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
-
SAN DIEGO, April 24 /CNW/ -- 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.
<<
(Logo: http://www.newscom.com/cgi-bin/prnh/20080303/LAM023LOGO)
>>
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(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 corporation 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 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 http://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.
-30-
/For further information: Donna Slade, Director, Investor
Relations of
Nventa Biopharmaceuticals Corporation, +1-858-202-4945,
dslade@nventacorp.com; or Tim
Brons of Vida Communication, +1-415-675-7402,
tbrons@vidacommunication.com,
for Nventa Biopharmaceuticals Corporation Web
Site: http://www.nventacorp.com/
Posted: April 2008
