Nventa Announces Presentation of Positive HspE7 Data from NCI-Sponsored Clinical Trial in Cervical Dysplasia



    - 78 Percent of Patients Showed Complete Response or Reduction of Lesion
    Size by More than Fifty Percent -

    SAN DIEGO, CA, March 5 /CNW/ - Nventa Biopharmaceuticals Corporation
(TSX:NVN) today announced the presentation of positive results from a clinical
trial examining the safety and efficacy of pilot process HspE7, an
investigational therapeutic vaccine for human papillomavirus (HPV)-related
diseases, in women with the highest grade of cervical dysplasia (CIN III). The
data from two posters were presented by Mark H. Einstein, M.D., the
investigator in the trial and an expert in the field of cervical dysplasia, at
the 37th Annual Meeting of the Society of Gynecological Oncologists in San
Diego. The trial was conducted by the New York Cancer Consortium (an
NCI-sponsored consortium) and the New York Gynecologic Oncology Group (NYGOG).
    "This trial may lead to a paradigm shift in how select patients with
high-grade CIN are treated," said Mark H. Einstein, M.D. "The administration
of HspE7 may be an attractive alternative to surgery for a subset of women
with high-grade CIN. Placebo-controlled trials need to be performed to fully
determine the treatment efficacy and to identify the appropriate subsets of
women who may benefit from HspE7." Dr. Einstein is Director of Clinical
Research for the Division of Gynecologic Oncology, Department of Obstetrics
and Gynecology & Women's Health at the Montefiore Medical Center at Albert
Einstein College of Medicine.
    Gregory M. McKee, President and Chief Executive Officer of Nventa
commented on the study: "The data from this cervical dysplasia trial are
consistent with other data in this indication that we have obtained from
previous HspE7 trials. We are advancing a new formulation of HspE7 which has
been shown to be more potent in preclinical testing and that may produce
better results in future clinical trials. We expect to commence a Phase I
bridging trial by mid-2007, pending submission of the final sections of an
amendment to our original HspE7 Investigational New Drug application to
the U.S. Food and Drug Administration."

    Trial Design
    ------------
    The trial presented today was a single-arm, open-label, Phase II study to
establish the response rate and safety profile of HspE7 in women with
biopsy-proven CIN III. The secondary aim was to correlate clinical responses
to HspE7 vaccination in women infected with HPV 16 compared to women infected
with other HPV types. Responses to HspE7 were determined by pathology of
post-vaccination Loop Electrosurgical Excision Procedure (LEEP) specimens.
(LEEP is a standard procedure for patients with high grade dysplasia to remove
the affected areas.) A pathologic complete response (pCR) was defined as a
specimen negative for CIN. A partial response (PR) was determined by a
50 percent or more reduction of lesion size post-vaccination.

    Trial Results
    -------------
    71 patients were registered, of whom 62 were eligible after screening. 58
patients completed the trial and were evaluable (31 in cohort 1, 27 in cohort
2). There were no significant HPV type differences between the 2 cohorts so
responses were combined for analysis. Of the 58 patients, 13 (22.5 percent)
had a pCR; 32 (55 percent) had a PR and 11 (19 percent) had stable disease.
Two (3.5 percent) patients in cohort 2 had microinvasive disease and were
defined as progressive disease. The overall response rate was 45/58
(78 percent). 33/58 (57 percent) of the patients were infected with HPV 16
prior to vaccination or in subsequent visits. There was no significant
difference in regression in women infected with HPV 16 compared to those
without HPV 16 infection (88 percent vs. 70 percent; p=0.12). Similar
responses were seen in patients infected with multiple HPV types compared to
those infected with one type (p=0.20). HspE7 showed efficacy in patients
infected with HPV types other than 16, suggesting cross-reactivity.
    In a second presentation of data from the same cohort of 58 evaluable
patients, CD4 and CD8 positive T cells were activated with pooled E6 and E7
peptides and tested for interferon gamma production and degranulation. Blinded
histologic sections of the final cervical conization specimens were
independently graded for inflammation using a standardized protocol (0 no
inflammation and 4 the highest level of inflammation.). There was
significantly more cervical inflammation in patients who did not undergo
regression after HspE7 immunotherapy. Local inflammation did not correlate
with type-specific HPV infection or systemic T cell responses to HPV peptides;
however, this study may have been underpowered to predict these observations
in this subset of women with heterogeneous T cell responses. Further studies
are currently underway.

    About HspE7, Lead Product Candidate:
    ------------------------------------
    HspE7 is a novel therapeutic vaccine candidate for the treatment of
diseases caused by the human papillomavirus (HPV), one of the most common
sexually transmitted diseases in the world. 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. Stress proteins, also known as heat shock
proteins (Hsps), are naturally present in the human body and play important
roles in the immune system, including transporting substances within cells and
activating cells of the immune system. Nventa is pursuing clinical development
of HspE7 in combination with an adjuvant.

    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 corporation 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, to the extent that they are
not recitations of historical fact 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 are intended to 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: the advancement
of a new formulation of HspE7 that may produce better results in future
clinical trials and our expectation that we will commence a Phase I bridging
trial by mid-2007.
    Such forward-looking statements or information involve known and unknown
risks, uncertainties and other factors that may cause our actual results,
events or developments, or industry results, to be materially different from
any future results, events or developments expressed or implied by such
forward-looking statements or information. Such factors include, among others,
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 and the possibility that the results of such trials, if commenced and
completed, will not establish the safety or efficacy of our products; our
dependence on suppliers, collaborative partners and other third parties and
the prospects and timing for negotiating supply agreements, corporate
collaborations or licensing arrangements; our ability to attract and retain
key personnel; our ability to protect and practice our intellectual property;
and other factors as described in detail in our filings with the Canadian
securities regulatory authorities at www.sedar.com. Given these risks and
uncertainties, you are cautioned not to place undue reliance on such
forward-looking statements and information, which are qualified in their
entirety by this cautionary statement.
    Assumptions underlying our expectations regarding forward-looking
statements or information contained in this press release include, among
others, 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 our adjuvant in a timely
manner; that enough HspE7 will be available to conduct out planned trials;
that we will be able to procure the necessary amount of adjuvant to conduct
our planned trials; that we will obtain timely approval from IRB; that the
results from additional preclinical work, if any, will be consistent with the
results we have already obtained; and that a sufficient number of patients
will be available to conduct our planned trials; and that sufficient data will
be generated to support an 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 2005 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, including Old Stressgen's 2005 Annual
Information Form dated March 16, 2006 may be reviewed on SEDAR at
http://www.sedar.com under the SEDAR profile GVIC Publications Ltd.
    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.

    %SEDAR: 00023483E




For further information:

For further information: Donna Slade, Director, Investor Relations, 6055
Lusk Boulevard, San Diego, CA, USA, 92121, Dir: (858) 202-4945,
dslade@nventacorp.com

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