RESEARCH TRIANGLE PARK, N.C., Nov. 15, 2010 /PRNewswire-FirstCall/ -- Talecris Biotherapeutics (Nasdaq: TLCR) announced today the publication of combined data from two studies demonstrating that augmentation therapy with Alpha(1)-Proteinase Inhibitor (Human) (A1PI) significantly reduces lung tissue loss in patients with emphysema related to Alpha(1)-antitrypsin (AAT) deficiency. Results of the studies, published as an integrated analysis of the raw data from two similar pilot trials, were published in the journal Respiratory Research. (http://respiratory-research.com/content/11/1/136)
AAT deficiency is a rare, genetic disease in which low levels of the AAT protein circulating in the lungs can increase an individual's risk of developing emphysema. Treatment with A1PI therapy augments or increases the levels of this protein in the lungs.
Two randomized, double-blind, placebo-controlled clinical trials investigated the effect of A1PI therapy on emphysema progression using change in lung density as a measure. Lung density is a validated and specific measure of tissue loss in emphysema that relates well to physiological and clinical features of the disease.
Although the two studies used different intravenous dosing regimens, they were comparable in treatment duration, patient characteristics and the use of computed tomography (CT) to study lung density. The similar characteristics of the studies allowed the pooling of the individual patient data, which increased the robustness of the analysis. An analysis of the data from both studies was conducted by Professor Robert A. Stockley, Birmingham, UK, and Professor Asger Dirksen, Hellerup, Denmark.
The results of the integrated analysis demonstrated a mean change in lung density from baseline to the final CT scan of -4.082 g/L for the AAT treatment group and -6.379g/L for the placebo group, a statistically significant difference of 2.297 (95% CI, 0.669 to 3.926; p = 0.006).
"The mean data from the integrated analysis demonstrate a deceleration of lung tissue loss with AAT augmentation therapy versus placebo with statistical significance," said Stockley.
The effect of augmentation therapy with any Alpha(1)-proteinase inhibitor (A1PI) on pulmonary exacerbations and on the progression of emphysema in Alpha(1)-antitrypsin deficiency has not been demonstrated in a single, prospective, randomized, controlled clinical trial.
The two clinical trials included in the integrated analysis were a three-year Danish-Dutch study of 56 patients (http://ajrccm.atsjournals.org/cgi/content/full/160/5/1468) and the EXAcerbations and CT scan as Lung Endpoints (EXACTLE) trial of 77 patients over 24 to 30 months (http://erj.ersjournals.com/content/33/6/1345.full). In both trials, patients were randomized to receive infusions of A1PI or a placebo. The results suggested a trend toward reduction in emphysema progression with A1PI therapy, as measured by CT densitometry. The trials were not powered to show efficacy; thus neither trial reached statistical significance on its own. Pooling the data increased the number of patients and the statistical power of the analysis.
Talecris Biotherapeutics, manufacturer of PROLASTIN®-C (Alpha(1)-Proteinase Inhibitor [Human]), funded the integrated analysis and the EXACTLE trial included in the analysis.
PROLASTIN-C is indicated for chronic augmentation and maintenance therapy in Alpha(1)-antitrypsin (AAT) deficiency in patients with emphysema. AAT deficiency is a genetic condition in which low levels of the alpha-1 protein can result in emphysema. The active protein in PROLASTIN-C increases or "augments" protein levels in AAT deficient patients. In the U.S., PROLASTIN-C has replaced PROLASTIN, the leading augmentation therapy in North America for more than 20 years.
Important Safety Information for PROLASTIN-C and PROLASTIN
The effect of augmentation therapy with any Alpha(1)-proteinase inhibitor (A1PI) 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 and PROLASTIN 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 observed at a rate of greater than or equal to 1% in subjects receiving PROLASTIN-C were chills, malaise, headache, rash, hot flush, and pruritus. The most serious adverse reaction observed during clinical studies with PROLASTIN-C was a rash on the abdomen and extremities in 1 subject. In clinical studies with PROLASTIN, reactions were observed in 1.16% of infusions, the most common being fever, lightheadedness and dizziness.
Both PROLASTIN-C and PROLASTIN are 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. There is also the possibility that unknown infectious agents may be present in such products.
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.
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