Overview / Executive Summary

Overview / Executive Summary

Product Overview

The small molecule is capable of exceptional dermal and pulmonary localization by topical application and inhalation, and safely exerts localized antiproliferative, antiviral, and anti-inflammatory activity by high-affinity binding to the peptidyl transferase site on ribosomes and inhibiting translation of RNA (RNAi) into proteins. This results in localized protein synthesis inhibition (PSI), also termed localized protein synthesis restriction (PSR).

Product Attributes

Antiproliferative: The antiproliferative attributes of the drug were well characterized in human clinical trials against cancer. The drug is not well suited for intravenous administration because of its blood insolubility and rapid, non specific, cellular internalization, however it is exceptionally well suited for topical and inhalable administration for exactly the same reasons. The drug is a G1 and G2 phase cytostatic. Apoptosis can be induced, if desired, by prolonged administration (for several days or more).

Antiviral: The antiviral activity of the drug was demonstrated, ex vivo, in virally infected human cells. Viruses require use of host ribosomes to translate viral RNA into viral proteins and accordingly this type of RNAi also inhibits translation of viral RNA into viral proteins. The data demonstrated full spectrum viral protein synthesis inhibition and inhibition of virus progeny DNA synthesis as a secondary effect of RNAi / PSI.

Anti-Inflammatory: The anti-inflammatory activity of RNAi / PSI was demonstrated in vivo in mouse models. Inflammation is a hyperactive protein synthesis driven event. RNAi / PSI inhibits synthesis of inflammatory proteins.

Localization: Human skin studies showed > 97 % dermal retention by topical application. Any drug entering the blood is readily metabolized by the liver.

Exceptional Safety: The therapeutic dermal and pulmonary doses are hundreds of times smaller than the systemic human No Observable Effect Level (NOEL) dose by intravenous infusion.

Markets Targeted / Market Advantages

We are targeting dermal and pulmonary indications where localization and/or dual action activity would be therapeutically desirable. Localization provides systemic safety by delivering the drug only where it is needed. Dual action provides a better treatment option.

Intellectual Property Summary - Issued US Patents

U.S. Pat. 6,342,520 - Cancer Treatment Method (Inhalable and Interstitial)
U.S. Pat. 6,346,251 - Psoriasis Treatment Method (Topical)
U.S. Pat. 6,355,251 - Epidermal Exfoliation Method (Topical)
U.S. Pat. 6,559,178 - Apoptotic Chemosurgery (Interstitial)
U.S. Pat. 7,012,091 - Pulmonary Anti-Inflammatory (Inhalable)
U.S. Pat. 7,015,244 - COPD Treatment Method (Inhalable)

Several other patent applications are currently pending

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DISCLAIMER AND IMPORTANT NOTICE: The Compositions and Methods presented on this website are all in preclinical stages. They are based only on our understanding of the proposed underlying mechanisms of action and on any available coincidental corroborative empirical evidence, any of which may in fact turn out not to be correct, or may be prevented from functioning as envisioned because of other factors or mechanisms of action not contemplated or considered, or may even cause harm because of factors or mechanisms of action not anticipated. The process of obtaining FDA approvals has not been started in any of the areas disclosed on this website. The disclosures here are purely for scientific information exchange purposes, representing one scientific point of view, and are not intended to suggest, or be used for, any proposed medical treatments.