Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Nexavar(R) (sorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that accounts for 95 percent of all liver cancer cases in Japan(1). Nexavar is also currently available in Japan as an approved treatment for unresectable or metastatic renal cell carcinoma (RCC).

The approval in Japan was based on the international, Phase 3 double-blind, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) study that evaluated more than 800 patients who received no prior systemic therapy. The study found that Nexavar improved overall survival in patients with HCC by 44 percent (HR=0.69; p=0.0006) versus placebo. Based on SHARP results, Nexavar is currently approved in more than 70 countries for liver cancer, including the U.S. and countries in Europe.

“Liver cancer is one of the leading causes of cancer-related deaths in Japan, and the incidence is continuing to rise,” said Gunnar Riemann, member of the Executive Committee of Bayer HealthCare. “We are pleased with today’s approval and what it may mean for liver cancer patients in Japan and their families who now have a therapy like Nexavar that has the potential to extend their lives.”

In Japan, approximately 40,000 people are diagnosed with liver cancer each year and approximately 36,000 die from the disease, making primary liver cancer the third leading cause of cancer-related death in Japan.(2)

Hepatitis B viral infection (HBV) and hepatitis C viral infection (HCV) are leading risk factors for developing primary liver cancer worldwide, with HCV being the primary risk factor in Japan. An estimated 80 to 90 percent of Japanese patients diagnosed with liver cancer have HCV.(3)

“This is a significant milestone in the Japanese region where patients, who have high rates of liver cancer, are truly in need of a treatment option that improves survival,” said Laura Brege, executive vice president and chief operating officer at Onyx Pharmaceuticals, Inc. “This latest approval provides further evidence that Nexavar is an important therapy for patients with liver cancer as well as kidney cancer, an indication for which Nexavar was first approved in Japan.”

Hepatocellular carcinoma is the most common form of liver cancer(4) and is responsible for about 90 percent of the primary malignant liver tumors in adults(5). Liver cancer is the sixth most common cancer in the world(6) and the third leading cause of cancer-related deaths globally(7). More than 600,000 cases of liver cancer are diagnosed worldwide each year (more than 400,000 in China, South Korea, Japan and Taiwan, 54,000 in the European Union, and 15,000 in the United States) and the incidence is increasing(4). In 2002, approximately 600,000 people died of liver cancer including approximately 370,000 in China, South Korea and Japan, 57,000 in the European Union, and 13,000 in the United States(4).

Nexavar’s Differentiated Mechanism

Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) - two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Preclinical models have also demonstrated that Raf/MEK/ERK has a role in HCC; therefore blocking signaling through Raf-1 may offer therapeutic benefits in HCC.

Nexavar is currently approved in more than 70 countries for liver cancer and in more than 80 countries for the treatment of patients with advanced kidney cancer. Nexavar is also being evaluated by the companies, international study groups, government agencies and individual investigators as a single agent or combination treatment in a wide range of cancers, including, lung cancer, breast cancer, colorectal cancer, lung cancer, ovarian cancer, and as an adjuvant therapy for kidney and liver cancer.

Important Safety Considerations For Patients Taking Nexavar

Based on the currently approved U.S. package insert for the treatment of patients with unresectable hepatocellular carcinoma, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. Bleeding with a fatal outcome from any site was reported in 2.4% for Nexavar and 4% in placebo. The incidence of treatment-emergent cardiac ischemia/infarction was 2.7% for Nexavar vs. 1.3% for placebo. Most common adverse events reported with Nexavar in patients with unresectable HCC were diarrhea, fatigue, abdominal pain, weight loss, anorexia, nausea and hand-foot skin reaction. Grade 3/4 adverse events were 45% for Nexavar vs. 32% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world’s leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units: Women’s Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

About Onyx Pharmaceuticals, Inc.

Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar(R) (sorafenib) tablets, a small molecule drug.

Forward Looking Statements

This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer Web site at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

This news release also contains “forward-looking statements” of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the results of the clinical development, safety, regulatory processes, commercialization efforts or commercial potential of Nexavar. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Onyx’s Annual Report on Form 10-K for the year ended December 31, 2008, filed with the Securities and Exchange Commission under the heading “Risk Factors” and Onyx’s Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.

Nexavar(R) (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals, Inc.

References

(1) British Medical Journal (BMJ), Liver cancer toll high in Japan, Adam Easton; 1999 June 5; 318(7197): 1510.

(2) Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. Available at: http://www-dep.iarc.fr. Accessed April 2009.

(3) El-Serag HB, Rudolf KL. Hepatocellular carcinoma: epidemiology and molecular carcinogenesis. Gastroenterology. 2007; 132(7); 2557-2576.

(4) El-Serag HB, Mason AC. Rising incidence of hepatocellular carcinoma in the United States. N Engl J Med. 1999;340:745-750

(5) Available at American Society of Clinical Oncology

(6) Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004.

(7) Forner A, Hessheimer AJ, Isabel Real M, Bruix J. Treatment of hepatocellular carcinoma. Crit Rev Oncol Hematol. 2006; 60: 89- 98.

Source: Bayer HealthCare Pharmaceuticals

View drug information on Nexavar.

Overall prognosis for gallbladder cancer appears to be improving, although many patients still have incurable disease and poor survival rates, according to a report in the May issue ofArchives of Surgery, one of the JAMA/Archives journals.

An estimated 9,520 new cases of gallbladder or bile duct cancer were diagnosed in the United States in 2008, and approximately 3,340 of these patients will die of their disease, according to background information in the article. The disease affects women more frequently than men and surgical removal of diseased portions of the organ (resection) is the only curative treatment. However, many patients present to the clinician with advanced-stage disease and are not candidates for this procedure. “Gallbladder cancer is characterized by locally aggressive behavior, with early spread to regional lymph nodes and distant dissemination,” the authors write. “In addition, it recurs rapidly even after presumed curative resection.”

Ioannis T. Konstantinidis, M.D., of Massachusetts General Hospital and Harvard Medical School, Boston, and colleagues identified 402 patients with gallbladder cancer at one university-affiliated tertiary care center between 1962 and 2008. Of these, 260 underwent surgical exploration at the same institution and were included in the data analysis. They were diagnosed during three periods: period A (1962 to 1979, 83 patients), period B (1980 to 1997, 105 patients) and period C (1998 to 2008, 72 patients).

Overall median (midpoint) survival improved from 3.5 months in period A to 6.5 months in period B and 12 months in period C. “The stage of disease at presentation affected the survival in all time periods (stage I, median survival not reached; stage II, 10.3 months; stage III, 4.7 months and stage IV, four months),” the authors write. “The survival of patients who presented with advanced-stage disease and who underwent palliative [treating symptoms only] procedures remained poor in all periods (A, 1.9 months; B, 3.9 months; and C, 3.6 months).”

Of the 260 cancer patients who had surgery to explore the extent of their disease, 151 (58.1 percent) underwent resection. Unresectable disease was found in eight patients and became less common over time (44.4 percent in periods A and B, 17.3 percent in period C).

Between January 1994 and March 2008, 6,881 laparoscopic cholecystectomies (procedures to remove gallstones) were performed at the same facility; 17 cases of gallbladder cancer were discovered incidentally during these procedures. “When gallbladder cancer is found incidentally during or after a cholecystectomy, aggressive resection should be performed either during the present operation or during a second operation,” the authors write. “In our series, 56 percent of patients who underwent re-exploration [a second surgery] were found to have residual disease. Patients underwent re-exploration at a median of 41 days, similar to other series. Increased T stage at cholecystectomy correlated with a higher frequency of residual disease.”

“Patients with gallbladder cancer continue to have a poor prognosis because many of the patients present with advanced disease,” the authors write. “Earlier detection coupled with an aggressive surgical approach leads to better outcomes. A better understanding of the molecular pathways contributing to the development of gallbladder cancer is needed to develop improved adjuvant therapies to increase overall survival.”

Arch Surg. 2009;144[5]:441-447.

Source
Archives of Surgery

In a study that could help explain the connections between depression and cancer, researchers at the University of Chicago have used an animal model to find, for the first time, a biological link between tumors and negative mood changes.

The team determined that substances associated with depression are produced in increased quantities by tumors and are transmitted to the brain.

Additionally, pathways that normally moderate the impact of depression-causing substances are disrupted when a tumor develops.

The research further showed that tumors induce changes in gene expression in the hippocampus, the portion of the brain that regulates emotion. Although researchers have long known that depression is a common outcome for people diagnosed with cancer, they had not known if it was brought on by a patient learning of the diagnosis or the result of treatments such as chemotherapy. Now a third source may have been identified.

“Our research shows that two types of tumor-induced molecules, one secreted by the immune system and another by the stress axis, may be responsible,” said Leah Pyter, a postdoctoral fellow and lead author of a paper, “Peripheral Tumors Induce Depressive-like Behaviors and Cytokine Production and Alter Hypothalamic-Pituitary-Andrenal Axis Regulation,” which is published in the current issue of the Proceedings of the National Academy of Sciences.

“Both of these substances have been implicated in depression, but neither has been examined over time frames and magnitudes that are characteristic of chronic diseases such as cancer,” she said.

For their research, the team conducted a series of tests on about 100 rats, some of whom had cancer to determine their behavioral responses in tests of emotional state.

“Rats are commonly used to test drugs that are being studied for potential human benefits, such as treating depression,” said Brian Prendergast, Associate Professor of Psychology at the University of Chicago, and the senior author on the study. “In this case, examining behavioral responses to tumors in non-human animals is particularly useful because the rats have no awareness of the disease, and thus their behavioral changes were likely the result of purely biological factors.”

The team used tests commonly used in testing anti-depressants on rats and found that the rats with tumors became less motivated to escape when submitted to a swimming test, a condition that is similar to depression in humans. The rats with tumors also were less eager to drink sugar water, a substance that usually attracts the appetites of healthy rats.

Further tests revealed that the rats with tumors had increased levels of cytokines in their blood and in the hippocampus when compared with healthy rats. Cytokines are produced by the immune system, and an increase in cytokines has been linked to depression.

The team also found that stress hormone production also was altered in rats with tumors. The rats with tumors also had dampened production of the stress hormone corticosterone. The hormone helps regulate the impact of cytokines and reducing its production therefore increases the impact of cytokines.

The project was supported by an American Cancer Society fellowship, an NIH grant and a grant from the Brian Research Foundation.

Source:
William Harms

University of Chicago

A year-long celebration marking the 25th season for the world’s largest grassroots fundraising activity, the American Cancer Society Relay For Life, is underway. The month of May marks the beginning of the 25th “birthday” year of Relay, the Society’s signature fundraising initiative, and 5,000 communities in the United States and 20 other countries will be celebrating and participating in Relay For Life events through the end of August.

Relay For Life started in 1985, when Dr. Gordy Klatt, a colorectal surgeon in Tacoma, Wash., circled a track for 24-hours to raise money for the American Cancer Society. The program has grown from one man’s passion into the world’s largest non-profit fundraising special event and community movement to end cancer, with one in every 100 Americans participating.

Today, more than 3.5 million people worldwide take part in Relay For Life each year, to celebrate those who have battled cancer, remember loved ones lost, and fight back against the disease. Because of those millions of dedicated Relayers, the American Cancer Society is saving lives and helping people celebrate more birthdays.

The funds raised by Relay For Life have played a role in nearly every major cancer research breakthrough in the last 25 years, leading to groundbreaking discoveries into cancer’s causes and cures. As well, Relay has contributed substantially to the American Cancer Society’s funding of crucial prevention and early detection services; numerous, life-enhancing patient support programs; and advocacy initiatives that encourage lawmakers to do their part to defeat cancer, while rallying communities to join the fight.

To participate in Relay’s 25th birthday year celebration and join the movement, consumers can visit http://www.RelayForLife.org, where they will find more information on:

- Joining or starting a team to raise money,
- Volunteering at an event in their community, and/or
- Making a donation to Relayers they know.

The American Cancer Society saves lives by helping people stay well, helping people get well, by finding cures and by fighting back. Relay For Life rallies communities and helps the American Cancer Society work toward its goal of a world with less cancer and more birthdays.

Source
American Cancer Society

SAN DIEGO, May 19 — Early-phase treatment modalities — ranging from a stem cell attack on metastatic cancer to what may be a true silver bullet against pulmonary infection — were highlighted at the annual meeting of the American Thoracic Society.

The studies are all in the pre-clinical stages but could represent “exciting” new approaches to a range of illnesses, according to Beth Laube, Ph.D., of Johns Hopkins University School of Medicine, who moderated a press conference at which the studies were discussed.

The stem cell study combines two separate areas of research, according to Michael Loebinger, M.D., of University College London.

• Explain to interested patients that new ways of delivering drugs may have important clinical applications, but note that this research is in its early stages.
• Note that this research was published in abstract form and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

On one hand, he said, it has been known for some time that mesenchymal stem cells in bone marrow have the ability to home in on and bind to tumor cells.

On the other, he said, researchers have known that the molecule dubbed TNF-related apoptosis-inducing ligand — or TRAIL — kills cancer cells but not normal cells.

Combining the two using genetic engineering, Dr. Loebinger told reporters, the new cells induced programmed cell death in vitro in a variety of cancer cells, including lung, squamous cell, breast, and cervical cancer cells, while leaving normal cells intact.

In mice, Dr, Loebinger said, injections of the cells reduced tumor growth significantly (at P<0.001 compared with sham injections) when the researchers grafted tumor cells into the animals.

And in animals prone to develop lung tumors (similar to human lung metastases), intravenous injections of the engineered cells meant that 38% of the animals did not develop tumors at all, and the rest had significantly reduced (at P=0.03) growth and number of tumors.

“The two different aspects of this therapy have been used in humans,” he said, but not together. TRAIL, for instance, has been used in phase I and II trials and appears to be safe.

The combination,” he said, “is quite promising” and would be applicable to a wide range of cancers.

Dr. Laube said the experiments are “very, very exciting,” not least because of the ability of the cells to seek out and destroy tumor cells wherever they are in the body.

“That’s got to be helpful to patients,” she said.

Another new treatment modality targeted cystic fibrosis. In CF, the ion channel defects reduce airway surface liquid, which results in reduced mucociliary clearance and recurrent infections, said Andrew Hirsh, Ph.D., of Parion Sciences in Durham, N.C.

One treatment that is sometimes used is the sodium channel blocker amiloride (Midamor), but it has several disadvantages, Dr. Hirsh said, including a relatively short effective span that requires frequent use.

Dr. Hirsh was reporting pre-clinical data on a new sodium channel blocker, dubbed GS-9411, that he said was 100 times more potent than amiloride (in terms of the 50% inhibition concentration).

The drug also was able to maintain 85% of sodium channel blockage after multiple washes, compared with less than 10% for amiloride, which should translate to longer effective time in the body, he said.

The drug, delivered as an aerosol, is now in phase I clinical trials with healthy volunteers, Dr. Hirsh said.

Meanwhile, researchers led by Carolyn Cannon, M.D., Ph.D., of Washington University School of Medicine in St. Louis, are studying how to deliver tiny nanoparticles containing silver compounds to lung infections.

So-called silver carbene complexes have been shown to have antibiotic activity and one developed by Dr. Cannon and colleagues — SCC1 — is now the subject of an investigational new drug application, she said.

For technical reasons, that compound can’t be put in nanoparticles, which she and colleagues thought would allow them to reduce the dose and number of doses needed to achieve a clinical effect.

So they synthesized another molecule — dubbed SCC22 — which could be loaded into nanoparticles of L-tyrosine polyphosphate and delivered using a nebulizer.

In mice infected with Pseudomonas aeruginosa, Dr. Cannon said, 100% survived if they were treated intra-nasally with the SCC-loaded particles, while all of the untreated mice died.

The survival advantage left the researchers “surprised and thrilled,” Dr. Cannon said.

With the nano approach, she said, the mice could be given a smaller dose of the compound and be treated only once a day, compared with twice a day for the drug alone.

Although the drug was tested in vivo against P. aeruginosa, Dr. Cannon said, it has been shown in vitro to be “effective against every bacterial species tested to date.”

It has not escaped her notice, she said, that — if the animal studies are replicated in humans — the compounds will be a true silver bullet against bacteria.

The stem cell study was supported by the Medical Research Council of the United Kingdom. Dr. Loebinger said he had no conflicts. The sodium channel blocker study was supported by Parion Sciences. Dr. Hirsh is an employee of the company and holds stock options. The silver study was supported by the NIH and an internal grant from Washington University. Dr. Cannon said she had no conflicts.

Primary source: American Thoracic Society

Source reference:
Hirsh AJ et al. “GS-9411: A Potential Aerosol Pharmacotherapy for CF” Am J Respir Crit Care Med 2009; 179: Abstract 1195.

Additional source: American Thoracic Society

Source reference:
Cannon CL et al. “Nebulized Nanoparticles Loaded with Broad-Spectrum Silver-Based Antimicrobials for Depot Treatment of Pulmonary Infections” Am J Respir Crit Care Med 2009; 179: Abstract 5035.

Additional source: American Thoracic Society

Source reference:
Loebinger MR et al. “On the TRAIL of a Killer: TRAIL-Expressing Mesenchymal Stem Cells Are Able To Target and Eliminate Lung Metastases” Am J Respir Crit Care Med 2009; 179: Abstract 5132.

IDF, WHF and UICC join forces

The International Diabetes Federation (IDF), International Union Against Cancer (UICC) and World Heart Federation (WHF) have issued a joint statement that calls on the international community to address urgently the epidemic of non-communicable diseases (NCDs), responsible for 35 million deaths a year. The statement demands a substantial increase in funding for NCDs and greater availability of essential medicines, among other urgent responses, in a way to accelerate achievement of the health Millennium Development Goals.

Public health experts are concerned about the impact of the global economic crisis and warn that the emerging epidemic of NCDs is threatening to overwhelm healthcare systems worldwide unless action is taken. Cardiovascular disease, diabetes, cancer and chronic respiratory diseases cause 60% of all deaths worldwide, with four in every five of these deaths occurring in low- and middle-income countries. NCDs are an under-appreciated cause of poverty and now present a serious barrier to economic development. They are estimated to reduce gross domestic product (GDP) by up to 5% in many low- and middle-income countries, dealing a double blow to fragile economies struggling in the global recession.

Professor Pekka Puska, President of the World Heart Federation states: “We can no longer ignore the burden that cardiovascular disease, together with the other NCDs including diabetes, cancer and chronic respiratory diseases, is placing on countries that are least equipped to deal with them. We urgently call on the international community to ensure that the funding models applied to infectious diseases, such as HIV/AIDS, TB and malaria are expanded to stop the spiralling death rates from NCDs before the most vulnerable are pushed further into the poverty trap.”

NCDs impact on the world

IDF, WHF and UICC are united by their concern with the consequences of physical inactivity, tobacco use and poor diet, three avoidable risk factors that contribute significantly to the NCDs responsible for 60% of global mortality.

Diabetes is a leading cause of blindness, kidney failure, heart attack, stroke and amputation. The number of people living with diabetes has increased considerably over the past 30 years. In 1985, an estimated 30 million people worldwide had diabetes. A little over a decade later, the figure had risen to over 150 million. Today, according to IDF figures, it exceeds 250 million. A further 300 million are at high risk of developing diabetes. Unless action is taken to implement effective prevention and control programmes, IDF predicts that the total number of people with diabetes will reach 380 million by 2025.

Cardiovascular disease (CVD) is the leading cause of death worldwide. An estimated 17.2 million people die from CVD each year, and that toll could increase to almost 20 million by 2015. The incidence of deaths attributable to CVD continues to rise sharply, accounting for 30% of all deaths globally. Around 80% of these deaths and 87% of related disabilities occur in low- and middle-income countries. Cardiovascular disease affects the heart or blood vessels and includes heart disease, stroke and high blood pressure.

Cancer is the second leading cause of death worldwide. More than 11 million new cases are diagnosed each year, and about 8 million people die from cancer - over 70% of them in low- and middle-income countries. On current trends, 15.5 million people will be diagnosed with cancer in 2030, and about 12 million people will die from the disease. Yet, we have more knowledge than ever before on how to bring cancer under control. About one-third (30-40%) of all cancers can be prevented, a further third can be cured (given early diagnosis and treatment), and effective palliative care can be provided to patients.

In its 2009-2013 Action Plan for the Global Strategy for the Prevention and Control of Noncommunicable Diseases, the World Health Organization identifies international partnerships as paramount in the global struggle against NCDS. WHO calls for concerted action on a global scale and identifies a key role for non-governmental organizations. IDF, WHF and UICC have taken up this call. Combined, the three organizations represent the interests of 730 member organizations in over 170 countries. They have joined forces to create a powerful voice for change and urge the international community to take action in the face of the NCD epidemic.

Professor David Hill, President of the International Union against Cancer states: “Now, more than ever, we need to join efforts to give cancer and the other NCDs the priority they deserve. The advantages that stand to be gained from the strength of strategic international partnerships, such as the one between our three organizations, will contribute towards a more effective global response to NCDs.”

Call for Action

The joint statement issued today in Geneva was timed to coincide with the meeting of the World Health Assembly. The organizations highlighted their support for the WHO Action Plan and call for the international community to:

1. Ensure the availability of essential medicines for people living with NCDs in low- and middle- income countries

2. Immediately and substantially increase financing for NCDs
3. Integrate NCD prevention into national health systems and the global development agenda
4. Create a Special Envoy of the UN Secretary-General for NCDs
5. Support a UN General Assembly Special Session on NCDs

WHO has shown that simple, cost-effective solutions exist to take on the burgeoning epidemic of NCDs. If the international community acts now, hundreds of millions of lives could be saved and the quality of life improved for millions more. Such action would bring the international community closer to achieving the UN Millennium Development Goals. Failure to act will have a detrimental effect on healthcare systems and economies worldwide. Governments who invest in prevention now will be spared the overwhelming costs of chronic care later.

Professor Martin Silink, President of the International Diabetes Federation explains: “the world has not previously had to cope with an epidemic of NCDs. Health systems will need to adapt fast to mobilize new and existing resources to tackle the epidemic through prevention and education. The majority of people with non-communicable diseases like diabetes, cardiovascular disease and cancer are responsible for most of their own care most of the time. Health systems will need to support the role of people with NCDs and see them as part of the solution.”

Source:
Kerrita McClaughlyn

International Diabetes Federation

The Multiple Myeloma Research Foundation (MMRF) has announced a collaboration with the Broad Institute of MIT and Harvard to systematically uncover the molecular changes underlying multiple myeloma by whole genome sequencing of individual patient tumors. The MMRF will provide both patient samples for analysis as well as funding for the project. All data from this collaboration will be put in the public domain.

“We are delighted to work with the MMRF, which has been a visionary organization in accelerating cancer research for the sake of patients and their families,” said Eric S. Lander, PhD, Director of the Broad Institute. “Through our work together on this critical pilot project in whole cancer genome sequencing, we hope not only to advance clinical progress for multiple myeloma, but to build knowledge and technical capabilities that can be applied to many other human cancers.”

“Three years ago, the MMRF launched a partnership with the Broad Institute and the Translational Genomics Research Institute - the Multiple Myeloma Genomics Initiative - a comprehensive genome mapping program to identity new targets and eventually new therapies for this incurable disease,” said Kathy Giusti, Founder and CEO of the MMRF, and a multiple myeloma patient. “As part of that larger effort, we are confident that this groundbreaking research will accelerate the development of next-generation treatments to extend the lives of multiple myeloma patients. Additionally, we believe that this work will not only ultimately pave the way to a cure for patients with multiple myeloma, but will benefit patients with other types of cancer.”

The creation of comprehensive catalogs of all commonly occurring cancer mutations is a current approach of several national and international consortia, including The Cancer Genome Atlas (TCGA) led by the US National Institutes of Health and the International Cancer Genome Consortium (ICGC), to understand major tumor types such as leukemia, lung cancer, glioblastoma and others. To date, only a handful of whole cancer genomes have been sequenced and only one has been published.

“The few cancer genomes sequenced to date have been informative, but we need many more to transform cancer research and ultimately cancer therapy,” said Stacey Gabriel, PhD, Co-Director of the Broad Institute’s Genome Sequencing and Analysis Program. “This exciting collaboration with the MMRF will advance these goals by contributing public domain data.”

Source:
Nicole Davis

Broad Institute of MIT and Harvard

A new sensor device allowing doctors to receive data on the precise amount of radiation being delivered to tumors and surrounding tissue is now being offered at Maury regional Medical Cancer Center. Maury Regional Medical Center is the first in Tennessee to use the technology called DVS® (Dose Verification System) for breast cancer patients undergoing radiation treatment.

John P. W. Brown, M.D., surgeon, inserts a device that is as small as the length of a dime and can be inserted inside the patient’s tumor bed in less than 15 minutes. After each radiation treatment, the DVS® provides the radiation oncologists (Dr. Michael Sattasiri and Dr. Joel Kochanski) with a measurement of the actual amount of radiation hitting the target where the malignant tumor was removed. This allows Dr. Sattasiri and Dr. Kochanski to make any necessary adjustments to the prescribed dose during the radiation therapy treatment course, making it more precise. The DVS® sensor wirelessly transmits data to the physician immediately following each radiation treatment.

Increasing cancer cure rates and decreasing complications associated with radiation therapy are the goals physicians strive for when treating their patients. DVS® is the first wireless, implantable radiation sensor available in the United States to assist physicians in obtaining these goals. The sensor provides data on the precise amount of radiation being delivered to the tumor and surrounding normal tissue.

“Patients with breast cancer are well educated and often spend considerable amounts of time researching new treatment options to help them in their battle with cancer. They also place tremendous value on being treated with the most up to date technologies. We are excited to be the first facility in Tennessee to offer this technology to patients with breast cancer,” says John Brown, M.D., breast surgeon at Maury Regional Medical Center. “Traditional radiation therapies rely on knowing the exact location of the tumor, but provide no guidance on quantifying the actual dose being delivered to the tumor. DVS® provides an unprecedented level of precision to physicians and added reassurance to breast and prostate cancer patients,” he adds.

Developed by Sicel Technologies, Inc., the DVS® sensors are implanted during a minimally invasive procedure and gather data on the amount of radiation being delivered to the tumor and normal tissue. Wireless technology transmits the radiation dose information to a hand-held monitor during each of the daily treatments, enabling doctors to verify that the patient is receiving the prescribed dose. If a dose deviation is detected, the treatment plan can be modified and corrected for each individual patient. Accurate delivery of the appropriate dose of radiation is critical for tumor control and cure.

“Maury Regional Medical Center is committed to bringing patients innovative new technologies that can have a positive effect on their end results. We provide many options to our patients and are now screening breast cancer patients to receive this breakthrough technology,” says Dr. Brown, who inserted the first DVS® sensor at Maury Regional Medical Center.

Source
Maury Regional Medical Center

Researchers at Fox Chase Cancer Center uncovered a genetic pattern that may help predict how gastrointestinal stromal tumor (GIST) patients respond to the targeted therapy imatinib mesylate (Gleevec). Moreover, their findings point to genes that could be suppressed in order to make these tumors respond more readily to imatinib.

Lori Rink, PhD, a postdoctoral fellow in the laboratory of Andrew K. Godwin, PhD, at Fox Chase, presents their findings at the 2009 Annual Meeting of the American Society of Clinical Oncology. The study uses tumor specimens collected as part of a Phase II trial on the use of the drug before surgical resection for GIST, which is led by the Radiation Therapy Oncology Group, a national clinical cooperative group funded by the National Cancer Institute.

“Imatinib has been the first drug that has really made a dent in GIST progression - up to 80 percent response - yet some GIST patients have little or no response to the drug,” says Rink. “We are looking to see how we can help clinicians make better decisions in applying imatinib or additional therapies to their GIST patients.”

Rink and her colleagues followed 63 GIST patients in the RTOG trial, who were given imatinib before surgery for primary or recurrent tumors. Using tumor samples collected before and after the patients were given the drug, the researchers studied which genes were active in the tumors and then compared these profiles of gene expression to how well the tumors responded to short-term imatinib treatment.

According to Rink, they found a selection of 38 genes that were expressed higher in tumors that did not respond well to imatinib. Of these, they identified 20 KRAB-zinc finger genes that encode for proteins that typically act as transcriptional repressors of other genes. Ten of these genes, Rink says, are located to a single section of Chromosome 19.

“Our data indicate that if we can alter the activity of some of these KRAB-zinc finger proteins, we may be able to enhance the effectiveness of imatinib therapy,” Rink says.

Funding for this study comes from the National Cancer Institute, the Radiation Therapy Oncology Group Foundation and the GIST Cancer Research Fund.

Abstract #10533:
Correlation of gastrointestinal stromal tumor (GIST) gene expression signatures and response to imatinib mesylate in the Radiation Therapy Oncology Group phase II clinical trial S-0132.
Poster Discussion, Saturday, May 30
2:00 p.m.-6:00 p.m. - Level 2, W240A
5:00 p.m.-6:00 p.m. - Level 2, West Hall F5

Source:
Diana Quattrone

Fox Chase Cancer Center

View drug information on Gleevec.

Researchers in the University of Colony Department of Urology hit matured a newborn method that could support physicians watch the prizewinning instruction of communication for patients pain from sac cancer.

Bladder cancer is typically aerated by neoadjuvant chemotherapy, a communication in which chemotherapy is administered to turn the filler of the cancer preceding to surgery, with the digit most commonly utilised therapy regimens existence M-VAC (methotrexate, vinblastine, adriamycin and cisplatin) and GemCis (gemcitabine and cisplatin). While M-VAC has daylong been thoughtful the more multipotent program and is ofttimes offered as the metallic accepted for treatment, it is quite cyanogenic and famous to successfully effect exclusive most 25 proportionality of patients who obtain it. Recent studies in metastatic cancer declare that GemCis is equally multipotent and haw be meliorate tolerated among patients; thus, it is commonly utilised in the neoadjuvant setting.

Dan Theodorescu, M.D., Ph.D., and colleagues hit unconcealed biomarkers whose countenance in patients’ piddle could accurately prognosticate whether or not a enduring is probable to move to M-VAC treatment. The biomarkers haw also prognosticate the probability of a flourishing outcome using the GemCis treatment. This novel, bioinformatics move to predicting the success of a portion communication over another regimens could advance to customized, more-effective communication for sac cancer patients.

“This is a promising, inexpensive and minimally intrusive possibleness move to appraise patients preceding to neoadjuvant chemotherapy,” said Theodorescu, academic of medicine and molecular physiology and administrator of the Apostle moneyman Urologic person Institute at U.Va.

The U.Va. Patent Foundation has filed a papers covering on the ingest of these biomarkers as a characteristic agency and is currently hunt an industrialized relation to boost amend and change the discovery. The biomarkers crapper easily be evaluated by assay (Enzyme-Linked Immunosorbent Assay) investigating or kindred profession in the urine.

“This elating newborn agency could enable physicians to watch not exclusive whether to travel with communication for sac cancer, but also which communication would be effective, on a case-by-case basis,” said Mikael C. Herlevsen, Ph.D., licensing assort at the U.Va. Patent Foundation. “This original profession shows a enthusiastic care of prospect and could hit a actual effect on patients’ lives.”

The National person Institute of the National Institutes of Health estimates more than 70,000 men and women throughout the U.S. module be new diagnosed with sac cancer in 2009

About the University of Colony Patent Foundation

The University of Colony Patent Foundation is a not-for-profit house that serves to alter U.Va. technologies to the orbicular activity by evaluating, protecting and licensing highbrowed concept generated in the instruction of investigate at U.Va. The Patent Foundation reviews and evaluates nearly 200 inventions per assemblage and has generated roughly $85 meg in licensing income since its manufacture in 1978.

Source: University of Colony

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