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NIH-FDA Collaboration Could Speed Innovations for Mesothelioma Treatment

Friday, March 12, 2010

by Nancy Meredith
In an effort to speed medical innovations to physicians and their patients, the United States Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have joined forces. The partnership has identified several key areas that could benefit including stem cells for Parkinson’s disease, safer pain medications, and personalized treatment for cancer through the use of markers.

Research is currently underway that could develop biomarkers for any cancer including mesothelioma making way for personalized treatment. Mesothelioma is a rare, aggressive form of cancer primarily caused by exposure to airborne asbestos fibers. There is no known cure for mesothelioma, however, many clinical trials and studies are in progress that could offer hope to mesothelioma patients.

Scientific Disciplines Come Together
Through collaboration the NIH and FDA will be developing initiatves to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients. To support this the agencies will bring together translational science and regulatory science.

Translational science is often referred to as the bench-to-bedside aspect of scientific discovery. This is where the discoveries are translated into practical applications. The scientists begin the process at "the bench" with basic research such as studying disease at the molecular level. They then provide the tools to clinicians to take the innovation to the clinical level or to the patient's bedside. This aspect is the NIH's discipline.

The FDA must then take the information from the translational research and develop policies and regulations that take the medical devices and products to market. Regulatory science is the science and tools used by the FDA and other government agencies to evaluate product safety, efficacy, potency, quality and performance to protect and benefit American citizens.

The agencies will be establishing a Joint NIH-FDA Leadership Council to spearhead collaborative work on important public health issues. The new council will ensure that regulatory considerations become an integral part of biomedical research planning, and that the latest science is integrated into the regulatory review process.

The Health and Human Services Secretary Kathleen Sebelius said that "collaboration between NIH and FDA will go a long way towards fostering access to the safest and most effective therapies for the American people."

Enhancing Regulatory Science and Encouraging Research
According to the FDA report "Speeding Progress to Patients" the development of new therapies has been in decline, and the costs of bringing them to market have soared.

This trend has had a negative impact on the economic health of the U.S. biotechnology industry. The report further states that “American lives are at risk” because the FDA's evaluation methods are not keeping pace with the changes in the drug discovery methodologies.

The NIH-FDA collaboration recognizes that breakthroughs in regulatory science are critical to ensure medical innovations reach the patients in a timely manner. In addition, incentives in the translational field are important.

Currently the FDA offers millions of dollars in grants each year per the U.S. Orphan Drug Act providing financial incentives to bring biological products for rare diseases, such as mesothelioma, to market. Only one drug, Alimta, has been approved as an orphan drug in the treatment of malignant pleural mesothelioma.

The joint team will make $6.75 million available over three years for work in regulatory science. The goal is to provide new methods for the scientific and regulatory communities to better evaluate medical product development.

Saving Lives
"I am confident that our strengthened coordination and collaboration with NIH will enhance our efforts and add important momentum toward achieving our common goals of improving health, reducing disease and saving lives," said Dr. Margaret A. Hamburg, M.D., Commissioner of Food and Drugs.

The FDA and the NIH will hold a public meeting in the spring to solicit input on how the agencies can work better together.

Sources:
NIH-FDA Collaboration
Speeding Progress
Hamburg Remarks



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posted by Nancy Meredith at 8:00 AM
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Rearcher to Study Link Between Mesothelioma and Cell Stress

Thursday, March 11, 2010

Dr. Stefan Marciniak of the University of Cambridge has been awarded funding for a project to study the relationship between cell stress and mesothelioma. The funding is provided by the British Lung Foundation and the June Hancock Mesothelioma Research Fund.

Marciniak and his colleagues have been studying endoplasmic reticulum (ER) dysfunction and the role it plays in many human diseases, including diabetes and cancer. It is critical for him and his researchers to understand the biological processes it provokes, and through this project he hopes to gain a better understanding of why mesothelioma progresses as it does.

Mesothelioma is a rare, aggressive cancer primarily caused by exposure to airborne asbestos fibers. Symptoms of mesothelioma may not appear until up to 50 years after initial exposure to asbestos. However, after symptoms become apparent, mesothelioma often rapidly progresses resulting in life-threatening complications.

The study will look at proteins produced by ER. Marciniak has shown that when ER proteins accumulate the cell is said to experience "ER stress," which is increased in mesothelioma cells. The researchers hope to assess whether the amount of ER stress on cells can predict the speed at which mesothelioma develops. This will in turn help determine the success of mesothelioma treatments including chemotherapy.

Upon receiving the grant Dr. Stefan Marciniak said,"I hope to be able to take my findings out of the laboratory to improve the treatments available to my patients in the future." Mesothelioma is highly aggressive and is resistant to many standard cancer treatments. Currently there is no known cure for mesothelioma.


Marciniak Receives Grant


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Labels: mesothelioma, Research News

posted by Nancy Meredith at 8:00 AM
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Predicting Post-Surgery Survival for Mesothelioma Patients

Wednesday, March 10, 2010

Results from a new study indicate that an RNA molecule found in cancerous tissue may be useful in predicting a mesothelioma patient’s chances for survival after surgery. The researchers reported in Cancer Research that the presence of even one specific microRNA has significant predictive value for determining the course that mesothelioma will take after surgery.

Mesothelioma, an unusual form of cancer caused by exposure to airborne asbestos fibers, often has a complex growth pattern making complete surgical removal a difficult task. The goal of the surgery is to achieve a macroscopically-complete resection, which refers to the removal of all visible tumor cells. This type of test will give doctors another tool to identify post-surgical treatment for patients including chemotherapy or radiation.

MicroRNAs play a key role in biological processes, such as development, cell proliferation and apoptosis (the process of cell death). Thus, altered microRNA is likely to contribute to cancer and other diseases. MicroRNAs have been used as prognostic markers for numerous forms of cancer and as biomarkers to pinpoint the tissue where cancer originated. But few studies have explored the role of microRNAs in malignant pleural mesothelioma.

“Mesothelioma is a terrible disease, and this specific microRNA may help doctors and clinicians give patients and their families a more accurate prognosis of the disease and how post-surgical patients will likely respond,” said attorney Joseph W. Belluck. “It’s an important step in understanding and combating this disease.”

Belluck, a partner in the law firm Belluck & Fox, said the research represented a potential breakthrough in helping guide treatment of mesothelioma patients.

The research was supported in part by philanthropic grants from the law firm of Belluck & Fox, LLP in New York and the Stephen Banner Lung Cancer Foundation.

Full Story




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Labels: mesothelioma, Research News

posted by Nancy Meredith at 7:48 AM
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9-11 Responders Have Access to Mesothelioma-Causing Asbestos Health Screening Tests

Tuesday, March 9, 2010

In February the Asbestos, Lead & Hazardous Waste Laborers' local union 78 placed a coffin on the streets of New York to draw attention to the health hazards associated with asbestos, and to the fact that asbestos has been linked to deadly diseases. This serves as a reminder that people that work around asbestos, or have been exposed to it, should carefully monitor their health for signs of mesothelioma or other asbestos-related diseases.

Many workers at New York's shipyards, powerhouses, plants and construction sites were exposed to asbestos. In addition, Ground Zero workers , especially those who were first on the scene, may be at risk for developing mesothelioma and other asbestos-related diseases in the coming years.

Asbestos is a known carcinogen and is linked to mesothelioma. Often called "asbestos cancer," mesothelioma is highly aggressive and is resistant to many
standard cancer treatments. When the towers collapsed, asbestos and other toxic substances such as mercury and lead were released into the air. Medical researchers are now seeing unusually high incidences of respiratory issues and lung scarring in the workers.

The National Institute for Occupational Safety & Health (NIOSH), in an effort to protect and treat 9-11 responders, are offering free health exams for volunteers or paid responders to the World Trade Center attack. The World Trade Center Medical Monitoring examinations are provided free-of-charge.

The tests consist of the following:

• Physical examination by a doctor


• Routine blood and urine tests (no drug or HIV testing)


• Breathing tests


• Interview by doctor or nurse about medical history


• Mental health questionnaire


• Questionnaire about occupational exposures


• Referral for treatment, if necessary


• Advice on Workers’ Compensation and other benefit programs, if necessary

According to the NIOSH website, there are three reasons for which they encourage participation in the screenings. 1) The program will follow participants health for a five-year period, and provide longer-term medical monitoring if resources become available. 2) Not all conditions cause symptoms, so by getting periodic examinations, it may be possible to detect any late-starting diseases. 3) The information that will be gained by following the group of 9/11 workers and volunteers will be extremely valuable in understanding how to protect worker health in future emergencies.

People who qualify include rescue and recovery workers, clean-up workers, anyone who performed essential restoration services, morgue personnel, and those who worked on the Fresh Kills landfill and barges.

See http://www.wtcexams.org/ for eligibility requirements, and for additional information.



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posted by Nancy Meredith at 8:00 AM
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Researchers Have Breakthrough in Development of Mesothelioma Vaccine

Monday, March 8, 2010

Reasearchers in the Netherlands, using a special type of cell known as a dendritic cell that is a key regulator in the immune system, have created an immunotherapy treatment against mesothelioma. They hope the research will one day lead to a vaccine for people who have been exposed to asbestos to help prevent asbestos-related diseases.

Mesothelioma is a rare form of cancer typically affecting the lining of the lungs. Primarily caused by exposure to airborne asbestos fibers, most cases of mesothelioma are diagnosed 30 years or more after exposure. The latency period can be as long as 50 years.

Immunotherapy uses the body's own immune system to target and destroy cancer cells. The aim of immunotherapy is to harness the strength of the immune system in a specifically focused attack on cancer cells, while avoiding the broader toxic effects of chemotherapy.

The researchers tested the vaccine on 10 patients achieving 80 percent effectiveness. The results generated an immune T-cell response against the mesothelioma tumors. T-cells assist other white blood cells in immunologic processes. Treatment is a series of three vaccinations given over a two week period after receiving chemotherapy.

“This is the first human study on dendritic cell-based immunotherapy in patients with mesothelioma,” said Dr. Joachim Aerts, a pulmonary physician at Erasmus Medical Center in the Netherlands and lead author of a study published online in the American Thoracic Society’s Journal of Respiratory and Critical Care Medicine.

While the size of the study was small, the researchers said the results suggest that selected patients may benefit from dendritic cell immunotherapy without major adverse effects.



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Labels: mesothelioma, Research News

posted by Nancy Meredith at 7:20 AM
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Mesothelioma: One of Over 6,000 Orphan Diseases

Friday, March 5, 2010

by Nancy Meredith
In the United States an "orphan disease" status is assigned to a disease or disorder if it affects fewer than 200,000 Americans at any given time. The Food and Drug Administration estimates that today there are over 6,000 rare diseases affecting more than 25 million people. According to the National Organization for Rare Disorders (NORD), 1 out of 10 Americans have a rare disease.

Mesothelioma is an aggressive form of cancer primarily caused by exposure to airborne asbestos fibers that is diagnosed in 3,000 Americans each year. Mesothelioma shares the orphan disease distinction with other well-known diseases including colon cancer, multiple sclerosis, AIDS, and cerebral palsy. Between 85 and 90 percent of the orphan diseases are serious or life-threatening.

1983 Orphan Drug Act
Many of these diseases afflict so few people that researchers and pharmaceutical companies do not find it beneficial to expend the time, effort or money to find treatments and cures. As a result foundations and organizations were formed to fund grants to entice researchers to dedicate resources to "their" disease, or to advocate Congress for support.

NORD was established in 1983 by patients and families who encouraged the U.S. government to take action towards supporting researchers in focusing on rare diseases such as mesothelioma.

In 1983 Congress passed the U.S. Orphan Drug Act offering financial incentives to help companies recover the cost of developing a drug for small patient populations. Orphan drug designation, which is intended to facilitate drug development, provides substantial potential benefits to the sponsor, including funding for certain clinical studies, study-design assistance, and several years of market exclusivity for the product upon regulatory approval.


The Office of Orphan Products
The Office of Orphan Products Development (OOPD), under the direction of the FDA, is dedicated to promoting and advancing the development of products (drugs, biologics, medical devices, and medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.

In addition, the office is to provide coordination among Federal, other public, and private agencies in carrying out their respective functions relating to the development of products for rare diseases or disorders.

According to the FY2010 OOPD Budget Report the Orphan Drug Act, and the operation of the program, has been successful. As of April 21, 2009, 339 drugs and biological products for rare diseases have been brought to market. In comparison, only 10 such designated products had been approved in the 10 years prior to the 1983 act.

Orphan Drug Grants
The OOPD also funds the Research Grants Program. The goal of the grant program is to encourage clinical development of products for use in rare diseases or conditions. The FY2010 budget for orphan product grants is $14,315,864.

Orphan product grants successfully fosters and encourages the development of effective medical products for the treatment and cure of rare diseases. The recipients of the grants are able to focus on product development in a compressed time period with a very modest investment. OOPD grant funding is typically offered for up to three years for Phase 1 trials, and up to four years for Phase 2 and 3 trials.

In addition, the Department of Defense awarded several million dollars for three important mesothelioma projects. The funds will support research into early detection of the disease and the development of new treatments, including clinical trials for a promising new vaccine that will directly impact patients.

Orphan Drug Designation
Only one drug has been APPROVED as an orphan drug in the treatment of mesothelioma. Pemetrexed Disodium (Alimta) was designated on February 28, 2001, with an exclusivity start date of February 4, 2004, for the treatment of malignant pleural mesothelioma. Specifically the approved orphan indication is for treatment of patients with malignant pleural mesothelioma whose disease is either unresectable or who are otherwise not candidates for curative surgery.

The following drugs hold the Orphan Drug designation status for the treatment of malignant mesothelioma, but have not yet been approved.

• 5,6-Dihydro-5-Azacytidine from ILEX Oncology, Inc, designated 5-11-1992


• Arenegyr from MolMed S.p.A. (Italian), designated 08-22-2008


• Aroplatin from Antigenics Incorporated, designated 09-01-1999


• Onconase from Alfacell Corporation, designated 01-25-2007


• Ss1(Dsfv)-Pe38 from National Institutes of Health Cancer Therapy Evaluation Program, designated 02-11-2002


• Vorinostat from Merck & Co., Inc., designated 03-17-2004

Coordination with European Medicines Agency (EMA)
On March 1, the U.S. FDA and the EMA announced they will coordinate on orphan drug designations through acceptance of a single annual report from sponsors of orphan drugs and biologic products designated by both the United States and the European Union. Prior to this agreement, drug sponsors had to submit separate reports.

Both agencies, as well as sponsors, will benefit from the single report. The report will contain a full set of data pertaining to an orphan drug including information on the ongoing clinical studies, a description of the investigation plan for the coming year and information on anticipated or current problems.

The single annual report submission to both regulatory agencies is voluntary and will apply only to sponsors who have obtained an orphan designation status for their product from both the FDA and EMA.



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posted by Nancy Meredith at 7:16 AM
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New Test May Determine if Mesothelioma is Gone

Thursday, March 4, 2010

Researchers from Johns Hopkins have created a test that can identify if and when a tumor is coming back after a patient has undergone initial treatment. Blood tests are compared with the unique genetic cancer sequences from the original tumor to tell whether surgeons removed all of the cancerous cells, whether the cancer has spread to other parts of the body, or whether the cancer is coming back. Called the PARE approach, researchers believe the test could be used to develop biomarkers for any cancer including mesothelioma.

Mesothelioma, an unusual form of cancer caused by exposure to airborne asbestos fibers, often has a complex growth pattern making complete surgical removal a very difficult task. The goal of the surgery is to achieve a macroscopically-complete resection, which refers to the removal of all visible tumor cells. Finding hidden cells can be close to impossible making a test like this critical to the treatment of both pleural mesothelioma and peritoneal mesothelioma.

Led by Victor E. Velculescu, MD, PhD, the team found that each patient's cancer is unique, which is the key to this new test that may revolutionize cancer treatment. The team identified nine unique tumor characteristic rearrangements at the ends of its chromosomes that together serve as the tumor's fingerprint. PARE is named for this finding: personalized analysis of rearranged ends.

This test is not yet widely available and the cost, around $5,000 per patient, may be prohibitive to some. Johns Hopkins University holds the patent on PARE.

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Labels: mesothelioma, treatments

posted by Nancy Meredith at 8:04 AM
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Natural Remedy Oncolyn Claims to be Effective in Mesothelioma Treatment

Wednesday, March 3, 2010

The makers of Oncolyn, a plant-derived natural anticancer remedy, claim that taking the tablets "caused objective and subjective improvement of patients with different types of cancers," including mesothelioma.

Mesothelioma is a rare form of cancer typically affecting the lining of the lungs. Primarily caused by exposure to airborne asbestos fibers, most cases of mesothelioma are diagnosed 30 years or more after exposure. The latency period can be as long as 50 years.

Often called “asbestos cancer,” mesothelioma is highly aggressive and is resistant to many standard cancer treatments. Currently there is no known cure for mesothelioma, and the average survival time varies from 4 - 18 months after diagnosis. With such a grim prognosis, looking for ways to live longer and to improve their quality of life, many patients are turning to alternative treatments, natural remedies, and holistic care.

A product derived from three edible plants and a unique immune enhancing botanical extract with anti-carcinogenic and antimutagenic functions, Oncolyn, is touted as helping to reduce and neutralize the toxicity of harmful agents, helping to enhance immune cellular function, enhancing energy and mood levels, and enhancing the protection of leukocytes and platelets.

The makers of Oncolyn studied the effect of Oncolyn with standard chemotherapeutic agents. They found that Oncolyn "causes reduction of tumor size, inhibited vascularity on the surface and in the periphery of implanted tumor fragment and other morphological changes such as karyopyknosis and karyorrhexis consistent with apoptosis." Apoptosis causes cancer cells to die.

In one study published in Natural Products in Cancer Therapy from a September 2008 symposium, researchers stated that when Oncolyn was used in the treatment of one pleural mesothelioma patient full remission was achieved and ten years later the patient remained cancer free.

Oncolyn was developed by Dr. Arthur H.K. D'Jang of Sante International. Dr. D'Jang is a licensed physician (M.D.) and certified specialist by the American Boards of Pathology (Clinical Pathology & Anatomic Pathology) and Nuclear Medicine and has expertise in Infectious Diseases, Biochemistry and Immunology ( Ph.D.,) Preventive Medicine ( M.P.H.) and Cytopathology.

Oncolyn is produced by Sante International. The drug is not FDA-approved, however, it does hold a U.S. patent.


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posted by Nancy Meredith at 7:44 AM
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Hard Rock Café Concert Being Held to Benefit Mesothelioma Patient

Tuesday, March 2, 2010

Bang Tango, a hard rock band dating back to the '80's, will be giving a benefit show at the Hard Rock Café in Pittsburgh, Pennsylvania at Station Square on March 9th to benefit a dedicated fan. The show called "Darryl Kunkle's Kickin' Cancer's A** Benefit" will raise funds towards additional medical and prescription costs needed for Kunkle's peritoneal mesothelioma treatment.

Mesothelioma is a very rare and aggressive cancer. The only established cause of the disease is exposure to asbestos. Asbestos was widely used in the military between the 1940s and 1970s putting workers at a greater risk of asbestos exposure. Mesothelioma has an extended latency period – symptoms can sometimes take between 20-50 years to appear.

Kunkle was stationed in Panama in the Air Force working on brake linings that may have been lined with asbestos. In addition, he worked at a Nabisco plant for six years which was eventually closed for asbestos removal. Kunkle has peritoneal mesothelioma, a cancer of the peritoneum, which is the lining of the abdomen.

Earlier this month he underwent surgery to remove a tumor from his abdomen and will soon begin chemotherapy treatment.

Bang Tango's lineup for the performance will include original lead singer Joe Leste alongside Alex Grossi of Quiet Riot and Anthony Focx of Beautiful Creatures on guitar, Trent Anderson from Dogs Divine on drums and Lance Eric of Lunchbox on bass.

Tickets can be purchased at www.showclix.com or by contacting the Hard Rock Café by phone at 412-481-ROCK. Tickets are only $13 in advance and $15 at the door.

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Labels: For Your Family

posted by Nancy Meredith at 8:22 AM
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Video-Assisted Thoracoscopic Surgery Useful for Mesothelioma Patients

Monday, March 1, 2010

A relatively new minimally-invasive surgical procedure known as Video-Assisted Thoracoscopic Surgery (VATS) that uses fiber-optic imaging to see a detailed view of the pleural cavity and its surrounding tissues offers another surgical option for pleural mesothelioma patients. Using video tools inserted through a small incision in the chest, the surgeon can conduct diagnostic tests or surgery without making incisions large enough to physically see and touch the inside of the patient’s body.

Pleural mesothelioma can be diagnosed with a VATS biopsy. VATS pleurodesis can also be performed on mesothelioma patients. Pleural mesothelioma is a form of lung cancer that is almost always caused by asbestos exposure and is most commonly found in the outer lining of the lungs called the mesothelium.

VATS is useful for many different diagnostic and treatment procedures, and each patient is evaluated to determine whether VATS is an appropriate procedure. According to surgeons at the Mayo Clinic, the best candidates are patients who have not previously had chest surgery as scar tissue from previous procedures can make access into the chest cavity difficult.

VATS offers many advantages over traditional thoracotomy, which uses one larger incision to gain access to the chest.

• Patients may be able to leave the hospital in only one to two days versus close to five days required otherwise


• Patients experience less trauma to the body


• Less pain medication is required


• VATS leaves a smaller surgical scar.

A study reported in Interactive Cariovascular and Thoracic Surgery concludes that VATS decortication (the removal of the visceral pleura encasing the lung) is useful as a palliative measure in advanced malignant mesothelioma, and that drainage of effusion and pleurectomy/decortication improves the quality of life and may increase survival as well.


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Labels: mesothelioma, treatments

posted by Nancy Meredith at 8:25 AM
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