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NVENTA ANNOUNCES ADDITIONAL POSITIVE
IMMUNOLOGICAL DATA FROM HSPE7 PHASE 1 CERVICAL DYSPLASIA TRIAL
All in Cohort 3 Demonstrated Improvement in T-Cell Responses
Further Supporting the Therapeutic Potential of HspE7
FOR IMMEDIATE RELEASE - May 12, 2008
San Diego, California USA - Nventa Biopharmaceuticals
Corporation (TSX:NVN) today announced positive immunological data
from the third cohort 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. HPV 16 E7-specific
T-cell responses were elicited in all four subjects in the study’s
third cohort following administration of 500 mcg of HspE7 and 1,000
mcg of Poly-ICLC, a potent toll-like receptor 3 (TLR-3) adjuvant.
All T-cell responses represented significant changes from baseline,
indicating that the responses were a direct result of treatment
with HspE7. As previously announced, three out of four of the patients
in cohort 2 (administered 500 mcg of HspE7 and 500 mcg of Poly-ICLC)
demonstrated a T-cell response, which may validate that HspE7 is
more active with an elevated dose of adjuvant.
“We continue to be very encouraged with the immunological
results from our Phase 1 HspE7 trial as they demonstrate that administration
of HspE7 induces T-cell responses that we believe to be therapeutic,”
said Gregory M. McKee, president and chief executive officer at
Nventa. “These positive immunological data, along with the
safety data analyzed to date, provide a strong foundation for our
Phase 2 trial expected to begin mid-2008."
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
induce a targeted immune response to effectively treat CIN.
As previously reported, HspE7 was found to be safe and well tolerated
in all four study cohorts, with no serious adverse events being
reported.
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. 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, combined with the cohort 3 data
announced today, provide additional evidence of 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.
Nventa is currently working with the U.S. Food and Drug Administration
(FDA) to finalize the trial design for the company’s Phase
2 clinical study for HspE7, which it expects to initiate in patients
with high grade cervical dysplasia (CIN 2/3) 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 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™ 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 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:
that HspE7 is more active with an elevated does of adjuvant; that
administration of HspE7 induces T-cell responses that are therapeutic;
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; that HspE7 may successfully
induce a targeted immune response to effectively treat CIN; the
potential of HspE7 to treat HPV-16 induced CIN; and initiation of
our Phase 2 clinical study in patients with CIN 2/3 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 three cohorts may not be consistent with findings from
our fourth cohort and future clinical studies; that safety and tolerability
findings in all four cohorts may not be consistent with findings
from 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, 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 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 three cohorts
will be consistent with findings from our fourth cohort and future
clinical studies; that safety and tolerability findings in all four
cohorts will be consistent with findings from 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 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.
Contacts:
Donna Slade
Director, Investor Relations
9381 Judicial Drive, Suite 180
San Diego, CA USA 92121
Dir: 858.202.4945 dslade@nventacorp.com
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