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NVENTA COMPLETES SAFETY EVALUATION ON
FINAL COHORT IN HSPE7 PHASE 1 CERVICAL DYSPLASIA TRIAL
-- HspE7 Phase 2 Trial for Cervical Dysplasia to Begin Mid-2008
--
FOR IMMEDIATE RELEASE - April 24, 2008
San Diego, California USA - Nventa Biopharmaceuticals
Corporation (TSX:NVN) today announced the completion of the safety
and tolerability assessment of the fourth and final cohort of patients
in its Phase 1 clinical trial of HspE7, its lead therapeutic candidate,
in women with cervical intraepithelial neoplasia (CIN). Findings
from the fourth cohort safety review demonstrated that HspE7 was
safe and well tolerated with no serious adverse events being reported.
An evaluation by the Safety Review Committee was performed after
each of the four cohorts reached five weeks of treatment (two doses
plus one week of follow-up). All of the patients in the Phase 1
study were administered 500 mcg of HspE7 with each of the four cohorts
receiving escalating doses of adjuvant – 50, 500, 1,000 and
2,000 mcg. The company previously announced that HspE7 was also
well tolerated in the first three cohorts.
In addition to safety data, immunological data were collected from
all patients pre-treatment, following each dose of HspE7 and at
the end of the study. 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 published by Jeffrey Weber,
M.D., Ph.D., in the journal Gynecologic Oncology demonstrate that
such an immune response may be associated with objective clinical
responses in patients with CIN. Therefore, Nventa believes that
HspE7 may successfully treat CIN by activating and enhancing the
body’s natural immune system. The company expects to release
immunological data from the third and fourth cohorts in the coming
months.
“We are pleased with the broad safety and initial activity
observed in our Phase 1 trial for HspE7, and are increasingly optimistic
about the drug’s potential to treat both high-grade and low-grade
CIN,” stated Gregory M. McKee, president and chief executive
officer at Nventa. “We are currently finalizing the design
for a Phase 2 trial of HspE7 and expect to initiate enrollment by
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.
About Phase 1 Trial Design:
This Phase 1 trial was designed to administer HspE7 with escalating
doses of adjuvant containing Poly-IC, a toll-like receptor-3 (or
TLR3) agonist, to four cohorts comprising a total of 17 patients
with CIN to assess the safety and tolerability of HspE7 plus Poly-IC.
All patients were administered 500 mcg of HspE7 with each of the
four cohorts receiving escalating doses of adjuvant – 50,
500, 1,000 and 2,000 mcg.
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 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 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 E7-specific T-cell immune
responses; that immune response may be associated with objective
clinical responses in patients with CIN; the belief that HspE7 may
successfully treat CIN by activating and enhancing the body's natural
immune system; expectations regarding the release of immunological
data from the third and fourth cohorts and the timing of such release
of immunological data; the drug's potential to treat both high-grade
and low-grade CIN; the finalization of the design for a Phase 2
trial of HspE7; and expectations regarding the timing of initiating
enrollment for a Phase 2 trial of HspE7.
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, our need for capital; the outcomes of our clinical
trials; the possibility that our drug will not treat target diseases
as intended; the possibility that we will not be able to recruit
patients for our trials in a timely manner;; 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
negotiating supply agreements, corporate collaborations or licensing
arrangements; 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 clinical trial results will be favorable; that
our drug will treat target diseases as intended; 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 our 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 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 2006
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 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
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