Nventa Announces Positive Interim Immunological Data From HspE7 Phase 1 Cervical Dysplasia Trial



    
    3 out of 4 Patients in Cohort 2 Demonstrate T-Cell Responses Indicating
    Potential HspE7 Therapeutic Benefit
    

    SAN DIEGO, March 26 /CNW/ -- Nventa Biopharmaceuticals Corporation (TSX:
NVN) today announced interim immunological data from the first two cohorts of
its ongoing Phase 1 clinical trial of its lead product candidate, HspE7, in
patients with cervical intraepithelial neoplasia, or CIN, a precursor to
cervical cancer.  Preliminary evaluation of biological samples collected from
the study's first and second cohorts indicates that administration of HspE7
results in an E7-specific T-cell immune response. Independent research
findings recently published in the journal Gynecologic Oncology by Jeffrey
Weber, M.D., Ph.D., associate director for clinical research at the University
of Southern California's Norris Comprehensive Cancer Center, demonstrated that
such an immune response may be associated with objective clinical responses in
patients with CIN.  Accordingly, Nventa believes that HspE7 may successfully
treat CIN by activating and enhancing the body's natural immune system.
    
    (Logo: http://www.newscom.com/cgi-bin/prnh/20080303/LAM023LOGO)
    
    As previously reported, doses administered in both study cohorts were
found to be safe and well tolerated, with no serious adverse events being
reported in either group.  Cohort 1 was designed to establish a baseline for
the study with patients in this group being administered 500 mcg of HspE7 and
50 mcg of Poly-ICLC, a potent toll-like receptor 3 (TLR-3) adjuvant.
Consistent with previous preclinical studies conducted by Nventa, this dose
level demonstrated anti-HspE7 antibody responses but limited T-cell responses.
In cohort 2, patients were administered 500 mcg of HspE7 and 500 mcg of
Poly-ICLC.  In this group, 3 out of 4 patients showed anti-HspE7 antibody
responses and HPV16 E7-specific T-cell responses.  These findings verify the
company's predicted mechanism-of-action of HspE7 as demonstrated by early
preclinical models and support the compound's potential to treat HPV-16
induced CIN.  HPV-16 is the most common subtype of the HPV virus and is
responsible for a significant percentage of cases of CIN.
    "We are very encouraged with the interim immunological results from our
Phase 1 HspE7 trial as they demonstrate the anticipated immune response
improvement from cohort 1 to cohort 2.  We believe that these results may
correlate to the activity of the drug in future clinical trials," said Gregory
M. McKee, president and chief executive officer at Nventa.  "We look forward
to reviewing the immunological data from the remaining two cohorts of this
study to determine if yet higher doses of HspE7 will improve the drug's
immunological activity."
    The company recently announced positive safety and tolerability findings
from cohort 3 in this Phase 1 study, as well as the completion of enrollment
and initiation of dosing for the study's fourth and final cohort.  Safety and
tolerability results from cohort 4 are expected in mid-April.  In addition to
safety findings, immunological samples for the study's third and fourth
cohorts are presently being collected and evaluated, and such findings will be
released in the next several months.
    Nventa is currently working with the FDA to finalize trial design for the
company's Phase 2 clinical study for HspE7, and expects to initiate this trial
in patients in CIN in mid-2008.  In addition to CIN, Nventa is currently
evaluating HspE7 as a potential treatment for a broad range of HPV-related
pre-cancerous and cancerous diseases, and has a platform to generate other
compounds that may treat a variety of other viral associated diseases.
    
    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 HPV
types, of which HPV-16 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 U.S. Food and Drug Administration (FDA)
for the treatment of any type of CIN.
    
    About HspE7:
    
    The company's lead 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 the human
papillomavirus (HPV).  The company is publicly traded on the Toronto Stock
Exchange under the symbol NVN.  For more information about Nventa, please
visit 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 financial and other projections as well as statements
regarding the company's future plans, objectives, performance, revenues,
growth, profits, operating expenses or the company's underlying assumptions.
The words "may", "would", "could", "will", "likely", "expect," "anticipate,"
"intend", "plan", "forecast", "project", "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 predictions, 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: that
administration of HspE7 results in an E7-specific T-cell immune response; that
such an immune response may be associated with objective clinical responses in
patients with CIN; verification of the company's predicted mechanism-of-action
of HspE7; that HspE7 may successfully treat CIN by activating and enhancing
the body's natural immune system; the potential of HspE7 to treat HPV-16
induced CIN; that the results may correlate to the activity of the drug in
future clinical trials; that safety and tolerability results from cohort 4 are
expected in April; that immunological findings for the study's third and
fourth cohorts will be released in the next several months; and initiation of
the company's Phase 2 clinical study in patients with CIN in mid-2008.
    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
immunology responses may not be a predictor of clinical benefit; that
immunological findings in our first two cohorts may not be consistent with
findings from our third and fourth cohorts and future clinical studies; that
safety and tolerability findings in our first three cohorts may not be
consistent with findings from our fourth cohort and future clinical studies;
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; 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 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 www.sedar.com.
    Assumptions underlying our expectations regarding forward-looking
statements or information contained in this press release include, among
others, that immunology responses are a predictor of clinical benefit; that
immunological findings in our first two cohorts will be consistent with
findings from our third and fourth cohorts and future clinical studies; that
safety and tolerability findings in our first two cohorts will be consistent
with findings from our third and fourth cohorts and future clinical studies;
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 enough HspE7 and Poly-ICLC will be available to conduct our
planned trials; that we will obtain timely approval from additional IRBs; 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 IND.
    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.  Historical filings
relating to the company prior to the completion of the Company's March 23,
2006 corporate reorganization may be reviewed on SEDAR at http://www.sedar.com
under the SEDAR profile GVIC Communications Corp.
    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, +1-858-202-4945, dslade@nventacorp.com; or Media, Tim Brons of Vida 
Communication, +1-415-675-7402, tbrons@vidacommunication.com, for Nventa Web
Site: http://www.nventacorp.com

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