Inhibitex Presents Encouraging Phase I Data on FV-100 At 21st International Conference on Antiviral ResearchATLANTA--(BUSINESS WIRE)--April 15, 2008 - Inhibitex, Inc. (Nasdaq: INHX), a biopharmaceutical company focused on the development of products to treat and prevent serious infectious diseases, announced that it is presenting data from a Phase I clinical study of FV-100, a highly potent antiviral compound in development for the treatment of shingles, at this week's 21st International Conference on Antiviral Research (ICAR) held April 13-17, 2008, in Montreal, Quebec. Pharmacokinetic and safety data from the study, which was conducted in the United States under an exploratory Investigational New Drug Application (IND), will be presented at a session later today and in an oral session tomorrow.
"We are very encouraged by the pharmacokinetic and safety data from our initial single ascending dose study of FV-100 in healthy volunteers," stated Dr. Joseph M. Patti, Chief Scientific Officer of Inhibitex. "The pharmacokinetic data suggest that FV-100, which is a prodrug, is rapidly converted to the active compound CF-1743 and we were able to observe levels of CF-1743 well above the EC50 for twelve hours at low doses of FV-100. Additionally, FV-100 appeared to be generally well tolerated, and there were no drug-related serious adverse events observed in the trial. Our near-term development goals for FV-100 are to advance it into an additional Phase I clinical trial under a regular IND in the first half of this year and initiate a Phase II clinical trial by year end."
Published in vitro studies have demonstrated that FV-100 is more potent against and can fully inhibit the replication of varicella zoster virus (VZV), the virus that causes shingles, substantially faster than other antiviral therapeutics currently used to treat shingles. The Company believes these characteristics provide the potential for FV-100 to be dosed once daily and reduce shingles-related symptoms, including the incidence and severity of post herpetic neuralgia (PHN), as compared to currently available antiviral medicines.
Shingles, also known as herpes zoster, is an infection caused by the reactivation of VZV, the same virus that causes chicken pox. Worldwide, it is estimated that there are in excess of 2.5 million cases of shingles each year. Shingles is generally characterized by skin lesions, rash, acute pain, and in many cases, PHN, a painful and sometimes debilitating condition that can last for several months or more. While shingles can develop in individuals of any age, it occurs most frequently in the elderly.
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company focused on the development of products that can treat or prevent serious infections. In addition to FV-100, the Company's anti-viral pipeline includes a series of HIV integrase inhibitors and HCV polymerase inhibitors in preclinical development, and compounds active against cytomegalovirus (CMV). Inhibitex has also licensed certain of its biologic-based technologies to Wyeth for the development of staphylococcal vaccines and 3M for the development of diagnostics. For additional information about the Company, please visit www.inhibitex.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts included in this press release, including those related to the potential for FV-100 to be dosed once daily and reduce shingles-related symptoms, including the incidence or severity of PHN and the Company's goal to advance FV-100 into an additional Phase I clinical trial in the first half of the year and initiate a Phase II clinical trial by year end, are forward-looking statements. These intentions, expectations, or potential may not be achieved in the future and various important factors could cause actual results or events to differ materially from the forward-looking statements that the Company makes, including the risk that: the pharmacokinetic or safety results of future preclinical and clinical studies of FV-100 do not confirm prior findings and support its further development; the Company does not obtain regulatory approval to advance the development of FV-100; FV-100 does not prove to be efficacious in reducing shingles-related symptoms in patients in future clinical trials; and other cautionary statements contained elsewhere herein and in its Annual Report on Form 10-K for the year ended December 31, 2007, as filed with the Securities and Exchange Commission, or SEC, on March 14, 2008. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release.
There may be events in the future that the Company is unable to predict accurately, or over which it has no control. The Company's business, financial condition, results of operations and prospects may change. The Company may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the Federal securities laws to update and disclose material developments related to previously disclosed information. The Company qualifies all of the information contained in this press release, and particularly its forward-looking statements, by these cautionary statements.
Inhibitex(R) is a registered trademark of Inhibitex, Inc.
Russell H. Plumb, 678-746-1136
Chief Executive Officer
Posted: April 2008