Category Archives: Stem Cell Medical Center


Coronavirus daily news update, April 6: What to know today about COVID-19 in the Seattle area, Washington state and the nation – Seattle Times

Washington state appears to be flattening its curve the impact on the hospital system at any one time according to the latest analysis from theUniversity of Washingtons Institute for Health Metrics and Evaluation(IHME). The IHME models suggest the state hit peak resource use on April 2 and project daily COVID-19 deaths will peak today, April 6, before dropping to 18 deaths per day during April 7-9 and declining slowly from there.

The model also revises its estimates of deaths in Washington sharply downward, to 632. Earlier model results had suggested about 1,400 people in the state were likely to die from the disease. IHME has been adjusting its model daily, and the latest results are based on a massive infusion of new data, institute director Christopher Murray said in a statement.

The estimated death toll nationwide remains at around 82,000, similar to earlier estimates. But the upper end of the uncertainly range has been lowered to about 136,400, from previous estimates of nearly 200,000.

Washington will return more than 400 of the 500 ventilators it recently received from the federal government, so they can go to New York and other states harder hit by the coronavirus crisis, Gov. Jay Inslee said Sunday.Vice President Mike Pence commended Inslee for returning the ventilators and said Washington and Oregon are two states leading by example in taking steps to slow the spread of the coronavirus that causes COVID-19.

The state Department of Health mirroring the Centers for Disease Control and Prevention recommends residents wear cloth face masks anytime they are in public and cant guarantee theyll be able to stay 6 feet away from another person.

The state health department on Sunday confirmed an additional 393 cases and 28 deaths from COVID-19 as of 11:59 p.m. Saturday, bringing the states totals to 7,984 cases and 338 fatalities.

Throughout today, on this page, well be posting updates from Seattle Times journalists and others on the outbreak and its effects on the Seattle area, the Pacific Northwest and the world. Updates from Sunday can be found here, and all our coronavirus coverage can be found here.

The following graphic includes the most recent numbers from the Washington State Department of Health, released Sunday.

President Trump and members of the Coronavirus Task Force have scheduled a press briefing for this afternoon.

Leticia Frutos never imagined shed spend weeks avoiding her month-old granddaughter because of her manufacturing job in Bothell.

The Mill Creek resident and material assistant for Ventec Life Systems is one of more than 1,000 workers nationwide on the front lines of Ventecs Project V venture with General Motors to make thousands of ventilators for the nations coronavirus fight.

Ventec, GM and the companies supplyingparts for them say worker safety is a prime concern. Its also a challenge, given the ramp-up inproduction means more workerson the production line, often for more hours per week, and at a hurried pacethat could lead to mistakes safeguarding against COVID-19, the illness caused by the novel coronavirus.

Read the full story here.

Geoff Baker

Thomas Lopez, who ran a fleet of Tacos El Tajin food trucks around Seattle, has died from COVID-19, the disease caused by the novel coronavirus, his family announced Monday afternoon.

After suffering flu-like symptoms, Lopez, 44, was hospitalized last week and put on a ventilator, but his condition got worse and he died on Thursday, his son Isaac Lopez said.

Lopez made national headlines in February 2017 for hawking tacos out of his food truck on Interstate 5 after a semitruck rolled over and brought traffic to a standstill. After realizing he would not make it to South Lake Union for the Amazon lunch rush and seeing how drivers around him were losing their patience, Lopez got out and started selling steak and chicken tacos to commuters as if he were parked in a food-truck pod.

Lopez, a Pacific resident, is survived by his wife Antonia Zamorano and their five children.

Read the full story here.

Tan Vinh

BELLINGHAM Escalating a global spat over workplace safety and the rights ofhealth-care workers during the coronavirus crisis, a top official of PeaceHealth has now confirmed the company ousted emergency physician Ming Lin for allegedly inciting public fear by criticizing the hospitals emergency precautions.

In a lengthy interview on a YouTube video blog popular with medical professionals, Richard DeCarlo, chief operating officer of PeaceHealth, which operates Bellinghams St. Joseph Medical Center, likened Lins public warnings about workplace coronavirus concerns to yelling fire in a crowded theater. He said the hospital had no choice but to remove Lin from his post of 17 years.

Lin said Monday that he had seen the video and urged members of the public to view his Facebook postsand draw their own conclusions. Lin on March 16 accused PeaceHealth management of mishandling early COVID-19 testing; failing to conduct proper triage of patients and staff entering the hospital; and lagging in procedures for protective equipment and other emergency measures.

Read the full story here.

Ron Judd

Boeing said Monday it will suspend its 787 production work in South Carolina until further notice, halting temporarily its last aircraft manufacturing center that was still operating.

The company closed its Seattle-area production facilities March 25, and announced Sunday it would keep them closed indefinitely as the coronavirus ravages airlines finances and the COVID-19 disease forces many factories to close.

Boeing said its suspension in North Charleston, S.C., affects its Airport Campus, Emergent Operations, Interiors Responsibility Center South Carolina and Propulsion South Carolina. Collectively these employ several thousand people in final assembly of the 787 and manufacturing some sections of the plane.

Read the full story here.

Seattle Times business staff

Employees at Valley Medical Center had a brush with COVID-19 even before the outbreak became publicly known in Western Washington after a man twice visited the Renton hospital in late February.

He came into the Emergency Department, got discharged, a few days later came in very sick and was admitted to the critical care unit, said Jamie Park, the hospitals chief medical officer.

In a March 1 conference call, hospital administrators told some clinicians as many as 350 staffers could have been exposed during the mans visits, according to two physicians who listened to the call.

Interviews with more than a dozen front-line Valley employees, including multiple physicians, and copies of emails and internal documents, underscore the concerns of many employees who said that COVID-19s sudden arrival left staff and administrators scrambling. Directives changed regularly and sometimes confusion reigned, fueling employees fears for their safety.

And since the outbreak began, a rift in understanding, amplified by stress, risk and fear, has grown between some Valley employees and management over access to personal protective equipment (PPE), testing availability and criteria and infection-control measures.

Read the full story here.

Evan Bush

Sound Transit will reduce Sounder South service by one round trip starting Wednesday because of reduced staffing availability,the agency said Monday.

A southbound train that departs from Seattle at 7:55 a.m. and a northbound train that departs from Lakewood at 10:16 a.m. will be removed from the schedule.

The reductions follow previous cuts to Sounder service because of concerns around the novel coronavirus pandemic.

Sounder ridership has declined by 92%, the agency said.

Sound Transit and King County Metro last monthbegan reducing service, eliminated fares and asked riders to board through rear doorson buses to reduce contact between drivers and riders.

Michelle Baruchman

The next time more than a million kids in Washington state attend classeswith their peers, it will be a new school year.

Washington schoolswill remain closed through the end of the academic year, Gov. Jay Inslee announced at a Monday news conference.Distance learning is expected to continue, and schools are expected to resume on a normal schedule this fall.

The announcement comes 20 days into a state-mandated closure of all public and private schools in an attempt to slow the spread of coronavirus. The closures werefirst supposed tolast until at least April 24, about six weeks, but state schools chief Chris Reykdal has repeatedly stressed the shutdown could last longer.

We simply cannot take the chance of reopening on site instruction in this calendar school year, Inslee said. We cannot risk losing the gains we have made after the peak of this pandemic presumably will have passed.

Read the full story here.

The Seattle Times

A Kitsap County resident has died of COVID-19, the first person from the county todie from the disease caused by the novel coronavirus, the Kitsap Public Health District said.

The person, who had tested positive for the virus, was an "older adult" with underlying health conditions, the Health District said.

"We were saddened to learn of the death of this community member and our hearts go out to their family and loved ones during this difficult time, Dr. Susan Turner,the district's health officer said. As a community, we must do everything we can to slow the spread of this illness and protect our neighbors who are most at risk. Please continue to stay home, wash your hands, and clean your living spaces. These simple steps can save lives.

As of Monday, 111 Kitsap County residents had tested positive for the virus, out of more than 1,900 tested, the Health District said.

David Gutman

New York City officials are starting to lay chilling contingency plans if deaths from the coronavirus outbreak begin to overwhelm the capacity of morgues: temporarily burying the dead in one of the citys public parks.

Mark Levine, chairman of the City Council health committee, said Monday that the office of the chief medical examiner was looking into creating temporary mass graves in a public park as it confronts the possibility that deaths from the coronavirus outbreak may soon exceed the capacity of city and hospital morgues.

Levine declined to say which park was under consideration, noting only that it would likely have to be a large one out of the way of the public.

Mayor Bill de Blasio said Monday that no such plan had been put in place yet, although he acknowledged it was under consideration.

If we need to do temporary burials to be able to tide us over to pass the crisis, and then work with each family on their appropriate arrangements, we have the ability to do that, he said, adding, We may well be dealing with temporary burials so we can deal with each family later.

Read the full story here.

The New York Times

Major supermarket chains are beginning to report their first coronavirus-related employee deaths, leading to store closures and increasing anxiety among grocery workers as the pandemic intensifies across the country.

A Trader Joes worker in Scarsdale, New York, a greeter at a Giant store in Largo, Maryland, and two Walmart employees from the same Chicago-area store have died of COVID-19 in recent days, the companies confirmed Monday.

Though more than 40 states have ordered nonessential businesses to close and told residents to stay home to stem the spread of the virus, supermarkets are among the retailers that remain open.

Read the full story here.

The Washington Post

British Prime Minister Boris Johnson was moved to the intensive care unit of a London hospital after his coronavirus symptoms worsened Monday, just a day after he was admitted for what were said to be routine tests

Johnson was admitted to St. Thomas Hospital late Sunday, 10 days after he was diagnosed with COVID-19.

Over the course of this afternoon, the condition of the Prime Minister has worsened and, on the advice of his medical team, he has been moved to the Intensive Care Unit at the hospital, his office said in a statement.

Downing St. said Johnson was conscious and does not require ventilation at the moment, but was in the intensive care unit in case he needed it later.

Read the full story here.

The Associated Press

Seattle's Woodland Park Zoo has canceled ZooTunes, its popular summer concert series, as well as summer day camps and other special events.

The zoo has been closed since early March because of the coronavirus pandemic.

The zoo, in a social media post, said it decided to cancel the summer events to "put community safety first and focus our resources and staff on our animals."

It said it has lost millions of dollars in revenue since it closed, nearly a month ago.

David Gutman

Tim Eyman, the anti-tax advocate and Republican candidate for governor, is urging his supporters to come to Seattle City Hall Monday afternoon to protest a new tax proposal at the weekly City Council meeting.

But there will be no City Council meeting at Seattle City Hall.

The City Council has moved to all-remote meetings, by teleconference, to slow the spread of the novel coronavirus.

Eyman, in a letter to supporters Monday morning, seemed unaware.

"Would we have beaten the British in the Revolutionary War if George Washington and his patriots had stayed home?" Eyman wrote. "At 1 p.m., at the east entrance to City Hall (dress warm), we will stay 6 feet apart and walk in together. We'll have signs for you. We'll have gloves and hand-sanitizer for you."

They will be waving signs to no one. While City Hall, and the Council chambers, will be unlocked, there will be no one there, except a staff member to operate a conference call line. City Council members will be participating from their homes.

Eyman is aware of his mistake. Seattle City Clerk Monica Martinez Simmons said she sent him a note letting him know Council chambers are closed (even if the room is not locked).

He did the same thing at an Edmonds City Council meeting two weeks ago, My Edmonds News reported, showing up to a meeting that was being held remotely.

Democratic State Rep. Gerry Pollet, an instructor at the University of Washington's School of Public Health, said it was "unconscionable" to encourage a gathering, like Eyman is doing.

"Eyman is demonstrating absolute ignorance of our states measures to prevent the spread of COVID-19," Pollet said. "Its inexcusable for anyone seeking to be in a position of leadership to be unaware of those measures."

Council members Kshama Sawant and Tammy Morales have been proposing a tax on big businesses, like Amazon. To "attend" the council meeting, tune in to the Seattle Channel or call 206-684-8566.

Council President M. Lorena Gonzalez said Monday she hopes to develop a tool to accept public comments during remote council meetings, but that won't be operational for at least a couple weeks.

David Gutman

Deja Vu Showgirls, an adult entertainment club in downtown Seattle, appears to be closed or clothed until April 30, according to a banner announcement outside the venue.

The club, across the street from Pike Place Market, is generally open 2 p.m. to 2:30 a.m. daily.

The windows have been boarded up with plywood as many other shops downtown have emptied in response to Gov. Jay Inslees stay-at-home order.

Jon Talton and Michelle Baruchman

Alaska Air Group said Monday it is cutting capacity for April May further than announced just two weeks ago, as it continues to experience demand that is 80% or more below normal levels.

In a regulatory filing, the company said, Today we are updating our capacity reduction plans to reflect 80% cuts in both April and May.

The parent of Alaska Airlines and Horizon Air added that for June and beyond, given current trends and circumstances, it is our expectation that sizable cuts will be necessary for the coming months.

Read the full story.

Seattle Times business staff

Washington State Superintendent Chris Reykdal says school buildings may stay closed through the end of the school year. Since schoolsclosed in mid-March, Reykdal and Gov. Jay Inslee have said buildings would remain closed until at least April 24.

Read more from the original source:
Coronavirus daily news update, April 6: What to know today about COVID-19 in the Seattle area, Washington state and the nation - Seattle Times

Celularity and Infectious Disease Research Institute will try out COVID-19 cell therapy – GeekWire

Celularitys subsidiary, LifebankUSA, maintains a repository of placental and cord blood, containing stem cells for potential therapeutic use. (LifebankUSA / Robert Hariri via Twitter)

Seattles Infectious Disease Research Institute and a New Jersey company called Celularity have been cleared by the Food and Drug Administration to start trials of an experimental cell-based therapy for COVID-19.

The immunotherapy treatment makes use of natural killer cells, or NK cells, which play a key role in the bodys natural defense against viral infections. Celularitys NK cell product, known as CYNK-001, is derived from placental stem cells for treating viral diseases as well as some types of blood cancers and tumors.

CYNK-001 has been safely given to patients in early trials for treating leukemia and multiple myeloma. Now the FDA has given investigational new drug clearance for its use to be extended to COVID-19, the disease caused by the coronavirus outbreak.

To date, efforts to treat COVID-19 cases have been primarily focused on antiviral medications, Corey Casper, who is CEO of the Infectious Disease Research Institute as well as a clinical professor of global health at the University of Washington, explained in a news release.While these are important, patients with serious disease may not respond completely to antiviral medications because they are experiencing damage already inflicted on the bodys vital organs.

About 80 to 100 patients diagnosed with pneumonia due to a COVID-19 infection will be enrolled at medical centers in the U.S., potentially including sites in Washington state. Participants in the study will be provided with infusions of CYNK-001.

The hypothesis is that administering NK cells to patients with moderate to severe COVID-19 will allow the immune cells find the sites of active viral infection, kill the virus, and induce a robust immune response that will help heal the damage and control the infection, Casper said. Beyond its promise as a critically needed treatment for COVID-19, the biology of NK cells indicates a possibility that this immunotherapy could be used as an off-the-shelf treatment for future pandemic infections.

Initial results are expected about 30 to 60 days after the first patients receive the cells. If the results are encouraging, a more rigorous clinical trial would follow.

Last weekend, Rudy Giuliani, President Donald Trumps personal attorney, touted the treatment on Twitter, saying that this therapy has real potential. This week, the FDA gave its clearance for the preliminary tests on an expedited basis.

In a statement issued today, Celularitys chairman and CEO, Robert Hariri, thanked the FDAs Center for Biologics Evaluation and Research for their tireless effort to guide us through the process of clearing the drugs use for COVID-19.

The New York Times quoted Paul Knopfler, a stem cell researcher at the University of California at Davis, as saying that Celularitys approach carried some risk. Its conceivable that the NK cells could exacerbate problems by massive killing of the patients respiratory cells, he told the Times.

The FDA has cleared testing of several other therapies for COVID-19, including use of the drugs hydroxychloroquine and remdesivir as well as blood plasma from recovered patients. In addition, the first U.S. clinical trial of a COVID-19 vaccine is underway at Seattles Kaiser Permanente Washington Research Institute.

Continue reading here:
Celularity and Infectious Disease Research Institute will try out COVID-19 cell therapy - GeekWire

CytoDyn CEO Dr. Pourhassan to Appear on Fox Business Network Friday, April 3, 2020 at 2:00 pm ET to Discuss Leronlimab Treatment of 10 Severely Ill…

Both Phase 2 and Phase 2b/3 trials for COVID-19 patients will be discussed

VANCOUVER, Washington, April 03, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that Nader Pourhassan, Ph.D., President and Chief executive Officer of CytoDyn will appear on Fox Business Network on the Making Money with Charles Payne program. The program will air from 2:00 pm ET to 3:00 pm ET (11:00 am PT to 12 noon PT) and is also available via live streaming at https://www.foxbusiness.com/shows/making-money-with-charles-payne.

The Companys investigational new drug, leronlimab, has been administered to 10 severely ill patients with COVID-19 at a leading medical center in the New York City area under an emergency IND recently granted by the FDA. The Company recently initiated enrollment in a Phase 2 trial for leronlimab treatment of COVID-19 patients with mild-to-moderate indications and under the same IND, is now proceeding with its second COVID-19 clinical, a Phase 2b/3 trial for the treatment of critically ill patients.

About Coronavirus Disease 2019SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

Story continues

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in April of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

Continue reading here:
CytoDyn CEO Dr. Pourhassan to Appear on Fox Business Network Friday, April 3, 2020 at 2:00 pm ET to Discuss Leronlimab Treatment of 10 Severely Ill...

Pinprick Blood Test To Identify Antibodies In Patients Approved By FDA – Kaiser Health News

The blood tests are important for a variety of reasons, including the fact that those with antibodies might be able to act as the first wave of people to re-start the economy. In other treatment news: an unproven stem cell therapy gets the green light, an oral antiviral spray shows promise to protect health workers, experts warn there's no "magic pill" to cure the virus, and the man behind a cocktail of drugs that's been criticized as giving Americans false hope.

The New York Times:F.D.A. Approves First Coronavirus Antibody Test In U.S.The Food and Drug Administration on Thursday approved a new test for coronavirus antibodies, the first for use in the United States. Currently available tests are designed to find fragments of viral genes indicating an ongoing infection. Doctors swab the nose and throat, and amplify any genetic material from the virus found there. The new test, by contrast, looks for protective antibodies in a finger prick of blood. It tells doctors whether a patient has ever been exposed to the virus and now may have some immunity. (Mandavilli, 4/2)

The Associated Press:Coronavirus Survivor: 'In My Blood, There May Be Answers'Tiffany Pinckney remembers the fear when COVID-19 stole her breath. So when she recovered, the New York City mother became one of the countrys first survivors to donate her blood to help treat other seriously ill patients. It is definitely overwhelming to know that in my blood, there may be answers, Pinckney told The Associated Press. Doctors around the world are dusting off a century-old treatment for infections: Infusions of blood plasma teeming with immune molecules that helped survivors beat the new coronavirus. (Neergaard and Ritzel, 4/3)

The New York Times:Unproven Stem Cell Therapy Gets OK For Testing In Coronavirus PatientsAn experimental stem cell therapy derived from human placentas will begin early testing in patients with the coronavirus, a New Jersey biotech company said Thursday. The treatment, being developed by the company Celularity, has not yet been used on any patients with symptoms of Covid-19, but it has caught the attention of Rudy Giuliani, President Trumps personal lawyer. Mr. Giuliani recently featured an interview with the company founder on his website and said on Twitter that the product has real potential, while also criticizing the Food and Drug Administration for not moving more quickly to approve potential remedies. (Thomas, 4/2)

Cincinnati Enquirer:Coronavirus: Oral Antiviral Spray To Be Tested For Infection PreventionAn antiviral oral spray that has been available over the counter since 2012 will undergo a clinical trial by University Hospitals in northeastern Ohio to see if it prevents front-line health care workers from becoming infected with the new coronavirus.We have every reason to believe it will be effective, said Dr. Robert A. Salata, chairman of the department of medicine at University Hospitals Cleveland Medical Center and principal investigator for the study. (Futty, 4/2)

Politico:No 'Magic Pill': The Fight Over Unproven Drugs For CoronavirusThe Food and Drug Administrations rush to greenlight unproven malaria medicines to fight the coronavirus may derail clinical trials of other potential cures for the deadly virus. Right now, dozens of potential therapies from antivirals to antibodies taken from the blood of coronavirus survivors are being tested in people. The first results from these studies could come within months if drugmakers enroll the thousands of patients needed to complete the research. (Owermohle, 4/2)

The New York Times:Touting Virus Cure, Simple Country Doctor Becomes A Right-Wing StarLast month, residents of Kiryas Joel, a New York village of 35,000 Hasidic Jews roughly an hours drive from Manhattan, began hearing about a promising treatment for the coronavirus that had been rippling through their community. The source was Dr. Vladimir Zelenko, 46, a mild-mannered family doctor with offices near the village. Since early March, his clinics had treated people with coronavirus-like symptoms, and he had developed an experimental treatment consisting of an antimalarial medication called hydroxychloroquine, the antibiotic azithromycin and zinc sulfate. (Roose and Rosenberg, 4/2)

See more here:
Pinprick Blood Test To Identify Antibodies In Patients Approved By FDA - Kaiser Health News

Is There a New CAR T-Cell Treatment for Mantle Cell Lymphoma? – AJMC.com Managed Markets Network

Maggie L. Shaw

Mantle cell lymphoma is a type of B-cell non-Hodgkin lymphoma with a typically poor prognosis. Even with an allogeneic stem cell transplant, patients can become resistant to chemotherapy. Most do not survive 4 or 5 years after diagnosis, and the 10-year survival rate hovers between 5% and 10%.

Chimeric antigen receptor (CAR) T-cell therapy has been making great inroads as targeted treatment for many types of cancers highly resistant to other treatments, by prolonging patient survival and increasing their quality of life. Until now, similar results have not been seen in patients with MCL. However, with their successful phase 2 ZUMA-2 trial results just published in the New England Journal of Medicine, a group of researchers led by Michael Wang, MD, from The University of Texas MD Anderson Cancer Center, are able to show that these patients can benefit from the specialized therapy.

In this study conducted in the United States and Europe, the patient population had relapsed/refractory progressive disease despite receiving Brutons tyrosine kinase (BTK) inhibitor therapy and from 3 to 5 prior therapies.

BTK inhibitor therapy has greatly improved outcomes in patients with relapsed or refractory mantle cell lymphoma, yet patients who have disease progression after receiving the treatment are likely to have poor outcomes, with median overall survival of just 6 to 10 months, the authors said.

The median patient age was 65 years (range, 38-79). They were evaluated for response to a single infusion of KTE-X19, an anti-CD19 CAR T-cell therapy, that was dosed at 2106 CAR T cells/kg of body weight. Seventy-four patients were enrolled between October 24, 2016, and April 16, 2019; the treatment was manufactured for 71 and ultimately administered to 68.

There was a follow-up after 60 patients were monitored for 7 months, at which time a primary efficacy analysis was conducted. The primary endpoint was objective response (complete [CR] or partial [PR]), which was confirmed via bone marrow evaluation and positron emission tomography-computed tomography.

Overall, 85% of the entire study cohort of 74 patients was able to reach an objective response to KTE-X19, 59% of whom had a CR. These numbers were even higher among the group of 60 patients. Ninety-three percent (95% CI, 84%-98%) achieved an objective response, which was evaluated by an independent radiologic review committee. And of this group, 67% (95% CI, 53%-78%) had a CR.

The median times to response were impressive, with there being 1 month (range, 0.8-3.1) to initial response and 3 months (range, 0.9-9.3) to CR. In addition, of the 42 patients who initially had a PR or stable disease (SD), 24 (21 who had a PR, 3 who had SD) progressed to a CR in a median 2.2 months (range, 1.8-8.3).

Progression-free (PFS) and overall survival (OS) results also show promise to treatment with KTE-X19. As of the data cutoff date, there was evidence of remission in 78% patients who had a CR, with similar results seen in 57% of patients from the primary efficacy analysis. Overall, at 12 months, the PFS and OS were 61% and 83%, respectively.

Common adverse events to the treatment of grade 3 or higher included cytopenias (94%) and infections (32%). Ninety-one percent also experienced cytokine release syndrome, with a median time to onset of 2 days (range, 1-13) for any grade and 4 days (range, 1-9) for at least grade 3, but none died as a result. According to the study authors, most symptoms were reversible.

ZUMA-2 is the first multi-center, phase 2 study of CAR T-cell therapy for relapsed/refractory mantle cell lymphoma, and these efficacy and safety results are encouraging, stated Wang. Although this study continues, our reported results, including a manageable safety profile, point to this therapy as an effective and viable option for patients with relapsed or refractory mantle cell lymphoma.

Reference

Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-Cell therapy in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2020;382;1331-1342. doi: 10.1056/NEJM0a1914347.

Follow this link:
Is There a New CAR T-Cell Treatment for Mantle Cell Lymphoma? - AJMC.com Managed Markets Network

North Jersey hitting the surge – Politico

This shouldnt come as a surprise given what New Jerseyans are seeing right across the river. But Im still a little taken aback with how little people are talking about it.

Yesterday, Health Commissioner Judith Persichilli said "It looks like the surge is beginning to occur in the northern part of the state.

Advertisement

Gov. Murphy acknowledged New Jersey will soon need refrigerated trucks for the bodies of coronavirus victims.

I dont have a specific day, but soon, Murphy said yesterday. The fact that were having this conversation, folks, means this is real.

Send tips to [emailprotected]

QUOTE OF THE DAY: There's no greater intervention, period, full stop, none, than physical distancing. California Gov. Gavin Newsom on CNN. (I bet you thought it was someone else)

WHERES MURPHY?: In Secaucus at 10 a.m. to tour the field hospital at the Meadowlands Exposition Center, then in Trenton for his daily briefing at 1 p.m.

HAPPY BIRTHDAY: My cousin Amanda, Princetons Brent Colburn, MBIs Michele Jaker, Environment New Jerseys Doug OMalley, Optimus Partners David Vitali

CORONAVIRUS TRACKER: The latest: 3,649 newly-diagnosed cases in New Jersey for a total of 22,255 since the pandemic hit. Ninety-one new deaths, for a total of 355.

Sign up for POLITICO Nightly: Coronavirus Special Edition, your daily update on how the illness is affecting politics, markets, public health and more.

THE ANTI-CHRISTIE In New Jersey, a quieter alternative to Cuomo leads the pandemic response, by POLITICOs Matt Friedman: In a matter of hours last month, New Jersey Gov. Phil Murphy went from dealing with the biggest personal health crisis of his life to overseeing the biggest health crisis his state has faced in more than a century. On March 4, Murphy reported to a New York City hospital at dawn for a surgical procedure in which doctors removed a cancerous tumor from his left kidney. Fourteen hours later, while recovering in his hospital bed, Murphy approved a statement from his office announcing New Jerseys first known case of the coronavirus. Since then, New Jersey has seen more than 22,000 of its residents test positive for Covid-19 and more than 350 die as the state is now the second-biggest hot spot in the nation behind New York. While New York Gov. Andrew Cuomo has become the national medias go-to governor as he deals with that states outbreak with tough talk and sometimes harsh, sometimes cajoling words for President Donald Trump, Murphy known locally more for his taste in Allbirds footwear and dad jokes than for being a disciplinarian has maintained a gentler, folksier style as he manages the crisis from the other side of the Hudson River.

STATEHOUSE REPORTERS LOOK FORWARD TO HARD CIDER DURING NEGOTIATION STAKE OUTS New Jersey to extend tax filing deadline to July 15, budget deadline to Sept. 30, by POLITICOs Katherine Landergan: New Jersey will extend the tax filing deadline to July 15 and the deadline for passing a state budget to Sept. 30, Gov. Phil Murphy and legislative leaders announced Wednesday morning. The state budget is typically due June 30, but that date is being pushed back three months to deal with severe financial disruptions caused by the coronavirus pandemic. The ongoing COVID-19 pandemic has caused hardships, financial strain, and disruptions for many New Jerseyans and New Jersey businesses. As part of our response, we have reached agreement that the state income tax filing deadline and the corporation business tax filing deadline will be extended from April 15 to July 15, Murphy, Senate President Steve Sweeney and Assembly Speaker Craig Coughlin said in a statement. Additionally, as part of the whole-of-government effort that is going into fighting COVID-19, we have agreed that the state fiscal year should be extended to September 30th, the statement said. This will allow the Administration and the Legislature to focus fully on leading New Jersey out of this crisis, and to allow for a robust, comprehensive, and well-informed budget process later in the year.

WHO COULDVE PREDICTED A DANGEROUS VIRUS COULD CAUSE PROBLEMS? Coronavirus in NJ: State was warned in 2015 about 'catastrophic' impact a flu-like disease could have, by The Asbury Park Press Michael L. Diamond: The New Jersey Department of Health updated its emergency influenza plan in 2015, predicting a devastating impact on the state if it were to get hit by a disease similar to the Spanish flu a century ago. It said nearly a third of the population would contract the illness, 277,000 would need to be hospitalized and 5,000 would die. Put into motion by the coronavirus, though, the blueprint has exposed shortfalls in preparation that have forced government and health leaders to improvise, leaving health care workers and patients at risk. In hindsight, we all should have paid attention" to the plan, said state Sen. Declan O'Scanlon, R-Monmouth. 'But without any frame of reference, it would have been hard to do.

BUILD THE WALL To stop coronavirus, Murphy wants to keep the 'lowest common denominator' out of NJ, by The Records Charles Stile: Coronavirus has converted Phil Murphy into a close-the-border hardliner. The liberal New Jersey governor, who daily invokes a 'One New Jersey family' slogan of solidarity, inclusiveness, now wants to keep 'the lowest common denominator' from traveling into the Garden State. By that he means people traveling in from other states that have been slow to take the threat seriously by refusing to close their beaches during spring break or shut down mega-churches where faith supersedes science. Murphy said he fears out-of-staters will restart the fire; or spark a second wave of infections and deaths when New Jersey life begins returning to normal his remarks are also puzzling that they come only two days after President Trump floated his own an unenforceable and constitutionally questionable travel ban of New Jersey, New York and Connecticut residents."

LUXURY APARTMENTS ARE ESSENTIAL Some NJ construction workers fear virus exposure as they continue to work, by News 12s Walt Kane: While most of New Jersey is under a stay at home order, construction workers across New Jersey are on the job. And some tell Kane In Your Corner the situation has them concerned for their safety, There's no social distancing at all, a construction worker says. I don't know why this is still going on. He's one of the hundreds who report to a job site in Jersey City each morning. Like all construction projects in the state, it's been deemed essential by Gov. Phil Murphy. But the project in question is Jersey Squared, a large, luxury high-rise complex in Journal Square that's been under construction, in stages, for years. The worker says he doesn't think it's essential at all. Other states, including New York, have taken a different approach to construction, shutting down all but essential projects.

SORRY ABOUT THAT BUT THANKS FOR THE REVENUE Pandemic isolation, shift to online gambling set up 'perfect storm,' experts say, by The Press of Atlantic Citys David Danzis: Gov. Phil Murphy ordered the indefinite closing of Atlantic Citys nine casinos March 16 but permitted online gaming to continue. Industry experts expect an escalation in online gaming activity because of the retail casino closings, and the anticipated growth in internet play has gambling addiction professionals worried. We believe every risk factor for gambling problems is increasing right now, said Keith Whyte, executive director of the National Council on Problem Gambling. The social distancing measures recommended by government health officials exacerbate conditions such as loneliness, isolation and depression that lead to problem behaviors, Whyte said.

HCQ OR CIALIS? In my bone of bones, I think this works: Pennacchio on HCQ, by InsiderNJs Fred Snowflack: Joe Pennacchio is no stranger to plunging ahead to make a point. He did that 26 years ago with a long shot primary challenge to Dean Gallo, a popular congressman. Now a state senator from Montville (LD-26) and also a co-chair of Donald Trumps New Jersey reelection effort, Pennacchio is energetically championing another and much more important cause a treatment for COVID-19. A dentist by profession, the man who called himself Jersey Joe during an unsucessful U.S. Senate bid more than a decade ago, has been firing off regular press statements praising the drug, hydroxychloroquine, or HCQ, as a treatment for the virus. The drug is not unknown. It is used to treat lupis, rheumatoid arthritis and malaria. In my bone of bones, I think this works, Pennacchio said this morning.

New Jersey should release elderly and pregnant prisoners amid coronavirus crisis, ACLU says

NJ Transit adds buses to alleviate crowding, encourage social distancing

State Board of Education allows students with disabilities to get services online

State financial aid deadline for New Jersey college students extended to June 1

A HARIRI SITUATION Rudy Giuliani wants FDA to fast-track a stem cell therapy for Covid-19; critics see political meddling, by STATs Adan Feuerstein: In recent days, Giuliani has used his Twitter account and podcast to tout the stem cell treatment being developed by a New Jersey biotech company, Celularity, despite scant evidence to date that its therapy will benefit Covid-19 patients. The company is currently seeking permission to start a clinical trial for the treatment. Giuliani, for his part, has been critical of the FDA, accusing it of standing in the way of important treatments. The general reputation of the FDA and I dont mean to be critical at a time like this but it is very slow, Giuliani said in an interview on his podcast with Bob Hariri, Celularitys founder and CEO Experts fear his argument could resonate with Trump, who has not only made Giuliani a close confidant but has long expressed impatience with the FDAs drug approval process. Giuliani could not be reached for comment.

You may remember Dr. Hariri, a Christie donor and former Celgene executive, from this.

PERIOD. LATE START Murphy hits back at Trump claim New Jersey was very late in coronavirus response, by POLITICOs Sam Sutton: New Jersey Gov. Phil Murphy pushed back Wednesday on President Donald Trumps assertion that the state got off to a very late start on coronavirus containment and mitigation, arguing that the Garden State was one of the first to begin preparing for the possibility of a coronavirus outbreak in January. I don't think that theres any state in America that was on this earlier than we were, Murphy said at his coronavirus press briefing, adding that Washington state where the first domestic case of coronavirus was discovered in January also responded rapidly. The facts dont support that. Period, full stop. At Tuesdays White House coronavirus briefing, Trump said that while he believes Murphy and New York Gov. Andrew Cuomo responded effectively to the public health crisis, they got off to a very late start" on containment.

Booker: Heres where all the stimulus checks will be going in New Jersey

Cerra to head N.J. League Of Municipalities

Dononhue: Bloomberg self-financing in recent presidential campaign makes past NJ mega-spenders look like skinflints

IM CONFIDENT HELL SURVIVE THE VIRUS, BUT CAN HE SURVIVE NOT GOING TO THE TURTLE BACK ZOO? Essex County Executive Joe DiVincenzo is latest N.J. official to test positive for coronavirus, by NJ Advance Medias Anthony G. Attrino: Essex County Executive Joseph N. DiVincenzo Jr., who has been self-quarantined for more than a week, has tested positive for the coronavirus, he announced Wednesday. I decided to get tested after experiencing a fever for several days and have been self-quarantined since March 21, DiVincenzo, 67 said in a Facebook post. DiVincenzo said his symptoms have been mild and that he feels OK.

SHOT Coronavirus in Lakewood: the pandemic has 'changed the way we live and celebrate', by The Asbury Park Press Gustavo Martnez Contreras: After seeing and hearing all the negativity targeting Lakewood in this novel coronavirus pandemic, a Howell man decided to take a drive and see for himself. The video travelogue that 28-year-old Boruch Perlowitz created reveals a township that is ostensibly on lock down, its residents sheltering in place and steering clear of favorite places, sometimes denied by chained and locked doors. As Perlowitz depicts it, usually bustling Lakewood is as sleepy as any other town in New Jersey. I said, let me find out the truth for my neighbors and friends, said Perlowitz. I wanted to do complete honest reporting. If places were open, I would say that places are open. Perlowitz's video aims to counter a narrative in social media that paints Lakewood as a lawless place where residents openly defy Gov. Phil Murphy's executive order shuttering businesses, barring large gatherings and requiring social distancing. Perlowitz said that narrative has engendered enmity toward the town's largely Orthodox Jewish community.

CHASER 10 charged at Lakewood engagement party in violation of coronavirus lockdown, cops say

Heres why large gatherings keep happening in Lakewood, as the coronavirus rages in N.J.

From News 12 anchor Kurt Sieglin on his Lakewood school bus tweets, which I included in Playbook earlier this week: In vetting a story, I screwed up yesterday. There were many reasons the tweets went out, but the responsibility is ultimately with me. Its my account. I have a brand to protect. I regret it. Im sorry for any pain or distrust the tweets created for residents who saw it. Much morehere

R.I.P. Five residents dead at New Milford nursing home, 16 test positive for coronavirus, by The Records Lindy Washburn: A nursing home in New Milford where at least five residents have died of complications of coronavirus is Bergen Countys first major outbreak at a long-term care facility. The disease already has nearly filled area hospitals. Sixteen residents and six staff members at Care One New Milford, known as Woodcrest, have tested positive for coronavirus and others are being tested, the company said late Tuesday night. Additional deaths at the facility also are being investigated to see if the residents had coronavirus.

Prosecutor shoots down idea of signs to label homes of quarantined"

A New York radio reporter, a party on LBI, and now 2 dead from coronavirus

Teaneck officials see signs of progress on COVID-19 because of lockdown

[Red Bank] official recovered from coronavirus. Now, he hopes to donate his plasma to critically ill patients

Red Bank councilman secures pandemic relief donations from more than 100 elected officials

Why the Hoboken mayor is asking residents to hold off food shopping for a couple days

Ex-Jersey City official who pleaded guilty to accepting $300 bribe loses pension appeal

100% THAT DISH Lizzo sends food to N.J. hospital, says were praying for you everyday, by NJ Advance Medias Bobby Olivier: After a hefty food donation from a pop superstar, Community Medical Center is hopefully feeling 'Good As Hell.' Lizzo, the breakout 'Truth Hurts' singer, sent food to the Toms River hospital Monday to thank the medical staff for their hard work battling the coronavirus outbreak. Hello Toms River! Lizzo said in a video posted by RWJBarnabas Monday. Thank you for working so hard for us. I wanted to show a token of my appreciation and just drop off some food, I hope you enjoy the meals.

R.I.P. Fountains of Waynes Adam Schlesinger Dead at 52 From Coronavirus, by Rolling Stone's Jon Blistein: "Adam Schlesinger, co-founder of the New Jersey power-pop group Fountains of Wayne and Emmy- and Grammy-winning songwriter for film, television, and theater, died Wednesday from complications related to COVID-19. He was 52."

R.I.P. N.J. ER doctor who twice survived cancer dies a week after developing coronavirus symptoms

Losing your job overnight: How NJ's LGBTQ community is affected by the coronavirus

Manahan: Coronavirus update: Wake up, N.J.! Florida is trying to kill us (and pin the blame on us)

Continue reading here:
North Jersey hitting the surge - Politico

PharmAbcine Announces Acceptance of Phase Ib Olinvacimab and Pembrolizuamb Combination Trial in rGBM Patients Abstract at the 2020 ASCO Annual Meeting…

PharmAbcine Inc. (KOSDAQ: 208340) announced today that the abstract summarizing interim data on its phase Ib trial of olinvacimab in combination with Mercks anti-PD-1 antibody Keytruda for recurrent glioblastoma multiforme (rGBM) patients has been accepted at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting.

Phase Ib study is to evaluate the safety of the combination therapy of two agents for rGBM patients and to explore appropriate clinical dose levels of the two agents as in a combination regimen. During the study, 200 mg of Keytruda was administered to patients every three weeks while 12 or 16 mg/kg of olinvaciamb was administered on a weekly basis. From the phase Ib study, there was no DLT (dose limiting toxicity) observed, and among 9 patients, 4 patients had SD (stable disease) and 5 patients experienced disease progression (PD).

rGBM is a rare tumor and there are only a few treatment options available to date. It is known to have the worst prognosis among any other types of cancers/tumors and the life expectancy of rGBM patients is less than 4 months upon diagnosis. There have been multiple clinical trials using immuno-oncology drugs to treat rGBM but the promising results have not been reported yet.

Previously Olinvacimab from its phase IIa clinical study in rGBM patients ascertained its significant improvement of brain edema and shrinkage of tumor. Now its use is being investigated in a phase II study for Avastin-refractory rGBM patients in US and Australia.

An ASCO annual meeting is a global conference, annually accommodating 40,000 people from 76 different countries.

About PharmAbcine Inc.

PharmAbcine is a clinical-stage biotech company focusing on the development of fully human antibody therapeutics to treat neovascular disorders and tumors by targeting molecules involved in angiogenesis and immune checkpoints, which are responsible for hindrance in immune response to tumors. Our innovative discovery technology coupled with dedicated R&D staff have enabled us to provide superlative therapeutic antibodies for a wide array of indications in oncology, immuno-oncology, ophthalmology, and renal pathology.

PharmAbcines HuPhage library and innovative selection system are priceless proprietary assets that can generate antibodies with greater diversity than 10^11.

PharmAbcines advanced 3G expression system accommodates high levels of antibody production with high reproducibility. With our highly advanced technology platforms, we provide high-quality antibody generation services.

PharmAbcines advanced evaluation platforms can facilitate the pipeline development by assessing its anti-tumor effects with greater precision and accuracy. Through the collaboration with Samsun Medical Centre, We have more than 300 patients-derived cancer stem cell libraries and a PDX (patient-derived xenograft) animal model system to evaluate internal pipeline development.

Additional information about PharmAbcine can be found on our website at http://www.pharmabcine.com

Contacts

Yohan Jung

82-42-863-2017

yohan.jung@pharmabcine.com

Read the original:
PharmAbcine Announces Acceptance of Phase Ib Olinvacimab and Pembrolizuamb Combination Trial in rGBM Patients Abstract at the 2020 ASCO Annual Meeting...

A word for those risking their lives amid the coronavirus crisis: Thanks – TwinCities.com-Pioneer Press

`It wasnt long after the events of Sept. 11, 2001, that cops, firefighters, first responders and volunteers from across the country and the world were lauded as heroes and temporarily replaced celebrities as the guest stars on talk shows.

The acknowledgment lasted for a while before actors hawking movies and pundits plugging books became the norm again.

As for the most affected first responders those who risked their health and spent weeks sifting through the rubble of the World Trade Center for remains and evidence too many succumbed to cancer and respiratory illnesses that took their lives or permanently scarred them physically and emotionally.

Hopefully, the workers now on the front line of the coronavirus crisis will receive a far more enduring tribute and recognition. Quite a number of them have been infected and some have died while trying to treat patients in their care. They range from the Chinese physician who sounded the first warning of this novel virus to doctors and nurses and others here who have come down with the deadly infection. Add the Italian pastor who died after willingly giving up his ventilator for a younger COVID-19 patient.

I know of this front-line work first hand.

Nine years ago this week on April Fools Day I got the news that I had multiple myeloma, a cancer of the plasma cells. More than 32,000 American adults are diagnosed annually with the incurable disease; more than 12,000 die of complications from it. I was informed I had the worst stage of it. Close to 80 percent of my plasma cells were cancerous. Tests also discovered fractured vertebrae and weakened bones byproducts of the cancer. The average survival rate for Stage III folks like me is 29 months, though treatment protocols have improved over the years.

I went through a year of chemo and a ruptured appendix during aggressive treatment that left me with an ugly but necessary vertical scar that wiped out my belly button. Throw in two autologous stem cell transplants as well as several bouts of pneumonia and other weird respiratory emergencies throughout the years.

Nine years later Im still above ground. I can still work, hoop and salsa, and I checked off some wishes Iike swimming with dolphins and experiencing the worlds second longest zipline. My only treatment since late 2012 is ingesting a daily Revlimid pill that doctors believe is keeping my cancer at below microscopic levels. My gut tells me it might also be the occasional Reeses Pieces, though I place my trust in the medical and scientific communitys assessment.

But Im blessed, thanks to my caretaker wife, the support from my family and friends, and the incredible knowledge and care I was given by those front-line health care workers who were with me step by step. Many are now dealing with the COVID-19 outbreak as well as the normal workload.

They include Dr. Mark Wilkowske, chief of oncology at the Frauenshuh Cancer Center in St. Louis Park, and Drs. Daniel Weisdorf, Philip McGlave and the team at the University of Minnesota Bone Marrow Transplant Program.

But I also am in debt to the long line of physicians, nurses and support staff who have helped me and many others recover from serious illnesses and other medical challenges throughout the years. We now see them profiled on TV sacrificing their own health, rightly pointing out the lack of official preparedness, and working double shifts while juggling family and emotional needs.

I have nothing against well-deserving celebrities. Whether they are musicians, actors or athletes, many have also stepped to the plate to entertain from home, donate to relief efforts or share words of support and solace through social media and other venues. But so have ordinary folks from all corners of the nation.

Maybe, when we do get back to normal, if we ever do, lets not forget what these health care folks and support staff are doing now, day in and day out. I know I wont.

Lets make that gratitude and star treatment last longer than it did 19 years ago.

Read the rest here:
A word for those risking their lives amid the coronavirus crisis: Thanks - TwinCities.com-Pioneer Press

AML Relapse: How IDH-Inhibitor Drugs Work To Achieve Remission Before Stem-Cell Transplant – SurvivorNet

When we have a patient whose AML has come back, the goal is to get them into a remission so we can take them to a stem cell transplant., saysDr. Tara Lin, director, Acute Leukemia Program, University of Kansas Medical Center. This starts with Drugs such asIvosidenib orEnasidenib, which are important because they can help us get patients into remission and then bridge to transplant.

Early trials and published trials of these drugs show that about 30% of these patients will go into remission. Among them, a smaller proportion of patients will go on to have a stem-cell transplant.That smaller proportion reflects that some patients, often older ones, who may choose not to go on to a stem cell transplant for reasons not fully disclosed.

But that would be the be long-term goal certainly for a younger fit patient with an IDH-1 or IDH-2 mutation whose going to receive these drugs as therapy in relapse, says Dr. Lin. The goal would be to put them back into a remission not with the expectation that these oral drugs will keep them in remission forever but that we can put them into a deep enough remission so that we can take them on to transplant which, at least, has a potentially curative option.

Learn more about SurvivorNet's rigorous medical review process.

Dr. Tara Lin is an Associate Professor of Medicine at The University of Kansas Medical Center. She specializes in acute leukemia and cancer stem cell targeted therapies. Read More

When we have a patient whose AML has come back, the goal is to get them into a remission so we can take them to a stem cell transplant., saysDr. Tara Lin, director, Acute Leukemia Program, University of Kansas Medical Center. This starts with Drugs such asIvosidenib orEnasidenib, which are important because they can help us get patients into remission and then bridge to transplant.

Early trials and published trials of these drugs show that about 30% of these patients will go into remission. Among them, a smaller proportion of patients will go on to have a stem-cell transplant.That smaller proportion reflects that some patients, often older ones, who may choose not to go on to a stem cell transplant for reasons not fully disclosed.

Learn more about SurvivorNet's rigorous medical review process.

Dr. Tara Lin is an Associate Professor of Medicine at The University of Kansas Medical Center. She specializes in acute leukemia and cancer stem cell targeted therapies. Read More

See more here:
AML Relapse: How IDH-Inhibitor Drugs Work To Achieve Remission Before Stem-Cell Transplant - SurvivorNet

Three Additional Patients with Severe COVID-19 Treated with Leronlimab in New York Medical Center Bringing the Total to 10 Patients – Associated Press

VANCOUVER, Washington, March 30, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that an additional three critically ill COVID-19 patients have been treated with leronlimab. These additional patients increase the total to 10 patients receiving leronlimab treatment under an Emergency Investigational New Drug (EIND) granted by the U.S. Food and Drug Administration (FDA).

The treatment with leronlimab is targeted as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19). Leronlimab is believed to provide therapeutic benefit by enhancing the immune response while mitigating the cytokine storm that leads to morbidity and mortality in these patients. The laboratory evaluation of the first four patients treated with leronlimab revealed that the immune profile in these patients approached normal levels and the levels of cytokines involved in the cytokine storm (including IL-6 and TNF alpha) were much improved. The results of the three additional patients are expected this week.

Jacob Lalezari, M.D., Interim Chief Medical Officer of CytoDyn, commented, The preliminary results observed in patients who were severely ill with COVID-19 and treated with leronlimab are encouraging. Although the data set is still small, we saw fairly rapid and positive laboratory responses in all 4 patients treated, and in three of the 4 patients these laboratory results were associated with a favorable clinical outcome. We eagerly await the results of additional patients treated under the FDAs emergency IND program, as well as the results of several randomized clinical trials about to start.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, added, We remain encouraged and hopeful that leronlimab will help patients from this devastating and relentless disease. We will aggressively pursue treatment for COVID-19 patients, and to explore leronlimabs role in helping to alleviate the impending burden of supply chain and institutional capacity issues.

About Coronavirus Disease 2019SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in April of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking Statements This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Companys cash position, (ii) the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv) the Companys ability to enter into partnership or licensing arrangements with third parties, (v) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Companys ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Companys clinical trials, (viii) the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEO RedChip Companies Office: 1.800.RED.CHIP (733.2447) Cell: 407.491.4498 dave@redchip.com

See the original post here:
Three Additional Patients with Severe COVID-19 Treated with Leronlimab in New York Medical Center Bringing the Total to 10 Patients - Associated Press