Friday, February 13, 2009

Ustekinumab stops Graft versus Host Disease

Researchers at the Wisconsin Cancer Center have shown that blocking IL-23 stops Graft versus Host Disease (GvHD). Interesting since GvHD is basically an out of control autoimmune reaction caused by the replacement of a patient's immune system (bone marrow) with a new one that attacks the patient's body. Ustekinumab stops GVHD. Ustekinumab stops psoriasis--an autoimmune disease. What a coincidence! NOT.

Another coincidence no matter how good Ustekinumab is no dying GvHD patient will have access. Why? The coincidence is the FDA will not put into effect rules to allow it, just like they would not approve it for psoriasis.

Let the patients suffer and die. Hey Hey Hey, we don't care. We are the FDA.

Two years after Ustekinumab showed "stunning results" in clinical trials the FDA has not approved it for suffering Americans. Nine months ago (June 2008) it was unanimously recommended for approval by an outside panel of experts. What did the FDA do? Of course they DELAYED. Four months ago clinical trial results showing it to be MORE EFFECTIVE than the number one medication for psoriasis were released. What did the FDA do? More DELAY. Even today, February 13, no approval and more DELAY.

Now we know it could save even more lives. Those poor patients who had bone marrow transplants to try to save their lives but whose new bone marrow (immune system) is dissolving their bodies(GvHD) in a most horrible way.

Ustekinumab could end their horrible suffering and save their lives, but the rules of the FDA will not allow its use. Hooray for the FDA!

Here is the article:

Bone Marrow Transplant Patients May Benefit From New Immune Research

12 Feb 2009

Bone marrow transplant (BMT) researchers at The Medical College of Wisconsin Cancer Center in Milwaukee may have found a mechanism that could preserve the leukemia-killing effects of a transplant graft, while limiting the damage donor immune cells might do to the recipient host's vital organs.

"Our results suggest that targeting of interleukin 23, (IL-23), an immune substance secreted by donor marrow cells, may be a viable way to limit graft-versus-host-disease without limiting graft-versus-leukemia activity," says lead researcher Rupali Das, Ph.D.

The study was presented at the national BMT Tandem Meetings in Tampa, Fla., Feb. 11, 2009, and was among those receiving the highest scores from the abstract review committee.

Dr. Das is a postdoctoral fellow in pediatric hematology/oncology at the Medical College in the laboratory of William R. Drobyski, M.D., professor of medicine in neoplastic diseases, and principal investigator of this study.

Dr. Drobyski practices at Froedtert Hospital.

In a recent study, the researchers found that donor mice with marrow cells incapable of producing IL-23, provided protection from graft-versus-host damage to the recipient's colon, but not to other organs.

They then conducted studies in which mice with leukemia received T cells from the marrow and spleen of IL-23-deficient donor mice. The recipient mice not only had longer survival times than those receiving T-cells from IL-23-producing mice, but also showed no evidence of leukemia.

Mice transplanted with T cells capable of producing IL-23 all died of graft versus host disease.

The study was funded by the Midwest Athletes Against Childhood Cancer (MACC) Fund, a major donor that has been supporting cancer research at the Medical College since 1976, and the National Institutes of Health's National Heart, Blood and Lung Institute.Medical College of Wisconsin8701 Watertown Plank Rd.MilwaukeeWI 53226United States

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