The immunotherapy drug ONCOS-102 has been granted Fast Track designation by the Food and Drug Administration (FDA). Fast Track designation speeds up the regulatory review process for the drug.
What Is ONCOS-102?
ONCOS-102 is an immune activator designed for pleural malignant mesothelioma and other solid tumors that are difficult to treat. The drug is being developed by Targovax, a small biotech company located in Norway. It is also being tested for use treating melanoma and colorectal cancer.
How Does It Work?
In the initial trial documents, the researchers describe ONCOS-102 as an “Immune-priming GM-CSF Coding Oncolytic Adenovirus”. The treatment is engineered to replicate inside only the cancer cells, resulting in their death. It leaves healthy cells unharmed. It also stimulates the immune system to create more ONCOS-102 particles, and to recognize and kill more tumor cells.
According to Targovax’s Chief Medical Officer, Dr. Magnus Jaderberg, “It is most encouraging that survival continues to track so well in the ONCOS-102-treated first line group. We have earlier seen and reported how ONCOS-102 drives profound remodeling of the tumor microenvironment. It is now becoming clear that this is translating into long-term survival benefit.”
Why Was ONCOS-102 Fast Tracked?
The FDA Fast Track designation is based on the promising interim results of the trial which were encouraging enough to speed the approval process. The results in February (21 months into the trial) showed that patients who received ONCOS-102 in combination with standard chemotherapy survived for months more than patients receiving only standard chemotherapy. With standard chemotherapy, patients at 21 months had a median overall survival rate of 13.5 months; with ONCOS-102 added, that increased to 20.5 months. Based on these positive interim results, the FDA issued the Fast Track designation.
Next Phase of ONCOS-102 Clinical Trial
Targovex, in partnership with Merck, plans to open a new phase of the clinical trial of ONCOS-102, pairing it with Merck’s cancer drug Keytruda. The new trial will compare the effectiveness of Keytruda plus chemotherapy to ONCOS-102, Keytruda and chemotherapy. Keytruda was only approved for malignant mesothelioma patients with specific genetic markers in 2020, after more than 600 clinical trials. Mesothelioma patients who wish to participate in any clinical trial should contact their doctor.
What Can You Do?
Thornton Law Firm has represented individuals and their families in mesothelioma claims since 1978. If you have been diagnosed with mesothelioma or any asbestos-related disease, please call Attorney Andrew Wainwright using our toll-free number 888-632-0108 or tell us your story here for a free, confidential consultation.
In May of 2020, the Environmental Protection Agency (EPA) published a review of continuing dangers associated with asbestos, pursuant to the the amended Toxic Substances Control Act (TSCA). This risk evaluation was widely criticized by scientists and advocates for people with mesothelioma and other asbestos-related disease. In the final month of the Trump Administration, the EPA then issued a Final Risk Evaluation for Asbestos.
Almost immediately, the Asbestos Disease Awareness Organization (ADAO), several other environmental groups, leading experts in asbestos disease and several states filed a petition seeking review of the EPA’s risk evaluation with the Ninth Circuit Court of Appeals. The petition was filed under the Toxic Substances Control Act (TSCA). These same groups also filed a 60-day letter with the EPA notifying the agency of their intent to sue under the TSCA to ensure that the EPA had met its obligation to thoroughly evaluate the asbestos found in buildings across the United States.
The following organizations joined the ADAO in these actions: American Public Health Association (APHA); Center for Environmental Health (CEH); Environmental Information Association (EIA): Safer Chemicals, Healthy Families (SCHF); and Vermont Public Interest Research Group (VPIRG), as well as the scientists Barry Castleman, ScD; Raja Flores, MD; Arthur Frank, MD, PhD; Philip Landrigan, MD, MSc; Richard Lemen, PhD, MSPH; and Celeste Monforton, DrPH, MPH. State attorneys general from 11 states also joined in, including California and Massachusetts.
In a press release, ADAO co-founder and President Linda Reinstein stated, “The EPA’s piecemeal and dangerously incomplete Final Risk Evaluation for Asbestos overlooks numerous sources of asbestos exposure and risk, and understates the enormous toll of disease and death for which asbestos is directly responsible.”
The ADAO intends to follow up with a lawsuit in Federal District Court seeking to force the EPA to comply with the Toxic Substance Control Act in its evaluation of asbestos currently in place in buildings across the country. Anticipating a more responsive government approach, Reinstein of the ADAO said, “We look forward to working with the Biden EPA and Congress to achieve the full protection Americans deserve from this deadly carcinogen.”
Thornton Law Firm LLP has represented individuals and families in asbestos claims since our inception in 1978. If you have been diagnosed with mesothelioma or another asbestos-related disease, call Attorney Andrew Wainwright using our toll-free number 888-632-0108 or tell us your story here for a free, confidential, no-risk consultation.
The Environmental Protection Agency (EPA) recently issued a Draft Asbestos Risk Evaluation that will keep Americans at severe risk of deadly exposure to asbestos according to the Asbestos Disease Awareness Organization.
The ADAO, an independent nonprofit dedicated to preventing exposure to asbestos through education, advocacy, and community initiatives, issued a press release critical of the EPA’s recent attempt to relax regulation and oversight regarding asbestos use. The U.S. continues to import tons of asbestos each year, although much of the public assumes that asbestos use is banned in the United States as it is across over 70 industrialized countries. The ADAO and others have advocated for a total ban on asbestos use, urging the EPA to adopt the Frank R. Lautenberg Chemical Safety for the 20th Century Act, and for Congress to pass the Alan Reinstein Ban Asbestos Now Act. Nevertheless, the EPA’s Draft Asbestos Risk Evaluation does the opposite. The ADAO press release observes that the new EPA evaluation is a big step backward from the decades of work by governmental scientists.
The ADAO highlights an event it sponsored where several experts in asbestos disease and other interested parties spoke out against the EPA Draft Asbestos Risk Evaluation. Among those experts, L. Christine Oliver, an asbestos disease expert who has been invited to testify before Congress and OSHA, commented that the EPA draft evaluation underestimates and understates the true risk posed by asbestos. Dr. Oliver notes that the EPA draft only considers the impact of one of six different types of asbestos fiber. It fails to use the validated and accepted statistical model for evaluating the impact of dose – the amount of exposure – to a carcinogen like asbestos. The National Institute of Occupational Safety and Health (NIOSH) recognizes there is no safe level of exposure to a carcinogen. It is well known that asbestos causes the cancer mesothelioma. Dr. Oliver also noted that the EPA ignored the impact of several asbestos-related diseases and cancers including mesothelioma, as well as multiple scientific studies that have helped define risk. Finally, Dr. Oliver noted that the current EPA draft evaluation pushed off consideration of “legacy” asbestos, asbestos products in place that were installed years ago. Legacy asbestos poses the greatest risk to the greatest number of Americans and must be addressed.
The ADAO and the doctors and scientists who support an America safe from the asbestos hazard created through the twentieth century are shining a light on the current Administration’s efforts to roll back what progress has been made. The ADAO is a strong advocate for the total ban on asbestos as the only way to ensure the greatest protection from its hazards. You can read the entire ADAO press release and the comments of various experts by clicking this link.
As the world confronts the novel coronavirus (and its associated illness, COVID-19), we are becoming more aware of how masks and respirators can, potentially, protect us from airborne contaminants. Individual respiratory protection devices have been around for over a hundred years. From the use of gas masks to protect soldiers from mustard gas in World War I, to masks used to protect health care workers from pathogens, we have relied on masks to prevent the inhalation of harmful substances.
The coronavirus relief bill enacted into law this week, the Families First Coronavirus Response Act, included a limitation of liability for respirator (i.e., N95 mask) manufacturers that will be in place until October 1, 2024. This new law bans health care workers and anyone else who wears an N95 mask from suing the manufacturers of those masks, as well as some other businesses involved in the respirator supply chain in coronavirus treatment. If the mask wearer subsequently develops an illness related to the 2019 novel coronavirus (2019-nCoV) or COVID-19 outbreak that the mask was intended to prevent, that person cannot bring a lawsuit for that illness. The immunity:
- Only applies for the duration of the COVID-19 public health emergency as declared by HHS (applicable through 2024)
- Only covers respirators that have an emergency use authorization issued by the FDA and
- Only extends to claims that have some relationship to treatment of COVID-19.
Further, on March 17, 2020, the Department of Health and Human Services submitted a Public Readiness and Emergency Preparedness (PREP) Act COVID-19 (coronavirus) declaration in the Federal Register for the following covered persons and countermeasures:
- Covered Persons: manufacturers, distributors, program planners, qualified persons, healthcare providers, and their officials, agents, employees. It also includes any person authorized to prescribe, administer, or dispense countermeasures.
- Countermeasures: any drug, diagnostic, device, or vaccine used to treat coronavirus, or any device used in the administration of any such product, and all components and constituent materials of any such product.
The time period for temporary immunity will be the final day the emergency declaration is in effect, or October 1, 2024, whichever occurs first.
The PREP Act also creates a measure much like worker’s compensation, called the Countermeasures Injury Compensation Program (CICP). CICP will provide benefits (which can include compensation for unreimbursed medical expenses, lost employment income, and/or survivor death benefits) to certain individuals or estates of individuals who sustain serious physical injuries or death as the direct result of a countermeasure.
Masks and respirators have also been used to protect workers from harmful dusts, such as silica and asbestos. However, not all masks or respirators are created equal. A mask does not provide the same level of protection as a respirator. In fact, in the world of industrial hygiene, the term “mask” has been designated for use only to prevent inhalation of nuisance dusts: dusts that do not pose a serious health risk. “Respirators”, on the other hand, are designated for use with harmful substances. These designations have often been confused, and the risks can be severe.
Some masks and respirators have been marketed and sold for protection against particular substances, such as asbestos, that they were not designed for. Others were just defectively designed and were ineffective at protecting workers as intended. Sometimes the respirators included valves that leaked, and certain masks were not properly designed to create a good fit against the face.
OSHA (Occupational Health and Safety Administration), NIOSH (National Institute for Occupational Safety and Health) and the U.S. Bureau of Mines have regulated the effectiveness, categorization and selection of respirators in specific work settings. These regulations have not always been followed closely.
Thornton Law Firm LLP has extensive experience in litigating dozens of asbestos cases against the manufacturers of defective masks and respirators. We have gone to trial and successfully settled these respirator cases. We know that just because a worker may have worn a mask or respirator while working with asbestos or any other industrial dust, it does not mean he or she was properly protected. The immunity for mask manufacturers under the PREP Act is limited to masks currently being manufactured in response to the COVID-19 crisis and should have no effect on litigation regarding asbestos. If you have contracted an asbestos-related disease after using a defective mask or respirator, we can help. Call Thornton Law Firm LLP at 888-491-9726 for a free consultation with an experienced attorney.
Thornton Law Firm LLP is located at One Lincoln St., 13th fl., State Street Financial Center, Boston, MA 02111.
Experienced Mesothelioma Lawyers Working for You
Thornton Law Firm LLP has been representing victims of asbestos-related diseases and their families for decades. Through our cases representing workers with mesothelioma, lung cancer, other cancers, and asbestosis, we have developed a sophisticated knowledge of how people have been exposed to asbestos.
In the early years of the firm, the late 1970s and much of the 1980s, the vast majority of our clients were insulation workers, pipe fitters, boiler makers and other trades in the shipbuilding and power generation industries. These were mostly union tradesmen who worked directly with asbestos-containing insulation materials. They were exposed to tremendous amounts of airborne asbestos throughout their careers building navy and merchant ships, power houses and large industrial facilities.
As the 1980s progressed, many of the manufacturers of industrial insulation materials sought to manage their asbestos liabilities through the bankruptcy process. These corporations segregated their assets and put their former asbestos insulation manufacturing subsidiaries into bankruptcy, leaving little for the victims of the asbestos products that profited those corporations through much of the 20th century.
Why is Mesothelioma Increasing in the Population?
Although asbestos was mostly removed from industrial insulation materials with the advent of OSHA in the early- to mid-1970s, and many of the industrial workers have succumbed to mesothelioma, lung cancer and other asbestos-related diseases, there are still people contracting and dying from mesothelioma.
These people fall into a few basic categories. There are the families of workers who brought asbestos home on their clothing; others were exposed to asbestos through products that contained asbestos that few people knew about. In addition, we have the people who were exposed to materials such as talc and vermiculite, which contained asbestos as a contaminant, not an intended ingredient. And again, these people had no knowledge that talc or vermiculite contained asbestos.
Who is At Risk?
Thornton Law Firm LLP has represented dozens of family members who themselves contracted mesothelioma. Spouses and children of industrial workers were exposed to asbestos dust brought into their cars and homes. Through helping with the laundry, giving daddy a hug when he got home from work, or simply riding in the family car children were exposed, and now, as adults many years later are getting mesothelioma. They never worked in factories, power houses or ships, and they never suspected that they were exposed to asbestos. Thornton Law Firm LLP has the experience and resources to investigate and successfully litigate these cases.
Surprising Sources of Asbestos Exposure
Asbestos has turned up in many places and products that those exposed would never have suspected. From various automotive products, such as brakes and gaskets to residential building materials such as floor tile, wall material, plaster, spackle, putty, siding, and roofing material, the home do-it-yourselfer typically worked with many asbestos-containing materials. Asbestos can be found in many plastics, especially in electrical equipment, such as circuit breakers. Asbestos has been used in filter material, including cigarette filters in the 1950s. Asbestos has even shown up as a contaminant in the most benign products, such as talcum powders, cosmetics and even baby powder.
Thornton Law Firm LLP has represented victims of mesothelioma and other asbestos-related diseases who have been exposed to all of these products. We are experienced in finding exposures to asbestos that the victims of mesothelioma would never have thought possible.
Thornton Law Firm LLP is located at One Lincoln St., 13th fl., State Street Financial Center, Boston, MA 02111.
A Middlesex County New Jersey jury awarded four sets of plaintiffs $37 million dollars against Johnson & Johnson for mesothelioma caused by talc baby powder. The consolidated trial lasted almost three months, and at the end, the judge struck the Johnson & Johnson attorney’s entire closing argument, ruling that the attorney had made improper comments on the evidence.
The jury’s unanimous verdict was that all of the plaintiffs had been exposed to asbestos by using Johnson and Johnson’s baby powder and Shower to Shower talcum powders contaminated with asbestos. The jury also unanimously ruled that J&J failed to warn the plaintiffs about the dangers of its talcum body powders. In a 5-1 vote, the jury ruled that those actions caused the plaintiffs’ mesothelioma. Mesothelioma is a rare and fatal cancer caused by exposure to asbestos.
The award is for compensatory damages only. Punitive damages may be awarded in a separate phase of the trial. Plaintiffs Douglas Barden and his wife, Roslyn Barden were awarded $7.25 million; David Etheridge and his wife, Darlene Etheridge were awarded $9.45 million; D’Angela McNeill was awarded $14.7 million; and William Ronning and his wife, Elizabeth Ronning. were awarded $5.9 million.
Johnson & Johnson had previously asked for a mistrial based on the trial judge striking its counsel’s closing argument from the record; after the verdict was announced, Johnson & Johnson said they intend to appeal the decision. Johnson & Johnson faces over 10,000 talc-related cancer claims in both federal and state courts. The Securities and Exchange Commission and the United States Department of Justice subpoenaed Johnson & Johnson in February for documents on talc powder safety. This followed a Reuters report published in December of 2018 entitled “Special Report: J&J knew for decades that asbestos lurked in its Baby Powder”.
If you or a loved one has been diagnosed with cancer – either mesothelioma or ovarian cancer – after using talcum powder (including Johnson & Johnson’s Shower to Shower Powder, baby powder, Colgate’s Cashmere Bouquet, or Avon’s body powder products), you may have a legal claim for damages. Call Thornton Law Firm’s female mesothelioma attorneys, Leah McMorris for a free, no obligation evaluation of your legal claim at 1-888-341-1405. Or tell us your story here. Seek legal advice immediately if you believe you may have a claim. Like all lawsuits, baby powder lawsuits must be filed within strict time limits.
Congratulations to the International Association of Heat and Frost Insulators and Asbestos Workers Local 6, Boston, MA on the occasion of their 25th annual retirees’ luncheon held at The Lantana, Randolph, MA on August 21, 2019. Thornton Law Firm was honored to be on hand to celebrate and reminisce with retirees and their loved ones. To cap off the afternoon, Mike Thornton was privileged to present Leo Santa Maria Memorial Scholarship awards to two retirees to help fund the education of their family members. Leo Santa Maria was a longtime officer of Local 6. A kind and generous man, Leo is remembered for his great sense of humor and his devotion to his family and his union. Thornton Law Firm established a scholarship fund in his name to honor his memory and service to Local 6.