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Patient Enrollment Complete for StaphVax Phase 3 Trial
ROCKVILLE, Md., Aug. 17 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals today announced the completion of two of its three major milestones in 2004 for the development of its lead program StaphVAX® [Staphylococcus aureus Polysaccharide Conjugate Vaccine]. The vaccine is being developed to prevent S. aureus infections in patients put at risk due to hospitalization or treatment in alternate healthcare settings, such as dialysis centers. The company's Phase III efficacy trial designed to confirm that StaphVAX can prevent S. aureus infections in end-stage renal (kidney) disease (ESRD) patients has been fully enrolled. ESRD patients are at a particularly high risk for infection. The data from the clinical trial is required for the submission of the U.S. Biological License Application (BLA) planned for 2005.
The company also announced the successful manufacture of three consistency lots of StaphVAX ahead of schedule. The data from manufacturing the vaccine at commercial scale is required for the StaphVAX Marketing Authorization Application (MAA) that will be submitted for the European Union (EU) by the end of 2004. This first application will be for the use of StaphVAX to prevent these infections in ESRD patients.
"We are proud of our success in completing these major efforts," stated Thomas H. McLain, chairman, chief executive officer and president of Nabi Biopharmaceuticals. Mr. McLain continued, "The significant progress that we have achieved is a direct result of the spirit and the drive of the entire Nabi Biopharmaceuticals team. These important achievements leave us in a strong position to complete our third major milestone, to file our first license application for StaphVAX by the end of this year."
By completing the enrollment of 3,600 patients in less than one year, the company remains on track to have data from the trial available by the third quarter of 2005. That timing will allow analysis of the results to be completed to support the filing of the BLA in 2005. The company also remains on track to file a supplemental MAA for the use of StaphVAX in broader at-risk patient groups in the EU by the end of 2005.
Patients with ESRD are at high-risk of developing S. aureus bacteremia and are among the most difficult patients to treat because they are immune- compromised due to their debilitating, underlying disease and because dialysis access provides an opportunity for bacteria to be introduced into their bloodstream. In addition, when these infections do develop, they are associated with substantial morbidity most often requiring hospitalization, often intensive care stay and in approximately 25% of the cases resulting in death. Other people at risk for those infections include surgery patients, cancer patients, and nursing home patients.
"Enrollment of 3,600 patients in less than a year is a tremendous accomplishment by anyone's standards," stated Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical, medical and regulatory affairs of Nabi Biopharmaceuticals. Dr. Rasmussen continued, "In part, this reflects the tremendous interest that the medical community has in advancing StaphVAX as a potential new weapon in the arsenal against Staph infections. It is also an affirmation of the talented team of dedicated professionals we have developed in our clinical and regulatory groups."
In addition to the Phase III confirmatory trial that is underway, enrollment is also successfully advancing in the first of a series of immunogenicity studies in other patient groups at risk for infection. The first of these trials is in cardiothoracic surgery patients being treated at leading centers in the U.S. The study is designed to evaluate safety and antibody levels over a six-month period and to provide evidence that broader, at-risk patient groups can achieve antibody levels equal to or greater than the levels proven to be protective in immune-compromised ESRD patients. The company plans to include data from this study in the BLA and MAA supplement to be filed in 2005.
Today, the company also announced the completion of three consistency lots of StaphVAX that were produced at commercial scale by the company's manufacturing partner, Cambrex. These lots are now in finished vials and were completed well ahead of the original production schedule. Since signing of the manufacturing agreement only 10 months ago, teams from Nabi Biopharmaceuticals and Cambrex have worked closely together to meet this objective. Numerous project steps were successfully completed including transfer of the manufacturing process to Cambrex, scaling the manufacturing process up to commercial quantities, training Cambrex employees on how to manufacture StaphVAX, transferring the testing methodologies, validating the manufacturing process and ultimately completing the manufacture and vialing of StaphVAX.
The early completion of these lots of vaccine allows the necessary time for completion of the chemistry, manufacturing and controls sections of the Common Technical Document (CTD). The CTD is the format Nabi Biopharmaceuticals is using to submit the MAA. It is composed of several modules, including details of the manufacturing process of StaphVAX that will be filed later this year. The company's manufacturing focus is now on characterizing the vaccine using laboratory tests.
"The successful manufacture of the StaphVAX consistency lots at Cambrex is a clear example of the valuable partnership between Nabi Biopharmaceuticals and Cambrex. By combining our strengths and capabilities, we accelerated the transfer of the manufacturing process," stated Raafat E.F. Fahim, Ph.D., senior vice president, research, technical and production operations of Nabi Biopharmaceuticals. He continued, "This achievement also affirms the capabilities and the knowledge of the team we have built within our vaccine research, development and manufacturing groups. Those same strengths will also be key in the successful construction of a vaccine plant within our manufacturing facility in Florida. That project remains on schedule and we plan to initiate the production of lots of StaphVAX in that facility during the first half of 2005."
About Staphylococcus aureus Infections
S. aureus is the most common cause of serious hospital-acquired bloodstream infections. Staphylococcal infections are difficult to treat because the bacteria that cause them are highly virulent and, in many cases, resistant to currently available antibiotics. This rise of antibiotic resistance has markedly curtailed options for treating S. aureus infections. According to the current estimates by the U.S. Centers for Disease Control and Prevention (CDC), more than two million patients in the U.S. each year contract an infection as a result of exposure to a pathogen while receiving care in a hospital. S. aureus can spread from the blood (bacteremia), to the bones (osteomyelitis), or the inner lining of the heart and its valves (endocarditis), or cause abscesses in internal organs such as the lungs, liver and kidneys. People most at-risk for these infections are surgical patients, trauma or burn victims, newborns whose immune systems are not yet developed, and patients with chronic illnesses such as diabetes, cancer, or lung or kidney diseases. People whose immune systems are suppressed due to disease, chemotherapy, or radiation therapy are generally more susceptible to these bacterial infections.
StaphVAX (Staphylococcus aureus Polysaccharide Conjugate Vaccine) is an investigational vaccine designed to prevent S. aureus infections in at-risk patients. This novel application of Nabi Biopharmaceuticals' vaccine technology stimulates the patient's immune system to build antibodies to the most common forms of S. aureus infections without the development of resistance. StaphVAX is currently in a confirmatory Phase III clinical trial. This double-blinded, placebo-controlled and randomized trial will be conducted in end-stage renal disease patients undergoing hemodialysis. The 3,600 patient study is designed to demonstrate statistical significance with a clinical reduction of 50% or more in types 5 and 8 S. aureus infections. Nabi intends to file for licensure of StaphVAX in the EU before the end of 2004. In the U.S., the company plans to file a Biologics License Application with the U.S. Food and Drug Administration by the end of 2005.
Source: Nabi Biopharmaceuticals