Category Archives: Immunology

Immunology

16 Symptoms You May Not Know Are Allergic Reactions – 24/7 Wall St.

Special Report

16 Symptoms You May Not Know Are Allergic Reactions

Hristina Byrnes

Allergies are a very common chronic condition among Americans. More than 7% of the adult population is diagnosed with hay fever every year, which is the common name for allergic rhinitis. In the spring, hay fever is often caused by various types of tree pollen, grass, and weeds.

An allergy is the immune systems hypersensitivity reaction to usually harmless substances in the environment. If the body is allergic to food, most symptoms occur around the mouth, throat, or stomach. If the allergen is something a person breathes in, the symptoms are then likely to affect the eyes, nose, and lungs.

24/7 Tempo reviewed information by the American Academy of Allergy, Asthma and Immunology and other health-focused sites to compile a list of both common and lesser-known symptoms of spring allergies.

The duration of the allergy season in the spring varies depending on geographic location. Cities in warmer climates tend to have longer pollen seasons, sometimes starting as early as January, while areas in colder climates tend to have shorter pollen seasons these are the 25 worst cities for people with spring allergies.

Click here for 16 symptoms you may not know are caused by spring allergies.

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Immunology

Doctors push for treatment of coronavirus with blood from recovered patients – NBCNews.com

In the absence of vaccines or antiviral drugs, researchers at Johns Hopkins University in Baltimore say the key to slowing and treating the coronavirus might be hidden in the blood of those whove already recovered from the disease.

The method of using convalescent serum essentially harvesting virus-fighting antibodies from the blood of previously infected patients dates back more than a century, but has not been used widely in the United States in decades.

During the Spanish flu epidemic of 1918, scientists reported that transfusions of blood products obtained from survivors led to a 50 percent drop in deaths among severely ill patients. A similar strategy was used to treat and slow the spread of polio and measles outbreaks decades ago, but the technique fell out of favor in the 1950s with the innovation of modern vaccine science and antiviral drugs, said Dr. Arturo Casadevall, chair of the molecular microbiology and immunology department at the Johns Hopkins Bloomberg School of Public Health.

When Casadevall learned in December that a new coronavirus was spreading rapidly in China, he started telling colleagues that it might be time to revive the antiquated treatment.

Im an infectious disease doctor who is interested in history, Casadevall said. I knew the history of what was done in the early 20th century with epidemics. They didnt have vaccines then, they didnt have any drugs then just like the situation we face now. But physicians then knew that, for certain conditions, you could take the blood of the immune and use it to prevent disease or treat those who became ill.

In a paper published Friday in the Journal of Clinical Investigation, Casadevall and a colleague, Dr. Liise-anne Pirofski, argued that collecting blood serum or plasma from previously infected people might be the best hope for treating severe cases of COVID-19, the disease caused by the virus, at least until a better treatment can be developed.

Theres some evidence from recent history that suggests the approach could work.

In 2003, doctors in China used plasma from recovered patients to treat 80 people suffering from the viral disease known as severe acute respiratory syndrome, or SARS an earlier coronavirus and found that the treatments were associated with improved outcomes and shorter hospital stays. In 2014, the World Health Organization published guidelines for using donated plasma to treat people infected with Ebola after the treatments showed promise.

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In an interview with Stat News last month, a top Food and Drug Administration official said convalescent plasma might be helpful in the fight against the new coronavirus. Although the treatment is not a cure, Casadevall says it might be an important stopgap.

Researchers in the U.S. and across the globe have been scrambling to develop drugs for the coronavirus, but federal officials say those treatments are likely months or in the case of a vaccine more than a year away. That leaves hospitals with few options other than ventilators to treat COVID-19 patients suffering from respiratory failure, stoking concerns nationally that a surge of severely ill patients in the coming weeks could overwhelm emergency rooms and intensive care units.

The approach definitely has merit, and whats remarkable about it is its not a new idea; its been with us for a good hundred years or longer, said Dr. Jeffrey Henderson, an assistant professor of medicine and molecular microbiology at the Washington University School of Medicine in St. Louis. I think we dont know until we have experience and case reports with this particular disease whether it will be effective, but just based on its track record with a number of other viruses, I think it has a very good chance of working.

Henderson said part of what makes the treatment attractive is its simplicity. Although there is danger in giving a patient the wrong type of blood, safety advancements over the past two decades have made adverse outcomes rare. And hospitals have the tools needed to begin harvesting and transfusing patients with blood serum right away, he said.

The Johns Hopkins team is planning to submit its plan for approval by the FDA, but Casadevall said they dont anticipate problems since the method has been used in the past and relies on standard blood-banking technology. He hopes to begin collecting serum from recovered patients within four to six weeks.

Patients tend to make large numbers of antibodies against an infecting pathogen, and these antibodies often circulate in the blood of survivors for months or years afterward. By collecting and transfusing a survivors serum or plasma the liquid portion of blood left once cells and platelets have been removed doctors could potentially boost an ailing patient's immune response, Casadevall said.

Doctors in China have begun treating COVID-19 patients with plasma harvested from survivors and have reported somewhat positive results, especially when the method is applied early in the disease, though it has not been tested widely.

The usage of plasma will probably reduce the time needed to treat the disease from five to 10 days to three to five days, said Dr. Zhang Wenhong, the leader of a medical team sent from Shanghai to Wuhan to help tackle the outbreak, in an interview with Al-Jazeera last week.

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Casadevall argues that convalescent serum could also be given to front-line health care workers to help protect them from becoming ill.

To implement his plan, academic hospitals would need to work collaboratively with blood banks to set up research protocols and treatment guidelines. Doctors at Johns Hopkins started that work weeks ago, Casadevall said, and they have begun drafting guidelines that can be copied by hospitals across the country.

Hes already been in touch with doctors at the Mayo Clinic in Minnesota, he said.

At the local level, hospitals and blood banks have everything they need to do this, Casadevall said. But what would really help is coordination from the federal government.

First, Casadevall said, the U.S. must immediately begin widespread testing, because its impossible to collect blood serum from survivors if public health officials dont know whos been infected. Second, Casadevall said federal officials may need to oversee the interstate shipment of blood products. He can imagine a scenario where blood banks in Seattle, which has been at the epicenter of the U.S. outbreak for weeks, might be in a position to send excess blood products to other cities where outbreaks are still ramping up.

And finally, Casadevall said, government officials would need to help spread the word. He believes people whove had the coronavirus and recovered will be eager to donate plasma if they believe it could help elderly patients and health care workers.

This is by no means a panacea, Casadevall said. But at a time when the message has been, Theres nothing you can do but wash your hands, this is an opportunity to do something proactive that can help fight this.

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Doctors push for treatment of coronavirus with blood from recovered patients - NBCNews.com

Immunology

Aimmune Announces New PALFORZIA Data Suggesting Increased Desensitization, Improved Tolerability and Continued Immunomodulation After 18 and 24 Months…

BRISBANE, Calif.--(BUSINESS WIRE)--Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and bringing new treatments to people with potentially life-threatening food allergies, today announced new data from the clinical development program for PALFORZIA [Peanut (Arachis hypogaea) Allergen Powder-dnfp], the first peanut allergy treatment approved by the U.S. Food and Drug Administration (FDA).

An analysis from ARC004, the open-label follow-on trial to the 52-week PALISADE trial, showed that patients tolerated more peanut protein, experienced fewer adverse events and continued immunomodulation changes in the body's immune system as evidenced by reductions in peanut-specific immunoglobulin (IgE) blood levels after an additional 56 weeks of daily treatment with PALFORZIA. These data were accepted for presentation at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2020 Annual Meeting; due to the cancellation of the meeting, the Company will host a conference call Monday, March 16 at 12:15 p.m. ET to discuss the data, and posters will be available on Aimmunes website prior to the call.

Additional data announced include:

PALFORZIA Long-term Clinical Trial Data

Peanut Allergy Data

Real-World OIT Practice Data

We are excited to share new long-term PALFORZIA data, which indicate that as patients remain on treatment, the immune system appears to develop an increased tolerance to the allergen, as demonstrated by the reduced frequency and severity of side effects, along with the potential for continued desensitization over time, said Daniel Adelman, M.D., Chief Medical Officer of Aimmune Therapeutics. Additional studies announced today further reinforce the daily burden of living with peanut allergy and suggest that treatment with PALFORZIA may improve its emotional and social impact on adolescents and caregivers alike. This, coupled with results from real-world surveys, suggests that most allergists who practice OIT for food allergy are seeing promising results and that patients with a wide range of baseline characteristics may benefit from treatment with PALFORZIA, is encouraging as we continue to advance our knowledge on the potential benefits of oral immunotherapy for food allergy.

Conference Call Details

In connection with this announcement, Aimmune Therapeutics will host a conference call and webcast Monday March 16 at 12:15 p.m. ET. To access the live call by phone, dial (877) 497-1438 (domestic) or (262) 558-6296 (international) and enter the passcode 1277785. To access a live or recorded webcast of the call, please visit the Investor Relations section of the Aimmune Therapeutics website at http://www.aimmune.com. The recorded webcast will be available for approximately 30 days following the call.

PALFORZIA (previously known as AR101) was approved by the U.S. Food and Drug Administration (FDA) on January 31, 2020. PALFORZIA is the first approved treatment for patients with peanut allergy.

INDICATION

PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years of age and older.

PALFORZIA is to be used in conjunction with a peanut-avoidant diet.

Limitations of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

IMPORTANT SAFETY INFORMATION

Boxed WARNING:

PALFORZIA can cause anaphylaxis, which may be life threatening and can occur at any time during PALFORZIA therapy.

Prescribe injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use.

Do not administer PALFORZIA to patients with uncontrolled asthma.

Dose modifications may be necessary following an anaphylactic reaction.

Observe patients during and after administration of the Initial Dose Escalation and the first dose of each Up-Dosing level, for at least 60 minutes.

PALFORZIA is available only through a restricted program called the PALFORZIA REMS.

CONTRAINDICATIONS

PALFORZIA is contraindicated in patients with uncontrolled asthma, or with a history of eosinophilic esophagitis and other eosinophilic gastrointestinal disease

WARNINGS AND PRECAUTIONS

Anaphylaxis

PALFORZIA can cause anaphylaxis, which may be life threatening. PALFORZIA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the PALFORZIA REMS because of the risk of anaphylaxis. Only prescribers, healthcare settings, pharmacies, and patients certified and enrolled in the REMS Program can prescribe, receive, dispense or administer PALFORZIA.

Anaphylaxis has been reported during all phases of PALFORZIA dosing, including Maintenance and in subjects who have undergone recommended Up-Dosing and dose modification procedures.

Do not initiate PALFORZIA treatment in a patient who has had severe or life-threatening anaphylaxis within the previous 60 days. PALFORZIA may not be suitable for patients with certain medical conditions that may reduce the ability to survive anaphylaxis, including but not limited to markedly compromised lung function, severe mast cell disorder, or cardiovascular disease. In addition, PALFORZIA may not be suitable for patients taking medications that can inhibit or potentiate the effects of epinephrine.

All Initial Dose Escalation doses and the first dose of each Up-Dosing level must be administered in a certified health care setting.

Patients may be more likely to experience allergic reactions following PALFORZIA administration in the presence of cofactors such as exercise, hot water exposure, intercurrent illness (e.g., viral infection), or fasting. Other potential cofactors may include menstruation, sleep deprivation, nonsteroidal anti-inflammatory drug use, or uncontrolled asthma. Patients should be proactively counseled about the potential for the increased risk of anaphylaxis in the presence of these cofactors. If possible, adjust the time of dosing to avoid these cofactors. If it is not possible to avoid these cofactors, consider withholding PALFORZIA temporarily.

Asthma

Uncontrolled asthma is a risk factor for a serious outcome, including death, in anaphylaxis. Ensure patients with asthma have their asthma under control prior to initiation of PALFORZIA.

PALFORZIA should be temporarily withheld if the patient is experiencing an acute asthma exacerbation. Following resolution of the exacerbation, resumption of PALFORZIA should be undertaken cautiously. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of PALFORZIA.

Eosinophilic Gastrointestinal Disease

Discontinue PALFORZIA and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastrointestinal symptoms, including dysphagia, vomiting, nausea, gastroesophageal reflux, chest pain, or abdominal pain.

Gastrointestinal Adverse Reactions

Gastrointestinal adverse reactions were commonly reported in PALFORZIA-treated subjects, and dose modification should be considered for patients who report these reactions. For severe or persistent gastrointestinal symptoms consider a diagnosis of eosinophilic esophagitis.

ADVERSE REACTIONS

The most common adverse events reported in subjects treated with PALFORZIA (incidence 5% and 5% than placebo) are abdominal pain, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, and ear pruritus.

Please see full Prescribing Information, including Boxed WARNING, and Medication Guide at http://www.PALFORZIA.com.

For more information about PALFORZIA, please call 1-844-PALFORZ (1-844-725-3679) or visit http://www.PALFORZIA.com.

About Aimmune

Aimmune Therapeutics, Inc. is a biopharmaceutical company developing and bringing new treatments to people with potentially life-threatening food allergies. With a mission to improve the lives of people with food allergies, Aimmune is developing and commercializing oral treatments for potentially life-threatening food allergies. The Companys Characterized Oral Desensitization ImmunoTherapy (CODIT) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies. For more information, please visit http://www.aimmune.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Aimmunes expectations regarding the potential benefits of PALFORZIA; the potential for PALFORZIA to increase desensitization over time and to improve patient quality of life; and Aimmunes expectations regarding potential applications of the CODIT approach to treating life-threatening food allergies. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Aimmune will need additional funds to finance its operations; Aimmunes dependence on the success of PALFORZIA; Aimmunes ability to build a commercial field organization and distribution network; the degree of acceptance of PALFORZIA among physicians, patients, healthcare payors, patient advocacy groups and the general medical community; Aimmunes ability to obtain favorable coverage and reimbursement from third-party payors for PALFORZIA; Aimmunes reliance on third parties for the manufacture of PALFORZIA; Aimmunes ability to implement and comply with the REMS for PALFORZIA; possible regulatory developments in the United States and foreign countries; and Aimmunes ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Aimmune's most recent filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2019. All forward-looking statements contained in this press release speak only as of the date on which they were made. Aimmune undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

This press release concerns PALFORZIA (AR101), which has been approved for marketing by the FDA in the United States and has not been approved for marketing by the EMA or Swissmedic. AR101 in Europe is currently limited to investigational use, and no representation is made as to its safety or effectiveness for the purposes for which it is being investigated.

PALFORZIA, AIMMUNE, AIMMUNE THERAPEUTICS and CODIT are trademarks of Aimmune Therapeutics, Inc.

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Aimmune Announces New PALFORZIA Data Suggesting Increased Desensitization, Improved Tolerability and Continued Immunomodulation After 18 and 24 Months...

Immunology

Are restaurants going to close because of coronavirus? – TODAY

There might never be a better (or worse) time to snag a reservation at that amazing restaurant that's usually booked up for months.

As concern over the coronavirus pandemic continues to escalate, more people are staying home. Eateries are emptying out and Chinese restaurants in particular have been facing a significant drop in business for weeks.

But if you're healthy and hungry, is it really necessary to forgo dining out? Here's what industry experts and those who study infectious disease say about whether it's OK to enjoy a meal outside the home right now.

"Any time you increase your exposure to public areas, you increase your risks," Charles P. Gerba, a professor of microbiology and immunology at Arizona State University, told TODAY.

But it's not only people you should avoid. It's just as important to avoid the surfaces they've touched. This is especially true if you're in an environment where you'll be putting things in your mouth. Restaurants most at-risk for this type of behavior are buffets, where all diners use the same serving utensils and have access to a lot of exposed food. Earlier this week, MGM Resorts International temporarily closed all of its buffets in Las Vegas and other resorts converted their buffets to serving stations.

However, that isn't necessarily a green light to go eat at traditional sit-down restaurants without taking a few precautionary steps.

"Unfortunately, I think all restaurants will suffer and I think full service will suffer the most because theres a perception that theyre more dangerous (than other public places)," Rick Camac, dean of restaurant and hospitality studies at the Institute of Culinary Education, said.

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People with underlying medical conditions, those who have recently traveled to countries hit hardest by the novel coronavirus, the elderly and those with compromised immune systems should stay home.

Camac, however, doesn't have any plans to stop eating out. "I ate dinner inches away from the next guest at the bar at Crown Shy last night and today I had lunch at Portale," said the dean. Ultimately, the decision is up to the consumer, so if you are an individual in relatively good health, there are several steps you can take to minimize the risk of contracting a virus while dining out.

Based on his studies, Gerba said the germiest areas in most restaurants are actually the sponges and cloths used to wipe down tables. These studies also indicated that menus and child seats are almost just as bad when it comes to harboring germs. "If you're gong out to eat bring hand sanitizer and a disinfectant wipe to wipe your table," recommended Gerba.

Of course, in the age of social distancing there may be fewer tables to wipe.

The critically acclaimed Plumed Horse in Saratoga, California, is being proactive by removing more than half of its 36 tables in its main dining room. This allows for at least 6 feet of space between groups, which is as far as the virus can travel. Normally, Plumed Horse only has 2 feet of space between its tables. Despite this change, owner Josh Weeks told TODAY he's had more than 1,000 cancellations for future reservations.

Weeks isn't the only restaurateur practicing social distancing.

Benjamin Ramos, general manager of Aejo Tribeca in New York City, has removed every other two-top table from his restaurant. Sam Nidel, co-owner of Motel Morris in New York City, told TODAY he's busy re-arranging his space after receiving word that Mayor Mayor Bill de Blasio is requiring all city restaurants to remove 50 percent of their seating.

But does putting distance between diners work? Not necessarily.

"You would have to feel confident that the restaurant is cleaning and disinfecting all surfaces touched by fellow diners," said Dr. Brittany Brinley, a Beverly Hills-based physician. "Evidence suggests the novel coronavirus can remain active on surfaces for hours to days."

Plus, if you're going outside, it's not like the restaurant is the only thing you'll be touching. "While it may be advised and help technically-speaking, logically, if you go to a half-empty restaurant but then get on the subway, ride in an upper, get into an elevator with others, etc., youre not really practicing social distancing," said Camac.

Some restaurants have decided that it's not even worth the risk right now.

On Friday, Danny Meyer, one New York City's most successful restaurateurs announced that he would be temporarily closing all 19 restaurants in his Union Square Hospitality Group.

If the confirmed cases of coronavirus continue to rise in the U.S., it wouldn't be surprising if more restaurants followed suit, or transitioned to a delivery service model in the coming weeks. Food delivery apps like Grubhub, Instacart and Postmates are now offering no-contact drop-off options.

Of course, like millions of Americans, you can also visit the grocery store and prepare your own food.

In that case, Gerba said it's important to not use a self-checkout touch screen unless you have hand sanitizer or immediately wash your hands after using it. Gerba also recommended taking advantage of the disinfectant wipes available at the entrance of most grocery stores to thoroughly clean the handles on your basket or cart.

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Are restaurants going to close because of coronavirus? - TODAY

Immunology

Bipolar Disorder and the Immune System – PsychCentral.com

Bipolar disorder affects more than moods. It is now considered a multi-system condition with serious impact on the immune system.

Co-morbidities, or conditions that frequently appear in people with BP, have long been known to include cardiovascular disease, diabetes, obesity and poor response to pharmacological interventions

The frontier of bipolar research, however, is the extremely high co-occurrence of auto-immune diseases in people with BP. Some researchers even surmise that BP itself is an autoimmune disorder.

Patients with Guillain-Barre syndrome, Chrons disease and auto-immune hepatitis have significantly higher rates of BP than the general population. Those with lupus are 6 times more likely to have BP, and people with MS are 30 times more likely to suffer from BP.

Thyroiditis plays a role in BP for many patients, and it is strongly heritable. The offspring of those with thyroiditis and BP often inherit both conditions.

The old model of diagnosing and treating BP as a psychiatric condition only, responsive to mood-stabilizers and psychotherapy, may be hopelessly out of date. The connections between BP and physical diseases, especially auto-immune disease, is too great to ignore.

Immunologists, neurologists and other medical specialists should be consulted in every new case of BP, and in every existing and long-term case.

Studies show that the addition of anti-inflammatory treatment to mood-stabilizers can significantly reduce the length and severity of depressive episodes. Research is ongoing on these therapies impact on mania and mixed states.

Researchers are investigating how an anti-inflammatory as simple as aspirin may positively impact those with BP.

The most significant physical factor that BP and auto-immune disorders have in common is the bodys reaction to stress. Severe stress often precipitates changes in mood and leads to increases in biochemical contributors to inflammation.

Stress management should be considered a primary, font line therapy for both BP and auto-immune disorders.

As science discovers more about the causes and co-morbidities of BP, psychiatry must keep up. More effort should be put into mind body medicine, treatments must expand to include immunology, and health insurance should adapt to cover physical therapies as well as more traditional psych meds and visits when diagnosis codes for BP are added to a patients records.

Source: https://www.karger.com/Article/Fulltext/356539

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Bipolar Disorder and the Immune System - PsychCentral.com

Immunology

Opdivo and Yervoy Combination Wins Accelerated Approval for HCC – BioSpace

The U.S. Food and Drug Administration (FDA) gave an accelerated greenlight to Bristol Myers Squibbs combination of Opdivo and Yervoy as a treatment for hepatocellular carcinoma in patients who have been previously treated with Bayers Nexavar (sorafenib).

Approval for the combination treatment was based on results from the Phase I/II CheckMate-040 trial in which Opdivo and Yervoy showed an overall response rate of 33% in this patient population. Of those, 8% had a complete response and 24% showed a partial response. Duration of responses (DOR) ranged from 4.6 to 30.5 months, with 88% lasting at least six months, 56% at least 12 months and 31% at least 24 months, BMS said.

Anthony B. El-Khoueiry, BMS lead investigator and phase I program director at the Keck School of Medicine, University of Southern California, said the overall response rate observed in the Opdivo and Yervoy combination of the CheckMate-040 trial underscores the potential of this dual immunotherapy as a possible treatment option for patients.

Opdivo (nivolumab) and Yervoy (ipilimumab) are cornerstones of BMS immunology treatments. Opdivo, a programmed death-1 (PD-1) immune checkpoint inhibitor, has been approved for the treatment of multiple cancers, including patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. Yervoy targets CTLA-4, a protein receptor that regulates the immune system.

The FDA gave the nod under accelerated approval. Continued approval in this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, the company noted. The Opdivo and Yervoy combination is the first and only dual immunotherapy approved in this setting, BMS said. The company added that this is the fourth regulatory approval for cancer from the FDA for the combination treatment. The combination treatment had been previously granted both Breakthrough Therapy Designation for this indication and a Priority Review from the FDA.

Hepatocellular carcinoma (HCC) is the most common type of liver cancer in adults. HCC represents about 80% of all primary liver cancers. The disease occurs most often in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection.

Adam Lenkowsky, general manager and head of U.S. Oncology, Immunology and Cardiovascular at Bristol Myers Squibb, said there is a critical need to provide patients with aggressive forms of cancer such as HCC with new treatment options that may offer clinically meaningful and ultimately durable responses. The approval, Lenkowsky said, builds on the companys legacy in pioneering immunotherapy treatments.

The incidence of liver cancer is rising in the United States, and HCC is the most common and aggressive form of the disease, Andrea Wilson, president and founder of Blue Faery: The Adrienne Wilson Liver Cancer Association, said in a statement. Todays approval provides a new option for patients with HCC previously treated with sorafenib, giving the community more hope.

Last year, Eli Lilly snagged regulatory approval for Cyramza as a single agent for the second-line treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) and have previously been treated with sorafenib. Also in 2019, Alameda, Calif.-based Exelixis, Inc. won approval for its HCC treatment, Cabometyx (cabozantinib).

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Opdivo and Yervoy Combination Wins Accelerated Approval for HCC - BioSpace

Immunology

Epinephrine More Commonly Used for Venom and Anaphylaxis Than Food Allergy – Pulmonology Advisor

Home Meetings AAAAI 2020

After careful consideration, the American Academy of Allergy, Asthma & Immunology canceled its annual meeting that was to take place in Philadelphia, Pennsylvania from March 13 to 16, because of concerns regarding the coronavirus disease 2019 (COVID-19) outbreak. Although the live events will not proceed as planned, our readers can still find coverage of research that was scheduled to be presented at the meeting.

Epinephrine is more often prescribed for venom allergy and idiopathic anaphylaxis than for food allergy despite its potential as a life-saving drug for allergic reactions, according to study results intended to be presented at the 2020 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI).

Researchers conducted this study to assess allergist trends in the use and prescription of epinephrine. A 19-item survey was electronically distributed to a 20% sample of AAAAI members, and to all members of the American College of Allergy, Asthma, and Immunology (ACAAI). The survey inquired about epinephrine prescribing trends and treatment scenarios.

Researchers revealed that 648 people responded to the survey; 97% of whom reported routinely prescribing epinephrine autoinjectors (EAIs). An estimated 70.1% of respondents always prescribed EAIs for food allergies compared with 92.3% who prescribed EAIs for idiopathic anaphylaxis, 84.4% for venom immunotherapy, 49.4% for biologics, and 29.4% for inhalant immunotherapy. A total of 58% respondents reported that antihistamines have no or a limited role in the treatment of allergic reactions and 13.8% recommended using epinephrine for a food trigger in patients with a history of mild symptoms, compared with 20.5% recommended it for a venom trigger.

In addition, 61.4% of respondents routinely provide emergency action plans to patients. Time in practice was significantly associated with reduced odds of EAI prescription for immunotherapy, but not with providing an emergency action plan, advising on preemptive use, or the use of antihistamines

The study researchers concluded that there are wide variations in practice in the use of epinephrine.

Reference

Greenhawt M, Wang J. Allergist trends in epinephrine prescribing and usage patterns. J Allergy Clin Immunol. 2020;145(Suppl 2):AB8.

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Epinephrine More Commonly Used for Venom and Anaphylaxis Than Food Allergy - Pulmonology Advisor

Immunology

Preclinical Data Show Tumor Treating Fields Induces Immunogenic Cell Death Resulting in Enhanced Antitumor Efficacy When Combined with Anti-PD-1…

Data from study on Tumor Treating Fields in combination with anti-PD-1 therapy published in Cancer Immunology, Immunotherapy

ST. HELIER, Jersey--(BUSINESS WIRE)-- NovoCure Ltd. (NASDAQ: NVCR) announced today that preclinical data on Tumor Treating Fields in combination with anti-PD-1 therapy were published in the peer-reviewed journal, Cancer Immunology, Immunotherapy. The published study suggests that Tumor Treating Fields therapy can induce anticancer immune response and provide the first evidence for the immunostimulatory effects of Tumor Treating Fields-induced cell death.

The published study evaluated whether Tumor Treating Fields-mediated cell death can elicit antitumor immunity. The data demonstrated that damage-associated molecular patterns were released in Tumor Treating Fields-treated cancer cells, and calreticulin was exposed on the cell surface. In addition, Tumor Treating Fields therapy promoted the engulfment of cancer cells by dendritic cells and dendritic cell maturation in vitro, as well as recruitment of immune cells in vivo. The combination of Tumor Treating Fields with anti-PD-1 therapy resulted in a significant decline in tumor volume and an increase in the percentage of tumor-infiltrating leukocytes in two animal tumor models.

The data demonstrated a potential therapeutic advantage for combining Tumor Treating Fields and anti-PD-1 therapy, highlighting that this combination may be a viable treatment regimen to enhance clinical outcomes. Novocure is currently testing the combination of Tumor Treating Fields with immune checkpoint inhibitors in its phase 3 pivotal LUNAR trial in patients with stage 4 non-small cell lung cancer who progressed during or after platinum-based therapy.

About Tumor Treating Fields

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with glioblastoma and in the U.S. for mesothelioma, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types including some of the most aggressive forms of cancer.

About Novocure

Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. Novocures commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma and in the U.S. for the treatment of adult patients with malignant pleural mesothelioma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer, liver cancer and gastric cancer.

Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. Additionally, the company has offices in Germany, Switzerland, Japan and Israel. For additional information about the company, please visit http://www.novocure.com or follow us at http://www.twitter.com/novocure.

Forward-Looking Statements

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocures current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as anticipate, estimate, expect, project, intend, plan, believe or other words and terms of similar meaning. Novocures performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Report on Form 10-K filed on February 27, 2020, with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

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Preclinical Data Show Tumor Treating Fields Induces Immunogenic Cell Death Resulting in Enhanced Antitumor Efficacy When Combined with Anti-PD-1...

Immunology

5 ways to make your home allergen resistant this spring – WSLS 10

Spring is on the horizon, which means allergy season is here.

Its bad enough to experience hay fever when you leave your house, but its downright miserable to have allergies even when youre indoors.

If youre suffering from allergies even on the days you stay home and keep the house shut, there are steps you can take to limit your allergic reactions. Check out the following ideas:

Changing your filter for your central air conditioner can greatly reduce the allergy symptoms you experience.

Switching out your filter every three months should help limit allergies as much as possible. Irritants will gather in your filter, and if you dont change it regularly, you are blowing those irritants back into the air. A clean filter will catch some of the pollen and other allergens that get blown in from outside.

Get draft protectors for all doors that lead outside.

Foam draft protectors are affordable and will help prevent wind from blowing in at the bottom of your door. If you dont like the look of foam draft protection, consider getting new weather stripping. Worn out weather stripping is responsible for air finding its way inside your house. Seal up doorways to reduce the amount of pollen that can enter your home.

Buying new windows is a costly project, but it will severely limit the allergens that enter your home.

Old, single-pane windows do not stop air from entering your home. Especially on a windy day, pollen will get in through the cracks of your window. Upgrading your windows will seal out air that you dont want inside. If you cant afford to do all the windows in your house, consider changing out windows in the rooms you spend the most time in, like the bedroom or living room.

Its important to clean the vents that blow air through your home. Dust accumulates very easily on vents, and if you dont deep clean your vents regularly, irritants will be blown into your home every time you use the air conditioner.

Dust your vents thoroughly several times a year, especially when its time to do some spring cleaning.

One of the best ways you can limit allergens in your home is to vacuum often. Pet dander and irritants tracked in from outside will settle into your carpet and cause you a lot of discomfort. If you have severe allergies, vacuum multiple times a week to keep your hay fever under control.

If you dont have the time to vacuum regularly due to a busy schedule, consider purchasing a smart vacuum that will clean your floors when youre not home.

If youve done everything you can to limit your hay fever at home, talk to your doctor. There are many different types of allergy medications that you can take to lessen your allergy symptoms this spring.

Need a doctor? Dr. Saju Eapen is a practicing allergist in the Roanoke and Lynchburg area. He has been in practice for almost 20 years. He is board-certified in Allergy and Clinical Immunology, as well as Internal Medicine. Before coming to the area, he trained with some of the leading researchers in the field of Allergy and Immunology.

The Asthma and Allergy Center is celebrating 70 years in practice. Interested in becoming a patient? Click or tap here.

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5 ways to make your home allergen resistant this spring - WSLS 10

Immunology

Opdivo and Yervoy Combination Wins Accelerated Approval for HCC – PharmaLive

The U.S. Food and Drug Administration (FDA) gave an accelerated greenlight to Bristol-Myers Squibbs combination of Opdivo and Yervoy as a treatment for hepatocellular carcinoma in patients who have been previously treated with Bayers Nexavar (sorafenib).

Approval for the combination treatment was based on results from the Phase I/II CheckMate-040 trial in which Opdivo and Yervoy showed an overall response rate of 33% in this patient population. Of those, 8% had a complete response and 24% showed a partial response. Duration of responses (DOR) ranged from 4.6 to 30.5 months, with 88% lasting at least six months, 56% at least 12 months and 31% at least 24 months, BMS said.

Anthony B. El-Khoueiry, BMS lead investigator and phase I program director at the Keck School of Medicine, University of Southern California, said the overall response rate observed in the Opdivo and Yervoy combination of the CheckMate-040 trial underscores the potential of this dual immunotherapy as a possible treatment option for patients.

Opdivo (nivolumab) and Yervoy (ipilimumab) are cornerstones of BMS immunology treatments. Opdivo, a programmed death-1 (PD-1) immune checkpoint inhibitor, has been approved for the treatment of multiple cancers, including patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. Yervoy targets CTLA-4, a protein receptor that regulates the immune system.

The FDA gave the nod under accelerated approval. Continued approval in this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, the company noted. The Opdivo and Yervoy combination is the first and only dual immunotherapy approved in this setting, BMS said. The company added that this is the fourth regulatory approval for cancer from the FDA for the combination treatment. The combination treatment had been previously granted both Breakthrough Therapy Designation for this indication and a Priority Review from the FDA.

Hepatocellular carcinoma (HCC) is the most common type of liver cancer in adults. HCC represents about 80% of all primary liver cancers. The disease occurs most often in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection.

Adam Lenkowsky, general manager and head of U.S. Oncology, Immunology and Cardiovascular at Bristol-Myers Squibb, said there is a critical need to provide patients with aggressive forms of cancer such as HCC with new treatment options that may offer clinically meaningful and ultimately durable responses. The approval, Lenkowsky said, builds on the companys legacy in pioneering immunotherapy treatments.

The incidence of liver cancer is rising in the United States, and HCC is the most common and aggressive form of the disease, Andrea Wilson, president and founder of Blue Faery: The Adrienne Wilson Liver Cancer Association, said in a statement. Todays approval provides a new option for patients with HCC previously treated with sorafenib, giving the community more hope.

Last year, Eli Lilly snagged regulatory approval for Cyramza as a single agent for the second-line treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) and have previously been treated with sorafenib. Also in 2019, Alameda, Calif.-based Exelixis, Inc. won approval for its HCC treatment, Cabometyx (cabozantinib).

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Opdivo and Yervoy Combination Wins Accelerated Approval for HCC - PharmaLive