- R788 in Phase 2 Study
- Enrolling: AKR-501 Phase 2 Clinical Trial
- Boost for Genetic Tests for Rare Diseases
- Health Effects of Mold
- Virgin Olive Oil Kills Ulcer Bug
- Greek Study Says High Carb Better than High Protein
- Food Safety Tips
- Top 10 Drug Errors
- Grass Roots Movement Takes on Medical Errors
- Parsley for Bruises?
R788 IN PHASE 2 STUDY
Rigel Pharmaceutical’s experimental drug, R788, is showing some activity in a phase 2 study in ITP patients, so the company has submitted a proposal to the FDA to expand the study to broaden the dosages tested. The oral drug is a syk kinase inhibitor that blocks the activation of immune cells called mast cells, macrophages, and B-cells that promote swelling, inflammatory responses, and tissue damage. It is being tested in patients with ITP, rheumatoid arthritis, and lymphoma. Rigel is based in San Francisco.
ENROLLING: AKR-501 PHASE 2 CLINICAL TRIAL
AKR-501 - This Phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging, parallel-group study will assess the efficacy, safety and tolerability, of AKR-501 tablets, as compared to placebo, in the treatment of patients with ITP. Approximately 65 eligible patients will be randomized for 28 days. Each AKR-501 dosing group will consist of 15 patients while the placebo group will consist of 5 patients. All study patients will be evaluated weekly with a final assessment for safety and effectiveness to be done 2 weeks after the last study dose. You can find out more information about the study at www.PlateletStudies.com/pdsa.
BOOST FOR GENETIC TESTS FOR RARE DISEASES
Development of new genetic tests for rare diseases has received a boost from a program of the National Institutes of Health (NIH). Called The Collaboration Education and Test Translation Program (CETT), and located in the Office of Rare Diseases at NIH, the program encourages formation of collaborative teams including clinicians, laboratories, researchers, and disease-specific advocacy groups. Collaborative groups can apply to the CETT Program for funds to help develop a new genetic test for a rare disease.
TPO-MIMETICS SHOWING PROMISE
TPO-mimetics are drugs that bind to the thrombopoietin (TPO) receptor, but bear no structural resemblance to TPO. The hypothesis is that these TPO-mimetics might treat ITP without causing production of anti-TPO antibodies. Examples of TPO-mimetics are AMG 531, Eltrombopag, and AKR-501. Researchers from New York Presbyterian Hospital reported on a phase 1/2 trial of AMG 531 in ITP. After testing various doses in phase 1, phase 2 included 16 patients with long-term ITP in a double-blind, placebo controlled trial. The compound produced a dose-dependent increase in platelet counts in ITP patients. A reviewer writes, “Although the data on TPO-mimetics are currently tantalizing, the long-term effects of these compounds remain to be established.”
Abrams C. Are TPO-Mimetics Better Than the Real Thing? The Hematologist, March/April 2007, Vol 4(2), pg. 7.
HEALTH EFFECTS OF MOLD
Mold needs to be taken seriously, especially in people with weakened immune systems, according to a review of several government reports and recent research. The review quotes the Centers for Disease Control and Prevention: "excessive exposure to mold-contaminated materials can cause adverse health effects in susceptible persons regardless of the type of mold or the extent of contamination." Asthma and other respiratory problems appear to be the biggest risks from mold exposure. Modern building practices—for example, tighter building envelopes, more insulation, paper-coated wallboard replacing plaster—have increased risk for mold growth. The report has links to a video on mold clean up, produced for New Orleans residents affected by Hurricane Katrina.
VIRGIN OLIVE OIL KILLS ULCER BUG
In laboratory tests, Spanish researchers found olive oil could kill eight strains of the bacterium H. pylori, which causes most stomach ulcers. The results need to be confirmed in humans.
J Agriculture and Food Chemistry, February 21, 2007.
(Note: The eradication of H.pylori is sometimes associated with an increase in platelets for patients with ITP)
GREEK STUDY SAYS HIGH CARB BETTER THAN HIGH PROTEIN
Results from the Greek cohort of the long-running EPIC (European Prospective Investigation Into Cancer and Nutrition) study indicate that diets that focus more on protein than carbohydrates may be harmful. From 1993 to 2003, 22,944 healthy adults described their dietary intake through questionnaires. Prolonged consumption of diets low in carbohydrates and high in protein was linked with higher mortality.
Trichopoulou A., et al. Low-carbohydrate—high-protein diet and long-term survival in a general population cohort. European Journal of Clinical Nutrition, 2007; 61:575-581.
(Note: In our 2001 survey responders reported that low-carbohydrate---high-protein diet was not as effective as other diets in helping platelet counts. Visit http://www.itppeople.com/surveyres/ )
FOOD SAFETY TIPS
Summer brings reminders to keep fruits and vegetables that will be eaten raw separate from raw meat, poultry or seafood—as well as the utensils used for those products. Sliced fruits and vegetables should be refrigerated. Washing fruits and vegetables before preparation is important. This includes scrubbing firm produce, such as melons and cucumbers, with a clean produce brush. Wash cutting boards, dishes, utensils and counter tops with hot soapy water between preparation of different foods.
TOP 10 DRUG ERRORS
At the 2007 American Pharmacists Association Annual Meeting participants heard about common medication errors and how to avoid them. The 10 drugs most commonly implicated in adverse events that require treatment in a hospital emergency department are: Insulin, anticoagulants, amoxicillin, aspirin, trimethoprim-sulfamethoxazole, hydrocodone/acetaminophen, ibuprofen, acetaminophen, cephalexin, and penicillin. Unintentional overdoses are the most prevalent cause of problems. Other common misuses are taking incorrect doses, taking doses at the wrong time, forgetting to take doses, or stopping medication too soon. For example, in people with arthritis, misuse of nonsteroidal anti-inflammatory drugs--either prescription or over the counter--leads to 103,000 hospitalizations and 16,000 deaths per year.
GRASS ROOTS MOVEMENT TAKES ON MEDICAL ERRORS
Several new groups, some formed by families who lost a loved one due to medical error, are creating online communities to share strategies for preventing medical errors and offering advice to consumers who have experienced harm. One such group, Consumers Advancing Patient Safety, is building a global network for the World Health Organization, and claims that an average of 1 in 10 hospital patients world-wide suffers some form of preventable harm. The Wall Street Journal published this list of organizations:
- Josie King Foundation: josieking.org
- Consumers Advancing Patient Safety: patientsafety.org
- Persons United Limiting Substandards and Errors in Health Care: pulseamerica.org
- Medically Induced Trauma Support Services: MITSS.org
Landro L. Patients, Families Take Up the Cause of Hospital Safety. Wall Street Journal, May 30, 2007, pg. D1-2.
PARSLEY FOR BRUISES?
The authors of “Bottom Line/Health” suggest treating a bruise by crushing a handful of chilled parsley sprigs and applying them straight to the bruise.
(Note: If you try this and it seems to help, please send a message to PDSA)