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NVENTA ANNOUNCES FINAL DATA FROM HSPE7
PHASE 1 CERVICAL DYSPLASIA TRIAL
-- Company Provides Update to Phase 2 Development Plan --
FOR IMMEDIATE RELEASE - July 28, 2008
San Diego, California USA - 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.
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™ 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: 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 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.
Contact:
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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