Main Category: Irritable-Bowel Syndrome
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 02 Jun 2011 – 0:00 PDT

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Tioga Pharmaceuticals, Inc. announced that its investigational compound asimadoline has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with diarrhea-predominant irritable bowel syndrome (D-IBS). Tioga is conducting a multi-center Phase 3 clinical trial evaluating asimadoline in D-IBS, conducted under a Special Protocol Assessment agreement with the FDA for U.S. registration.

The Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs. New drug applications for products in the Fast Track program ordinarily are eligible for priority review.

“The FDA’s granting of Fast Track designation for asimadoline signals the agency recognizes that diarrhea-predominant irritable bowel syndrome is a serious illness and that patients lack a safe and effective therapy,” said Stuart Collinson, Ph.D., Chairman and CEO of Tioga Pharmaceuticals.

About Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is a common, chronic gastrointestinal disorder characterized by recurrent episodes of abdominal pain or discomfort associated with a change in bowel pattern, such as loose or more frequent bowel movements, diarrhea and/or constipation. While the exact etiology of IBS is unknown, it is believed to be due to a disturbance in the interaction between the intestines, the brain and the autonomic nervous system that alters regulation of bowel motility or sensory function. IBS patients fall into different subtypes based on their predominant symptoms: IBS with diarrhea (D-IBS), IBS with constipation (C-IBS) and IBS with alternating diarrhea and constipation (A-IBS). IBS afflicts an estimated 60 million patients in the U.S. and Europe, with roughly equal prevalence of each subtype, and it is the most common diagnosis made by gastroenterologists.

About Asimadoline

Asimadoline is an orally administered small molecule that is a highly selective, peripherally restricted, kappa opioid receptor agonist. In a 596-subject Phase 2b clinical trial asimadoline demonstrated statistically significant results in the treatment of D-IBS patients with at least moderate pain across multiple parameters including endpoints of pain, urgency, frequency and bloating in both males and females. A therapeutic benefit was observed within the first month of treatment and was sustained for the three-month duration of the trial. Asimadoline appeared to be well tolerated with no adverse events occurring in a dose-dependent manner throughout the randomized, double-blind, placebo-controlled, dose-ranging clinical trial. Asimadoline has been tested in over 1,100 subjects to date and has a positive safety profile.

Source: Tioga Pharmaceuticals, Inc

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Main Category: Irritable-Bowel Syndrome
Also Included In: GastroIntestinal / Gastroenterology;  MRI / PET / Ultrasound;  Radiology / Nuclear Medicine
Article Date: 19 Oct 2010 – 1:00 PDT

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San Antonio, Texas, October 18, 2010 At the American College of Gastroenterology’s (ACG) 75th Annual Scientific meeting in San Antonio, Texas, several studies of the effectiveness of non-X-ray techniques to evaluate Crohn’s disease revealed that diagnostic strategies such as capsule endoscopy (CE) and magnetic resonance enteroscopy (MRE) are useful in managing patients with inflammatory bowel disease (IBD) and avoiding ionizing radiation.

IBD Patients Exposed to Significant Ionizing Radiation

Radiographic imaging is an important tool for diagnosis and management of IBD. In the study, “Effect of Age, Gender, and Ethnicity on Radiation Exposure among a Multi-Ethnic IBD Population of Low Socioeconomic Status,” researcher Jason Hou, M.D. and colleagues from Baylor College of Medicine, noted a lack of data quantifying radiation exposure in IBD patients. Dr. Hou and his team conducted a retrospective analysis of 287 patients in Harris County Hospital District in Houston, Texas to compare the effect age, gender and ethnicity on ionizing radiation exposure among adults with IBD in a county hospital with a multi-ethnic population.

The investigators found that patients with IBD treated at a county hospital were exposed to a significant amount of ionizing radiation. The mean total radiation exposure was 35.7 millisieverts (mSv) per patient. In the Harris County study, patients with Crohn’s disease received over 1.5 times the radiation dose as patients with ulcerative colitis. While overall there was no difference in radiation exposure between men and women, there was a trend among male patients younger than 35 towards increased radiation exposure compared to females. In the study, 21 percent of patients under 35 received greater than 75 mSv of radiation. In comparison, a full-body CT scan measures an estimated 2 millisieverts to 16 millisieverts. A mammogram measures about .4 millisieverts. Americans get small amounts of ionizing radiation each year from natural sources, according to the U.S. Food and Drug Administration

Magnetic Resonance Enteroscopy a Clinical Useful Tool in Crohn’s Disease

Magnetic resonance enteroscopy (MRE) to evaluate Crohn’s disease was the subject of two different studies presented at the ACG 2010 Annual Scientific Meeting in San Antonio, Texas. Researchers at the University of Wisconsin developed a clinical efficacy measure for the usefulness of MRE in the care of patients with Crohn’s disease in their study, “Clinical Efficacy of MR Enterography in the Diagnosis and Management of Crohn’s Disease.”

“Assessing Crohn’s disease activity in the small bowel is challenging as direct visualization is difficult and traditional radiographic studies can result in large cumulative radiation disease,” according to Siobhan Byrne, M.D. and Helen Fasanya-Uptagraft, M.D. MR enteroscopy is a diagnostic technique performed without ionizing radiation. Researchers looked at the clinical utility of MRE in Crohn’s disease in a study that included 50 MREs and developed a clinical efficacy score which attempted to correlate MRE findings and clinical activity and evaluate the impact of the MRE on management of Crohn’s patients.

Their findings revealed that more than half of clinically severe cases had higher MRE scores, and 75 percent had definite disease activity. In cases judged mild to moderate by symptoms reported by patients, MRE was unlikely to show active disease, with 68 percent having low clinical efficacy scores.

“MRE had the greatest impact when it was employed to differentiate active Crohn’s disease from other non-functional GI diagnoses,” said Dr. Byrne. Because MRE revealed no active disease in those patients reporting mild to moderate symptoms, MRE prevented escalation of therapy and led to the work-up of alternate diagnoses. “Overall, MRE was a useful tool in this clinical setting, leading the management change in 86 percent of patients with Crohn’s without the use of ionizing radiation,” concluded the investigators.

Sensitivity and Specificity of MRE Compares Favorably to Endoscopy and Pathology

In another assessment of MR enteroscopy, “Efficacy of MR Enterography for Evaluation of Known or Suspected Crohn’s Disease,” Samir A. Shah, M.D., FACG and Adam Harris, M.D. of Brown University retrospectively evaluated the sensitivity and specificity of MRE compared to traditional endsocopy and pathology. Their aim was to analyze the efficacy of this test in evaluating Crohn’s disease among 310 patients who also had endoscopy and laboratory studies within 90 days of the MRE. The investigators found that in this patient group the overall sensitivity and specificity of MRE (using endoscopy as a gold standard) were 84 percent and 76 percent respectively. Results improved as the time between the MRE and endoscopy decreased. In 162 patients who underwent endoscopy within 30 days of MRE, the sensitivity remained 84 percent, but the specificity increases to 82 percent.

“MRE highly correlates with enodsopic and histological assessment for the evaluation of known or suspected Crohn’s disease non-invasively and without the exposure to ionizing radiation of CT enterography,” explained Dr. Shah.

Capsule Endoscopy Impacts Management of IBD

In a study at the University of North Carolina Hospitals, “The Impact of Capsule Endoscopy on Management of IBD: A Single Tertiary Care Center Experience,” Dr. Millie Long and colleagues conducted a retrospective cohort study of capsule endoscopy performed among patients previously diagnosed with IBD. They analyzed the use of IBD-specific medications, surgeries and imaging studies within the three months prior to and three months following the capsule endoscopy examination. “We aimed to define results of capsule endoscopy in symptomatic Crohn’s disease, indeterminate colitis and pouchitis and to determine whether use of the capsule was associated with management changes in these different subtypes of inflammatory bowel disease,” explained Dr. Long.

Among Crohn’s patients undergoing capsule endoscopy, overall 61 percent had a change in medication in the three months after the exam, with almost 40 percent initiating a new IBD medication, and about 13 percent underwent surgery. In comparing patients in whom capsule exam found evidence of severe disease to those with minimal or no findings, the percentage of patients with changes in the management of their disease was even larger: 73 percent of those with severe findings changed medication, 58 percent added medications, and 21 percent had surgeries. “We found that capsule endoscopy resulted in management changes in the majority of cases, regardless of the findings or the subtype of IBD,” explained Dr. Long.

Source: American College of Gastroenterology (ACG)

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Main Category: GastroIntestinal / Gastroenterology
Also Included In: Medical Devices / Diagnostics;  Irritable-Bowel Syndrome;  Crohn’s / IBD
Article Date: 08 Nov 2010 – 0:00 PDT

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Nanoparticles could help smuggle drugs into the gut, according to a study published this month in the International Journal of Nanotechnology.

There are several drugs that would have more beneficial therapeutic effects if they could be targeted at absorption by the lower intestine. However, in order to target the colon for treating colon cancer for instance, medication delivered by mouth must surmount several barriers including stomach acidity, binding to mucus layers, rapid clearance from the gut, and premature uptake by cells higher up the gastrointestinal tract. Being able to deliver a drug by mouth has several benefits over injection or suppository: ease of dosing, for instance, and better patient compliance.

Various methods have been tried, including coating drug molecules with a polymer shell. However, Kevin P. O’Donnell and Robert O. Williams III of the Division of Pharmaceutics, at The University of Texas at Austin, have reviewed the various techniques on offer and suggest that encapsulating a drug molecule within nanoparticles offers the best option for controlling drug delivery and targeting the colon.

The Texas team has reviewed the state of the art in nanotechnology for delivery of therapeutic agents to the colon. They explain that advances in particle engineering techniques have recently made it possible to made drug products on the nanoscale. Techniques such as spray drying, antisolvent methods, dialysis methods, emulsion methods and cryogenic methods are all now available for drug formulation. Converting a drug powder into nanoparticles can often render a compound that is poorly soluble in water soluble or increase bioavailability simply through an increase in the surface area to volume ratio. Smaller particles mean a bigger surface area to interact with absorbing surfaces in the gastrointestinal tract. Indeed, fatty but solid nanoparticles of the compound quercetin (a health supplement) are absorbed almost 6 times more effectively by the gut in nanoparticle form than the common drug suspension formulation.

The researchers explain that nanoparticle drug delivery could be particularly beneficial for patients suffering from inflammatory bowel diseases including Crohn’s Disease, ulcerative colitis and irritable bowel syndrome, all which often require long-term treatment. However, they also add that because there are no digestive enzymes in the colon and its neutral pH it is a prime target for the delivery of therapeutic proteins, peptides, viral vectors, and nucleotides for a wide range of disease not simply those associated with the colon.

“Nanoparticulate systems for oral drug delivery to the colon” in International Journal of Nanotechnology, 2010, 8, 1/2, 4-20

Source:
Robert Williams
Inderscience Publishers

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