided” over the radiation dose effects of CT scans and that the findings in the Journal article were based on “flawed assumptions” and were not conclusive. While agreeing with the Journal article’s authors, Drs. David Brenner and Eric Hall, that CT scans should only be used judiciously and when medically necessary, Boone says CT experts in the AAPM “feel that much of the message of this article may be misconstrued or misunderstood by the press or by the public who may not be experts in CT.”

Brenner and Hall, in their article, said that while they save lives and speed diagnosis, the 62 million CT scans done in the United States each year may soon be responsible for 2 percent of all cancers. They further suggested that their “back of the envelope” estimate is that about a third of all CT scans are unnecessary.

Boone responds in his statement that the assumptions about the hazards of CT scan radiation exposure “remain controversial, even among experts in radiation biology.” The method of determining risk used in the article is derived from Japanese citizens exposed to large amounts of radiation during the atomic bomb attacks on Hiroshima and Nagasaki in World War II, and the extrapolation of those extremely high radiation exposure rates down to the low CT exposures “remains very controversial,” Boone says.

Another “significant flaw” in the article was the attempt to compare the Japanese bomb victims to “patients receiving CT in the US in 2007,” Boone says. The article “did not correct for the many underlying confounding age dependent variables that differ between (the Japanese population) and older Americans, such as the incidence of obesity and diabetes.”

Boone encourages patients who have had CT scans, or are slated for CT exams in the next few weeks, to “discuss with their physicians not only the radiation risks of the CT examination, but the risks of not having the diagnostic information that CT provides.”

While Boone notes that Brenner and Hall are “esteemed scientists and respected experts in radiation risk . . . the conclusions of the Brenner article are based on statistics and many statistical assumptions (and not) on the actual observation of somebody dying from having a CT scan.”

Radiologists are investigating the use of computed tomography (CT) as a tool for civilian medical examiners’ autopsies in the United States. According to findings presented today at the annual meeting of the Radiological Society of North America (RSNA), CT autopsy has the potential to replace conventional autopsy in determining the cause of certain accidental deaths.

“CT is a sensitive imaging tool for detecting injuries and cause of death in victims of blunt trauma,” said Barry Daly, M.D., professor of radiology at the University of Maryland School of Medicine in Baltimore. “When there are major injuries, such as those resulting from a motor vehicle accident, CT may provide enough information to enable a conventional autopsy to be avoided altogether.”

All states are required by law to perform an autopsy in cases of sudden and unexplained deaths. Of the 8,000 such deaths referred to the chief medical examiner of the state of Maryland last year, approximately one-half required full autopsy.

CT autopsy compares favorably to conventional autopsy in several ways. In cases of suspicious death, the noninvasive procedure does not damage or destroy key forensic evidence, as can happen during a conventional autopsy. In addition, CT can be used in situations where autopsy may be prohibited by religious or cultural beliefs. CT autopsy is considerably less expensive than conventional autopsy and can be performed in a fraction of the time. A forensic medical examiner requires several hours to conduct a full autopsy, while multi-detector CT scanning and interpretation can be completed in about 30 minutes.

In Dr. Daly’s study, 20 autopsies were performed using whole-body multi-detector CT at the University of Maryland Medical Center.

Interpretations of the CT scans by two radiologists were compared with the results of a conventional autopsy performed on each body by state forensic medical examiners. Included were 14 victims of blunt trauma and six victims of a penetrating wound made either by a knife or ballistic weapon.

In all 14 blunt trauma cases and five of the six penetrating wounds, CT accurately identified the cause of death. The radiologists and forensic medical examiners evaluated the CT findings as comparable to conventional autopsy in 13 of the 14 blunt trauma cases and as a helpful adjunct in five of the six penetrating wound cases. In the study, CT was able to localize rapidly all 26 major ballistic fragments recovered from the victims during conventional autopsy.

“Autopsy is mandatory in deaths involving gunshot wounds, but CT can serve as a powerful adjunct to the conventional exam,” Dr. Daly said. “Performing CT imaging first may speed up a conventional autopsy, especially when it comes to locating ballistic fragments, which are so important to criminal investigations.”

In addition, CT was more sensitive than conventional autopsy in identifying air embolism, an often undetected important contributing factor in fatal trauma.

While CT has previously been used in autopsies of American soldiers and in a few countries outside the U.S., the technology is only now generating strong interest within the nation’s forensic community.

“Although these preliminary results are promising, more research is needed to show that CT could be widely used within the U.S. medical examiners system,” Dr. Daly said.

Toshiba Medical Systems Corporation, a leader in diagnostic and medical imaging, today announced its milestone of producing 20,000 CT units. To demonstrate Toshiba’s continued innovation in the evolution and development of computed tomography (CT), the 20,000th CT unit, an Aquilion™ 64, will be showcased at the Radiological Society of North America’s (RSNA) annual meeting held in Chicago, Nov. 25-30 (Booth # 7130).

“This milestone event is the culmination of years of innovation by Toshiba’s engineers based on the needs of our customers,” said Doug Ryan, senior director, CT Business Unit, Toshiba. “Through our commitment to leading innovation, we are constantly seeking to improve healthcare worldwide, and look forward to more milestones ahead.”

Toshiba’s advancement of CT technology is demonstrated in the KLAS Top 20: 2007 Mid-Year Report. In the report, Toshiba’s Aquilion 64-slice CT system was ranked first among all 64-slice CT systems, receiving the highest score in three out of four categories. Additionally, 100 percent of Aquilion 64 respondents said they would purchase the product again and would recommend the product to a colleague. Toshiba’s Aquilion 16-slice CT system was ranked second overall in CT, with 100 percent of the respondents saying they would recommend the product. For more KLAS information, please visit http://www.healthcomputing.com.

Industry recognition for Toshiba’s equipment continues to grow and can be attributed to Toshiba’s design philosophy for its CT products to produce the thinnest possible slices and clearest possible images. With the development of Toshiba’s first Aquilion multi-slice CT system, the company created Quantum Advantage detector technology, which offers the industry’s thinnest slices (0.5 mm) across all its CT systems. Building on this platform, Toshiba has been able to offer the same 0.5 mm slice thickness across the board, from the Aquilion 4 to the Aquilion 64. The Quantum Advantage ensures that whether physicians are doing a routine chest CT on the Aquilion 16-slice or a cardiac study on the 64-slice, consistent, high-quality images will be produced.

About Toshiba

With headquarters in Tustin, Calif., Toshiba America Medical Systems markets, sells, distributes and services diagnostic imaging systems, and coordinates clinical diagnostic imaging research for all modalities in the United States. Toshiba Medical Systems Corp., an independent group company of Toshiba Corp., is a global leading provider of diagnostic medical imaging systems and comprehensive medical solutions, such as CT, Cath & EP Labs, X-ray, Ultrasound, Nuclear Medicine, MRI and information systems. Toshiba Corp. is a leader in information and communications systems, electronic components, consumer products, and power systems. Toshiba has approximately 191,000 employees worldwide and annual sales of $60 billion.

The St Trudo regional hospital in Belgium has invested in the digital mammography system, Sectra MicroDose Mammography, from the IT and medical-technology company Sectra. This is the first Belgian order for Sectra’s digital mammography system, which provides the lowest dose on the market.

Early detection of breast cancer saves lives and approximately 2 million Belgian women undergo mammography examinations (both diagnostic and screening procedures) each year. With this order, the St Trudo Hospital will be the first in Belgium to offer women mammography examinations with the lowest radiation dose on the market.

The order also comprises Sectra breast imaging PACS, Sectra’s system for processing and archiving of patient data and images. The system will be integrated to the existing hospital image management system and combined with Sectra MicroDose Mammography form a complete digital solution.

“We chose Sectra MicroDose Mammography because we foresee throughput and ergonomic advantages but, most importantly, we will avoid exposing women to higher radiation levels than necessary. This will be of great benefit to the women and also to our practice,” says Dr. S. Verhamme and Dr. G. Vandenbosch , breast radiologists at the St Trudo Hospital Radiology Department.

“The Belgian market for digital mammography is taking off and most hospitals are now digitizing their mammography operations,” says Wim Schuur, Vice President Sales and Marketing of Sectra’s medical operations in the Benelux region. “At the same time, care quality awareness is increasing. We provide customers with systems that promote the development of safe digital mammography screening for women. Accordingly, we are well positioned to take advantage of this growing market.”

Safe and effective mammography screening

With retained or superior imaging quality, Sectra’s mammography system, Sectra MicroDose Mammography, generates by far the lowest dose of radiation among all of the systems offered on the market. The lowest radiation dose combined with good ergonomics and a well-conceived workflow enables mammography nurses and radiologists to work more efficiently and safely. At the same time, the radiation to which the women are exposed is minimized to the lowest conceivable level. Sectra MicroDose Mammography is based on unique detector technology that counts every X-ray photon. This is considered by many to be the X-ray technology of the future.

About St Trudo Hospital

The 310-bed St Trudo regional hospital serves the “Zuidwest Limburg” region and south Vlaams-Brabant. About 80 physicians and 600 staff members provide high-quality healthcare. The imaging department headed by Dr. Verhamme is a cornerstone in the radiology services delivered by the hospital.

About Sectra’s medical operations

Sectra develops and sells IT-systems and products for radiology, mammography and orthopedic departments. More than 950 hospitals worldwide use the system daily, together performing over 40 million radiology examinations annually. This makes Sectra one of the world leading companies within systems for handling digital radiology images (PACS). In Scandinavia, Sectra is the market leader with more than 50% of all film-free installations. Outside Scandinavia, Sectra’s system is installed at customers in North America and most major countries in Europe and the Far East.

About the Sectra Group

Sectra successfully develops and sells cutting-edge products in the expansive niche segments of medical systems and secure communication systems. The company was founded in 1978 and has its roots in the Linköping Institute of Technology in Sweden. Today, Sectra has offices in eleven countries and operates through partners worldwide. Sales in the 2006/2007 fiscal year totaled SEK 673 million. The Sectra share is quoted on the Nordic Exchange in Stockholm.

Insight Agents GmbH has announced the European launch of two new generic contrast media solutions for injection. MAGNEGITA® 500 Micromol/ml (Gadopentetate Dimeglumine) is about to be introduced for MRI in 22 European countries* and IOPAMIGITA® 300 mg Iod/ml (Iopamidol) will be available for X-ray/CT in Germany. Insight Agents plans to launch the products in other countries excluding the U.S. as soon as a product authorisation for the respective countries is granted. The company is also looking for (i) distributors worldwide and (ii) international members to join its medical advisory board.

At the same time, Insight Agents presents an attractive business model, which includes a broad range of services to radiologists. These include top purchase conditions from one of Europe’s largest group purchasing organisations in radiology. Instead of an expensive sales force, Insight Agents provides value added consulting services (see http://www.radiology-management.com) for hospital and private radiologists. Additionally, radiologists are offered a highly profitable and legally proven investment in a fast growing international venture with a promising development pipeline in an industry that will become fully generic in the next 5 years.

MAGNEGITA® and IOPAMIGITA® are produced in Europe, providing well-established active substances at an attractive price. “Our one-stop product range with surprisingly wide indication lists has a significant substitution potential in MRI and CT. As of today, our pro-active ingredients contribute to considerable cost savings in the health care sector”, Dr. Johannes Schmidt-Tophoff, CEO of Insight Agents, says. “In addition, Insight Agents offers shares to radiologists and is committed to working hard for a potential benefit to radiology budgets and lobbying.”

MAGNEGITA® and IOPAMIGITA® are neither available, nor offered for sale, nor available for use in the U.S. They are also not approved for use in the U.S. by the U.S.F.D.A. Insight Agents is not seeking distributors in or for the U.S. market.

About the products

MAGNEGITA® 500 Micromol/ml is the first European-wide authorized generic Gadopentetate Dimeglumine. With one of the widest indication lists among Gadolinium-based contrast agents, MAGNEGITA® can be used for the majority of contrast-enhanced MRI procedures in both adults and pediatric patients, including newborns. In addition to its indications in contrast-enhanced imaging of the whole body, the CNS and angiography (excluding coronary arteries), MAGNEGITA® is also indicated for imaging of the heart to measure myocardial perfusion under pharmacological stress conditions and for viability diagnostics (using delayed enhancement). Comprehensive presentation forms of MAGNEGITA® include glass vials of 5, 10, 15, 20, 30 and 100 mL. Prefilled syringes are pending approval and are expected to be available in 2008.

IOPAMIGITA® 300 mg Iod/ml (Iopamidol): Indications of this non-ionic contrast medium for X-ray and CT examinations are arteriography, angiography throughout the cardiovascular system, peripheral venography (phlebography), digital subtraction angiography, urography and intravenous adult and pediatric contrast enhancement of CT head and body imaging. IOPAMIGITA® is supplied in infusion bottles with a fill of 50, 75, 100 or 200 mL.

About Insight Agents

Insight Agents GmbH is a subsidiary of Curagita AG and develops, produces and distributes contrast media. It has branch offices in Germany, Austria, Switzerland, France and Belgium as well as distributors in many countries. Insight Agents also holds the German authorisations for all other strengths of Iopamidol and for Iohexol and plans to expand its portfolio to include a full and internationally available product range of generic contrast agents.

About Curagita

Founded in 1999, Curagita AG is the leading independent radiology services company in Germany, managing a cooperative radiology group of 200 radiologists. The objectives of the cooperative are to save costs, to implement quality combines and to use marketing and contracting synergies as a powerful group generating value added for referring doctors, patients and insurances. By group purchasing of contrast agents, consumables and equipment/IT incl. maintenance contracts, the costs of participating radiologists as well as of health insurances are significantly reduced. Other common projects include mammography screening, PET-CT, prevention programs, information portal http://www.radiologie.de, indication guidelines for referrals, teleradiology, ISO-quality management, consulting incl. external management, benchmarking of departments and centers, transactions and restructuring for hospital departments and imaging centers. In 2006, Curagita was awarded “Service Company of the Year” and “Top-10-Grow-up-Company”.

* Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France (under review, expected 2008), Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Poland, Slovakia, Slovenia, Spain, Sweden, United Kingdom and Switzerland (under review, expected 2007).