24.08.2010 13:32
www.finanznachrichten.de/...-growth-hormone-in-the-u-s-008.htm
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PROLOR Biotech Receives FDA Clearance for a Phase II Trial of Its Long-Acting Human Growth Hormone in the U.S.
NES-ZIONA, Israel, Aug. 24 /PRNewswire-FirstCall/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical trial in the U.S. of its longer-acting version of human growth hormone, hGH-CTP. The regulatory clearance followed PROLOR's submission of an Investigational New Drug (IND) application for hGH-CTP that included preclinical and Phase I clinical data, as well as plans for additional animal studies that the company intends to complete prior to initiation of Phase III trials. The hGH-CTP Phase II clinical program is currently ongoing in various clinical centers in Europe.
"The FDA regulatory clearance for conducting a Phase II trial of hGH-CTP in the U.S. is an important milestone for PROLOR," said Dr. Abraham Havron, CEO of PROLOR. "This Phase II trial, which is underway at centers in a number of European countries, is an integral part of a comprehensive and coordinated clinical development program that has been carefully designed to generate the data that we anticipate will be necessary to obtain future marketing authorization in the U.S. and Europe, as well as in other localities. We currently do not plan to include sites in the U.S. in this Phase II trial, but the FDA clearance helps ensure that we will be fully in sync with regulatory requirements in key territories, including the U.S., allowing us to utilize the hGH-CTP European Phase II program as the basis for our anticipated submission of applications to conduct Phase III trials in both the U.S. and Europe."
PROLOR is developing hGH-CTP to provide growth hormone deficient adults and children with growth hormone therapy that requires only once-weekly or bi-monthly injections, rather than the multiple injections per week required by current hGH regimens. The hGH-CTP Phase II clinical program follows a successful Phase I trial that suggested that hGH-CTP, in addition to meeting all safety and tolerability endpoints, could potentially be effective when injected just twice per month.
The hGH-CTP Phase II trial is a randomized, open-label, dose-finding study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected either weekly or twice-monthly in patients with growth hormone deficiency who currently receive daily injections of growth hormone. The trial is being conducted at up to 14 sites in six countries.
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25.03.2010 13:05
www.finanznachrichten.de/...-29-2010-under-symbol-pbth-008.htm
PROLOR Biotech Announces NYSE AMEX Listing / - Trading on NYSE AMEX Begins Monday, March 29, 2010 under Symbol ''PBTH'' -
NES-ZIONA, Israel, March 25 /PRNewswire-FirstCall/ -- PROLOR Biotech, Inc., (BULLETIN BOARD: PBTH) , a company developing next generation biobetter therapeutic proteins, today announced that it has been authorized to list its shares of common stock on the NYSE AMEX stock exchange. The company anticipates that its common stock will begin trading on the NYSE AMEX on Monday, March 29, 2010, under the trading symbol "PBTH." Until that time, PROLOR's common stock will continue to trade on the OTC Bulletin Board under the trading symbol "PBTH."
"We are pleased to be moving the listing of our common stock from the OTCBB to the NYSE AMEX," said Shai Novik, President of PROLOR. "This is an important milestone that we anticipate will raise PROLOR's profile in the global investor community and permit a larger number of institutional funds to consider adding PROLOR to their investable universe. Listing on the NYSE AMEX marks an important step in our ongoing efforts to improve the liquidity of our common stock while we continue to execute our growth strategy."
"We welcome PROLOR Biotech to the NYSE Euronext family of listed companies and to NYSE AMEX," said Scott Cutler, NYSE Euronext Executive Vice President and Head of Listings, Americas. "PROLOR Biotech and its stockholders will benefit from our superior market quality and technology, a broad array of issuer and investor services, and a global brand association. We look forward to building a strong and lasting partnership with the company and its stockholders."
Earlier this year, PROLOR reported results from a Phase I clinical study of its biobetter form of human growth hormone (hGH) that demonstrated its potential to reduce the required dosing frequency from one injection per day as required for currently available hGH to as few as two injections per month. Last week, PROLOR announced that it had closed a $24.4 million private placement of its common stock.
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HOMEPAGE: www.prolor-biotech.com/
www.finanznachrichten.de/...-growth-hormone-in-the-u-s-008.htm
§
PROLOR Biotech Receives FDA Clearance for a Phase II Trial of Its Long-Acting Human Growth Hormone in the U.S.
NES-ZIONA, Israel, Aug. 24 /PRNewswire-FirstCall/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical trial in the U.S. of its longer-acting version of human growth hormone, hGH-CTP. The regulatory clearance followed PROLOR's submission of an Investigational New Drug (IND) application for hGH-CTP that included preclinical and Phase I clinical data, as well as plans for additional animal studies that the company intends to complete prior to initiation of Phase III trials. The hGH-CTP Phase II clinical program is currently ongoing in various clinical centers in Europe.
"The FDA regulatory clearance for conducting a Phase II trial of hGH-CTP in the U.S. is an important milestone for PROLOR," said Dr. Abraham Havron, CEO of PROLOR. "This Phase II trial, which is underway at centers in a number of European countries, is an integral part of a comprehensive and coordinated clinical development program that has been carefully designed to generate the data that we anticipate will be necessary to obtain future marketing authorization in the U.S. and Europe, as well as in other localities. We currently do not plan to include sites in the U.S. in this Phase II trial, but the FDA clearance helps ensure that we will be fully in sync with regulatory requirements in key territories, including the U.S., allowing us to utilize the hGH-CTP European Phase II program as the basis for our anticipated submission of applications to conduct Phase III trials in both the U.S. and Europe."
PROLOR is developing hGH-CTP to provide growth hormone deficient adults and children with growth hormone therapy that requires only once-weekly or bi-monthly injections, rather than the multiple injections per week required by current hGH regimens. The hGH-CTP Phase II clinical program follows a successful Phase I trial that suggested that hGH-CTP, in addition to meeting all safety and tolerability endpoints, could potentially be effective when injected just twice per month.
The hGH-CTP Phase II trial is a randomized, open-label, dose-finding study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected either weekly or twice-monthly in patients with growth hormone deficiency who currently receive daily injections of growth hormone. The trial is being conducted at up to 14 sites in six countries.
**************************************************
25.03.2010 13:05
www.finanznachrichten.de/...-29-2010-under-symbol-pbth-008.htm
PROLOR Biotech Announces NYSE AMEX Listing / - Trading on NYSE AMEX Begins Monday, March 29, 2010 under Symbol ''PBTH'' -
NES-ZIONA, Israel, March 25 /PRNewswire-FirstCall/ -- PROLOR Biotech, Inc., (BULLETIN BOARD: PBTH) , a company developing next generation biobetter therapeutic proteins, today announced that it has been authorized to list its shares of common stock on the NYSE AMEX stock exchange. The company anticipates that its common stock will begin trading on the NYSE AMEX on Monday, March 29, 2010, under the trading symbol "PBTH." Until that time, PROLOR's common stock will continue to trade on the OTC Bulletin Board under the trading symbol "PBTH."
"We are pleased to be moving the listing of our common stock from the OTCBB to the NYSE AMEX," said Shai Novik, President of PROLOR. "This is an important milestone that we anticipate will raise PROLOR's profile in the global investor community and permit a larger number of institutional funds to consider adding PROLOR to their investable universe. Listing on the NYSE AMEX marks an important step in our ongoing efforts to improve the liquidity of our common stock while we continue to execute our growth strategy."
"We welcome PROLOR Biotech to the NYSE Euronext family of listed companies and to NYSE AMEX," said Scott Cutler, NYSE Euronext Executive Vice President and Head of Listings, Americas. "PROLOR Biotech and its stockholders will benefit from our superior market quality and technology, a broad array of issuer and investor services, and a global brand association. We look forward to building a strong and lasting partnership with the company and its stockholders."
Earlier this year, PROLOR reported results from a Phase I clinical study of its biobetter form of human growth hormone (hGH) that demonstrated its potential to reduce the required dosing frequency from one injection per day as required for currently available hGH to as few as two injections per month. Last week, PROLOR announced that it had closed a $24.4 million private placement of its common stock.
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HOMEPAGE: www.prolor-biotech.com/
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