CSL Biotherapies Announces Start of U.S. H1N1 Vaccine Clinical Trials

Studies to Evaluate Potential Effectiveness of CSL's Experimental H1N1 Vaccine in Adults and Children

KING OF PRUSSIA, PA, USA | August 24, 2009 | CSL Biotherapies has announced the initiation of the company’s first U.S. clinical trials of its candidate Influenza A/H1N1 2009 vaccine. Study investigators will administer vaccinations to the first U.S. study volunteers today, August 24. The studies will determine the safety of CSL’s candidate vaccine and its ability to elicit an immune response (also referred to as immunogenicity) in adults and children. The pediatric study will evaluate CSL’s candidate vaccine in a thimerosal-free (i.e., preservative-free) formulation.

The clinical studies are sponsored by CSL Biotherapies and are being funded in whole or in part with Federal funds from the U.S. Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority. They will take place at 24 study sites throughout the country. It is anticipated that findings from these trials will be used to determine the most appropriate dosing schedule of the Influenza A/H1N1 2009 vaccine for use in the general population. This clinical trial program is part of a larger, global effort by CSL Biotherapies, in partnership with government and regulatory bodies, to bring an Influenza A/H1N1 2009 vaccine to market in the United States, in Australia and in select regions of the southern hemisphere.

“The H1N1 pandemic has had a significant toll on the health and well-being of people worldwide, which makes the development of an effective vaccine against the virus an urgent public health need,” said Kawsar Talaat, MD, principal investigator of the CSL vaccine adult trials and assistant scientist in the Johns Hopkins Bloomberg School’s Department of International Health. “Through these trials, we hope to identify the most effective dose and dosing regimen to protect the public against this highly infectious new strain of influenza virus.”

“Children are often at greater risk from influenza infection and its complications than adults, so it is extremely important to understand the efficacy of an H1N1 vaccine in this very vulnerable population,” said Pedro Piedra, MD, principal investigator for the vaccine pediatric trials and professor in the department of molecular virology and microbiology, and pediatrics at Baylor College of Medicine. “The clinical trials of CSL’s candidate vaccine will be the first to use a thimerosal-free formulation of the H1N1 vaccine antigen.”

About CSL’s H1N1 Clinical Trial Initiative

The goal of CSL’s H1N1 clinical trial program is to evaluate the safety and efficacy of the Influenza A/H1N1 2009 vaccine in adults and children (http://www.clinicaltrials.gov). Approximately 1,300 adults (aged 18 years and older) and 450 children (aged ≥ 3 months to < 9 years) are expected to be enrolled in the randomized, placebo-controlled U.S. studies. In the adult trials, three doses of the vaccine -- 7.5, 15 and 30 mcg – will be evaluated, administered as two vaccinations, three weeks apart.

In the pediatric trials, two doses – 7.5 and 15 mcg – will be evaluated, administered as two vaccinations, three weeks apart. The studies will also evaluate the incidence of adverse events up to six months after first injection. CSL’s Influenza A/H1N1 2009 vaccine is manufactured by a process identical to the one used in manufacturing CSL’s U.S. Food and Drug Administration-licensed trivalent seasonal influenza vaccine; only the single A/H1N1 flu strain differs between the two.

CSL Limited, the parent company of CSL Biotherapies, initiated Australian clinical trials of its Influenza A/H1N1 2009 vaccine candidate with a design and study objectives similar to its U.S. program. First administration in healthy adult volunteers began on July 22, 2009 and in healthy pediatric volunteers on August 3, 2009, making CSL the first vaccine manufacturer to initiate human studies of this vaccine. CSL expects to report interim post-dose 1 data from the adult trials in Australia by mid-September.

CSL Biotherapies recently signed an initial contract for $180 million to supply the U.S. Department of Health & Human Services with Novel influenza A (H1N1) antigen.

About Influenza and the Novel Influenza A/H1N1 Virus

Influenza (commonly referred to as the flu) is a serious illness that accounts for approximately 36,000 deaths annually in the U.S. While most healthy individuals recover from influenza within a few days to a week, some people, especially those with certain chronic illnesses, such as heart or lung disease, can develop complications. Seasonal influenza vaccination has been shown to reduce illness, hospitalization and death. The emergence of the novel H1N1 flu, which was first detected in humans in April 2009, has proven to be very contagious, spreading worldwide, and has led to the World Health Organization declaring a pandemic on June 11, 2009. The pandemic virus has caused more than a thousand deaths worldwide and created a significant burden on hospitals.

Vaccination against pandemic influenza is the most important step in bringing the pandemic under control and protecting those most at risk from infection. CSL Biotherapies is developing and producing candidate Influenza A/H1N1 2009 vaccine, drawing on four decades of experience with its proven vaccine production processes.

About CSL Biotherapies

CSL Biotherapies is the U.S. subsidiary of CSL Limited, one of the world’s largest influenza vaccine manufacturers. The U.S. headquarters of CSL Biotherapies are located in King of Prussia, Pa. Its parent company, CSL Limited, in Melbourne, Australia, operates one of the world's largest influenza vaccine facilities for global markets. CSL Biotherapies, which shares its U.S. headquarters with its sister company, CSL Behring, is commercializing influenza vaccine products globally. At CSL Biotherapies, delivering vaccines is our mission, protecting lives our passion. The CSL Group, which includes CSL Biotherapies, CSL Research & Development, CSL Bioplasma, and CSL Behring, has more than 10,000 employees and operates in 27 countries worldwide. For more information, visit us at www.cslbiotherapies-us.com, or call 1-888-435-8633.

SOURCE: CSL Biotherapies

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