Navigation Links
Phosphagenics Initiates its Phase 2 Clinical Trial in Type 1 Diabetes
Date:3/19/2008

MELBOURNE, Australia, March 19 /PRNewswire-FirstCall/ -- Phosphagenics Limited (ASX: POH, AIM: PSG, OTCQX: PPGNY) today announced that it has received ethics approval to commence treating patients with Type 1 diabetes in a Phase 2 clinical trial using its patented transdermal insulin delivery system, TPM/Insulin. The lead clinical investigators of the trial will be Dr. Michael D' Emden, Department of Endocrinology, Royal Brisbane and Women's Hospital, and William Hsu, who is an Assistant Investigator in the Section on Clinical Research at the Joslin Diabetes Centre and an Assistant Professor of Medicine at Harvard Medical School, Boston, MA.

Ethics approval was granted on the basis of data generated from previous trials and the first arm of the Phase 2 trial, which involves the treatment of patients with Type 2 diabetes. Phosphagenics had to demonstrate safety and the effective delivery of insulin into the bloodstream of patients with Type 2 diabetes prior to receiving ethics approval to commence a trial for patients with Type 1 diabetes.

The Phase 2 trial in Type 1 patients is due to commence next month and will be conducted at QPharm in Queensland, Australia. QPharm is a well- established clinical facility and uniquely placed to conduct this type of diabetes trial. The trial is a randomized, single-blinded trial which aims to assess the efficacy of TPM/Insulin. The results of this trial will be used to assist in obtaining an IND from the FDA. This will enable Phosphagenics to commence the next phase of its clinical development program for TPM/Insulin at the Joslin Diabetes Centre. It is anticipated that the U.S. portion of the study will start this year.

"We have gathered the appropriate positive data to progress our Phase 2 study to the treatment of patients with Type 1 diabetes, which is the ideal patient population to prove the efficacy of our TPM/Insulin," said Dr. Esra Ogru, Executive Vice President of Research and Development at Phosphagenics. "The Australian clinical trials conducted to date have demonstrated that our TPM/Insulin formulation can safely penetrate through human skin and deliver insulin into the blood stream over a sustained period of time without any adverse events."

"We will continue to gather additional data and treat Type 2 patients at The Royal Adelaide Hospital under the guidance and supervision of Dr. Sepehr Shakib, Director, Department of Clinical Pharmacology, Royal Adelaide Hospital," continued Dr. Ogru.

About Phosphagenics Limited

Phosphagenics is a Melbourne-based, globally driven biotechnology company focused on the discovery of new and cost effective ways to enhance the bioavailability, activity, safety and delivery of proven pharmaceutical and nutraceutical products.

Phosphagenics' core technology is built around the science and application of phosphorylation, a process where the addition of a phosphate group has been found to enhance the bioavailability, activity and safety of existing pharmaceuticals and nutraceuticals, as well as to assist in the production of drug delivery platforms.

Phosphagenics' shares are listed on the Australian Stock Exchange (POH) and the London Stock Exchange's Alternative Investment Market (PSG). An ADR - Level 1 program was established in the U.S. with The Bank of New York Mellon (PPGNY) for U.S. investors to trade in Phosphagenics' stock on the 'over-the- counter' market. In July 2007, this was upgraded to the International OTCQX, a new premium market tier in the U.S. for international exchange-listed companies, operated by Pink Sheets, LLC.

For more information, please visit Phosphagenics' web site at http://www.phosphagenics.com

Safe Harbor Statement

This press release contains forward-looking statements based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialise, actual results could vary materially from the Phosphagenics' expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations.


'/>"/>
SOURCE Phosphagenics Limited
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
2. Phosphagenics to Commence Phase 2 TPM/Insulin Clinical Trial
3. Phosphagenics to Conduct a Phase 1 Transdermal Oxycodone Clinical Trial
4. Nestle Nutrition and Phosphagenics to Commence Phospha E(R) Phase 2 Clinical Trial
5. Update on Progression of Phosphagenics and Nestle Nutritions Phospha E(R) Trial
6. Phosphagenics Initiates U.S. Clinical Trials for Its Topical Retinoic Acid
7. Carrington Subsidiary DelSite Initiates Critical Toxicology Studies of Its Nasal Powder Bird Flu Vaccine
8. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
9. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
10. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
11. MedImmune Initiates Phase 2a Multi-Dose Study in Patients with Asthma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... F ast access to ... at the point of need   ... and services, has launched a ClinicalKey mobile app that enables ... Elsevier designed the mobile app to allow users to select access to ... Android and iOS formats for mobile phone and tablet. ...
(Date:2/11/2016)... , Feb. 11, 2016 Scientists ... cell-isolation method that opens the door to genetic ... now have been impossible to isolate with 100 ... isolate specific tumor types in various stages of ... variants of these cells that are clinically relevant, ...
(Date:2/11/2016)... , Feb. 11, 2016  NanoViricides, Inc. ... it has entered into an agreement with the ... nanoviricides® drug candidates in standard animal models of ... , Research Director. Dr. Romanowski has extensive experience ... --> Eric Romanowski , Research ...
Breaking Medicine Technology:
(Date:2/11/2016)... ... February 11, 2016 , ... From March ... Academy of Dermatology Annual Meeting at the Walter E. Washington Convention Center in ... for both the condition of hyperhidrosis (excessive sweating) and its treatment options. Specifically, ...
(Date:2/11/2016)... ... February 11, 2016 , ... Husted Kicking has completed its Third ... February 6th & 7th, 2016 according to kicking coach Michael Husted. , “This event ... the NFL’s combine in Indianapolis,” says Husted. “The NFL uses a third party organization ...
(Date:2/11/2016)... ... February 11, 2016 , ... The book, “Computers Should ... services, what questions to ask your IT consultant before signing a contract and how ... computer network. , “With companies relying heavily on e-mail and technology, it’s more important ...
(Date:2/11/2016)... ... February 11, 2016 , ... As part of their 2015 end of ... Round Table Foundation (MDRTF), has gifted $10,000 to University of Chicago to support ovarian ... Billy Cundiff. , “We are honored to support a promising young investigator from Dr. ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... as the World Molecular Imaging Congress (WMIC), will be held in New York ... meeting is “Imaging Biology…Improving Therapy.” The congress will highlight and emphasize how imaging ...
Breaking Medicine News(10 mins):