Osiris Prochymal Stem Cell Transplant Update and XBP1 Info

So I have to think that I got more than a placebo. While on the high level I am more relaxed, happy and content than I though possible, I am also under a lot of day-to-day stress and pressure. As almost anyone with Crohn's Disease will tell you, there is a near concrete link between stress and Crohn's Disease flare ups. With my recent stress levels, I am pretty confident that pre-Osiris Prochymal I would be in a flare up. The good news is that I am not. The pain has subsided quite a bit and I am generally feeling really great as it relates to Crohn's. My improvements were enough to qualify me for phase II and as soon as I enter a flare-up, I am ready for 4 more treatments. I am more living with Crohn's now than I am suffering from it, and that is a big step in the right direction! Anyways, to you guys that are in Crones flare-ups or have been recently diagnosed....keep your heads up...and let me know if you have any questions. Be sure to use the search feature on this blog as we have covered alot of topics over the years.

-Scottie

PS - Intersing info here exploring the genetic link to Crohn's

A team of scientists have discovered that the XBP1 gene is a risk factor for developing Crohn’s disease and ulcerative colitis, forms of inflammatory bowel disease (IBD).

The investigators created a mouse model in which they deleted XBP1within the epithelium. They found that the mice spontaneously developed an intestinal inflammation that resembled IBD. The lack of the XBP1 gene disabled the normal communication between intestinal epithelial cells and gut bacteria, resulting in dysfunctional immune response and disease, the researchers explain.

The researchers then reportedly demonstrated that alterations in this gene in the intestinal-lining cells represent risk factors for development of Crohn's and colitis. The study was conducted by scientists from Brigham and Women's Hospital, Harvard Medical School, and institutes in Germany, The Netherlands, and Austria. Results appear in the September 5 issue of Cell.

Crohn's Disease Drugs Stolen - Procrit and Remicade

HORSHAM, Pa., May 15 /PRNewswire/ -- JOM Pharmaceutical Services, Inc. (JOM), a service coordinator that provides delivery services and customer support to Centocor, Inc. and Ortho Biotech, L.P., was notified May 6, 2008, that a transport trailer carrying DOXIL(R) (doxorubicin HCl liposome injection), PROCRIT(R) (epoetin alfa) and REMICADE(R) (infliximab) was stolen while the driver was traveling from a distribution center in Kentucky to a specialty distributor. This incident has been reported to local and federal law enforcement offices, as well as the U.S. Food and Drug Administration; however, the transport trailer and product have not yet been recovered.

To ensure patient safety, Centocor and Ortho Biotech are voluntarily withdrawing products with lot numbers matching those of the stolen product from the market and communicating this action to all authorized distributors and all prescribing physicians, healthcare providers, and patients.

If the stolen product were to be reintroduced into distribution channels, the companies cannot guarantee that products were stored at appropriate temperatures, nor can the companies guarantee the products were not damaged. A voluntary withdrawal of products with lot numbers corresponding to that of the stolen product minimizes the possibility of inadvertent use of stolen product by physicians and, therefore, the overall risk to patients.

On May 7, 2008, JOM discontinued shipment of products with lot numbers matching those of the stolen product. Healthcare providers and patients that did receive product shipped from an authorized distributor on or before this date should consider the product safe for use. Healthcare providers and patients that are concerned about products shipped after this date with the following NDC and lot numbers can return the product by contacting the companies at (888) 626-5660:NDC Description Lot Number Expiration
Date
59676-3100-1 Cartons containing six (6)D091534 07/2010
single dose vials of
PROCRIT(R) (epoetin alfa)
10,000 U/mL
59676-3200-4 Cartons containing four (4) P113612 09/2010
multidose vials of
PROCRIT(R) (epoetin alfa)
20,000 U/mL
59676-3400-1 Cartons containing four (4) P106803 06/2010
single dose vials of
PROCRIT(R) (epoetin alfa)
40,000 U/mL
17314-9600-1 Cartons containing 1 0717124 03/2009
DOXIL(R) (doxorubicin HCl
liposome injection) 20mg in
10mL (2 mg/mL) single use vial.
17314-9600-2 DOXIL(R) (doxorubicin HCl 0715423 02/2009
liposome injection) 50mg in
25mL (2mg/mL) single use vial
57894-0300-1 Cartons containing one (1)8AM26021P1 01/2011
vial of REMICADE(R)
(infliximab) 100mg
57894-0300-1 Cartons containing one (1)8BK35014P1 02/2011
vial of REMICADE(R)
(infliximab) 100mg

No other lot numbers of product are impacted by this incident. All three of these products have tamper-evident features that can be used to authenticate the package. Healthcare professionals and patients who have concerns about any product they possess may contact the number below for assistance with the identification of these features.

The amount of stolen and withdrawn product represents a very small proportion of the total product within the distribution channel; therefore the companies do not anticipate a disruption in product availability for patients.

JOM, Centocor, and Ortho Biotech will continue to work closely with healthcare providers and authorized distribution partners to identify and isolate product with lot numbers corresponding to those of the stolen product, and ask that anyone report any questionable activities to the appropriate authorities. Healthcare professionals, distributors or patients are asked to direct questions related to this voluntary withdrawal to the companies by calling (888) 626-5660.
Please see Important Safety Information for REMICADE(R) (infliximab), PROCRIT(R) (epoetin alfa), and DOXIL(R) (doxorubicin HCl liposome injection) at their respective websites.
About JOM Pharmaceutical Services, Inc.

JOM Pharmaceutical Services, Inc. is a service provider that is dedicated to providing safe and on-time delivery of pharmaceutical products for Ortho Biotech, L.P., Centocor, Inc., and other U.S. pharmaceutical companies.

About Ortho Biotech, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit www.orthobiotech.com.

About Centocor, Inc.
Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis. The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders.

Crohn's Disease Patients Should Limit Their Exposure to Radiation!

Specialist centres must take steps to reduce the amount of radiation people with Crohn's disease are exposed to from diagnostic imaging, radiologists have urged [1]. Patients with Crohn's disease may be particularly vulnerable to radiation owing to their young age at presentation and an elevated risk of some intestinal malignancies such as small bowel lymphoma.

Researchers estimated the cumulative effective dose (CED) of diagnostic radiation of 354 patients with Crohn’s disease treated at a tertiary centre.They found that 55 patients, 15.5 per cent, had a 'high' CED – defined as greater than 75mSv.Less than six imaging studies were performed per patient over the first five years of the 15-year study. During this period the mean CED was 7.9mSv, with CT accounting for 46.3 per cent of radiation exposure.During the last five years, these figures had increased to almost seven images per patient and a mean CED of 25.1mSv. CT accounted for 84.7 per cent of radiation exposure at this time.

The likelihood of having a high CED was increased by an earlier diagnosis, upper gastrointestinal tract disease, the use intravenous steroids or infliximab, and multiple surgical procedures.The authors said: "Strategies to reduce the effective dose of radiation incurred by patients undergoing CT imaging can be employed without sacrificing image quality and should be considered for all patients, particularly those who are likely to require multiple examinations."

Cimzia Approved to Treat Crohn's Disease - Another New Crohn's Drug

The US Food and Drug Administration has approved a new drug for sufferers of Crohn's disease. Certolizumab pegol (Cimzia) received approval for use in adults with moderate to severe Crohn's disease who have not responded to conventional therapies. This product was approved with a Medication Guide."Crohn's is a debilitating disease that disrupts the quality of life for its sufferers," said Julie Beitz, MD, Director, Office of Drug Evaluation III, Center for Drug Evaluation and Research, FDA, Rockville, Maryland. "This drug works to reduce the signs and symptoms of Crohn's, but it also carries risks that will require patients on it to be closely monitored by their physicians or other healthcare professionals."Patients treated with certolizumab will receive an injection every 2 weeks for the first 3 injections. Once benefit has been established, certolizumab should be given once every 4 weeks.The most common side effects of certolizumab are headache, upper respiratory infections, abdominal pain, injection-site reactions, and nausea.Patients taking certolizumab are at increased risk for serious adverse effects, including serious infections that can lead to hospitalisation or death. Because certolizumab affects the immune system, it can lower the body's ability to fight infections, such as tuberculosis and other opportunistic infections. Certolizumab is a tumour necrosis factor inhibitor and may cause lymphomas and other malignancies. Although an increased risk of tumours was not noted in studies of certolizumab, the modest size and relatively short duration of the controlled studies prevent any firm conclusion. Postmarketing studies and clinical trials will be required to obtain long-term safety data.Patients taking certolizumab should be educated about how to identify an infection and should be instructed to contact their healthcare professional at the first sign of infection. In cases of serious infections, the drug should be discontinued immediately.SOURCE: US Food and Drug Administration

Living with Crohn's Disease - Crohn's Blog

Hey guys, have had a recent upswing in traffic here at the living with crohn's disease blog (livingwithcrohnsdisease.blogspot.com) and just wanted to welcome the new visitors. Feel free to comment or share your stories and advice about living with crohn's disease. Have a great weekend.

Also, have seen an increase in traffic in those looking for basic Crohn's Disease information and am hearing the question "What is Crohn's Disease?" Quick refresher for those folks:
An estimated 500,000 Americans have Crohn's disease, an inflammatory bowel disease (IBD) that causes chronic inflammation of the intestinal tract. Like ulcerative colitis, another common IBD, Crohn's disease can be both painful and debilitating and sometimes may lead to life-threatening complications.In my case, the disease is centralized near my terminal ilieum (near the colon). There's no known medical cure for Crohn's disease. However, therapies are available that may greatly reduce the signs and symptoms of Crohn's disease and even bring about a long-term remission. (When healthly I take about 16 pills a day, when in a flare up, I lose count.)