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Segunda-feira, 05.05.14





CD47 is a kind of protein that is found on the surface of many cells in the body. It tells circulating immune cells called macrophages not to eat these cells. The body uses the CD47 protein to protect cells that should be protected and to help dispose of cells that are aged or diseased. For instance, red blood cells start off with a lot of CD47 on their cell surface when young but slowly lose CD47 as they age. At some point, the amount of CD47 on the surface of an aging red blood cells is not enough to stave off the macrophages, and those older cells are devoured and destroyed, making way for new red blood cells. In this way, the supply of fresh blood cells is constantly replenished.

Unfortunately, some cells that should be destroyed are not. Researchers at Stanford have discovered that nearly every kind of cancer cell has a large amount of CD47 on the cell surface. This protein signal protects the cancer against attack by the body's immune system. Stanford investigators have discovered if that they block the CD47 "don't-eat-me" signal through the use of anti-CD47 antibodies, macrophages will consume and destroy cancer cells. Deadly human cancers have been diminished or eliminated in animal models through the use of anti-CD47 antibody.

Clinical Trials in humans

After the successful outcomes of the experiments testing the use of anti-CD47 antibodies against human cancers transplanted into mice, plans were immediately begun to start clinical trials in humans. Unfortunately, the process of preparing for human clinical trials is long. The initial experiments were done in animals and the animal versions of anti-CD47 antibody cannot be used in humans. So researchers first have to create a "humanized" antibody to CD47, then the production of antibody must be scaled up in a sterile facility of the kind that is used to create other pharmaceutical products. Finally, clinical trials must be designed so that the data they generate will produce a valid scientific result, and the trials must be approved by regulatory officials.

All of this takes time.

For the last year, many people have been working to make clinical trials possible. We are now hopeful that the first human clinical trials of anti-CD47 antibody will take place at Stanford in mid-2014, if all goes well. Clinical trials may also be done in the United Kingdom.

As we get closer to clinical trials, we will start posting information about enrollments on this page.


(3/31/14) Update on the anti-CD47 cancer therapy clinical trials

Researchers and staff at Stanford are continuing to work hard preparing the groundwork for the clinical trials of our anti-CD47 antibody as a cancer therapy. As often happens during the development of new therapies, various complexities have pushed back the planned start date of the clinical trials. Although we had hoped to begin clinical trials in the first half of this year, we were aware that “unforeseen delays could slow progress," and indeed we are now hoping that clinical trials will begin in the summer or early fall 2014.

Again, we want to emphasize that, as is typical of FDA phase I clinical trials, the first tests of this therapy will be very small safety trials involving only a very few patients. Unfortunately, this means only a tiny fraction of those interested will be admitted to the first phase I clinical trials. Accordingly, we are urging patients to continue exploring existing treatments and other clinical trials.


Scientists awarded $12.7 million for cancer immunotherapy trial


Researchers at the School of Medicine have been awarded $12.7 million from the California Institute of Regenerative Medicine to move toward phase-1 clinical trials of an anti-cancer antibody called anti-CD47.

This round of grants, presented during a meeting of the agency's governing board in Los Angeles, is aimed primarily at furthering the development of previously funded, and successfully completed, CIRM projects.

The Stanford team, headed by Irving Weissman, MD, professor of pathology and of developmental biology, received $20 million from the agency for the project in 2009 to develop an antibody to CD47, a molecule found on the surface of cancer stem cells that appears to protect the cells from attack from the immune system. The researchers call CD47 the "don't eat me" molecule. Tests of the antibody in mice bearing human tumors have shown that the antibody allows the animals' immune system to destroy the cancer stem cells. The researchers will use the new funding to support future phase-1 trials in patients with acute myelogenous leukemia or solid cancers for which there are no standard treatment options.

Weissman is director of Stanford's Institute for Stem Cell Biology and Regenerative Medicine and the Virginia & D.K. Ludwig Professor for Clinical Investigation in Cancer Research. He is also a member of the Stanford Cancer Institute.

Stanford's funding was a portion of the roughly $61 million awarded Dec. 12 as part of the state stem cell agency's third round of disease team grants. Other diseases targeted by successful grant applications include sickle cell disease and macular degeneration.

"The goal of the Disease Team Award is to help accelerate the development of new therapies," said CIRM president Alan Trounson, PhD. "I think this is the sharp end of the CIRM program — we need to get therapies into clinical trials. The scientists are working together as teams to demonstrate the safety and efficacy of their products that have evolved from discoveries in the laboratory. What's impressive about this series of awards is that five of the six successful applications are for the continuation of work we had previously funded. It's a reflection of the importance of continuity of funding, enabling scientists to keep their teams together and move their work forward as quickly as possible."

With this award, Stanford has received about $290 million from the stem cell agency. CIRM was established in November 2004 with the passage of a statewide ballot measure that provided $3 billion in funding for stem cell research at California universities and research institutions.



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por cyto às 11:54

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De diskfaktory a 24.09.2014 às 01:12

high quality cd duplication and replication

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Maio 2014