Oramed’s Oral Insulin Moving Through Clinical Trials

Oramed’s Oral Insulin Moving Through Clinical Trials

Oramed Pharmaceuticals Reports Positive Results from a Study of Oral

Insulin Capsule on Type 1 Diabetic Patients

JERUSALEM, Israel – July 21, 2009– Oramed Pharmaceuticals, Inc.

(OTCBB: ORMP.OB) (http://www.oramed.com), a developer of alternative

drug delivery systems, today reported positive results from a Phase 2A study

of its oral insulin capsule, ORMD-0801, on type 1 diabetic patients. The

completion of this study marks Oramed’s first clinical trial on patients with

Type 1 Diabetes Mellitus, whereas, all Oramed’s trials up to date have been

conducted on type 2 diabetic patients. This study evaluated safety, tolerability,

and food effects in type 1 diabetic patients.

Oramed’s oral insulin capsule, (ORMD-0801), was well tolerated by patients

and no serious adverse events were observed. The insulin absorption was not

affected when given before meal ingestion.

Oramed Chief Scientific Officer, Miriam Kidron, PhD., remarked, “These

results demonstrate that Oramed’s oral insulin capsule had a good safety

profile and was effective on patients with type 1 diabetes when taken prior to a

meal.”

Currently, Oramed is conducting its Phase 2B clinical trial in South Africa, in

which the company is evaluating the effects of ORMD-0801 on type 2 diabetic

patients.

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for

drugs and vaccines presently delivered via injection. Oramed is seeking to revolutionize the

treatment of diabetes through its patented flagship product, an orally ingestible insulin capsule

currently in phase 2 clinical trials. Established in 2006, Oramed’s technology is based on over

25 years of research by top research scientists at Jerusalem’s Hadassah Medical Center. The

Company’s corporate and R&D headquarters are based in Jerusalem.

For more information, please visit www.oramed.com

Forward-looking statements

Some of the statements contained in this press release are forward-looking statements which

involve known and unknown risks, uncertainties and other factors which may cause the actual

results, performance or achievements of the company, or industry results, to be materially

different from any future results, performance or achievements expressed or implied by such

forward looking statements, including the risks and uncertainties related to the progress,

timing, cost, and results of clinical trials and product development programs; difficulties or

delays in obtaining regulatory approval for our product candidates; competition from other

pharmaceutical or biotechnology companies; and the company’s ability to obtain additional

funding required to conduct its research, development and commercialization activities.

Please refer to the company’s filings with the Securities and Exchange Commission for a

comprehensive list of risk factors that could cause actual results, performance or

achievements of the company to differ materially from those expressed or implied in such

forward looking statements. The company undertakes no obligation to update or revise any

forward-looking statements.

In May 2010, the Company reported results for the recently completed Phase 2b non-FDA clinical trial of its flagship oral insulin capsule, ORMD-0801.

The randomized, double-blind, placebo-controlled, multi-centered study in South Africa evaluated responses of Type 2 diabetes patients to ORMD-0801. Insulin-loaded or placebo capsules were administered to patients, who were closely monitored throughout the 6-week study period. Safety, tolerability and efficacy parameters of Oramed’s oral insulin were assessed. The reported results substantiate the safety and tolerability of ORMD-0801 and demonstrate that oral insulin has a relevant clinical impact at the tested dose.

In August 2008, Oramed successfully completed Phase 2A clinical trials of its oral insulin capsule. This trial was the first to expose patients with type 2 diabetes to ORMD 0801 and its primary goals were to assess the safety, tolerability and pharmcodynamic effects in these patients. ORMD 0801 was well tolerated by all patients and had a good safety profile; no serious adverse events were encountered throughout the study. In two thirds of the subjects analyzed, statistically significant reductions in glucose as well as C-peptide were observed.

Oramed also conducted another Phase 2a study with Type 1 diabetic patients and positive results were reported in July of 2009. The oral insulin capsule was safe, tolerable, and was not vulnerable to food effects.

Phase 1B trials were completed in March 2008 and were intended to find the optimal dosage of ORMD 0801. These trials were conducted with healthy volunteers.

In August 2007, Phase 1A clinical trials were completed, the goal of which was to assess both the safety/tolerability and absorption properties of Oramed’s proprietary delivery technology. The trials examined changes in insulin, glucose and C-peptide plasma concentrations over time in healthy volunteers under several differing oral dosing scenarios.

Oramed, a Jerusalem, Israel firm has developed a tablet form of insulin in which the hormone’s protein structure is supposedly protected by special adjuvants from destruction by gastric juice. The firm just reported positive results from a Phase 2A clinical trial with Type I diabetics.

From the announcement:

The completion of this study marks Oramed’s first clinical trial on patients with Type 1 Diabetes Mellitus, whereas, all Oramed’s trials up to date have been conducted on type 2 diabetic patients. This study evaluated safety, tolerability, and food effects in type 1 diabetic patients.

Oramed’s oral insulin capsule, (ORMD-0801), was well tolerated by patients and no serious adverse events were observed. The insulin absorption was not affected when given before meal ingestion.

Currently, Oramed is conducting its Phase 2B clinical trial in South Africa, in which the company is evaluating the effects of ORMD-0801 on type 2 diabetic patients.

Source : http://www.oramed.com/index.php?page=14

Related Posts Plugin for WordPress, Blogger...
Be Sociable, Share!

About the Author

has written 1822 posts on this blog.

Copyright © 2017 Medical Technology & Gadgets Blog MedicalBuy.net. All rights reserved.
Proudly powered by WordPress. Developed by Deluxe Themes