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8-K - PROLOR Biotech, Inc. | v183140_8-k.htm |
EXHIBIT 99.1
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PROLOR
BIOTECH REPORTS NEW PRECLINICAL DATA SUPPORTING THE
ENHANCED
BIOLOGICAL ACTIVITY POTENTIAL OF ITS BIOBETTER PIPELINE
Nes-Ziona, Israel– May 3, 2010 – PROLOR Biotech,
Inc. (NYSE Amex: PBTH), a company developing next generation biobetter
therapeutic proteins, today reported new preclinical data on the company’s
pipeline of drug candidates designed to reduce the dosing frequency of
therapeutic proteins and peptides. The data will be discussed by
PROLOR’s management at the 2010 BIO International Convention in Chicago, as well
as at the upcoming Rodman & Renshaw 6th Annual
Global Healthcare Conference in London and the Jefferies 2010 Global Life
Sciences Conference in New York City.
The data
includes an update on PROLOR’s preclinical development program for its
CTP-enhanced version of interferon beta (IFN-Beta), a widely used drug for the
treatment of multiple sclerosis (MS). In January 2010, the company
reported positive results from a study in primates comparing intravenous
injections of commercial IFN-Beta with PROLOR’s CTP-enhanced version of
IFN-Beta. PROLOR’s new data includes the results of experiments
comparing IFN-Beta-CTP with commercially available IFN-Beta administered by
subcutaneous injection.
The
preclinical data shows that the AUC (overall drug exposure) of PROLOR’s
CTP-modified IFN-Beta administered subcutaneously was more than 200 times
greater than an equivalent dose of commercial IFN-Beta, expanding on the results
in the January study, which showed that CTP-modified IFN-Beta administered
intravenously had 55 times greater overall drug exposure compared to commercial
IFN-Beta. In both studies, CTP-modified IFN-Beta also demonstrated
strong biological potency as measured by several well-validated
biomarkers. The results further validate the potential of
IFN-Beta-CTP to significantly reduce the current dose level and dosing frequency
of interferon beta for the treatment of MS, potentially also reducing the
associated side effects.
PROLOR is
also presenting preclinical data on its programs for CTP-enhanced Factor Vll and
Factor lX, potential drugs for the treatment of blood clotting
disorders. In these studies, the durability of the CTP-enhanced
compounds was increased approximately three to six-fold compared to commercially
available Factor VII and Factor IX. In addition, the
company is presenting initial data on its novel anti-obesity peptide, showing
that the durability of its biobetter version is100 times greater than the
durability of the naturally-occurring anti-obesity peptide.
“These
promising new data from four different PROLOR drug development programs add to
our confidence that our technology has the potential to significantly increase
the duration of effect and reduce the dosing frequency for a wide variety of
therapeutic proteins,” said Abraham Havron, Ph.D., CEO of
PROLOR. “These positive new preclinical data support our plans to
advance our anti-obesity candidate and our Factor VII and Factor IX biobetter
compounds into clinical trials during 2011, in addition to our planned
initiation of Phase II trials with our proprietary biobetter version of human
growth hormone, scheduled for this year.”
Dr. Havron added, “We intend to seek a
partner for the development of our CTP-enhanced biobetter version of IFN-Beta,
and, with the successful completion of studies in our primate subcutaneous
injection model, we believe that we now have sufficient data to pursue
discussions with potential partners who have an interest in co-developing this
promising drug candidate.”
ABOUT
CTP TECHNOLOGY
PROLOR’s CTP technology, which was
discovered by researchers at Washington University in St. Louis, is based on a
short amino acid sequence that occurs naturally in humans, the carboxyl terminal
peptide (CTP). When attached to a therapeutic protein, CTP extends
the time that the protein is active in the body, reducing the required frequency
of administration. The potential utility of the technology has been
demonstrated by Merck, which licenses the CTP technology for fertility
applications only. Early this year, Merck received European
Commission authorization to market its fertility drug ELONVA, a CTP-enhanced
version of recombinant follicle stimulating hormone (FSH). A single
injection of the recommended dose of ELONVA is indicated to replace the first
seven injections of daily FSH for ovarian stimulation in infertility
patients. PROLOR is
using the same CTP technology to extend the duration of action of human growth
hormone, interferon beta and other therapeutic proteins. It has an
exclusive license from Washington University to the CTP technology for use with
all therapeutic proteins and peptides except for the four endocrine hormones
licensed to Merck
ABOUT
PROLOR BIOTECH
PROLOR
Biotech, Inc. is a biopharmaceutical company applying unique technologies,
including its patented CTP technology, primarily to develop longer-acting,
biobetter, 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 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,” “would”,
“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 generating any revenues or 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:
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MEDIA
CONTACT:
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Shai
Novik, President
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Barbara
Lindheim
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PROLOR
Biotech, Inc.
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GendeLLindheim
BioCom Partners
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Tel:
+1 866 644-7811
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+1
212 918-4650
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Email: shai@prolor-biotech.com
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