Inhibitex Provides Update on Its Staph Vaccine, FV-100 and INX-189 Development Programs
- Category: Vaccines
- Published on Monday, 11 January 2010 02:00
- Hits: 1628
Pfizer has initiated patient recruitment for 408-patient, randomized, double-blind Phase I clinical trial to evaluate the safety, tolerability, and immunogenicity of three ascending dose levels of a 3-antigen Staphylococcus aureus (S. aureus) vaccine (SA3Ag) in healthy adults
ATLANTA, GA, USA | January 11, 2010 | Inhibitex, Inc. (Nasdaq: INHX) today announced that its collaborator, Pfizer, Inc., has initiated patient recruitment for 408-patient, randomized, double-blind Phase I clinical trial to evaluate the safety, tolerability, and immunogenicity of three ascending dose levels of a 3-antigen Staphylococcus aureus (S. aureus) vaccine (SA3Ag) in healthy adults. The SA3Ag vaccine contains an antigen originating from the Company’s MSCRAMM® protein platform. The Company licensed its MSCRAMM® protein platform to Wyeth (acquired by Pfizer in 2009) on an exclusive worldwide basis for the development of active vaccines against staphylococcus in 2001. Pfizer is responsible for all clinical development, manufacturing and marketing of the vaccine. Inhibitex is eligible to receive a payment upon the achievement of this and future regulatory milestones, as well as royalties on future net sales.
In addition to announcing the initiation of this Phase I vaccine study, the Company also provided an update on the status of FV-100, a highly potent oral antiviral compound in Phase II clinical development for the treatment of herpes zoster (shingles), and INX-189, a nucleotide polymerase inhibitor in late preclinical development for the treatment for chronic infections caused by hepatitis C virus (HCV).
The independent Data Safety Monitoring Board (DSMB) responsible for reviewing data from the Company’s ongoing Phase II clinical trial of FV-100 met, as scheduled, in early December after the Company had provided it with complete 30-day follow-up data on the first quartile of patients enrolled in the trial. Based upon its review, the DSMB unanimously recommended that the trial should continue, as originally designed, without modification. The Company anticipates that an interim analysis of the complete 30-day follow-up data on the first half (50%) of patients enrolled in the trial will be completed in the first quarter of 2010. Further, the Company anticipates completing enrollment in and having top-line data available from this trial in the second half of 2010.
The Phase II trial is a well-controlled, double-blind study comparing two arms of FV-100 to an active control (valacyclovir). The Company plans to enroll and randomize approximately 350 patients, aged 50 years and older, equally to one of three treatment arms: 200 mg FV-100 administered once daily; 400 mg FV-100 administered once daily; and 1,000 mg valacyclovir administered three times per day. In addition to further evaluating its safety, the objectives of the trial are to evaluate the potential therapeutic benefit of FV-100 in reducing the severity and duration of shingles-related pain, the incidence of post herpetic neuralgia (PHN), and the time to lesion healing.
The Company has completed the requisite Good Laboratory Practices (GLP) preclinical studies to support the filing of an investigational new drug application (IND) for INX-189. Based on the results of these studies, the Company continues to anticipate filing an IND and, subject to FDA review, initiating a Phase I clinical trial of INX-189 in the first half of 2010.
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company focused on developing products to treat serious infectious diseases. The Company’s pipeline includes FV-100 for the treatment of shingles and INX-189, a nucleotide polymerase inhibitor, for the treatment of chronic hepatitis C infections. The Company has additional HCV nucleotide polymerase inhibitors in preclinical development, and has also licensed the use of its proprietary MSCRAMM® protein technology to Pfizer for the development of staphylococcal vaccines.
SOURCE: Inhibitex, Inc.