TLCR, Talecris Biotherapeutics Holdings Corp.
TLCR a biopharmaceutical company, engages in the production and marketing of plasma-derived protein therapies worldwide.
TLCR develops, produces, markets, and distributes therapies for people suffering from chronic and acute conditions, such as chronic inflammatory demyelinating polyneuropathy, primary immune deficiencies, alpha-1 antitrypsin deficiency, bleeding disorders, infectious diseases, and severe trauma.
Primary immunodeficiency diseases are intrinsically or genetically-occurring defects of the immune system, and comprise a diverse group of illnesses. Among the subcategories of PI are a group of disorders in which antibody production is reduced or absent.
Increased susceptibility to infection is common to all of the PI disorders. More than 250,000 people in the United States are diagnosed with primary immunodeficiency (NASDAQ:PI) diseases, and many more go undetected.
** The U.S. Food and Drug Administration (FDA) approved Gamunex®-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI).
The newly approved Gamunex-C provides both the intravenous route of administration and a new subcutaneous route of administration. The intravenous delivery mode is approved to treat PI, chronic inflammatory demyelinating polyneuropathy (CIDP), and idiopathic thrombocytopenic purpura (ITP). The subcutaneous mode is approved to treat only PI.
The difference between Gamunex and Gamunex-C is the labeling and packaging information. Gamunex-C labeling describes both the intravenous and subcutaneous routes of administration, whereas Gamunex labeling describes only intravenous administration. Subcutaneous administration delivers the product under the skin into the subcutaneous tissue and intravenous administration is delivered through a vein.
Through its FDA approval, Gamunex-C becomes the first and only immunoglobulin therapy approved in the U.S. with both intravenous and subcutaneous routes of administration to treat PI. In clinical studies of Gamunex-C, the most common adverse reactions associated with subcutaneous administration were infusion site reactions, headache, fatigue, arthralgia and pyrexia.
More about TLCR at www.talecris.com
PROT, Proteonomix, Inc., PROT.OB
PROT is a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives.
Proteoderm, Inc. a wholly owned subsidiary of PROT that has recently opened its retail web site, Proteoderm.com, and begun accepting pre-orders for its anti-aging line of skin care products.
PROT subsidiary StromaCel, Inc.’s goal is the development therapeutic modalities for the treatment of Cardiovascular Disease (NYSE:CVD). StromaCel, Inc. is pursuing the licensing of other technologies for therapeutic use.
National Stem Cell, Inc. is PROT’s operating subsidiary. The Sperm Bank of New York, Inc. is a fully operational tissue bank.
Proteonomix Regenerative Translational Medicine Institute, Inc. (”PRTMI”) intends to focus on the translation of promising research in stem cell biology and cellular therapy to clinical applications of regenerative medicine.
PROT intends to create and dedicate a subsidiary to each of its technologies.
** PROT has filed a utility patent application for the Preparation and Use of Stromal Cells for Treatment of Cardiac Diseases.
This is another step in the development of PROT’s intellectual property and getting StromaCel into the commercial market.
The technology covered by the patent application will reduce the cost to the patient of this type of treatment and when trials are completed and regulatory approvals are obtained PROT believes that the stromal cell technology will have major importance in the treatment of cardiac damage caused by heart attacks.
Without going into proprietary details, Mr. Cohen, President of PROT noted that the application relates to cell line expansion that he believes represents a fundamental improvement in the efficiency of producing stem cells which should have applications far beyond the cardiac therapy to which the present application relates.
More about PROT at www.proteonomix.com
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