| |
|
          |
|
|
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
FOR IMMEDIATE RELEASE - March 26,2008
San Diego, California USA - 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.
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 50mcg 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 pre-clinical models and support the compound’s potential
to treat HPV-16 induced CIN. HPV-16 is the most common sub-type
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™ 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.
Contact:
Donna Slade
Director, Investor Relations
9381 Judicial Drive, Suite 180
San Diego, CA USA 92121
Dir: 858.202.4945
dslade@nventacorp.com
|
Download a PDF file of this release
|
|