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Cedars-Sinai to Test Stem Cells in Eye Disease Treatment

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Cedars-Sinai to Test Stem Cells to Treat Eye Disease

LOS ANGELES — Cedars-Sinai investigators have received funding to launch a clinical trial to test the safety of using stem-cell technology as a potential treatment for retinitis pigmentosa, an inherited eye disease with no known cure.

The trial, approved by the Food and Drug Administration earlier this year, has been awarded $10.5 million by the California Institute for Regenerative Medicine (CIRM), the state-funded stem cell research institute.

The principal investigator for the CIRM grant is Clive Svendsen, PhD, professor of Biomedical Sciences and Medicine and director of the Cedars-Sinai Board of Governors Regenerative Medicine Institute. November has been a significant month for Svendsen, who received another grant, for $1.5 million, from The Paul G. Allen Frontiers Group, a division of the Allen Institute. He was one of five recipients of this year’s Allen Distinguished Investigator awards. The funds will allow Svendsen’s team to study the role of the gut microbiome in Parkinson’s disease.

The $10.5 million CIRM grant for the retinitis pigmentosa trial follows many years of promising preclinical research on this disease led by Shaomei Wang, MD, PhD, professor of Biomedical Sciences and a research scientist in the Eye Program at the Board of Governors Regenerative Medicine Institute.

Retinitis pigmentosa gradually destroys the photoreceptor cells of the retina — the structure in the back of the eye that detects light. The disease, believed to affect more than 80,000 people in the U.S., typically manifests as poor night vision early in life and progresses to legal blindness in adulthood.

The clinical trial involves injecting a cortical progenitor cell product known as CNS10-NPC into the eye. Progenitor cells, descendants of the body’s stem cells, can make certain other cells. In tests with laboratory animals, Wang and her colleagues showed that these injected cells migrated and formed a new layer of cells adjacent to the photoreceptor cells. These new cells slowed degeneration of the retina and preserved vision.

The FDA has authorized up to 16 retinitis pigmentosa patients to participate in the clinical trial. In each patient, one eye will receive injected progenitor cells and one will not. Vision in the two eyes then will be compared and the overall safety evaluated. “We want to sure make the injections do not have unwanted side effects, such as surgical complications or an immune reaction,” Svendsen said.

The clinical principal investigator for the trial will be ophthalmologist David Liao, MD, from the Retina-Vitreous Associates Medical Group in Beverly Hills, who will perform the injections and assess the patients’ vision in the treated and untreated eyes. “We are very excited about this trial and this novel cell-based approach to a devastating disease,” Liao said. The clinical-grade progenitor cells have been manufactured at the City of Hope Center for Biomedicine and Genetics in Duarte, California.

The preclinical research, which led to FDA approval of the trial, was funded by a $4.9 million grant from CIRM. With the receipt of this latest CIRM grant, investigators will be able to launch the Phase I/IIa clinical trial after their study protocol receives final institutional review.

“Throughout our years of painstaking research on retinitis pigmentosa, CIRM has been a steady partner and supporter of our work,” Svendsen said. “This $10.5 million award will propel us into the next phase of our effort by allowing us to move forward with a clinical trial.”

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Health

Elton John Academy Awards Viewing Party Raised Over $6.4 Million for AIDS

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LOS ANGELES – The 28th annual Elton John AIDS Foundation Academy Awards Viewing Party with Netflix’s Queer Eye Fab Five: Bobby Berk, Tan France, Karamo, Antoni Porowski and Jonathan Van Ness raised over $6.4 million for the global effort to end AIDS.

The gala, which took place on Sunday, February 9 at West Hollywood Park in Los Angeles was generously supported by Presenting Sponsors IMDb, Walmart and Neuro Drinks and the Event Hosts Heidi Klum, Diane Lane, Eric McCormack and Billy Porter. 

The Foundation welcomed Sir Elton John and David Furnish, following Elton John and Bernie Taupin’s win for Best Original Song “(I’m Gonna) Love Me Again” from Rocketman at the Academy Awards.

Guests arrived at the Academy Awards Viewing Party for cocktails followed by a gala dinner and viewing of the 92nd Academy Awards® telecast. Chef Wayne Elias and Crumble Catering designed and prepared the delicious gala dinner enjoyed by guests. IMDb once again broadcast its annual “IMDb Live” streaming show during the party. IMDb’s four-hour show was co-hosted by Aisha Tyler and Dave Karger.

Following dinner and an exciting live auction conducted by Alexander Gilkes, British actor, singer-songwriter and BRITS Critic Choice Award winner in 2018, Sam Fender performed.  “What a night. It is so special to celebrate our Foundation’s 28th annual Oscar Party with the Fab Five and Sam Fender and to top it off, another Oscar win!” says Elton John.

“But most importantly, tonight we have come together to raise urgently needed funds and awareness for the LGBT community at risk or living with HIV in the U.S. and around the world. A gay man is 27 times more likely to have HIV than their straight peers, so tonight helps us to remind people that we still have a long way to go to end the AIDS epidemic.” 

During the live auction, an artwork specifically created for the Elton John AIDS Foundation by Nathaniel Mary Quinn – one of the world’s most sought-after artists entitled, “She Would Have Loved The Galas” – was bought by Sir Elton John himself, who made it back to the party quickly after his award. In a surprise addition to the auction, Elton John played a white Yamaha Grand Piano that was featured in the film Rocketman and was then auctioned off. 

Sharon Stone took the stage to auction off two VIP tickets to the Versace Cruise Collection fashion show taking place in a secret location. She was so compelling she sold the auction lot twice. The incredible amount of money raised this year will help the Foundation to continue providing testing, treatment and prevention services for people at risk or living with HIV in the LGBT community in the U.S. and around the world.  

Cadillac, Gilead Sciences, M&M’s Chocolate Candies and M∙A∙C Viva Glam partnered with the Foundation as the evening’s Co-Sponsors; Fin Gray and Michael Melnick and Bob and Tamar Manoukian were Associate Sponsors. Wines were provided courtesy of Domaine Bertaud Belieu and champagne was donated by Chandon.

Spirits were courtesy of Cîroc Vodka and Tequila Don Julio.  The Foundation is especially grateful to the City of West Hollywood for continued collaboration and to American Airlines as the Foundation’s official airline.  

The Foundation’s Academy Awards Viewing Party benefits the Elton John AIDS Foundation raising millions for their lifesaving work since the Party began in 1992.

The Foundation works across four continents to provide treatment, testing, care and support to people at risk of or living with HIV, especially marginalized groups that are disproportionately affected such as men who have sex with men, people who inject drugs, sex workers. 

Follow the Elton John AIDS Foundation on: facebook.com/eltonjoh and on Twitter.

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Health

Equal Insurance HIV Act to End Discrimination Against HIV-Positive Patients

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SACRAMENTO — Senator Lena Gonzalez (D – Long Beach), Insurance Commissioner Ricardo Lara, and Equality California have announced the Equal Insurance HIV Act to stop insurance companies from denying life and disability income insurance coverage based solely on HIV status.

This bill proposal would enact anti-discrimination protections in life and disability income insurance products for those living with HIV by banning HIV discrimination to ensure they have equal access to the coverage they deserve.

“Everyone deserves access to life and disability income insurance, regardless of preexisting conditions,” said Senator Lena Gonzalez. “I am so proud that my first bill introduced in the legislature will ensure access to the coverage they deserve.

“Everyone deserves access to life and disability income insurance, regardless of preexisting conditions,” said Senator Lena Gonzalez. “I am so proud that my first bill introduced in the legislature will ensure access to these critical resources for residents who are HIV-positive. It is time that we end the practice of insurance companies refusing to provide services to those who need it most.”

This proposed bill overturns a law passed in 1989 when treatment for someone who tested HIV positive was extremely limited. Therapies were ineffective, highly expensive, and came with severe side effects causing many individuals who were HIV positive to bypass treatment.

Today, with the access to health care, advancement in HIV testing, and more effective treatment, a person who is HIV positive and undergoes and remains on treatment can live a long healthy life. HIV status is treated by medical professionals like any other treatable chronic condition.

“A person should not be defined by their HIV status and it should not be the only factor when determining their right to insurance protection,” said Insurance Commissioner Ricardo Lara. “People living with HIV are raising families and seeing their children grow up just like anyone. This legislation is crucial to ensure they have equal access to the same kinds of insurance that helps us all plan for the future.”

With HIV positive people living longer healthy lives, their need for life and disability income insurance is imperative to protect themselves and their families. Current California law allows insurers to deny coverage for life or disability income insurance to HIV-positive individuals based on positive results of an ELISA test followed by a positive Western Blot Assay performed by or at the direction of the insurer – tests that are no longer commonly used today.

“Thanks to modern medicine, people living with HIV lead happy, healthy lives,” said Equality California Executive Director Rick Zbur. “It’s time for our laws to keep up with the science and protect Californians living with HIV from insurance discrimination. Our goal to end HIV by 2030 means ending all HIV transmissions, deaths and stigma. This bill is a critical step to getting there.”

A person’s HIV positive status should be treated in the same way as any other chronic condition in the writing of life and disability income insurance. This bill proposal will ensure that life and disability insurance companies can no longer use an outdated and discriminatory insurance underwriting law that allows insurers to refuse life and disability income insurance applications for HIV positive individuals based solely on a positive HIV test.

“The life expectancy of people who are HIV positive has dramatically changed in the last two decades thanks to highly effective HIV treatment regimen including new antiretroviral drugs and existing antiretroviral therapy,” said Dr. Tasnim Khan, Chief Medical Officer of One Community Health. “It is now time to acknowledge the advances in HIV care and prevention and how to work collaboratively with the insurance industry to review policies on life and disability income coverage to people living with HIV.”

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Drugs and Alcohol

CA’s Four U.S. Attorneys Agree to Permanent Ban on Fentanyl

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SACRAMENTO — The following statement was issued by the four U.S. Attorneys who serve California: Nicola T. Hanna (Central District of California), David L. Anderson (Northern District of California), Robert S. Brewer (Southern District of California) and McGregor W. Scott (Eastern District of California)

To fight this epidemic, law enforcement must have all the necessary tools at their disposal. One such tool is the Drug Enforcement Administration’s (DEA) 2018 order making all fentanyl-related drugs illegal in the United States.

Unfortunately, that order was temporary and will expire in less than two weeks. The Senate recently passed bipartisan legislation approving a 15-month extension of the temporary order. While this is a step in the right direction, and the House should pass the Senate’s bill, a longer term solution is needed. We need a permanent ban on all fentanyl-like drugs.

Illicit fentanyl is manufactured in labs in China and Mexico and smuggled into the United States. It is 50 times more powerful than heroin and 100 times more powerful than morphine. So powerful, in fact, that only a couple milligrams – the size of a few grains of salt – can kill the average person.

Fentanyl, however, is unique. Because it is made in labs using chemicals, its structure is easily manipulated. And the drug cartels that manufacture and traffic this synthetic poison into our neighborhoods understand American laws and know how to exploit them.

They know that by changing a single molecule in the chemical structure of fentanyl, they have essentially created a new drug. One that, unlike fentanyl, is not illegal in the United States. These drugs, known as “fentanyl analogues,” do as fentanyl does: create more addicts and kill more Americans. The analogues – which can be up to 100 times more potent than fentanyl and 10,000 times more potent than morphine – will become legal if Congress fails to act.

The DEA’s 2018 decision to temporarily schedule – that is, to make illegal – all fentanyl-related substances was a response to the extraordinary legal loophole exploited by drug traffickers. In April 2019, China also outlawed all fentanyl-related substances. This is extraordinary progress, with one caveat. Unlike China’s law, the United States’ has an expiration date.

On Feb. 6, 2020, the DEA’s temporary order expires, and all drugs seized by U.S. investigators over the past two years that have tested positive as fentanyl analogues will no longer be illegal. If Congress fails to pass the legislation it will have a dramatic impact not just on the prosecutors and law enforcement officers who spend their lives investigating and prosecuting drug dealers, but on communities already hard hit by the opioid epidemic, many of which are right here in California.

Despite the tireless efforts of law enforcement, California continues to be a main thoroughfare for fentanyl and fentanyl-like drugs arriving from China and Mexico. In 2019, federal law enforcement agents seized approximately three-quarters of a ton of fentanyl at the six ports of entry we share with Mexico and in all places in between.

That’s 20 percent more than in 2018. And our federal resources are not infinite; we need all the help we can get. Passing this legislation would provide invaluable support to us as prosecutors and the entire law enforcement community as we continue to combat the opioid crisis in California and throughout America.

 A number of organizations have voiced opposition to the proposed legislation, arguing that the bill does not “embrace public health approaches to the overdose crisis.” We agree that a comprehensive approach to the crisis is needed, and a permanent fentanyl analogue ban should be viewed as part of a holistic effort.

But time is running out. There is no doubt that drug traffickers are eagerly awaiting the temporary order’s expiration to start flooding our communities with these dangerous drugs. The passage of this legislation is quite literally a matter of life and death.

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