INHX: Begins Ph I Trial of FV-100 to Treat Herpes Zoster (Shingles)

Wed. October 24, 2007; Posted: 12:54 PM

Inhibitex, Inc. (INHX) has begun enrollment in a Phase I clinical trial of FV-100, an orally bioavailable nucleoside analogue being developed to treat herpes zoster (shingles). The single ascending dose study is being conducted in the United States under an exploratory Investigational New Drug Application and will evaluate the safety and pharmacokinetics of three doses of FV-100 in 24 healthy volunteers.

Russell H. Plumb, president and CEO of Inhibitex said, "We anticipate that top line data from this trial will be available around year end."

Shingles is an infection caused by the varicella zoster virus (VZV), the same virus that causes chicken pox. The virus travels along the path of a nerve to the skin's surface, where it causes shingles. Shingles is generally characterized by skin lesions, blisters and rash, and in many cases, post-herpetic neuralgia, which is a painful and sometimes debilitating condition resulting from nerve damage. Shingles cannot be passed from one person to another. However, the virus that causes shingles can be spread from a person with active shingles to a person who has no immunity to the virus by direct contact with the rash, while in the blister phase. The person exposed would then develop chicken pox, not shingles. There are estimated to be in excess of 2.5 million cases of shingles worldwide each year. It is frequently misdiagnosed as other diseases with similar symptoms, including heart attacks and renal colic. Some patients may have these symptoms without developing the characteristic rash.

Treatment is generally with antiviral drugs such as GlaxoSmithKline's (GSK) Zovirax(R)(acyclovir), or prodrugs such as Novartis's (NVS) Famvir(R)(famciclovir), or GlaxoSmithKline's Valtrex(R) (valacyclovir). Maximum efficacy of antiviral drugs occurs if the treatment is commenced within 72 hours of appearance of definitive symptoms. Zostavax(R)(Zoster Vaccine Live) is a vaccine developed by Merck & Co. (MRK), which has proven successful in preventing half the cases of herpes zoster. Merck's Varivax(R)(Varicella Virus Vaccine Live) is indicated for vaccination against varicella in individuals 12 months of age and older.

Inhibitex is focused on products to treat or prevent serious infectious diseases. Clinical-stage programs include Aurexis(R), a humanized monoclonal antibody in Phase II for the adjunct treatment of serious staphylococcus aureus infections. Programs in pre-clinical development include compounds for HIV, hepatitis C and cytomegalovirus.

Staphylococcus aureus is the most common cause of staph infections. It can cause a range of illnesses from minor skin infections, such as pimples, impetigo, boils, cellulitis and abscesses, to life-threatening diseases, such as pneumonia, meningitis, endocarditis, Toxic shock syndrome (TSS), and septicemia. Each year some 500,000 patients in American hospitals contract a staphylococcal infection.

Cytomegalovirus is a common virus known as human herpesvirus. It requires close, intimate contact with a person excreting the virus in their saliva, urine, or other bodily fluids. It rarely becomes active for the first time or reactivates unless the immune system weakens and is no longer able to hold the virus in check. It can also be transmitted via breast milk, transplanted organs, and rarely from blood transfusions. Exposure can result in infectious mononucleosis, fever blisters, and genital herpes. Between 50% and 85% of people in the United States have had cytomegalovirus. These viruses all share the ability to remain alive, but dormant, in the body for life. It rarely becomes active for the first time or reactivates unless the immune system weakens and is no longer able to hold the virus in check.

In an action last week, the Supreme Court of New York vacated approximately $3.3 million out of a total of approximately $4.5 million that an arbitrator had awarded Nabi Pharmaceuticals (NABI) earlier this year. The arbitration related to amounts Nabi alleged were owed to it by the Company in connection with the Company's termination in early 2006 of a manufacturing and supply agreement. The Court confirmed the $1.2 million award of restitution and vacated the $3.3 million award of cancellation fees.

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