Navigation Links
Tranzyme Pharma Presents Initial Phase IIa Data for its Novel,Ghrelin Agonist, TZP-101, in Patients with Diabetic Gastroparesis

RESEARCH TRIANGLE PARK, N.C. & SHERBROOKE, Quebec--(BUSINESS WIRE)--Jun 26, 2007 - Tranzyme Pharma, a leading biopharmaceutical company developing small molecule drugs for the treatment of gastrointestinal and metabolic diseases, today announced positive results for its novel ghrelin agonist, TZP-101, in accelerating gastric emptying in diabetic patients with gastroparesis. The data from a pilot Phase IIa study were presented at the American Diabetes Association's 67th Scientific Sessions in Chicago, IL by Dr. Gordana Kosutic, Tranzyme's VP of Clinical and Regulatory Affairs. Tranzyme is developing TZP-101 as a first-in-class gastroprokinetic agent for the treatment of severe gastroparesis and post-operative ileus (POI).

Using scintigraphy and a standardized meal, this double blind, randomized, four-way crossover study assessed the efficacy of three different dose levels of TZP-101 on gastric emptying in patients with long standing Type 1 diabetes and severe gastroparesis. The data showed that TZP-101 significantly accelerated gastric emptying at all doses tested, whereas placebo had no effect. These results suggest that TZP-101 is a promising agent for the management of gastroparesis and that further investigation is warranted.

"These data are very encouraging and I am looking forward to continuing with the clinical investigation of TZP-101 in patients with severe diabetic gastroparesis, as ghrelin is one of the most attractive targets for the therapeutic management of this serious medical condition," said Dr. Niels Ejskjaer, principal investigator from the Aarhus University Hospital, Denmark.

Gastroparesis is a disorder characterized by delayed emptying of food from the stomach. It exists in mild to moderate (chronic) and severe (acute) forms and is a common disorder among diabetics, and others with impaired gastric autonomic nerve function. In severe cases, patients may require hospitalizat ion to treat pain, nausea, vomiting, and even malnutrition. Gastroparesis represents a significant unmet medical need as Propulsid(TM) (cisapride), the most widely used product for treating this disorder was removed from the U.S. market in 2000 due to significant cardiovascular adverse effects.

Tranzyme earlier reported that TZP-101 demonstrated excellent tolerability and safety, as well as a desirable pharmacokinetic profile in healthy subjects in two Phase I clinical studies. The Company plans to initiate full Phase II development of TZP-101 for both POI and severe gastroparesis in 3Q 2007. In addition to the ongoing clinical testing of TZP-101 (an intravenous drug), Tranzyme is developing a new oral ghrelin agonist, TZP-102. Tranzyme expects to initiate Phase I clinical testing of TZP-102 in the first quarter of 2008 for the treatment of mild to moderate chronic gastroparesis.

"The Company is making great progress in the development of TZP-101," said Dr. Vipin Garg, President & CEO of Tranzyme Pharma. "Tranzyme's novel ghrelin agonists (TZP-101 and TZP-102) are promising breakthrough drugs with huge commercial potential. Most prokinetic agents under development and on the market act on predominantly central nervous system receptor targets that are also found in the GI tract. Many show potentially serious CNS side effects. Our small molecule ghrelin agonists target a receptor that is more directly involved with regulating gastrointestinal motility."

About Gastroparesis

Gastroparesis results from dysfunction of the nerves of the stomach, leading to postprandial fullness, bloating, early satiety, nausea and vomiting. The three most common etiologies of gastroparesis are diabetes (an estimated 30% of gastroparesis patients), unknown etiology (36%), and post-surgical causes (13%). The prevalence rate of gastroparesis is especially high among diabetic patients, as up to 50% of diabetics worldwide are reported to suffer from gastroparesis . Gastroparesis has serious implications in diabetic patients, where failure to tolerate food and oral medications may lead rapidly to metabolic instability and the need for immediate treatment or hospitalization. Alternative therapeutic approaches, applicable in limited cases, include surgery, botulinum toxin injections (to reduce pyloric tone) and electrical stimulation of the gut.

Tranzyme Pharma discovers and develops breakthrough small molecule drugs for diseases where there is a high unmet medical need. Tranzyme has developed a pipeline of novel drugs for the treatment of gastrointestinal and metabolic diseases. Tranzyme's proprietary chemistry technology and discovery capabilities provide competitive advantages in developing drugs being sought by pharmaceutical companies. For more information, please visit: www.tranzyme.com.

Contact

Tranzyme Pharma
Vipin K. Garg, Ph.D., President & CEO, 919-313-4764
vgarg@tranzyme.com
or
Mark L. Peterson, Ph.D.
VP, Operations & Intellectual Property
819-820-6845
mpeterson@tranzyme.com
or
Gordana Kosutic, M.D.
VP, Clinical & Regulatory Affairs
919-313-4765
gkosutic@tranzyme.com


'"/>




Related medicine technology :

1. Sygnis Pharma AG announces date for presentation of clinical results
2. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
3. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
4. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
5. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
6. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
7. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
8. EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
9. Array BioPharma to Present at the C.E Unterbeg, Towbin Emerging Growth Conference
10. AM-Pharma Announces Positive Results of Phase IIa Clinical Trial with Alkaline Phosphatase For Ulcerative Colitis
11. TransPharma Medical Announces Positive Results of Phase I Clinical Trials for Transdermal Delivery of hPTH (1-34) for Osteoporosis Treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... IRVING, Texas , Oct. 11, 2017  Caris ... science focused on fulfilling the promise of precision medicine, ... Institute has joined Caris, Precision Oncology Alliance™ (POA) as ... leading cancer centers, the St. Jude Crosson Cancer Institute ... to advance the use of tumor profiling, making cancer ...
(Date:10/7/2017)... , Oct. 6, 2017   Provista, a ... than $100 billion in purchasing power, today announced a ... information. The Newsroom is the online home ... trends, infographics, expert bios, news releases, slideshows and events. ... to a wealth of resources at their fingertips, viewers ...
(Date:10/2/2017)... Mich. , Oct. 2, 2017 Diplomat ... 8th Day Software and Consulting, LLC , and ... 8th Day Software, based in Tennessee ... LLC. 8th Day expands EnvoyHealth,s service offerings for health ... development. "In an ...
Breaking Medicine Technology:
(Date:10/13/2017)... SAN LUIS OBISPO, Calif. (PRWEB) , ... October 13, 2017 , ... ... with Alzheimer’s or dementia. However, many long-term care insurance companies have a waiver for ... mean is the 90-day elimination period, when the family pays for care, is often ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented ... the lowdown on sciatica in a new episode of "Success Files," which is ... events and innovation and investigates each subject in-depth with passion and integrity. , ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... are now treating sleep apnea using cutting-edge Oventus O2Vent technology. As ... serious sleep disorder characterized by frequent cessation in breathing. Oral appliances can offer ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... a leader in post-acute health care, have expanded their existing home health joint ... Health. , AccentCare has been operating a joint venture home health company with ...
(Date:10/12/2017)... ... 12, 2017 , ... On Saturday, October 21, the Health & Wellness Center ... to raise money for the American Heart Association Heart Walk. Teams of up to ... together to keep their treadmills moving for 5 hours. Treadmills will start at 7:00 ...
Breaking Medicine News(10 mins):