ATLANTA, April 28 /PRNewswire-FirstCall/ -- Inhibitex, Inc. today announced several operational and strategic developments related to its Veronate(R) program for the prevention of hospital-associated infections in premature, very low birth weight infants.
The company provided an update on the progress of its review of the Veronate(R) program. The review is focusing on whether the results of the recently completed Veronate Phase III trial were a consequence of one or more factors, including the potency and consistency of the clinical trial material, the immune status of very low birth weight infants, the change in the dosing schedule and the utility of donor-selected polyclonal anti-MSCRAMM(R) antibodies on staphylococcal organisms. Inhibitex is currently conducting various analyses of its preclinical and clinical data, as well as analyzing the various lots of clinical trial material used in the Phase II and Phase III trials. In addition, the company has assembled an independent panel of experts in the fields of neonatology, immunology and infectious diseases to review the Veronate program in its entirety. The panel is scheduled to convene in May and the company anticipates communicating its assessment of the ongoing analyses and the panel's findings near the end of June.
"The results of the Veronate Phase III trial demonstrated that staphylococci-related late-onset sepsis in premature neonates represents a significant unmet medical need," stated William D. Johnston, president and chief executive officer of Inhibitex, Inc. "We continue to believe in the potential for our MSCRAMM protein platform to play a role in preventing and treating staphylococcal infections, and may seek a collaborator to assess this potential in very low birth weight infants. However, regardless of what we ultimately determine was the cause of the Phase III results, at this time we do not foresee performing additional clinical trials in very low birth weight infants with our current donor-selected immune globulin form of Veronate."
The company also announced that it will halt the manufacture of the clinical trial material it has used in the clinical development of Veronate to-date. As a result, the company has terminated its contract manufacturing relationship with Nabi Biopharmaceuticals and has suspended future collections of all plasma used to manufacture the current donor-selected immune globulin form of Veronate.
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company focused on the discovery, development and commercialization of antibody-based products for the prevention and treatment of serious, life-threatening infections. All of the company's drug development programs are based on its proprietary MSCRAMM protein platform. MSCRAMM proteins are located on the surface of pathogenic organisms, and are responsible for the initiation and spread of infections. The company's most advanced clinical development programs are Veronate and Aurexis(R), for which the company has retained all worldwide rights. The company's preclinical programs include a collaboration and joint development agreement with Dyax to develop fully human monoclonal antibodies against MSCRAMM proteins on enterococci and a partnership with Wyeth to develop staphylococcal vaccines. For additional information about the company, please visit www.inhibitex.com.
Inhibitex(R), MSCRAMM(R), Veronate(R), and Aurexis(R) are registered trademarks of Inhibitex, Inc.
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 statements regarding: the company's intent to convene a panel of experts in May, communicate its assessment of its ongoing analyses and the panel's findings in June, halt the manufacture of the current donor-selected immune globulin form of Veronate, and seek a collaborator to assess the potential of the company's MSCRAMM protein platform in addressing staphylococci-related infections in premature neonates; the potential for the company's MSCRAMM protein platform to address staphylococcal infections; and the likelihood of the company repeating a similar clinical trial in premature neonates with the same clinical trial material or pursuing the development of an alternate form of Veronate are forward-looking statements. These plans, intentions, expectations or estimates may not actually be achieved and various important factors could cause actual results or events to differ materially from the forward-looking statements that the company makes, including the outcome of the company's ongoing analyses of the Phase III Veronate trial results and the ability of its expert panel to perform a meaningful assessment of the Veronate program on a timely basis, the company's ability to attract a collaborator or collaborators under acceptable terms and conditions, if at all; the viability of the MSCRAMM platform and other risks and cautionary statements contained elsewhere herein and in risk factors described in or referred to in greater detail in the "Risk Factors" section of the company's Annual Report on Form 10-K for the year ended December 31, 2005 as filed with the Securities and Exchange Commission, or SEC, on March 13, 2006. 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.
Russell H. Plumb Laura Perry (Investors)
Chief Financial Officer Stern Investor Relations, Inc.
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