PROLOR Biotech Reports Positive Top-Line Results From Phase I Study of its Longer-Acting Version of Human Growth Hormone
-- Data Show PROLOR's Biobetter Form of hGH has Potential to Reduce Required Dosing Frequency from One Injection Per Day to Two Injections Per Month -- -- Phase I Safety and Tolerability Endpoints Met --
NES-ZIONA, Israel, Feb. 2 /PRNewswire-FirstCall/ -- PROLOR
Biotech, Inc., (OTC:PBTH) (BULLETIN BOARD: PBTH) today reported
positive top-line results from a Phase I study of its longer-acting
version of human growth hormone (hGH). The study was designed to
measure the potential durability (half-life), overall drug exposure
(AUC) and biological efficacy, as well as the safety and
tolerability of PROLOR's longer-acting CTP-modified human growth
hormone (hGH-CTP).
The Phase I study enrolled 24 healthy adults who were randomized
to receive one of three doses of hGH-CTP (4mg, 7mg, or 21mg) or
placebo. The study results showed that safety and tolerability
endpoints were met at all doses in all participants. The potential
clinical efficacy of hGH-CTP was assessed by measuring the extent
to which hGH-CTP induced insulin-like growth factor-1 (IGF-1) in
subjects. This biomarker is the clinically accepted primary
indicator of hGH biological activity and is used by
endocrinologists to optimize dosing for hGH-deficient adults. Based
on this measure, the study results suggest that the daily
injections required by patients using conventional hGH could
potentially be replaced with just two monthly injections of
hGH-CTP.
"We believe that the results from this first human clinical
trial of a PROLOR CTP-modified drug are very encouraging and
exemplify the promise of biobetter therapeutics," said Dr. Avri
Havron, CEO of PROLOR Biotech. "Our hGH-CTP appears to be a safe
and highly potent version of commercially available human growth
hormone. Replacing the daily injections required by current hGH
users with just two injections per month could dramatically improve
the quality of life for patients receiving growth hormone therapy.
Based on these Phase I results, we anticipate moving forward
rapidly with the planning and execution of a Phase II study of
hGH-CTP."
ABOUT hGH-CTP
hGH-CTP is PROLOR's proprietary biobetter version of human
growth hormone. hGH is used for the long-term treatment of children
and adults with growth hormone deficiency due to inadequate
secretion of endogenous growth hormone. It is also sometimes used
to counter involuntary weight loss and certain physical
manifestations of aging. Currently available forms of hGH must be
injected daily. In contrast, hGH-CTP is expected to require only
bi-monthly or weekly injections. Current global sales of human
growth hormone products are estimated at about $3 billion
annually.
ABOUT PROLOR BIOTECH
PROLOR Biotech, Inc. is a biopharmaceutical company applying
unique technologies, including its patented CTP technology,
primarily to develop longer-acting, proprietary versions of already
approved therapeutic proteins that currently generate billions of
dollars in annual global sales. The CTP technology is applicable to
virtually all proteins and PROLOR is currently developing
long-acting versions of human growth hormone, which is in clinical
development, and interferon beta, factor VII, factor IX and
erythropoietin, which are in preclinical development, as well as
GLP-1 and other therapeutic peptides. For more information on
PROLOR, visit http://www.prolor-biotech.com/.
Safe Harbor Statement: This press release contains
forward-looking statements, which may be identified by words such
as "expects," "plans," "projects," "will," "may," "anticipates,"
"believes," "should," "intends," "estimates," "suggests" and other
words of similar meaning, including statements regarding the
results of current clinical studies and preclinical experiments and
the effectiveness of PROLOR's long-acting protein programs, which
are made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Investors are cautioned
that forward-looking statements involve risks and uncertainties
that may affect PROLOR's business and prospects, including the
risks that PROLOR may not succeed in developing any commercial
products, including any long-acting versions of human growth
hormone, erythropoietin, interferon beta, GLP-1, and other
products; that the long-acting products in development may fail,
may not achieve the expected results or effectiveness and/or may
not generate data that would support the approval or marketing of
these products for the indications being studied or for other
indications; that ongoing studies may not continue to show
substantial or any activity; that the actual dollar amount of any
grants from Israel's Office of the Chief Scientist is uncertain and
is subject to policy changes of the Israeli government, and that
such grants may be insufficient to assist with product development;
and other risks and uncertainties that may cause results to differ
materially from those set forth in the forward-looking statements.
The results of clinical trials in humans may produce results that
differ significantly from the results of clinical and other trials
in animals. The results of early-stage trials may differ
significantly from the results of more developed, later-stage
trials. The development of any products using the CTP platform
technology could also be affected by a number of other factors,
including unexpected safety, efficacy or manufacturing issues,
additional time requirements for data analyses and decision making,
the impact of pharmaceutical industry regulation, the impact of
competitive products and pricing and the impact of patents and
other proprietary rights held by competitors and other third
parties. In addition to the risk factors described above, investors
should consider the economic, competitive, governmental,
technological and other factors discussed in PROLOR's filings with
the Securities and Exchange Commission. The forward-looking
statements contained in this pres release speak only as of the date
the statements were made, and we do not undertake any obligation to
update forward-looking statements, except as required under
applicable law.
PROLOR CONTACT: MEDIA CONTACT: Shai Novik, President Barbara Lindheim PROLOR Biotech, Inc. GendeLLindheim BioCom Partners Tel: +1 866 644-7811 +1 212 918-4650 Email: shai@prolor-biotech.com
Source: PROLOR Biotech, Inc.
CONTACT: Shai Novik, President of PROLOR Biotech, Inc.,
+1-866-644-7811,
shai@prolor-biotech.com; or
MEDIA, Barbara Lindheim of GendeLLindheim BioCom
Partners, +1-212-918-4650
Web Site: http://www.prolor-biotech.com
Posted: February 2010
