FermaVir Announces New Preclinical Oral Bioavailability Data for FV-100, Its Clinical Candidate for Shingles; Data Confirms Excellent Oral Bioavailability of the ProDrug in Another Preclinical Model
Posted on: Monday, 19 June 2006, 09:00 CDT
FermaVir Pharmaceuticals, Inc., (OTCBB:FMVR), announced today that new preclinical studies show that when its prodrug FV-100 is dosed orally, exceptional concentrations of active compound can be measured in the blood. These experiments showed that at the highest level of dosing required by the Food and Drug Administration in preclinical studies, levels of the active compound exceeded 50,000 (fifty-five thousand) times the EC50 for antiviral activity against varicella zoster, the causative virus for Shingles. The EC50 is a measure of the amount of a compound which inhibits 50% of the virus in vitro. Significantly, concentrations of the active compound remained well over 100 times the EC50 for over seventy-two hours after dosing. FV-100 is a novel antiviral drug candidate to address the potentially serious and debilitating viral condition known as shingles.
"We are extremely pleased with the latest data for FV-100. Not only does this data confirm our previous oral bioavailability data in another model but it also shows that single doses at the highest levels required by the FDA guidelines show no overt toxicity." said Dr. Geoffrey Henson, CEO of FermaVir. "The data also suggests that we might be able to achieve once a day dosing. This would be very helpful when compared to the currently approved drugs for shingles on the market today which require three to five doses per day."
The Company has initiated preclinical studies with its proprietary antiviral compound, currently known by its laboratory designation, FV-100, to be followed by clinical studies, as part of a long-term strategic plan for ultimate drug approval and commercialization. Research data suggests that the compound is believed to be 10,000 times more potent than currently approved drug treatments for shingles.
FV-100 is among a portfolio of FermaVir's proprietary medical technologies and clinical candidates planned for development to treat a family of viral diseases related to herpes. Among FermaVir's other lead drug candidates are powerful antiviral compounds to treat Cytomegalovirus, another potentially debilitating condition.
About FermaVir Pharmaceuticals, Inc.
FermaVir Pharmaceuticals, Inc. is an emerging biotechnology company positioned for rapid growth by developing important antiviral drugs and other treatments in underserved segments of the pharmaceutical development marketplace. The Company's Intellectual Property portfolio includes a number of patent applications and a worldwide exclusive license for potential new drug treatments of infectious diseases. Among FermaVir's lead drug candidates is a breakthrough antiviral treatment that has demonstrated powerful inhibitory activity and may have potential therapeutic benefit for the treatment of shingles, also known as herpes zoster. FermaVir's proprietary compound is believed to be 10,000 times more potent than currently approved shingles drug treatments. FermaVir is also developing a compound that could provide the first improved effective treatment in years for Cytomegalovirus (CMV) infection, a currently incurable viral disease from the herpes family that can threaten eyesight as well as cause severe morbidity and mortality.
Forward-Looking Statements
Certain statements made in this press release are forward looking. Such statements are indicated by words such as "expect,""might,""should,""anticipate" and similar words indicating uncertainty in facts and figures. Although FermaVir believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations reflected in such forward-looking statements will prove to be correct. As discussed in the Form SB-2 of FermaVir dated March 8, 2006,, actual results could differ materially from those projected in the forward-looking statements as a result of the following factors, among others: uncertainties associated with product development, the risk that FermaVir will not obtain approval to market its products, the risk that FermaVir technology will not gain market acceptance, the risks associated with dependence upon key personnel, and the need for additional financing.
Source: Business Wire
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