Mickelson Announcement Prompts Expedited Filing Of Psoriasis Research Plan With FDA By Energex Systems, Inc.

A research plan that is designed to determine the degree of effectiveness of an experimental non-drug therapy known as ImmunoModulation for the treatment of psoriasis as a primary indication and psoriatic arthritis as a secondary indication, will be filed with the Federal Food and Drug Administration in an expedited manner.


In a letter that was delivered to the FDA today, medical technology developer Energex Systems, Inc. requested a Pre - Investigational Device Exemption (IDE) meeting to (i) review the safety and efficacy data that was submitted to the agency as a result of the company's ongoing research, (ii) discuss the hypothesis of the mechanism-of-action that it will rely on to support an IDE for the primary and secondary indication, and (iii) understand the agency's requirements for such an application. In its letter, the company pointed to the fact that the agency has previously awarded the company with (1) approval to conduct preliminary human research on HIV and (2) approvals for preliminary human research on Hepatitis C. "It was during our Hepatitis C research that our investigators observed a marked improvement in skin condition, physical discomfort and quality-of-life of those that also suffered from moderate to severe psoriasis," said Thomas R. Petrie, the Director of Engineering and Research at Energex.


Psoriasis is an autoimmune disorder that results in patches of thick, red skin covered in silvery scales, often on the elbows, knees and scalp, which can be itchy and excruciatingly painful. Psoriatic Arthritis is a disorder that causes the body's immune system to overreact and misfire against its own joints and tendons, causing inflammation and pain. In other words the body attacks its own cells. It often strikes between the ages of 30 and 55. At present there is no cure for either disorder.


"The effects of the therapy produced by our ImmunoModulator technology have a unique ability to stimulate an up and/or down immune response as needed. In our Hepatitis C and HIV research we witnessed consistent viral load reductions that were the result of a stimulated immune response. Conversely, in our animal research consisting of mice infected with H1N1 that typically succumb to inflamed lungs caused by an over reactive immune response, we witnessed a down regulation of the response and significantly less lung inflammation in the treated mice when compared to their sham-treated counterparts," continued Petrie.


"As a company that develops therapies and processes for unmet medical needs, we were saddened by Phil Mickelson's announcement that he has been diagnosed with psoriatic arthritis. I believe the attention that he has brought to this debilitating disease will be one of his greatest contributions to society. It is that attention that has caused us to expedite our research in an effort to provide a safer more effective treatment for those that suffer from it and other autoimmune disorders," said Thomas J. Fagan, CEO and President of Energex Systems.


Source:

Energex Systems, Inc.

Recommendations:


•   Buy ProSolution without Prescription
•   Buy Speman without Prescription