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Feb. 8, 2010, 8:30 a.m. EST ? Recommend ? Post:
Researchers Report Elevated Levels of TB4 Levels Predict Patient Survival in Hepatitis B Virus-related Liver Failure
TB4 -- Potential New Therapeutic Agent for Liver Failure
BETHESDA, Md., Feb 08, 2010 (BUSINESS WIRE) -- REGENERX BIOPHARMACEUTICALS, INC. /quotes/comstock/14*!rgn/quotes/nls/rgn (RGN 0.59, +0.06, +10.38%) announced today that researchers have correlated TB4 levels with the clinical course of patients with hepatitis B virus-related liver failure. It was reported that serum thymosin B4 levels were significantly lower in patients with chronic hepatitis B infection and that the magnitude of the reduction of thymosin B4 was closely related to the severity of the hepatic injury and to patient death. Since patients with higher TB4 levels survived the disease, changes in TB4 values could reflect outcome in some liver failure patients.
Moreover, liver failure is a systemic inflammatory reaction, causing severe deterioration in liver function, according to the research team. Liver failure occurs when the extent of hepatocyte (liver cells) death exceeds the liver's regenerating capacity and recent findings have shown that TB4 regulates certain molecules that play a role in preventing hepatic cell death and promoting hepatic regeneration. Liver regeneration is considered to be suppressed in liver failure. "The study demonstrated that the thymosin B4 level was significantly lowered in liver failure patients, suggesting that thymosin B4 might become a new therapeutic agent for liver failure caused by chronic HBV infection," concluded the research team.
"This study is particularly important as it confirms and extends, in humans, data published (Annals. N.Y. Acad. Sci. 2007:1112:154-160) by Dr. Marcos Rojkind and his colleagues at The George Washington University Medical Center showing that TB4 up-regulates certain molecules known to play key roles in stimulating liver regeneration. It also strongly suggests that observing low levels of circulating TB4 in the blood may be a useful early warning signal to identify HBV patients, and perhaps patients with HCV infection, cirrhosis of the liver or other liver diseases, who are heading into liver failure," stated Dr. Allan L. Goldstein, Professor of Biochemistry and Molecular Biology, The George Washington University School of Medicine, and chief scientific advisor to RegeneRx.
The research team was led by Tao Han, MD, Ph.D., professor, Department of Hepatology, Tianjin Institute of Hepatobiliary Disease, Tianjin Medical University, Tianjin, China. The paper was published in the World Journal of Gastroenterology, February 7, 2010; Volume 16, Issue 5; pp. 625-630
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the discovery and development of novel peptides to accelerate tissue and organ repair. Currently, RegeneRx is developing three product candidates, RGN-137, RGN-259 and RGN-352 for dermal, ophthalmic, and cardiovascular tissue repair, respectively. These product candidates are based on TB4, a synthetic copy of a 43-amino acid, naturally occurring peptide, in part, under an exclusive world-wide license from the National Institutes of Health. RegeneRx holds over 60 world-wide patents and patent applications related to novel peptides. It is currently in phase II clinical development for dermal and ophthalmic wound healing and has now completed a Phase I clinical trial supporting delivery of RGN-352 for acute cardiovascular and other indications requiring systemic administration. RegeneRx is also developing novel peptides for the cosmeceutical industry based on its experience with TB4 and its biological activities in the skin.
RegeneRx Technology Background
TB4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class, multi-faceted molecule that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, and collagen deposition, while down-regulating inflammation. RegeneRx has identified several molecular variations of TB4 that may affect the aging of skin, among other properties, and could be important candidates as active ingredients in pharmaceutical and consumer products. Researchers at the National Institutes of Health, and at other academic institutions throughout the world, have published numerous scientific articles indicating TB4's in vitro and in vivo efficacy in accelerating wound healing and tissue protection under a variety of conditions. Abstracts of scientific papers related to TB4's mechanisms of action may be viewed at RegeneRx's web page: www.regenerx.com.
Forward-Looking Statements
Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of The Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the words "project," "believe," "anticipate," "plan," "expect," "estimate," "intend," "should," "would," "could," "will," "may" or other similar expressions and include statements regarding the safety and efficacy of RGN-137, RGN-259, and RGN-352, including in diseases such as chronic hepatitis B and liver failure related thereto. Further, the Company's product candidates may not demonstrate safety and/or efficacy in current or future clinical trials or as a result of various important factors described in the Company's filings with the Securities and Exchange Commission ("SEC"), including those identified in the "Risk Factors" sections of the annual report on Form 10-K for the year ended December 31, 2008 and such other items described in the filed Company's quarterly report on Form 10-Q for the fiscal quarter ended September 30, 2009 or other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company anticipates that subsequent events and developments may cause its views to change, and the Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.
SOURCE: RegeneRx Biopharmaceuticals, Inc.
For RegeneRx:
J.J. Finkelstein, 301-208-9191
Feb. 8, 2010, 8:30 a.m. EST ? Recommend ? Post:
Researchers Report Elevated Levels of TB4 Levels Predict Patient Survival in Hepatitis B Virus-related Liver Failure
TB4 -- Potential New Therapeutic Agent for Liver Failure
BETHESDA, Md., Feb 08, 2010 (BUSINESS WIRE) -- REGENERX BIOPHARMACEUTICALS, INC. /quotes/comstock/14*!rgn/quotes/nls/rgn (RGN 0.59, +0.06, +10.38%) announced today that researchers have correlated TB4 levels with the clinical course of patients with hepatitis B virus-related liver failure. It was reported that serum thymosin B4 levels were significantly lower in patients with chronic hepatitis B infection and that the magnitude of the reduction of thymosin B4 was closely related to the severity of the hepatic injury and to patient death. Since patients with higher TB4 levels survived the disease, changes in TB4 values could reflect outcome in some liver failure patients.
Moreover, liver failure is a systemic inflammatory reaction, causing severe deterioration in liver function, according to the research team. Liver failure occurs when the extent of hepatocyte (liver cells) death exceeds the liver's regenerating capacity and recent findings have shown that TB4 regulates certain molecules that play a role in preventing hepatic cell death and promoting hepatic regeneration. Liver regeneration is considered to be suppressed in liver failure. "The study demonstrated that the thymosin B4 level was significantly lowered in liver failure patients, suggesting that thymosin B4 might become a new therapeutic agent for liver failure caused by chronic HBV infection," concluded the research team.
"This study is particularly important as it confirms and extends, in humans, data published (Annals. N.Y. Acad. Sci. 2007:1112:154-160) by Dr. Marcos Rojkind and his colleagues at The George Washington University Medical Center showing that TB4 up-regulates certain molecules known to play key roles in stimulating liver regeneration. It also strongly suggests that observing low levels of circulating TB4 in the blood may be a useful early warning signal to identify HBV patients, and perhaps patients with HCV infection, cirrhosis of the liver or other liver diseases, who are heading into liver failure," stated Dr. Allan L. Goldstein, Professor of Biochemistry and Molecular Biology, The George Washington University School of Medicine, and chief scientific advisor to RegeneRx.
The research team was led by Tao Han, MD, Ph.D., professor, Department of Hepatology, Tianjin Institute of Hepatobiliary Disease, Tianjin Medical University, Tianjin, China. The paper was published in the World Journal of Gastroenterology, February 7, 2010; Volume 16, Issue 5; pp. 625-630
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the discovery and development of novel peptides to accelerate tissue and organ repair. Currently, RegeneRx is developing three product candidates, RGN-137, RGN-259 and RGN-352 for dermal, ophthalmic, and cardiovascular tissue repair, respectively. These product candidates are based on TB4, a synthetic copy of a 43-amino acid, naturally occurring peptide, in part, under an exclusive world-wide license from the National Institutes of Health. RegeneRx holds over 60 world-wide patents and patent applications related to novel peptides. It is currently in phase II clinical development for dermal and ophthalmic wound healing and has now completed a Phase I clinical trial supporting delivery of RGN-352 for acute cardiovascular and other indications requiring systemic administration. RegeneRx is also developing novel peptides for the cosmeceutical industry based on its experience with TB4 and its biological activities in the skin.
RegeneRx Technology Background
TB4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class, multi-faceted molecule that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, and collagen deposition, while down-regulating inflammation. RegeneRx has identified several molecular variations of TB4 that may affect the aging of skin, among other properties, and could be important candidates as active ingredients in pharmaceutical and consumer products. Researchers at the National Institutes of Health, and at other academic institutions throughout the world, have published numerous scientific articles indicating TB4's in vitro and in vivo efficacy in accelerating wound healing and tissue protection under a variety of conditions. Abstracts of scientific papers related to TB4's mechanisms of action may be viewed at RegeneRx's web page: www.regenerx.com.
Forward-Looking Statements
Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of The Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the words "project," "believe," "anticipate," "plan," "expect," "estimate," "intend," "should," "would," "could," "will," "may" or other similar expressions and include statements regarding the safety and efficacy of RGN-137, RGN-259, and RGN-352, including in diseases such as chronic hepatitis B and liver failure related thereto. Further, the Company's product candidates may not demonstrate safety and/or efficacy in current or future clinical trials or as a result of various important factors described in the Company's filings with the Securities and Exchange Commission ("SEC"), including those identified in the "Risk Factors" sections of the annual report on Form 10-K for the year ended December 31, 2008 and such other items described in the filed Company's quarterly report on Form 10-Q for the fiscal quarter ended September 30, 2009 or other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company anticipates that subsequent events and developments may cause its views to change, and the Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.
SOURCE: RegeneRx Biopharmaceuticals, Inc.
For RegeneRx:
J.J. Finkelstein, 301-208-9191