News Room
March 2011
New Study on Pain Impact in IBS Published (Hellstrom et al, Am J Gastroenterol; 29 March 2011)
As part of Rose's commitment to research on pain in IBS, Rose sponsored a major international study on the impact of acute pain attacks on IBS patients. The results have now been published in the American Journal of Gastroenterology. The study included 4 sites in Europe and 2 in the US (Mayo Clinic and UCLA) and the highlights were presented at DDW 2010.

The study defined a pain attack as onset of pain of at least grade 4 on a 0-10 rating scale and is characterized as moderate or severe. The study has shown:
  • About 10% of all pain attacks are treated with opioid medication. This is the target market for ROSE-010 as opioids have significant gastric side-effects.
  • The median pain intensity was 7 on the 0-10 scale, a significant level of pain.
  • The majority of pain attacks interfered with work or daily activities.
  • Once established, the majority of pain attacks last several hours.
  • Most pain attacks are untreated with a significant number of subjects simply going to bed.
The study is significant in that it shows the need for effective pain treatments and supports the concept that pain treatment alone in the absence of an effect on other IBS symptoms is a valid clinical endpoint in management of IBS.
May 2010
Rose at Digestive Disease Week May 2010

Pain in IBS
Results from the Rose sponsored study on the natural history of pain attacks were presented at DDW 2010 in two talks by Prof Lin Chang (UCLA) and Prof Per Hellstrom (Uppsala). 

- Prof Chang’s presentation entitled “Impact of Pain Attacks on Behavior and Health-Related Outcomes in Patients with Irritable Bowel Syndrome Meeting Rome III Criteria” described  the effect of IBS acute pain attacks on behaviors and daily activities.The results showed that only a minority of pain attacks were effectively managed with medication  and that treatment of pain attacks remains an unmet need in IBS and should be a focus of IBS management.

- Prof Hellstrom ‘s presentation entitled “Characteristics of Acute Pain Attacks in Patients with Irritable Bowel Syndrome (IBS) Meeting Rome III Criteria” summarized the study results on frequency, duration and intensity of pain attacks.  The results show that acute severe pain attacks are highly prevalent in IBS patients regardless of stool pattern subtype and that patients prospectively followed suffered about 8 pain attacks per month with an average intensity is 7 on a 0-10 pain scale.


Willingness to Use ROSE-010
Results from the Rose sponsored study on patients willingness to use ROSE-010 for treatment of acute pain attacks in IBS were presented at a poster session by Dr Brennan Spiegel (UCLA).  The results showed that 50% of patients would be willing to use ROSE-010 for treatment of IBS pain based on its clinical profile established in the Phase IIa pain study. 

For the full presentation, click here


Mechanism of Action of ROSE-010
Rose presented results of a non-clinical study on the mechanism of action of ROSE-010 at a poster session.  These confirm that ROSE-010 uses the GLP-1 receptor. 

April 2010
First Patient Treated in Mayo Clinic Study

Rose announced that the first patient had been treated in a pharmacodynamic study of ROSE-010 at the Mayo Clinic, Rochester, USA.  The lead investigator is Prof Michael Camilleri and the study uses the scintigraphy model for gastric and bowel transit developed at the Mayo Clinic.  The study aims to completely map the effects of ROSE-010 on the stomach, small intestine and large intestine and involves multiple treatments and assessments. 

Further details can be found at:

http://www.clinicaltrials.gov/ct2/show/NCT01056107?term=rose-010&rank=1
August 2009
Rose presents data on inhaled delivery of ROSE-010 at Neurogastroenterology and Motility meeting Chicago, August 2009.
ROSE-010 has been efficiently delivered by inhaled delivery through the lung with comparable bioavailability and pharmacology when compared to subcutaneous or intravenous delivery.   The study was carried out by Prof Per Hellström (Karolinska, Sweden) in an established model of intestinal motility and using MannKind Corporation’s Technosphere particulate delivery system (www.mammkindcorp.com).  This new development shows the potential for IBS treatment by an inhaled formulation of ROSE-010.
To view the abstract please click here
August 2009
Rose presents data on mechanism of action of ROSE-010 at Neurogastroenterology and Motility meeting, Chicago, August 2009.
ROSE-010, a GLP-1 analogue, exerts its effect on small intestine motility and contractility through the GLP-1 receptor.  Blockage of the receptor eliminates the ROSE-010 response.  These results show that the mechanism of action of ROSE-010 is mediated through the GLP-1 receptor and suggest that ROSE-010 is exploiting a natural feedback mechanism in digestion in the treatment of IBS.
January 2009
Results of positive Phase IIa  clinical results for ROSE-010 in treatment of IBS published, January 2009.
This randomized, placebo-controlled, double-blind study in 166 IBS patients showed that ROSE-010 was well tolerated and provided fast and effective relief of acute pain attacks on demand.  A greater percentage of patients were very satisfied with ROSE-010 compared to placebo and rated ROSE-010 significantly better than previously prescribed IBS medications.
For a copy of the publication (Hellström et al., Aliment Pharmacol Ther 29, 198-206) please click here
January 2008
Gastrotech signs licensing agreement with Eli Lilly and Company for compound to treat Irritable Bowel Syndrome
Gastrotech Pharma, a biopharmaceutical R&D company with a focus on the medical applications of gastrointestinal hormones, has signed an agreement with Eli Lilly and Company.
Read more