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Re: Cassius Longinus post# 234963

Saturday, 07/21/2018 8:03:56 AM

Saturday, July 21, 2018 8:03:56 AM

Post# of 403039
Prurisol as a potential oral treatment for ulcerative colitis, etc.

The Interleukin-20 Cytokines in Intestinal Diseases

Autoimmune/inflammatory intestinal diseases, such as Crohn’s disease and ulcerative colitis, infectious gastrointestinal diseases, and gastrointestinal cancers, such as colorectal cancer, are worldwide a significant health problem....


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6015891/

EXPANDED ACCESS AND COMPASSIONATE USE
Innovation Pharmaceuticals is dedicated to discovering and advancing innovative medical therapies with dermatology, oncology, anti-inflammatory and antibiotic applications.

At this stage in our drug development program, we are evaluating the safety and efficacy profiles of three first-in-class drug candidates—Prurisol, Kevetrin and Brilacidin—to inform our understanding of their full therapeutic potential. Such work is being conducted in preparation for potential submission to the Food and Drug Administration (FDA) for drug approval, pending continued successful outcomes.

To learn more about our clinical trials, including possible opportunities to participate in ongoing or upcoming studies, visit ClinicalTrials.gov—a government-run database listing private and publicly-funded clinical studies conducted around the world.

As part of drug development, the FDA allows for potential Expanded Access / Compassionate Use of an Investigational New Drug before any regulatory approval might be achieved. This opportunity applies only to patients with serious or life-threatening conditions who are unable to participate in a clinical trial and have exhausted alternative treatment avenues.

For FDA regulations on Expanded Access / Compassionate Use, please visit the FDA website.

Patients and physicians should refer to the following information before contacting us about potential Expanded Access / Compassionate Use opportunities.



Innovation Pharmaceuticals places patient safety first—whether for an Investigational, Expanded or Approved use of our drug treatments.

We will only consider Expanded Access/Compassionate Use if the following criteria are met:

A sufficient safety profile of an investigational drug has been determined;
if the Expanded Access / Compassionate Use will not interfere with or compromise clinical trials that could be used to support an FDA application for approval of the treatment;
and when there is an adequate supply of drug treatment for the necessary clinical trials before supplying drug treatment for Expanded Access / Compassionate Use patients.
If you are a potential patient and your physician believes you may be a candidate for an Expanded Access / Compassionate Use of one of our drugs—having already prepared the necessary documentation for submission—please ask your physician to contact us at expandedaccess@ipharminc.com. Innovation Pharmaceuticals will review and respond to Expanded Access / Compassionate Use requests within 10 days of receipt.



Research of a human xenograft animal model of psoriasis conducted by Cellceutix on KM-133 (Prurisol) measuring it against methotrexate, a commonly used drug today in the treatment of psoriasis, showed a faster reduction of lesion appearance (84% versus 63%), a greater reduction in serum PRINS (96 versus 48%) and a significant reduction in serum IL-20 (87% versus 46%) in models treated with KM-133 (Prurisol) as compared to methotrexate. More importantly, psoriasis lesions showed no reoccurrence in models treated with KM-133 throughout the 180-day study whereas psoriasis lesions reappeared in those treated with methotrexate in 61 days.



http://www.ipharminc.com/press-release/2016/11/17/cellceutix-to-pursue-505b2-clinical-process-for-psoriasis-drug?rq=IL-20

Good luck and GOD bless,

George

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