These are the Phase II results per the 8k filed on 3/3/2006, just a month ago
. They completely conflict with the phase III results, so they are going to get some outside experts on it. They are also going to completely compare the two phases' results and look for inconsistencies. Granted if this drug has no effect as the Phase III trial indicates, this stock is doomed. If the company can show that the Phase III results were inaccurate back to 7.00 we go and beyond IMHO.
Inhibitex (MM) Inhibitex Presents Data From Aurexis Phase II Trial at ICAAC
-Represents Novel Antibody Approach for Treating Serious Staph Infections-
WASHINGTON, Dec. 16 /PRNewswire-FirstCall/ -- Inhibitex, Inc. (NASDAQ:INHX) today presented results from a Phase II clinical trial evaluating Aurexis as a first-line therapy, in combination with standard of care antibiotics, for serious, life-threatening Staphylococcus aureus ("staph") bloodstream infections at the 45th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, DC. This study was primarily a test of safety and pharmacokinetics, but also represents an initial step in assessing the potential of Aurexis to improve cure rates over current standard of care therapy.
Dr. J. John Weems, Professor of Medicine, Department of Medicine, Medical University of South Carolina, a lead investigator in the study, presented results from the 60-patient Phase II trial. Patients with both hospital- associated and community-acquired staph bloodstream infections were included in the trial. Positive trends were observed in the composite primary endpoint of mortality, relapse rate and infection-related complications, and a number of secondary endpoints, including the progression in the severity of sepsis and days in the intensive care unit. Based on these findings, Inhibitex plans to initiate additional clinical studies in this indication in 2006.
"More than 60,000 cases of staph bloodstream infection occur annually in the United States," Dr. Weems reported to the conference attendees. "Associated mortality and relapse rates remain unacceptably high, and metastatic complications affect approximately one-third of these patients. Increasing antibiotic resistance to staph emphasizes the need for alternative approaches to current therapy."
Serious infections caused by staph represent a growing problem at hospitals, particularly as bacterial resistance to existing antibiotics increases. One-half of the patients in the Inhibitex study had infections caused by staph that were resistant to the most commonly used antibiotics. In addition to the challenges these infections pose to hospitals, staph infections that are serious and often resistant to antibiotics are now appearing in the community at an increasing rate. In fact, in the Inhibitex study, approximately 30% of the patients had infections that originated in the community, not in the hospital.
"Unfortunately, it is becoming evident that the development of new antibiotics is not improving outcomes or keeping pace with the increasing rates of antibiotic resistance among bacteria," said Dr. William Johnston, CEO of Inhibitex. "Our strategy at Inhibitex is to develop novel antibody-based drugs that augment current antibiotics, resulting in significantly improved therapeutic outcomes."
About Aurexis Phase II Trial
The Phase II trial was a randomized, placebo-controlled, double-blind study of 60 patients with documented staph bloodstream infections. Patients were randomized to one of two arms; standard of care antibiotic therapy plus placebo, or standard of care antibiotic therapy plus Aurexis (single administration at 20mg/kg). Nearly 60% of the patients already had serious complications from their staph infection at the time of diagnosis. Four patients in the group that received antibiotics alone met the primary composite endpoint, compared with two in the group that also received Aurexis. The other primary objectives of the study were pharmacokinetics (PK) and safety. The PK profile indicated that the plasma levels of Aurexis were lower in infected patients than those observed in healthy subjects in an earlier Phase I trial. Comparison of adverse events and laboratory values between the groups demonstrated that Aurexis was generally safe and well tolerated in this patient population. Among the secondary endpoints, progression in severity of sepsis was observed in four patients in the group that received antibiotics alone and none in the group that also received Aurexis. Total hospital days were similar for both groups of patients; however of those patients admitted to the ICU, the median duration of stay in the ICU was seven days for patients who received antibiotics alone compared to three days for patients who also received Aurexis. The median duration of mechanical ventilation use was eight days for those receiving Aurexis compared to four days for patients receiving antibiotics alone. The trial was not powered to show statistically significant differences in the primary endpoint between the cohorts. The study was conducted at 12 leading infectious disease hospitals within the United States.