- HspE7 Well-Tolerated; Safety Evaluation Allows
Advancement to Third Cohort -
SAN DIEGO, CA, Jan. 14 /CNW/ - Nventa Biopharmaceuticals Corporation
(TSX:NVN) today announced the completion of the safety and tolerability
assessment in its second cohort of patients in a Phase 1 clinical trial of new
HspE7 in patients with cervical intraepithelial neoplasia (CIN). HspE7's
safety data were normal and met the limits prescribed in the trial protocol,
allowing advancement to the third cohort of patients in the study.
The evaluation by the Safety Review Committee was performed after the
second cohort reached five weeks of treatment (two doses plus one week of
follow-up). The dosing of the third cohort of patients is expected shortly.
At the end of each cohort, Nventa is also collecting immunological data
that may provide an early indication of potential efficacy of the compound.
All patients are being typed for class I and II human leukocyte antigen (HLA)
subtypes, and are being evaluated for cytokine responses, anti-HspE7
antibodies and cellular (T-cell) immunology.
The trial is expected to dose up to 5 cohorts comprising twenty-four
patients. The first cohort of patients was administered 500 mcg of HspE7 and
50 mcg of adjuvant containing Poly-IC, a toll-like receptor-3 (or TLR3)
agonist. The second cohort was administered 500 mcg of HspE7 and an escalated
dose of 500 mcg of adjuvant. The third cohort will be administered 500 mcg of
HspE7 and 1,000 mcg of adjuvant, and the fourth cohort will be administered
500 mcg of HspE7 and 2,000 mcg of adjuvant. An additional cohort of six
patients administered 1,000 mcg of HspE7 and 2,000 mcg of adjuvant may be
added if deemed appropriate based on data from the previous four cohorts.
Following successful completion of this Phase 1 trial, the Company
anticipates launching a Phase 2 clinical trial with new HspE7 in patients with
high-grade cervical intraepithelial neoplasia (CIN 2/3). The Company is also
in discussions with clinical investigators regarding the design and
implementation of a second Phase 2 trial with new HspE7 in patients that are
HIV-positive with low-grade CIN.
Affiliations and investigators in this trial currently include the
Montefiore Medical Center; William D. Kolton, M.D. of San Diego, California;
Linda Roman, M.D. of the University of Southern California (USC); Michael L.
Twede, M.D. of the Salt Lake Women's Center in Sandy, Utah; and Mark T.
Saunders, M.D. at the Mt. Timpanogos Women's Healthcare/Physician's Research
in Pleasant Grove, Utah.
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. Heat shock proteins (Hsps), also known as
stress proteins, 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.
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
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: the collection
and use of immunological data to indicate efficacy of the compound; the number
of cohorts and patients and the expected dosing amounts in the Phase 1 trial;
successful completion of the Phase 1 trial; the launching of a Phase 2
clinical trial in patients with high-grade cervical intraepithelial neoplasia
(CIN2/3); the possibility of a second Phase 2 trial in HIV-positive low-grade
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 we will
not be able to recruit patients for our 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 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 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 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
For further information:
For further information: Donna Slade, Director, Investor Relations, 9381
Judicial Drive, Suite 180, San Diego, CA, USA, 92121, Dir: (858) 202-4945,