RESEARCH TRIANGLE PARK, N.C., Dec. 9, 2010 /PRNewswire-FirstCall/ -- Talecris Biotherapeutics, Inc. (Nasdaq: TLCR) announced today the initiation of a clinical trial evaluating the safety and the pharmacokinetic profile of two doses of PROLASTIN®-C (Alpha(1)-Proteinase Inhibitor [Human]) (A1PI), a therapy indicated for chronic augmentation and maintenance in adults with emphysema due to alpha(1)-antitrypsin (AAT) deficiency. AAT deficiency is a rare, genetic disorder in which low levels of the alpha(1) protein circulating in the lungs can increase an individual's risk of developing emphysema.
This study will investigate the safety and pharmacokinetic profile of a higher dose, 120 mg/kg weekly, of PROLASTIN-C versus the licensed dose of 60 mg/kg weekly. Subjects in the study will be randomized to receive either the 120 mg/kg dose or the 60 mg/kg dose for 8 weeks. Subjects will then cross over to the alternate dose for an additional 8 weeks. The study will be conducted at five sites across the United States. Further information regarding this ongoing study can be found on ClinicalTrials.gov (study identifier NCT01213043).
"As part of our ongoing commitment to the Alpha-1 community, Talecris is exploring the possible use of higher doses of PROLASTIN-C in patients with emphysema due to AAT deficiency," said Kim Hanna, Vice President of Clinical Development at Talecris. "Data from this study may set the foundation for future research to further evaluate higher doses."
PROLASTIN-C is indicated for chronic augmentation and maintenance in adults with emphysema due to deficiency of alpha(1)-proteinase inhibitor (alpha1-antitrypsin deficiency). AAT deficiency is a genetic condition in which low levels of the alpha1 protein can result in emphysema. The active protein in PROLASTIN-C increases or "augments" protein levels in AAT deficient patients. In the U.S. and Canada, PROLASTIN-C has replaced PROLASTIN, the leading augmentation therapy in North America for more than 20 years.
Important Safety Information for PROLASTIN-C
The effect of augmentation therapy with any alpha(1)-proteinase inhibitor on pulmonary exacerbations and on the progression of emphysema in alpha(1)-antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials.
PROLASTIN-C may contain trace amounts of IgA. Patients with known antibodies to IgA, which can be present in patients with selective or severe IgA deficiency, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. PROLASTIN-C is contraindicated in patients with antibodies against IgA.
The most common drug related adverse reactions during clinical trials in greater than or equal to 1% of subjects were chills, malaise, headache, rash, hot flush, and pruritus. The most serious adverse reaction observed during the clinical studies with PROLASTIN-C was an abdominal and extremity rash in one subject.
PROLASTIN-C is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
In the US, for additional information on PROLASTIN-C, please see full prescribing information at www.PROLASTIN.com. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
About Alpha(1)-Antitrypsin Deficiency
Alpha(1)-antitrypsin deficiency, also known as AAT deficiency or Alpha-1, is an inherited disorder that causes significant reduction in the naturally occurring protein alpha(1)-proteinase inhibitor. It is most common in the Caucasian population of northern Europe and North America. AAT deficiency is also the most common cause of genetic liver disease in children, and genetic emphysema (shortness of breath) in adults. Individuals suffering from AAT deficiency often develop severe chronic obstructive pulmonary disease (COPD) causing disability and premature death. AAT deficiency is estimated to affect 200,000 people in North America and Europe combined, although greater than 90% remain undiagnosed.
About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
Talecris Biotherapeutics (Nasdaq: TLCR) is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology, neurology and hemostasis. (www.talecris.com)
Cautionary statement regarding forward-looking statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, quotations from management in this press release, statements regarding strategic and operation plans, and statements regarding the development or commercialization of therapies. Forward-looking statements are based on current beliefs and expectations and are subject to inherent risks and uncertainties. You are cautioned not to place undue reliance on forward-looking statements. Although Talecris believes that the forward-looking statements contained in this press release are reasonable, there is no assurance that expectations will be fulfilled.
The following factors, among others, could cause actual results to differ materially from those expressed or implied in forward-looking statements: possible U.S. legislation or regulatory action affecting, among other things, the U.S. healthcare system, pharmaceutical pricing and reimbursement, including Medicaid and Medicare; our ability to procure adequate quantities of plasma and other materials which are acceptable for use in our manufacturing processes from our own plasma collection centers or from third-party vendors; our ability to maintain compliance with government regulations and licenses, including those related to plasma collection, production and marketing; our ability to identify growth opportunities for existing products and our ability to identify and develop new product candidates through our research and development activities; and the timing of, and our ability to, obtain and/or maintain regulatory approvals for new product candidates, the rate and degree of market acceptance, and the clinical utility of our products. Additional information about factors that could affect the business and financial results of Talecris is contained in its final Prospectus filed pursuant to Rule 424(b)(1) with the Securities and Exchange Commission on October 1, 2009. Talecris undertakes no duty to update any forward-looking statement.
SOURCE Talecris Biotherapeutics, Inc.