, Sept. 20
/PRNewswire/ -- Talecris Biotherapeutics GmbH announced yesterday the recipients of the 2010 European alpha1-antitrypsin Laurell's Training Awards (eALTA). The annual awards, sponsored by Talecris, provide two fellowships of 50,000 euros
to young investigators whose research aims to enhance the understanding and treatment of alpha1-antitrypsin deficiency (AAT deficiency). AAT deficiency is a rare, genetic condition in which low levels of the alpha-1 protein can result in emphysema and liver disease.
The 2010 recipients of eALTA are Sandra Pelz, postgraduate research fellow at the Martin-Luther-University in Halle-Wittenberg, Germany and Dr Adriana Ordonez, post-doctoral research fellow at the Cambridge Institute for Medical Research Wellcome Trust. Pelz and Ordonez were presented with the awards during the 2010 European Respiratory Society (ERS) Annual Congress in Barcelona at a Talecris-sponsored symposium. The symposium also featured research presentations by the 2009 eALTA award winners.
Pelz and Ordonez's research projects will both explore potential new therapies to treat AAT deficiency. Pelz's research project will use a mouse model to investigate the potential use of stem cell-derived liver cells, known as hepatocytes, to correct the genetic defect that gives rise to liver disease associated with AAT deficiency. Ordonez's project will study the mechanism by which small molecule inhibitors a specific class of drug can block the Alpha-1 protein from abnormally folding and accumulating in the endoplasmic reticulum of hepatocytes.
"Research initiatives such as eALTA not only increase our understanding of the disease, but they also help stimulate the interest and commitment of early career scientists and clinicians who represent the future of research and new treatments for the Alpha-1 community," said Claus Vogelmeier, Professor for Internal and Respiratory Medicine and Chair of the independent eALTA Review Team.
Talecris sponsors the awards program to gain new insights into the epidemiology, pathophysiology and clinical treatment of AAT deficiency and associated disorders. As the manufacturer of PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]), Talecris demonstrates its ongoing commitment to the Alpha-1 community through eALTA and other research programs. PROLASTIN®-C is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to deficiency of Alpha1-Proteinase Inhibitor. To date, Talecris has provided more than 650,000 euros through the eALTA program.
"Supporting the discovery of new insights into the mechanisms behind this life-threatening disease is important to Talecris," said Marion Wencker, Head of Medical and Clinical Affairs Europe, Talecris Europe, headquartered in Frankfurt, Germany. "We feel a strong responsibility to contribute to the knowledge base of alpha-1 and the potential new therapies that may improve treatment for patients worldwide. eALTA provides one avenue through which we accomplish this important goal."
The European Alpha-1 Antitrypsin Laurell's Training Award supports basic and clinical research through two annual grants provided to early career investigators. The program is named in honor of Dr Carl-Bertil Laurell, who first described Alpha-1 Antitrypsin Deficiency (AAT deficiency) in 1963. The primary goal of the eALTA program is to identify and support research projects that enhance the understanding of disease mechanisms of AAT deficiency, improve existing therapies, and identify potential new therapies. The eALTA program also promotes the entry of new clinicians and scientists into the field of AAT disorders and encourages collaborations among scientists in the field. For more information, go to http://www.eALTA.eu/.
PROLASTIN-C is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to deficiency of alpha1-proteinase inhibitor (AAT deficiency). 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. PROLASTIN-C will replace PROLASTIN in the US and Canada.
Important Safety Informationfor PROLASTIN-C and PROLASTIN
The effect of augmentation therapy with any alpha1-proteinase inhibitor (A1PI) on pulmonary exacerbations and on the progression of emphysema in AAT 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 observed at a rate of > or = 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
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, 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.
In Canada, please see PROLASTIN-C Product Monograph for complete prescribing details. To obtain a copy of this Monograph from Talecris, please call 1-866-482-5226.
About Alpha1-Antitrypsin Deficiency
Alpha1-antitrypsin deficiency, also known as AAT deficiency or Alpha-1, is an inherited disorder that causes significant reduction in the naturally occurring protein alpha1-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 obstructive pulmonary disease (COPD) causing disability and premature death. AAT deficiency is estimated to affect 200,000 people in North America and Europe.
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