- IVIG Supply
- Clinical Trial Results of Rituxamab in Childhood and Adolescent Chronic ITP
- A Clinical Trial Disaster in the UK Raises Questions
- Vitamin D Helps You Heal
- Black Mold Creates Toxin that Kills Mouse Brain Cells
- NIH Studying Bone Marrow Failure
- FDA Magazine: New Technologies, New Treatments, New Diagnostics
- Drug Action: Men and Women Differ
Recently, IVIG shortages have been reported by various users. The Plasma Protein Therapeutics Association (PPTA), an organization established and supported by the global suppliers of plasma therapeutics, reports a 2 – 5 weeks supply of IVIG at the manufacturer level. Their supply information is updated frequently and is available on line at www.pptaglobal.org.
CLINICAL TRIAL RESULTS OF RITUXIMAB IN CHILDHOOD AND ADOLESCENT CHRONIC ITP
In a Phase I/II clinical trial studying the safety and efficacy of rituximab in 36 patients under the age of 18 with severe, chronic ITP, 30% achieved a platelet count greater than 50,000. First-dose infusion related toxicity was common and six percent of subjects developed serum sickness. The study highlights that children are not just small adults and react differently to treatments. Unfortunately there has not been a large scale study to determine the optimal dose, frequency of administration, or duration of treatment.
Cines, D.B., “Putting the ‘Tux’ on ITP”, Blood, vol. 107, no. 7, April 2006, pp. 2590-2591.
Bennett, C.M.et al, “Prospective phase 1 / 2 study of rituximab in childhood and adolescent chronic immune thrombocytopenic purpura” Blood, vol. 107, no. 7, April 2006, pp. 2639- 2642.
(Patients can receive a complementary copy of this article by sending the article citation including author(s), title of article, issue date & page number and your name and email address to email@example.com See. www.bloodjournal.org)
A CLINICAL TRIAL DISASTER IN THE UK RAISES QUESTIONS
In January the FDA said low dose trials in people will eliminate poor drug candidates sooner and result in fewer people being exposed to dangerous or ineffective agents. Last month a low dose trial in the UK of a super-antibody drug (TGN1412 by TeGenero in Germany meant to treat autoimmune diseases) resulted in six of the eight participants being rushed to intensive care. Early reports indicated that the participants were struck by a huge immune reaction called a cytokine storm. In such an event, a flood of inflammatory molecules released by helper T-cells shuts down organs in hours. No deaths have been reported but the trial was halted immediately. Since no impurities have been identified and the antibody had been tested in animals, questions surrounding the protocols followed to permit the trial in the first place are being examined carefully. It remains to be seen what the long-term impact is on practices in the US.
Nature Medicine, vol 12, no 4, April 2006, p 372.
Hopkin, M., “Can Super-Antibody Drugs be Tamed?”, Nature, vol 440, April 2006, pp 855-856.
VITAMIN D HELPS YOU HEAL
A recent paper offers a tentative explanation of the mechanism of vitamin D. The authors demonstrate how vitamin D might influence the innate immune response by activating monocytes (a cell involved in the destruction of virus and bacteria, among other things) to kill certain bacteria. Vitamin D also activates two powerful immunosuppressents in the skin that have an anti-inflammatory effect on a wide spectrum of tissues.
Liu, P.T., et.al., “Toll-Like Receptor Triggering of a Vitamin D-Mediated Human Antimicrobial Response”, Sciencexpress, February 23, 2006, www.sciencexpress.org.
Zasloff, M., “Fighting Infections with Vitamin D”, Nature Medicine, vol. 12, no. 4, April 2006, p388-390.
The Office of Dietary Supplements at the NIH provides additional information on Vitamin D
BLACK MOLD CREATES TOXIN THAT KILLS MOUSE BRAIN CELLS
A toxin produced by a black mold found in water-damaged buildings and already linked to respiratory irritations and asthma in people, was demonstrated in mice to kill specific nasal cells. The cells affected were sensitive to odors and ran from the inside of the nose to the brain’s smell center. The findings raise concerns not only among clean-up crews in New Orleans but for anyone who comes in contact with black mold in basements and damp areas.
J.R., Science News, vol 169, March 25, 2006, p 190.
The full report appears in Environmental Health Perspectives
NIH STUDYING BONE MARROW FAILURE
NCI’s Clinical Genetics Branch is undertaking the largest epidemiologic study of its kind in North America to identify adults and children with a diagnosis or suspected diagnosis of an inherited bone marrow failure syndrome in themselves or a family member. Individuals or family members with any of the diagnoses listed below may call the National Cancer Institute at 1-800-518-8474 or visit the Web site at marrowfailure.cancer.gov to find out more details about the protocol and to talk with the research nurse. Diagnosis: Fanconi’s Anemia, Diamond-Blackfan Anemia, Shwachman-Diamond Syndrome, Dyskeratosis Congenita, Severe Congenital Neutropenia, Thrombocytopenia Absent Radii, Pearson’s Syndrome, Amegakaryocytic Thrombocytopenia, Bone Marrow Failure Other Than Acquired.
FDA MAGAZINE: NEW TECHNOLOGIES, NEW TREATMENTS, NEW DIAGNOSTICS
The Food and Drug Administration’s magazine, FDA Consumer, has developed a special issue (November-December 2005, Vol. 39 No. 6) devoted to educating consumers about new technologies that may lead to new diagnostics and treatments. It includes explanations of genomics, proteomics, nanotechnology, gene expression, and others.
To locate other issues of FDA Consumer go to the FDA home page, www.fda.gov and scroll to the bottom right of the page to “FDA Consumer-Current Issue.”
(This information was sent to us from the National Organization of Rare Diseases, www.rarediseases.org)
DRUG ACTION: MEN AND WOMEN DIFFER
Women may metabolize a wide variety of drugs differently than men. Some examples: Prednisone is processed more quickly in women because of high levels of progesterone just before menstruation. Coumadin may have a more powerful effect in women when their estrogen levels are highest. Valium is broken down more quickly in women perhaps requiring higher or more frequent doses.
“World News Tonight,” ABC News, John McKenzie (from “Infocus” Autoimmune Diseases Association)