PDSA E-News: May 31, 2015



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Stephen L. Reisman, MDWholeness in Healing: Taking a Holistic Approach to Chronic Illness, with Stephen L. Reisman, MD. Since 1991 Dr. Reisman has devoted his time to practicing medicine with a mind-body-nature orientation. He continues to dedicate himself to a way of practicing medicine that recognizes the benefits of a truly integrative approach, incorporating natural medicines, alternative treatments, and attention to mind-body connections into the established spectrum of medical care. See more about this year's speakers and all of the conference information here:





PRTX-100 is New Treatment for ITP in Development

The US Food and Drug Administration (FDA) has accepted biopharmaceutical company Protalex Inc.’s Investigational New Drug Application (IND) for PRTX-100, a highly purified form of Staphylococcal protein A (protein from the cell wall of Staphylococcus aureus bacteria). The IND will allow clinical studies of the drug in immune thrombocytopenia (ITP) patients to proceed. A study of PRTX-100 in adults with persistent/chronic ITP is expected to start enrolling patients in June 2015. The studies will be completed by December 2016. Pre-clinical data has shown PRTX-100 may have the potential to treat ITP by reducing the immune-mediated destruction of platelets. Dr. William E. Gannon, Jr., the study’s director and medical officer at Protalex said, “We are very pleased with the results. PRTX-100 appears to be very safe and well tolerated. We hope that it will have a positive effect on patient care and be more cost effective than the other medications available.” PRTX-100 has already shown an acceptable safety profile based on data from five clinical studies of rheumatoid arthritis (RA) patients.

Protalex Announces FDA Acceptance of Investigational New Drug Application for PRTX-100 to Treat Immune Thrombocytopenia [press release]. Florham Park, NJ; Protalex Inc.; March 31, 2015.

Janeczko L. “New Treatment Option for ITP in Development.” Rare Disease Report, May 19, 2015.


New Triple Therapy for ITP Uses Dexamethasone, Rituximab and Cyclosporine

There have been recent promising reports of using combined immunosuppressant treatment with high dose dexamethasone and rituximab for patients with ITP. In a new study from Australia, researchers investigated the novel triple combination of high dose dexamethasone, low dose rituximab, and cyclosporine (an immunosuppressant drug). From 2011 to 2014 20 patients were enrolled in the phase IIb study of the safety, efficacy, and tolerability of the combination treatment. Treatments given included oral dexamethasone (40 mg on Days 1-4), oral cyclosporine (2.5-3 mg/kg/daily for Days 1-28), and intravenous (IV) low dose rituximab (100 mg on Days 7, 14, 21, and 28). The six-month response rate was 60%. The researchers reported the treatment was well tolerated with no therapy-related serious adverse side effects. Those who had responded enjoyed a relapse-free survival of 92% at 12 months, and 76% at 24 months. Their study offers the promise of enduring remission after four weeks of triple combination therapy.

Choi PY, Roncolato F, Badoux X, et al., “A novel triple therapy for ITP using high dose dexamethasone, low dose rituximab and cyclosporine (TT4).” Blood 2015, May 13, [Epub ahead of publication].


Is Your Current ITP Treatment Working for You?

Rigel Pharmaceuticals, Inc. logoIs your current ITP treatment working for you? Rigel Pharmaceuticals Inc. is conducting a Phase 3 clinical study with fostamatinib, an investigational drug for the treatment of patients with persistent or chronic ITP. If you are at least 18 years of age, have had a diagnosis of ITP for at least 3 months, and have previously received at least 1 typical regimen for the treatment of ITP — you may be eligible. There are a number of clinical trial sites already open in the U.S., Canada and Europe.

For a complete site list, please visit - http://tinyurl.com/RigelPhase3ITP.


Are you living with ITP?

Bristol-Myers Squibb logoBristol-Myers Squibb is conducting a clinical study with an investigational drug for the treatment of adults with persistent or chronic ITP. If you are 18 years of age or older, have previously received one or more prior therapies and initially responded to at least one therapy – you may be eligible. There are a number of clinical trials sites open in the U.S., Canada and Europe.

For a complete site list, please visit - MyITPStudy.com.




Patients Face Greater Risk from Surgeries at Low-Volume Hospitals

Generic hospital roomA new U.S. News & World Report analysis found that in thousands of US medical centers patients undergoing common surgical procedures face higher risk of death and complications because their surgical team does too few procedures each year. The analysis found large numbers of low-volume hospitals continue to put patients at higher risk even after there has been three decades of published research showing patients are more likely to die or suffer complications when treated by doctors who only occasionally see similar patients, rather than treated by experienced teams at hospitals with higher patient volume. Elective hip and knee replacement surgeries are prime examples. Large urban centers do hundreds of the surgeries per year while smaller, low-volume hospitals may only do 29-30 hip and 50-52 knee replacements a year. Death rate for these operations is about 1 in 1,000 nationally. Medicare data in the US showed that relative risk of death was 24 times the national average for knee replacement and three to four times the national average for hip replacement when performed in a low-volume hospital.

Patients often think it’s better to get their surgery in a nearby small hospital, closer to home and family. Studies show they may incur greater risk by choosing the low-volume closer hospital rather than going to a larger, high-volume hospital an hour away. When facing any type of surgery it’s important for patients and their families to inquire about the experience of the surgeon who will perform the procedure and about the number of that procedure done at the planned hospital. Proficiency standards for doctors and surgical teams to keep their skills sharp state that the average hospital does 400 heart cases per year with two to three surgeons on the team. Ideally, you’d want a surgeon who has done at least 100 heart cases a year.

Sternberg S and Dougherty G, “Risks Are High At Low-Volume Hospitals.” U.S. News & World Report, May 18, 2015.




Genes That Promote Inflammation Increased During Winter Season

Closeup of flowersMany of us get colds and flus more often in the winter and allergies and hay fever in the spring. Seasons of the year appear to influence when certain genes in the body become more active. Genes associated with inflammation were found more active in the winter. In a study of more than 16,000 people in five countries (US and European countries in the Northern Hemisphere; Australia in the Southern Hemisphere) researchers discovered that activity of about 4,000 genes appears to be affected by the seasons of the year.

These findings may explain why certain diseases are more likely to strike at certain times of the year. When researchers looked at the data one big thing stood out -- genes promoting inflammation were increased in the winter and genes that suppress inflammation were decreased in the winter. This led to an overall increased level of inflammation in the winter season. We know inflammation is associated with many types of health problems. In the winter days get shorter and colder so possibly daylight and temperature could be factors. Researchers said there are wider implications for the findings: for instance, the seasons may affect how people metabolize the drug treatments they receive for illness.

“Seasons May Tweak Genes That Trigger Some Chronic Diseases.” National Public Radio, “All Things Considered” with Rob Stein, NPR Shots, May 12, 2015.




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June 2: ITP Parents Teleconference
June 13: Atlanta, GA
June 13: Nashville, TN
June 24: Canadian Teleconference
June 27: Sacramento, CA

July 9: Cleveland, OH
July 11: Chicago, IL
July 26: Seattle, WA





Pump it Up for Platelets
July, 2015: 100 Mile Challenge, Oak Ridge, NJ
September 19, 2015: 
Chicago, IL
September 27, 2015: Everett, WA
November 21, 2015: Pedal for Platelets El Tour de Tucson, AZ
TBD: Cleveland, OH





Question marks"Where would you like to see a future ITP Conference held?"
The choices we gave you were Orlando, San Diego, Boston, Seattle, Cleveland and Washington, D.C.

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