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FermaVir Announces FDA Response to Its Pre-IND Submission for Initial Bioavailability Studies in Human Clinical Trials of FV-100; Response Enables Company to Plan Clinical Development Program for Novel Antiviral Drug Candidate

Posted on: Monday, 5 June 2006, 09:02 CDT

FermaVir Pharmaceuticals, Inc., (OTCBB:FMVR), committed to the development of breakthrough antiviral drugs and other therapies, announced today that the U.S. Food and Drug Administration (FDA) has responded to its pre-Investigational New Drug (IND) application for FV-100, a pro-drug of CF-1743 to address the potentially serious and debilitating viral condition known as shingles. The FDA response will enable FermaVir to proceed with clinical development of FV-100 for the treatment of shingles.

Dosing with FV-100 increases bioavailability of CF-1743, 8 to 10 fold in an animal model compared to dosing with CF-1743 itself. Due to this finding, development of FV-100 as opposed to CF-1743 may have significant benefits in both amount of drug necessary for both therapeutic dosing and manufacturing. Previously, the FDA commented on FermaVir's pre-IND application for CF-1743 in a letter that also included a series of recommendations for the company's drug development program. These FDA recommendations were reconfirmed in the latest response.

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.

"We are extremely pleased with the FDA's response to our Investigational New Drug application for preclinical and clinical studies related to our novel antiviral compound," said Dr. Geoffrey Henson, CEO of FermaVir. "The guidelines provided will enable us to launch a fast development track for this compound, which we believe has the potential to become a critically needed new antiviral therapy for the treatment of 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.

"It is encouraging that the Agency's pre-IND letter effectively reinforces FermaVir's planned clinical strategy and anticipated timelines, including bioavailability and safety studies in human clinical trials that we expect to initiate within the second half of this year," said Dr. Henson.

Among FermaVir's other lead drug candidates is a powerful antiviral compound to treat Cytomegalovirus, another potentially debilitating condition in the herpes family.

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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