- Two New ITP Treatments in Testing Announced
- Long-term Steroid Use Linked to Cardiovascular Problems
- Saline Spray May Limit Spread of Diseases
- Glycemic Index Diet May Lower Levels of C-Reactive Protein
- Find a Hematologist Section of ASH Website Open to Public
- New Benefits attributed to Vitamin D
TWO NEW ITP TREATMENTS IN TESTING ANNOUNCED
At the recent American Society of Hematology meeting two companies reported studies of new treatments for ITP. Both promote thrombopoietin levels, stimulating platelet production; one is administered by injection, the other orally.
Amgen announced the results of a study involving an agent (AMG531) that stimulates thrombopoietin levels. The phase 2 study was multi-center, randomized, double blind, and placebo controlled. Study subjects had to have a platelet count less than 30,000 or less that 50,000 if on corticosteroids, between 18 and 65 years of age, diagnosed with ITP at least three months, and no history of thrombosis. The study objective of maintaining platelet count between 50,000 and 450,000 for these ITP patients was met at both dosage levels of 1ug/kg and 3ug/kg. The treatment was well tolerated by the patients overall. However several patients experienced adverse events. A large clinical trial is being planned.
GlaxoSmithKline announced results of a study testing an orally administered small molecule (SB497115) that stimulates platelet production. This phase 1 study was randomized, single blind, placebo controlled and involved 72 healthy male subjects. The study observed a dose dependent response of platelets in these subjects. The treatment was reported well-tolerated; no serious adverse events were reported, and there was no observed relationship between the incidence or severity of adverse events and dose. SB 497115 will be studied in phase 2 trials involving thrombocytopenic patients.
Note: Thrombopoietin is a substance in your blood that stimulates platelet production. You would expect it to be higher in people who have low platelets, but that is not the case for people with ITP. Also, about 30% of people with ITP have platelet production problems in addition to platelet destruction problems. As the results of the studies noted above show, encouraging additional platelet production in people with ITP can raise platelet counts. We will send an e-mail about the new clinical trials as soon as the information is available to us.
Kuter, D., et al, “A Phase 2 Placebo Controlled Study Evaluating the Platelet Response and Safety of Weekly Dosing with a Novel Thrombopoietic Protein (AMG531) in Thrombocytopenic Adult Patients (pts) with Immune Thrombocytopenic Purpura (ITP)”, Blood: Journal of the American Society of Hematology, November 16, 2004, vol. 104, no. 11, Part 1, p 148a.
Jenkins, J., et al, “An Oral, Non-Peptide, Small Molecule Thrombopoietin Receptor Agonist Increases Platelet Counts in Healthy Subjects”, Blood: Journal of the American Society of Hematology, November 16, 2004, vol. 104, no. 11, Part 1, p 797a.
LONG-TERM STEROID USE LINKED TO CARDIOVASCULAR PROBLEMS
A new study of 68,781 patients on long-term steroid use of more than 7.5 mg/day were found to be 2.5 times more likely to develop heart disease than people who did not use steroids. The study compared the steroid using patients with 82,202 people who did not use these drugs. The researchers found that patients on doses below 7.5 mg/day did not face an increased risk of heart disease. The study did not isolate the role of steroids as a cause of the increased cardiovascular events from the role of the underlying disease. And factors such as diet, smoking, and exercise were not considered.
Wei, L., et al, “Taking Glucocorticoids by Prescription is Associated with Subsequent Cardiovascular Disease”, Annals of Internal Medicine, November 16, 2004, vol. 141, Issue 10, pp 764 – 770.
SALINE SPRAY MAY LIMIT SPREAD OF DISEASES
In this study eleven volunteers inhaled a saltwater spray and then researchers measured the number of germ-spreading particles given off when they coughed. Those prone to producing the most droplets when coughing saw up to a 70 % reduction in germ-spreading particles or droplets. Researchers said that this type of spray could prove effective in controlling the spread of tuberculosis and flu. The study was conducted by Gerhard Scheuch of Harvard University and colleagues at Pulmatrix and Inamed, two biotechnology firms.
Washington Post, November 30, 2004, p.A3.
GLYCEMIC INDEX DIET MAY LOWER LEVELS OF C-REACTIVE PROTEIN
In a glycmic index diet, the dieter consumes carbohydrates that do not cause a sharp rise in blood sugar. These ‘good’ carbohydrates include whole grains such as oatmeal. C-reactive protein (CRP) is a special type of protein produced in the liver that has been thought to be present only during episodes of acute inflammation; recent studies indicate CRP may also be elevated in heart attacks. One of the findings in a recent study of the glycemic index diet (GID) at Boston’s Children’s Hospital led by David Ludwig, was that people on the GID experienced a reduction in the levels of CRP.
Note: This is potentially important information for those managing an auto-immune disease. Lowering the level of C-reactive protein could play a role in delaying onset or flare-ups of auto-immune reactions. For a list of PDSA’s diet recommendations see http://www.pdsa.org/diet.htm
Washington Post, November 24, 2004, p.A11.
FIND A HEMATOLOGIST SECTION OF ASH WEBSITE OPEN TO PUBLIC
A new feature of the website of the American Society of Hematology (ASH), “Find a Hematologist”, is open to the public and may prove very useful to patients. This new feature is an online directory of ASH members (physicians) who added their name to this list. The service is designed for both patients looking for hematologists in their community and medical professionals who want to make referrals. ASH is encouraging members to sign up.
E-Newsletter, American Society of Hematology, November 22, 2004.
NEW BENEFITS ATTRIBUTED TO VITAMIN D
Vitamin D’s role in protecting bone strength is well established and widely understood. What is less well understood but equally clear to researchers is that vitamin D is important in regulating cell growth, immunity, and energy metabolism as well as providing some protection against multiple sclerosis, diabetes, and cancer. Recently, Margherita T. Cantorna and colleagues reported new findings describing how the presence of vitamin D during T cell development affects how the mature cells operate. They found that vitamin D deficiency during development “leads the cells to produce agents that are more reactive to other cells than those produced when the killer T cells grow up with abundant vitamin D.” Unfortunately Cantorna suspects that once full-blown autoimmune disease appears, “you’ve already lost your window of opportunity to change the kind of T cells that develop.”
Raloff, J., “Vitamin Boost”, Science News, October 9, 2004, vol. 166, p. 232-233.