Nventa Announces Final Data from HspE7 Phase 1 Cervical Dysplasia Trial



    
    -- Company Provides Update to Phase 2 Development Plan --

    
    SAN DIEGO, July 28 /CNW/ -- Nventa Biopharmaceuticals Corporation (TSX:
NVN) today announced that it has completed analysis of immunological data from
all four cohorts of its Phase 1 clinical trial for HspE7, its lead product
candidate.  HspE7 is a therapeutic treatment for patients with cervical
intraepithelial neoplasia, or CIN, a precursor to cervical cancer.  The
primary cause of CIN is infection with certain human papillomavirus (HPV)
types, of which HPV16 is the most common.  Based on an analysis of HPV16
E7-specific T-cell responses across all cohorts, Nventa has identified a dose
regimen of 500 mcg of HspE7 and 1,000-2,000 mcg of Poly-ICLC, a toll-like
receptor 3 (TLR3) adjuvant, for subsequent Phase 2 trials.
    
    (Logo: http://www.newscom.com/cgi-bin/prnh/20080303/LAM023LOGO)
    
    The purpose of the Phase 1 trial was to determine the safety,
tolerability and immunogenicity of HspE7 plus escalating doses of adjuvant
(50, 500, 1,000 and 2,000 mcg of Poly-ICLC).  All dose regimens were found to
be safe and well tolerated.  Immunogenicity analysis demonstrated that the
adjuvant potently enhanced HPV16 E7-specific T-cell responses in subjects who
demonstrated no or low responses at baseline.
    "This Phase 1 trial has not only demonstrated HspE7's excellent safety
profile, it has also provided compelling data to support the immunologic
activity of the compound and identified the appropriate dose regimen for our
future trials," said Gregory M. McKee, president and chief executive officer
at Nventa.  "We are very encouraged by these results and believe that HspE7
may offer an important therapeutic benefit for the millions of women with
CIN."
    In the first cohort (500 mcg of HspE7 and 50 mcg of Poly-ICLC), which was
designed to establish a baseline for the study, there was limited HPV16
E7-specific T-cell responses.  In cohort 2 (500 mcg of HspE7 and 500 mcg of
Poly-ICLC), three out of four patients showed HPV16 E7-specific T-cell
responses.  In the third cohort (500 mcg of HspE7 and 1,000 mcg of Poly-ICLC),
HPV16 E7-specific T-cell responses were elicited in all four subjects and all
of these T-cell responses represented significant changes from baseline,
indicating that the responses were a direct result of treatment with HspE7. In
the trial's fourth and final cohort (500 mcg of HspE7 and 2,000 mcg of
Poly-ICLC), two of five patients had significant increases in HPV16
E7-specific T-cells from baseline while the remaining three patients
maintained high levels of HPV16 E7-specific T-cells that were already present
at baseline.  The absolute levels of HPV16 E7-specific T-cells in patients in
the fourth cohort were similar to levels observed in the third cohort.  The
data, therefore, support doses of 500 mcg of HspE7 and 1,000-2,000 mcg of
Poly-ICLC as appropriate for advancing into Phase 2 studies.
    Findings from this trial verify the company's predicted mechanism of
action for HspE7 as demonstrated by early preclinical models and support the
compound's potential to treat HPV16- induced CIN.  HPV16 is the most common
subtype of the HPV virus and is responsible for a significant percentage of
cases of CIN.
    
    Phase 2 Development Plan Update:
    
    Following discussions with, and input from, the U.S. Food and Drug
Administration (FDA), Nventa has finalized its protocol for a multi-center,
randomized, double-blind, placebo-controlled Phase 2 trial of HspE7 in
patients with high-grade cervical dysplasia (CIN 2/3).  Preparations have been
made at approximately 40 clinical investigational sites in the U.S., Canada
and Latin America.  The company has also designed a Phase 2 trial of HspE7 in
patients with low-grade cervical dysplasia (CIN 1).  Evaluation of clinical
investigational sites in Europe and Latin America are underway.  The company
intends to initiate one or both of these Phase 2 trials once it has secured
necessary financing.
    
    About Cervical Intraepithelial Neoplasia (CIN):
    
    CIN, also known as cervical dysplasia, is characterized by the presence
in the cervix of abnormal cells that precede and can develop into cervical
cancer.  The primary cause of such abnormalities is infection with certain
human papillomavirus (HPV) types, of which HPV16 is the most common.  In the
U.S., these infections are typically discovered through nearly 60 million Pap
screens completed each year, at a cost of up to $6 billion.  Each year in the
U.S., an estimated 1.2 million women are diagnosed with low-grade cervical
dysplasia (CIN 1), 300,000 with high-grade dysplasia (CIN 2/3) and 2.4 million
with atypical squamous cells of undetermined significance (ASCUS).  No
therapies other than surgery are currently approved by the FDA for the
treatment of any type of CIN.
    
    About HspE7:
    
    The company's lead product candidate, HspE7, is a novel therapeutic
candidate intended for the treatment of precancerous and cancerous lesions
caused by the human papillomavirus (HPV), one of the most common sexually
transmitted diseases in the world.  HspE7 incorporates the proprietary
adjuvant, Poly-ICLC, a toll-like receptor-3 (TLR3) agonist.  An adjuvant is a
substance added to vaccines to improve immune responses against target
antigens.  HspE7 is derived from Nventa's proprietary CoVal(TM) fusion
platform, which uses recombinant DNA technology to covalently fuse stress
proteins to target antigens, thereby stimulating cellular immune system
responses.  Nventa is developing HspE7 for multiple indications.
    
    About Nventa Corporation:
    
    Nventa is developing innovative therapeutics for the treatment of viral
infections and cancer, with a focus on diseases caused by HPV.  The company is
publicly traded on the Toronto Stock Exchange under the symbol "NVN".  For
more information about Nventa, please visit http://www.nventacorp.com.
    This press release contains statements which may constitute
forward-looking information under applicable Canadian securities legislation
or forward-looking statements within the meaning of the United States Private
Securities Litigation Reform Act of 1995.  Such forward-looking statements or
information may include statements regarding the company's future plans,
objectives, performance, growth or the company's underlying assumptions.  The
words "may", "would", "will", "expect", "intend", "plan",  "estimate" and
"believe" or other similar words and phrases may identify forward-looking
statements or information.  Persons reading this press release are cautioned
that such statements or information are only expectations, and that the
company's actual future results or performance may be materially different.
    Forward-looking statements or information in this press release include,
but are not limited to, statements or information concerning: our intent to
use 500 mcg of HspE7 and 1,000-2,000 mcg of Poly-ICLC in our Phase 2 trials;
that 500 mcg of HspE7 and 1,000-2,000 mcg of Poly-ICLC is the optimal dose
regimen for advancing into Phase 2 trials; that HspE7 may offer an important
therapeutic benefit for the millions of women with CIN; the potential of HspE7
to treat HPV16 induced CIN; and our intent to initiate a Phase 2 clinical
trial in patients with CIN 2/3 and/or a Phase 2 clinical trial in patients
with CIN 1 once we have secured necessary financing.
    Such forward-looking statements or information involve known and unknown
risks, uncertainties and other factors that may cause our actual results,
events or developments to be materially different from results, events or
developments expressed or implied by such forward-looking statements or
information. Such factors include, among others, the possibility that 500 mcg
of HspE7 and 1,000-2,000 mcg of Poly-ICLC is not the optimal dose regimen; the
possibility that immunology responses may not be a predictor of clinical
benefit; that immunological findings in our Phase 1 trial may not be
consistent with findings from future clinical trials; that safety and
tolerability findings in our Phase 1 trial may not be consistent with findings
from future clinical trials; that results from future clinical trials will not
be consistent with our expectations; that we will not be able to recruit
patients for our planned trials in a timely manner; our need for capital,
which may not be available on a timely basis, or at all; risks associated with
requirements for approvals by government agencies such as the FDA before
products can be tested in clinical trials; the possibility that such
government agency approvals will not be obtained in a timely manner or at all
or will be conditioned in a manner that would impair our ability to advance
development; risks associated with the requirement that a drug candidate be
found safe and effective after extensive clinical trials; our dependence on
suppliers, collaborative partners and other third parties and the prospects
and timing for obtaining clinical supply materials; our ability to attract and
retain key personnel; and other factors as described in detail in our filings
with the Canadian securities regulatory authorities at http://www.sedar.com.
    Assumptions underlying our expectations regarding forward-looking
statements or information contained in this press release include, among
others, that 500 mcg of HspE7 and 1,000-2,000 mcg of Poly-ICLC is the optimal
dose regimen; that immunology responses are a predictor of clinical benefit;
that immunological findings in our Phase 1 trial will be consistent with
findings from future clinical trials; that safety and tolerability findings in
our Phase 1 trial will be consistent with findings from future clinical
trials; that results from future clinical trials will be consistent with our
expectations; that we will raise enough capital, on reasonable terms and in a
timely manner; that we will retain our key personnel; that we will obtain the
necessary regulatory approvals related to HspE7 and Poly-ICLC in a timely
manner; that sufficient HspE7 and Poly-ICLC will be available to conduct our
planned clinical trials; that we will obtain timely approval from additional
Investigational Review Boards; that the results from additional preclinical
and clinical work, if any, will be consistent with the results we have already
obtained; that a sufficient number of patients will be available to conduct
our planned trials; and that sufficient data will be generated to support our
Biologics License Application.
    In the event that any of these assumptions prove to be incorrect, or in
the event that we are impacted by any of the risks identified above, we may
not be able to continue in our business as planned.
    For a complete discussion of the assumptions, risks and uncertainties
related to our business, you are encouraged to review our filings with
Canadian securities regulatory authorities, including our 2007 Annual
Information Form filed on SEDAR at http://www.sedar.com.
    All forward-looking statements and information made herein are based on
our current expectations as of the date hereof and we disclaim any intention
or obligation to revise or update such forward-looking statements and
information to reflect subsequent events or circumstances, except as required
by law.




For further information:

For further information: Donna Slade, Director, Investor Relations of
Nventa Biopharmaceuticals Corporation, +1-858-202-4945, dslade@nventacorp.com;
Media, Tim Brons, +1-415-675-7402, tbrons@vidacommunication.com, of Vida
Communication for Nventa Biopharmaceuticals Corporation; Michael Moore,
+1-416-815-0700, ext. 241, mmoore@equicomgroup.com, of The Equicom Group for
Nventa Biopharmaceuticals Corporation Web Site: http://www.nventacorp.com

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