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Nventa Announces Positive Interim Immunological Data From HspE7 Phase 1 Cervical Dysplasia Trial
Nventa Biopharmaceuticals
Corporation (TSX: NVN) 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 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 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 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 http://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.
Nventa Biopharmaceuticals Corporation
http://www.nventacorp.com
Nventa Announces pozitive interimar imunologice date de la HspE7 Faza 1 displazie de col uterin Trial - Nventa Announces Positive Interim Immunological Data From HspE7 Phase 1 Cervical Dysplasia Trial - articole medicale engleza - startsanatate