Thursday, July 20, 2017

McCain's Cancer and the California Stem Cell Agency: The Promising Approaches of Genetic Engineering

City of Hope video on T-cell treatment of glioblastoma

The type of aggressive brain cancer that is now afflicting U.S. Sen. John McCain is a disease that has been long targeted by California's $3 billion stem cell agency.

The agency, formally known as the California Institute for Regenerative Medicine (CIRM), has spent more than $90 million for research dealing with brain cancer, which claims the lives of 13,000 people each year.

Particularly deadly is glioblastoma, the form of cancer involving McCain.

In January, Karen Ring, a stem cell scientist and overseer of CIRM's social media, wrote on the agency's blog about an early stage clinical trial involving glioblastoma, describing it as "a new cell-based therapy that melted away brain tumors in a patient with an advanced stage" of the disease.

The research was conducted at the City of Hope's Alpha Clinic, an effort created by the stem cell agency.

In March, Behnam Badie, who is leading the research, discussed the therapy at a symposium dealing with results from year two of the Alpha Clinic program. Badie, whose father died of brain cancer, described how the use of T-cells beneficially affected the patient, Richard Brady, who was also a surgeon. 
Richard Brady, City of Hope photo
In a video presented at the symposium, Badie's colleague, Christine Brown, described T-cells as the "soldiers of the immune system." Brady also appeared in the video, saying, 
"I find myself in disbelief that I am here." 
On its web site, the agency says,
"Stem cell approaches look promising for treating gliomas. Certain types of stem cell tend to migrate toward the tumor cells wherever they are in the brain. CIRM-funded researchers are trying to genetically engineer those stem cells to produce cancer-killing molecules. Transplanted into the brain, these cells would seek out the cancer cells and deliver their therapy directly where it is needed. This approach could significantly decrease toxic side-effects to normal tissues, preserving or improving the patient's quality of life."
Brady, however, was not cured by his treatment and ultimately succumbed to the spread of the cancer. Ring wrote in January,
"The effects of the immunotherapy lasted for seven-and-a-half months. Unfortunately, his glioblastoma did come back....Patients with advanced cases of glioblastoma like Richard often have only weeks left to live, and the prospect of another seven months of life with family and friends is a gift."
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Tuesday, July 18, 2017

Correction

Two items today and yesterday on the California Stem Cell Report incorrectly said that Carmen Puliafito was reappointed as a member of the stem cell agency's governing board in 2010 by Gov. Jerry Brown. The re-appointment was made by then Gov. Arnold Schwarzenegger. Brown was elected in 2010 but did not take office until 2011.
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'Secret Life' Flap: Former USC Med School Dean-Stem Cell Agency Board Member on Leave from School

The former dean of the USC medical school, who is also a member of the governing board of the $3 billion California stem cell agency, is on leave and no longer seeing patients, the Los Angeles Times is saying today.

The news came after the Times reported yesterday that Carmen Puliafito had a "secret life" involving illegal drug activity, some of which was captured on video.

Puliafito was appointed in 2008 to the 29-member board of the California Institute for Regenerative Medicine (CIRM), as the agency is officially known,  by then Gov. Arnold Schwarzenegger and reappointed by him in 2010. Puliafito's term expired last fall but he is permitted to serve until a replacement is named.

The governor's office has not responded to requests yesterday by the California Stem Cell Report for a comment about the matter.

Puliafito has made no comment about the Times' reports.

(Editor's note: An earlier version of this item incorrectly said that Puliafito was reappointed by Gov. Jerry Brown. Brown was elected in 2010 but did not take office until 2011.) Sphere: Related Content

Monday, July 17, 2017

LATimes: 'Secret Life' of Former USC Med School Dean and California Stem Cell Agency Director

Carmen Puliafito (right), a member of the governing board of the California
stem agency, and Robert Klein, then chairman of the agency. USC photo 2009
The headline in the Los Angeles Times this morning said:
"An overdose, a young companion, drug-fueled parties: The secret life of USC med school dean"
Put together by a team of five reporters, the article called Carmen Puliafito a "towering figure," a "renowned eye surgeon" and a prodigious fund raiser, bringing in more than $1 billion for USC by his own estimate. And then it said, 
"During his tenure as dean, Puliafito kept company with a circle of criminals and drug users who said he used methamphetamine and other drugs with them, a Los Angeles Times investigation found.
"Puliafito, 66, and these much younger acquaintances captured their exploits in photos and videos. The Times reviewed dozens of the images."
Puliafito resigned his $1.1 million position as dean in March 2016, declaring he wanted to pursue outside opportunities. He still serves, as a gubernatorial appointee, on the board of the California Institute for Regenerate Medicine (CIRM), as the stem cell agency is formally known. The board position pays $100 a day for meeting attendance. The board meets 10 to 12 times a year. 
USC has received $110 million from CIRM since 2004, ranking No. 6 among all California institutions that have won stem cell awards from the state agency. USC has had a representative on the board since its inception in 2004.
Paul Aisen, San Diego UT photo, Howard Lipin
Puliafito remains on the USC faculty and continues to accept patients. He is a "central witness" in a $185 million, legal wrangle involving UC San Diego researcher Paul Aisen. Puliafito has described himself as the "quarterback" in the effort to hire Aisen away from UC San Diego. The Times wrote,
"Curing Alzheimer’s is a top priority for government agencies and pharmaceutical companies, and Aisen’s lab was overseeing groundbreaking research, including drug trials at 70 locations around the world. More than $340 million in funding was expected to flow to his lab, according to court records.
"UC contended in its suit that its private school rival went beyond the bounds of academic recruiting by targeting professors and labs based on grant funding. The suit accused USC of civil conspiracy, aiding and abetting breach of fiduciary duty and other misconduct."
Puliafito's current term on the stem cell agency board term expired Nov. 3, 2016, according to a governor's office document. However, members of the board may serve until a replacement is named. He was appointed in 2008 by then Gov. Arnold Schwarzenegger and reappointed in 2010, also by Schwarzenegger, according to the governor's office document.

In response to a query, Kevin McCormack, senior director of communications for the agency, said via email,
"We were surprised to read the allegations about Dean Puliafito in the Los Angeles Times. Since being appointed to the CIRM Board by Governor Arnold Schwarzenegger, in late 2008, Dean Puliafito has served with distinction, bringing knowledge, expertise and deep commitment to our mission."
The California Stem Cell Report also asked Brown's office for comment. When it responds, the full text of the comments will be carried.

The reporters who put together the story are Paul Pringle, Harriet Ryan, Adam Elmahrek, Matt Hamilton and Sarah Parvini.

(Editor's notes: An earlier version of this item said that Puliafito was reappointed by Brown in 2010. The re-appointment was by Schwarzenegger. Brown was elected in 2010 but did not take office until 2011.
(This article was picked up Capitol Weekly, a news and information service devoted to California public policy issues. The Capitol Weekly version can be found here.)
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Thursday, July 13, 2017

Two Rounds of Transplants, 70 Drugs: An Advocate's Journey into Stem Cell Safety

Lukas Wartman
Science magazine, Whitney Curtis photo
The California stem cell agency today related a compelling story concerning a physician named Lukas Wartman who received "a life-saving stem cell treatment that is now threatening his health."

The headline on the item on the agency's blog, The Stem Cellar, said,
"One man’s journey with leukemia has turned into a quest to make bone marrow stem cell transplants safer"
Karen Ring, a scientist herself and overseer of social media at the California Institute for Regenerative Medicine (CIRM), wrote about the case after she read an article by Jon Cohen in Science Magazine concerning Wartman. He is a physician at the Washington University School of Medicine. Ring wrote,
"He was first diagnosed with a type of blood cancer called acute lymphoblastic leukemia (ALL) in 2003. Since then he has taken over 70 drugs and undergone two rounds of bone marrow stem cell transplants to fight off his cancer."
The first transplant came from his brother but the second round was from an unrelated donor and was different. Ring said, 
"While the second transplant and cancer-fighting drugs have succeeded in keeping his cancer at bay, Wartman is now suffering from something equally life threatening – a condition called graft vs host disease (GVHD). In a nut shell, the stem cell transplant that cured him of cancer and saved his life is now attacking his body."
Ring discussed the currently available treatments and continued, 
"Another promising therapy is called Prochymal. It’s a stem cell therapy developed by former CIRM President and CEO, Dr. Randy Mills, at Osiris Therapeutics. Prochymal is already approved to treat the acute form of GVHD in Canada, and is currently being tested in phase 3 trials in the US in young children and adults.
"While CIRM isn’t currently funding clinical trials for GVHD, we are funding a ($20 million) trial out of Stanford University led by Dr. Judy Shizuru that aims to improve the outcome of bone marrow stem cell transplants in patients. Shizuru says that these transplants are “the most powerful form of cell therapy out there, for cancers or deficiencies in blood formation” but they come with their own set of potentially deadly side effects such as GVHD."
Ring said that Wartman's battle with the disease has made him "one of the strongest patient voices advocating for new treatments" for his affliction. Ring said Wartman is an inspiration to funding agencies and other scientists. She said,
"We don’t want these patients to suffer quietly. Wartman’s story is an important reminder that there’s a lot more work to do to make bone marrow transplants safer – so that they save lives without later putting those lives at risk."
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Monday, July 10, 2017

California's Stem Cell CEO Search: $3 Billion Agency Needs New President

California's $3 billion stem cell research program is looking for a new president to carry the state agency through what may be the last three years of its life.

The search committee of the agency's 29-member governing board meets July 17 to discuss the matter behind closed doors. But members of the public will have a chance to comment during an open portion of the meeting. Or they can email comments directly to the board at info@cirm.ca.gov ahead of the meeting.

So far, no comments have been received from the public concerning the selection of a new president, according to an agency spokesman.

Currently Maria Millan is the interim president and CEO of the 12-year-old program, replacing Randy Mills, who is taking a job in Minneapolis. Mills has said that Millan is his choice as a successor. Millan joined the agency in December 2012 and was vice president for therapeutics before her interim appointment.

Last month, directors of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, ratified her as interim president, voicing no reservations in public about the action.

The current salary for the position ranges from $311,000 to $575,000 annually.

The main location for next week's session is the Claremont Hotel in Berkeley. Teleconference locations where the public make direct audio comments to the board are available in Sacramento and at UCLA in Los Angeles. Details are available on the agenda.

The agency has projected that it will run out of funds for new awards in June 2020. However, the end of funding could come sooner or later depending on the agency's rate of spending for awards. The agency relies on money borrowed by the state (bonds), which roughly doubles the cost of the research to about $6 billion because of  interest costs.

Earlier, there was talk about a possible $5 billion bond election in 2018 to continue funding the agency. However, that possibility appears to have been delayed until November 2020, which would be beyond the date when the agency is currently expected to run out of cash.

Bob Klein, the Palo Alto real estatement investment banker who led the 2004 ballot campaign that created the stem cell agency, is the chief voice behind the idea of another bond issue. He has not responded to inquiries from the California Stem Cell Report about his latest bond plans. This blog will carry the full text of his comments if he does respond.

Here is a list of the members of the CIRM search group: Deborah Deas, Judy Gasson, David Higgins, Steve Juelsgaard, Al Rowlett, Jeff Sheehy, Jonathan Thomas, Art Torres and Kristiina Vuori. Biographical sketches can be found here.



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