- HspE7 Well Tolerated; Fourth Cohort to be Dosed Shortly -
SAN DIEGO, March 3 /CNW/ -- Nventa Biopharmaceuticals Corporation (TSX:
NVN) today announced the completion of the safety and tolerability assessment
of its third cohort of patients in a Phase 1 clinical trial of new HspE7
(HspE7 + Poly-ICLC) in patients with cervical intraepithelial neoplasia (CIN).
The safety data from the cohort were normal and met the limits prescribed in
the trial protocol, allowing advancement to the fourth cohort of patients in
The evaluation by the Safety Review Committee was performed after the
third cohort reached five weeks of treatment (two doses plus one week of
follow-up). The dosing of the fourth 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 was administered 500 mcg of
HspE7 and 1,000 mcg of adjuvant. The fourth cohort will be administered 500
mcg of HspE7 and 2,000 mcg of adjuvant. An additional cohort of 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
cervical intraepithelial neoplasia (CIN). 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
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 + Poly-ICLC:
The Company's lead candidate, HspE7 + Poly-ICLC, 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 + Poly-ICLC contains the novel
CoVal(TM) fusion protein, HspE7, that is co-administered with the adjuvant,
Poly-ICLC, a toll-like receptor-3 (TLR3) agonist adjuvant. 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 + Poly-ICLC 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
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 expected
dosing of the fourth cohort of patients; 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 cervical intraepithelial neoplasia (CIN); the possibility of a
second Phase 2 trial in HIV-positive low-grade CIN patients.
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 http://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 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
For further information:
For further information: Donna Slade, Director, Investor Relations of
Nventa Biopharmaceuticals Corporation, +1-858-202-4945, firstname.lastname@example.org
Web Site: http://www.nventacorp.com