Mesothelioma Drug Given Promising Innovative Medicine Status in the UK

Boehringer Ingelheim has announced that the UK is following in the footsteps of the U.S. in the latest designation for the company’s drug nintedanib. In December 2016, the U.S. Food and Drug Administration granted orphan drug designation to the investigational cancer drug for the treatment of mesothelioma. Now, the UK Medicine and Healthcare Products Regulatory Agency has designated nintedanib a Promising Innovative Medicine for the treatment of malignant pleural mesothelioma.

The PIM designation, according to Gov.UK, is an indication that the product may be eligible for the early access to medicines scheme (EAMS) that brings medicines to patients with life threatening conditions when there is an unmet medical need. The designation was assigned based on the encouraging results of the phase II/III LUME-Meso trial, according to a Jan. 4 PharmaTimes article.

“This is fantastic news and the right decision taking into account the risk/benefit profile of nintedanib from a very credible Phase II trial,” said Professor Dean Fennell, Chair of Thoracic Medical Oncology at the University of Leicester and University Hospitals of Leicester NHS Trust, UK, commenting on the decision.

Results from the LUME-Meso Trial showed “statistically significant improvements,” according to Pharma Times, with mesothelioma patients treated with the drug plus chemotherapy achieving 9.4 months of progression free survival compared to 4.7 months for those patients receiving chemotherapy alone.

Nearly 2,500 cases of pleural mesothelioma are diagnosed each year in the UK. With limited effective treatment options the median survival is less than 14 months. Reports indicate that nearly 3,000 Americans are also diagnosed with the deadly cancer each year. New, effective treatments are critically important to improve mesothelioma patient survival.

To find out more about the LUME-Meso trial, see ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/results?term=%22malignant+mesothelioma%22&recr=Open&pg=1

Sources :

U.S. Food and Drug Administration
http://www.mercknewsroom.com/news-release/oncology-newsroom/merck-announces-fda-acceptance-review-mk-3475-biologics-license-appli
Gov.UK
https://www.gov.uk/government/news/medical-innovation-doctors-and-patients-encouraged-to-give-views
PharmaTimes
http://www.pharmatimes.com/news/pim_status_for_boehringers_mesothelioma_drug_1215220

35th Anniversaries of NORD and The Orphan Drug Act

Many mesothelioma patients may not know that every day the National Organization for Rare Disorders has a team of people fighting for them. NORD was established in 1983 to improve the lives of individuals and families affected by rare diseases. This month the organization announced it will be spending 2018 marking 35 years of advocacy.

Not coincidentally, the Orphan Drug Act, that provides incentives to the pharmaceutical industry to invest in developing therapies to help small patient populations, has also reached the 35-year milestone. The Act was created and passed by the hard work of an ad hoc coalition of parents of children with rare diseases who lobbied Congress and the medical and pharmaceutical communities to call attention to rare diseases. After the successful passage of the law, the coalition formed NORD.

“The advances in diagnosis, treatments and care for patients with rare diseases have been remarkable, but we still have many challenges ahead of us,” said Peter L. Saltonstall, President and CEO of NORD, in a Jan. 4 press release announcing the milestone. “The Orphan Drug Act and the creation of NORD brought national attention to rare diseases. The joint anniversaries are an appropriate time for us to recognize the progress made and rededicate ourselves to the needs of the patient community.”

A disease is designated as rare or orphan when less than 200,000 Americans are affected by the disease at any given time. Over 7,000 diseases affect close to 30 million Americans. Mesothelioma is responsible for approximately 3,000 new cases of cancer each year in the U.S. Although there is no cure for mesothelioma, it can be treated with varying degrees of success through the use of surgical procedures, chemotherapy and radiation.

While there is ongoing research to find new treatments or a cure for these orphan diseases, research requires significant amounts of time and money. Since many of these illnesses affect so few people, researchers and pharmaceutical companies do not find it beneficial to expend the time, effort or money to find treatments and cures. Although the Orphan Drug Act has helped in the development of some treatments, still less than 500 of the orphan diseases have an approved treatment, according to NORD.

Some of the milestones NORD highlights from its 35-year history include:

Named a 4-star charity by Charity Navigator, one of the 100 Best Charities by Worth Magazine, and “Charity of the Week” by The Week Magazine;
In at least two instances, NORD’s rare disease research grant program has resulted in FDA-approved orphan therapies;
NORD established a Natural History Study program and entered into a cooperative agreement with FDA to further rare disease research.

Since inception of the Orphan Drug Act, the FDA has approved more than 600 orphan products and 4,000 orphan drug designations. The Orphan Drug Act, according to NORD, is credited with helping to drive innovation in cancer treatment and gene therapies.

“The Orphan Drug Act is just as important today as it was in 1983,” Saltonstall said. “This year, we will be saluting the progress made to date, we will also be focusing on the fact that much remains to be done.”

Improving Immune System’s Memory May Lead to New Mesothelioma Treatment

Mesothelioma patients often lose ground when fighting back against the deadly cancer due to a compromised immune system. Immunotherapy is one way oncologists and researchers use to awaken the immune system so it can successfully fight the cancer. Now, researchers report they may be able to stimulate the immune system’s ability to “remember” infections leading to new treatments that may better help fight disease.

Researchers from Monash University in Australia report they have discovered a “novel molecular ‘blueprint’” that could be the key to immunological memory, according to a Dec. 20 press release from Monash University’s Biomedicine Discovery Institute. The team found that when the immune system fights an infection, the B and T cells create memory cells. This memory is how immunity is developed and how vaccines work by mimicking that immunity.

B cells generate antibodies, whereas T cells are known as killer cells and destroy the invading sick cells. Using a strain of the flu, the researchers found the T cells, that the team called hit men, “are genetically wired to behave” the way they do. This finding broke new ground in understanding the changes T cells undergo when fighting an illness.

“What we found is there’s a specific sort of wiring that seems to characterise this type of immunological memory – it’s like an electrical circuit,” Professor Turner said. “We were able to identify specific ‘switches’ that are used in parts of the genome that actually give T cells their function.”

Mesothelioma, a signature cancer of asbestos, is extremely aggressive, and the cancer cells continue to grow and multiply as the patient’s immune system is compromised. Finding a way to wake up the immune system is critical for extending survival. Immunotherapy has been used successfully in some mesothelioma patients, however, this research points to another way to engage the immune system. In fact, Turner said, the “blueprint could serve as a benchmark for research, and potentially be used to hone and personalise therapies.”

Understanding immunological memory may help them improve existing treatments or create new ones that use the immune system to fight cancer, the researchers concluded.

The team will continue this research and reports the next step is to use the human influenza virus next.

Read the full study in the Dec. 19, 2017, issue of Cell Reports.

Libby, Montana Mesothelioma Doctors Contribute Knowledge to Medical Journals

The doctors at Libby, Montana’s Center for Asbestos Related Disease (CARD) know a thing or two about mesothelioma. The town is home to a vermiculite mine blamed for widespread contamination from asbestos exposure and for hundreds of cases of mesothelioma, and CARD has been the hub for care and screening of many of the patients. Now, the medical team is sharing their knowledge of this deadly disease through collaboration on articles for scientific journals.

Dr. Brad Black and Dr. Gregory Loewen, both physicians at CARD, were among the authors in two separate studies published recently in the peer-reviewed journals Inhalation Toxicology and the Journal of Occupational and Environmental Medicine (JOEM), according to a Dec. 29 article in The Western News. The two provided their expertise into the studies looking at the pulmonary function of miners at Libby’s vermiculite mine.

In the study of 256 individuals who worked at the mine for a minimum of six months, the researchers concluded “eighty-seven percent of miners exposed to Libby Amphibole had pleural abnormalities on CT [computed tomography].” The study was published in JOEM.

“… most doctors probably don’t know about this unique type of asbestos related disease and wouldn’t be able to recognize it in their patients if they didn’t hear about it,” said Dr. Black on why the study is important.

The W.R. Grace vermiculite mine and mill located in Libby, closed since 1990, was found to have an asbestos deposit in the mine and is the site of significant asbestos exposure. According to reports, nearly 3,000 residents and former miners have been diagnosed with an asbestos-related disease, and over 400 have died from mesothelioma. Contamination from the site led the federal government to declare Libby a health emergency.

Asbestos is a known carcinogen and is proven to cause mesothelioma, a serious cancer caused by breathing in the asbestos fibers that then become lodged in the thin membrane that lines and encases the lungs.

The second study followed one individual who worked at the mine from 1969 to 1990 and had no other known exposure to asbestos. The person developed “asbestos-like” pathological features and eventually an adenocarcinoma. According to the authors, “This is to our knowledge the first time such an extensive evaluation has been conducted in a vermiculite miner from Libby, Montana.”

About CARD

CARD’s primary goal is to provide specialty healthcare and screening to those affected by Libby Amphibole Asbestos. CARD’s secondary goal is to stimulate research from around the country to gain further understanding of disease mechanisms, improve early disease and cancer detection and intervention, and develop effective health management strategies in hope of finding answers to improve health outcomes for individuals and communities.

Find out more about the Center for Asbestos Related Disease on its website.

Read the studies in the Dec. 1 issue of the Journal of Occupational and Environmental Medicine and in the Oct. 17 issue of Inhalation Toxicology.

Sources:

Center for Asbestos Related Disease
http://www.libbyasbestos.org/
Inhalation Toxicology
http://www.tandfonline.com/doi/abs/10.1080/08958378.2017.1372536
Journal of Occupational and Environmental Medicine
http://journals.lww.com/joem/pages/default.aspx
The Western News
http://www.thewesternnews.com/front_page_slider/20171229/libby_asbestos_clinic_contributes_research_to_two_journals

How Paralegals Help with Your Mesothelioma Case

Paralegals can be found in every area of the law. One of the largest areas to utilize paralegals, though, is the personal injury field. Personal injury law is the field of law devoted to helping those who have been injured unjustly to seek compensation. For those who have been diagnosed with mesothelioma after being exposed to asbestos, compensation can be sought from the companies that failed to warn them of the danger.

Paralegals who work in the complex asbestos litigation field assist the attorneys who fight for the rights of victims who have been diagnosed with mesothelioma, asbestos lung cancer, asbestosis, and other asbestos diseases. These paralegals do a lot of behind-the-scenes work to help build the claim for maximum compensation, whether through litigation or asbestos bankruptcy funds.

Although many asbestos cases end in settlements, there are also many that go to trial, requiring a strong and experienced team of attorneys, paralegals, and other professionals. Paralegals assist attorneys in all aspects of asbestos litigation, from initial client interviews to appeals.

Common tasks performed by a paralegal for a mesothelioma case include:

Interviewing clients, doctors, medical specialists, and former co-workers or fellow veterans
Gathering medical records and other supporting evidence, such as documentation to pinpoint where and when the patient was exposed to asbestos
Aiding the attorney in determining what types of damages a plaintiff may be entitled to recover
Communicating with the client and insurance companies
Filing legal documents with the court
Locating expert witnesses to interview
Maintaining a calendar of pretrial and trial order deadlines
Preparing pretrial and trial motions

Asbestos litigation paralegals are specifically trained to work in this area of the law. Because of the complexities of mesothelioma cases, these legal professionals must possess a special set of skills and knowledge to assist attorneys and, ultimately, clients.

Ways paralegals help mesothelioma patients and their families pursue maximum compensation:

Client Services

Because asbestos attorneys are very busy and cannot perform every function necessary to successfully take on a case, paralegals provide extensive support involving client services. Paralegals help interview and screen potential clients, keep current with case status, and interact with clients and their families in a meaningful way to ensure their needs are being met.

Drafting

Asbestos paralegals must be skilled in drafting and submitting legal documents related to mesothelioma claims. Although the attorney ultimately reviews these documents, the paralegal spends the time drafting them and ensuring they are submitted on time.

Analysis

Paralegals must have specific training or experience in order to handle the medical aspects of a mesothelioma case. The paralegals will ascertain which medical records and bills are needed from the patient and determine what future cost projections or experts are needed. Many paralegals in this field are familiar with how asbestos diseases affect patients. This knowledge allows paralegals to prepare medical chronologies, medical expense itemizations, deposition summaries, and demand packages.

Trial Preparation

Asbestos litigation paralegals play an important role in trial preparation. They perform a variety of tasks to assist attorneys, including jury selection preparation, opening and closing statements, and witness outlines. Paralegals also determine which exhibits will be utilized and ensure that they are properly prepared for trial.

Trial

One of the paralegal’s main jobs is assisting the attorney(s) with the entire voir dire process, including taking notes and helping the attorney strike or select jurors. Once the trial is under way, paralegals pull and pass exhibits to the attorney, act as a liaison to the client, communicate with the bailiff or court reporter if issues arise, bring witnesses into the courtroom when it is their turn to testify, and act as a second set of eyes and ears in the courtroom.

Although this is not an exhaustive list of everything an asbestos litigation paralegal does to assist attorneys in mesothelioma cases, it certainly shows that paralegals play a pivotal role in helping clients pursue maximum compensation for their injuries. If you would like to learn more about the paralegal profession, visit Fremont College. The school’s website offers a number of resources for those looking for a career as a paralegal.

An ABA accelerated paralegal certificate program that allows you to finish your schooling in just 15 months. Robust education that speaks to essential skills needed for those looking to be successful in the legal field. Lean more about the Paralegal Studies program by visiting http://fremont.edu/ For more information, please visit us at www.fremont.edu or call us at 1-800-373-6668 / 1-800-FRE-MONT

Category: Mesothelioma