Navigation Links
DiObex Presents Phase 2a Data of DIO-902 Demonstrating Trends of,Improved Glycemic Control and Significant Reductions of,LDL-Cholesterol and C-Reactive Protein

Top Line Data for the Treatment of Type 2 Diabetes Presented at the 67th Annual Scientific Sessions of American Diabetes Association

SAN FRANCISCO, June 25, 2007 /PRNewswire/ -- DiObex, Inc., a privately-held biopharmaceutical company focused on the development of therapeutics to treat metabolic diseases, today announced the presentation of top line data of its phase 2a study of DIO-902, a first-in-category Cortisol Synthesis Inhibitor for the treatment of type 2 diabetes.

Results of the two week placebo-controlled, dose-ranging study demonstrated that in patients treated with DIO-902 there was a trend toward improved glycemic control as measured by HbA1c, fructosamine and fasting blood glucose, as well as significant dose-dependent reductions in total and LDL- cholesterol. Mean levels of C-reactive protein (a marker of cardiovascular inflammation) were also significantly reduced in a dose-dependent fashion. Besides glycemic control, the additional benefits provided by DIO-902 may allow type 2 diabetes patients to manage their disease with fewer medications.

The data was presented at the 67th Annual Scientific Sessions of the American Diabetes Association (ADA) in Chicago, IL by Sherwin Schwartz, MD, lead investigator from the Diabetes and Glandular Disease Clinic of San Antonio, Texas. In his oral presentation, Dr. Schwartz detailed the results of the recently completed multi-center, randomized, placebo-controlled trial of DIO-902 in patients with type 2 diabetes.

"DIO-902 was well tolerated and we saw early signals of improvements in glycemic control," said Dr. Schwartz. "In addition, DIO-902 also showed early indications of potential to reduce the risk of heart disease through the significant reduction of LDL-cholesterol by as much as 46 percent at the highest dose studied. The prospect of a single therapeutic which has the potential to address multiple co-morbidities is very exciting."< /p>

DIO-902 is an oral, once-daily drug being developed for the treatment of type 2 diabetes. It is a single enantiomer of racemic ketoconazole which suppresses cortisol production by inhibiting the 11 beta hydroxylase enzyme, the terminal step in the adrenal synthesis of cortisol. This novel mechanism of action makes DIO-902 a first-in-category cortisol inhibitor.

"Our unique approach to inhibition of cortisol synthesis offers the potential to address one of the underlying causes of type 2 diabetes, as well as multiple co-morbidities associated with both the disease, and its precursor, metabolic syndrome," said David A. Cory, Chief Executive Officer of DiObex, Inc. "DIO-902 offers patients the promise of effectively managing glycemia and lipids with a single medication. We are excited about the preliminary data generated to date and are rapidly progressing DIO-902 to the next stage of clinical development."

Data from various preclinical, epidemiological and clinical studies have suggested that a link exists between high cortisol levels and visceral adiposity, insulin resistance, and hyperglycemia -- common elements of the metabolic syndrome and type 2 diabetes.

The two-week trial with DIO-902 enrolled 37 patients with type 2 diabetes who were randomized to placebo, three different doses of DIO-902 ( 200 mg, 400 mg and 600 mg) or ketoconazole. Patients were either drug naove or on metformin, and had lipid-lowering agents washed out for at least 21 days prior to the first dose of the study drug. No serious adverse effects related to the study drug were reported. Liver function tests were carefully monitored, and no clinically meaningful changes were observed in any of the treated subjects. In fact, a number of subjects enrolled with mild transaminase elevations normalized during the two week treatment.

DiObex will conduct a multi-center, 16-week, phase 2b dose-ranging study with DIO-902; this study is scheduled to start enrolling patien ts in three countries in mid-2007.

About DiObex

DiObex, Inc. is a San Francisco-based biopharmaceutical company founded to develop novel products for the treatment of metabolic diseases. DiObex has two products preparing to enter Phase 2b clinical development. DIO-901 is a formulation of Very Low Dose Glucagon (VLD Glucagon) for reducing or preventing insulin induced hypoglycemia. DIO-901 has received Fast Track status from the Food and Drug Administration. DIO-902 is a single enantiomer of ketoconazole and is a novel cortisol synthesis inhibitor. Abnormalities in cortisol activity may play an important role in the development of metabolic syndrome, a constellation of conditions that place people at high risk for type-2 diabetes and cardiovascular disease. For more information, visit www.diobex.com.

CONTACT: John Cummings, of Burns McClellan on behalf of DiObex, Inc.,+1-415-352-6262, jcummings@burnsmc.com

Web site: http://www.diobex.com/

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Inspiration Biopharmaceuticals Presents Data From Hemophilia Program at International Society On Thrombosis and Haemostasis (ISTH) Annual Meeting
2. European Society for Medical Oncology (ESMO) Presents Data from the Clinical Trial of MediGenes Cancer-Killing Virus in Press Conference
3. Cytogen Presents Phase 1 Data Showing Promising Antitumor Activity and Safety Profile of Quadramet at International Myeloma Workshop
4. SemBioSys Presents Positive Insulin Data at the American Diabetes Association Conference
5. Tranzyme Pharma Presents Initial Phase IIa Data for its Novel Ghrelin Agonist, TZP-101, in Patients with Diabetic Gastroparesis
6. Novagali Pharma Presents at AACO the Results of its Pivotal Phase III Clinical Trial of Vekacia in Children Suffering From Vernal Keratoconjunctivitis
7. BioLife Solutions Presents Data on CryoStor at International Society for Cellular Therapy Annual Meeting
8. Genaera Presents Preclinical Data on Trodusquemine (MSI-1436) for the Treatment of Obesity at the American Diabetes Association 67th Scientific Session
9. Elixir Pharmaceuticals Presents Preclinical Data Highlighting Its Ghrelin Antagonist Program at the American Diabetes Associations Annual Meeting
10. BioCryst Presents Phase I Peramivir Data at the Options for the Control of Influenza Conference
11. Solstice Neurosciences Presents Escalating Dose Study at International Congress in Istanbul, Turkey
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/28/2017)... March 28, 2017  Medeon Biodesign, Inc., a ... is pleased to announce that the Company led ... Panther Orthopedics, Inc., a San Jose, ... solutions for orthopedic extremity applications.  ... rapidly, primarily due to procedure volume growth, lifestyle ...
(Date:3/28/2017)... , Va. and PHOENIX , March 28, ... Avella Specialty Pharmacy released a new white ... allergies and the use of latex in healthcare. Specifically, there ... in healthcare. In fact, the FDA has urged manufacturers to ... latex" claim from labels, because of the challenge to ensure ...
(Date:3/28/2017)... Kingdom and  BOSTON , March 28, 2017 ... Linguamatics today announced a partnership with premium ... agreement allows pharmaceutical companies to extract key insights ... text mining technology. The Linguamatics ... the top 20 global pharmaceutical companies. The Linguamatics-Dow ...
Breaking Medicine Technology:
(Date:3/28/2017)... ... March 28, 2017 , ... ... advancing the science and clinical practice of radiosurgery, announced today the publication ... multi-institutional, observational registry established to standardize data collection from patients treated with ...
(Date:3/28/2017)... , ... March 28, 2017 , ... ... today that the University of Pittsburgh Medical Center (UPMC) will acquire QuikClot® Bleeding ... Pennsylvania. , The program, developed in association with efforts by the American College ...
(Date:3/28/2017)... ... , ... The Radiology Business Management Association (RBMA) is pleased to ... executive director. Mr. Still was selected through a careful months-long search by the RBMA ... known to our members, has been a part of building the RBMA since 1992,” ...
(Date:3/28/2017)... , ... March 28, 2017 , ... ... Wethersfield, Conn., has relocated its corporate headquarters to a new, more expansive office ... , In October 2016, Qualidigm purchased a distressed office building in Wethersfield, Conn. ...
(Date:3/28/2017)... ... March 28, 2017 , ... METTLER ... ions found in power plant water and steam. , Chlorides and sulfates cause ... boilers, leading to extensive maintenance and unplanned shutdowns. Monitoring these ions at low ...
Breaking Medicine News(10 mins):