Viventia Biotech to Explore Strategic Alternatives - Reports Positive Pivotal Phase III Interim Efficacy Data



    TORONTO, Jan. 29 /CNW/ - Viventia Biotech Inc., a privately held
biopharmaceutical company advancing a portfolio of novel antibody therapeutics
focused on cancer, announced today it intends to explore strategic
alternatives to further advance and realize value from its pipeline of
therapeutic antibodies, its antibody discovery platform and its antibody
manufacturing capabilities. The Company will consider potential strategic
opportunities including, but not limited to, the sale or merger of the Company
with another entity, and has retained HSBC to act as advisors in this process.
    The Company also provided an update on the clinical development programs
for Proxinium(TM) (Phase 3), Vicinium(TM) (Phase 2) and VB6-845 (Phase 1).
Proxinium(TM) is undergoing a global pivotal Phase 3 trial (the 'TARGET'
trial) in approximately 300 patients with advanced head and neck cancer.
Viventia recently completed an interim efficacy assessment on the study's
primary endpoint of median survival. These preliminary results demonstrated a
clear survival advantage in the Proxinium(TM) arm.
    "We have successfully advanced three antibody programs into clinical
trials, and are about twelve months from expected final efficacy data for our
pivotal Phase 3 TARGET trial of Proxinium(TM). We believe that our recently
performed interim efficacy analysis of survival data from TARGET strongly
supports the future prospects for this drug. In addition to our clinical
programs, we have generated a broad pipeline from our antibody discovery
platform, which has yielded a number of compelling novel targets, including
several that have expression profiles consistent with cancer stem cells, an
exciting new area of cancer research," said Dr. Nick Glover, President and CEO
of Viventia Biotech. "We believe it is important to explore all options to
ensure adequate resources are available for the advancement of our products
through to commercialization and to further recognize the value of our
proprietary discovery platform."
    Viventia's late-stage pipeline consists of Armed Antibodies(TM), a novel
class of anti-cancer therapeutics that are designed to be safer and more
beneficial for cancer patients. These products are fusion proteins comprised
of human/humanized monoclonal antibody fragments specific to cancer cell
markers, conjugated to highly potent cytotoxic proteins.
    Viventia's three lead products target EpCAM, which has recently also been
identified as a cancer stem cell marker and is one of the most frequently
over-expressed cancer antigens known. A growing body of evidence implicates a
functional role for EpCAM in diverse cellular processes such as signaling,
cell migration, proliferation, and differentiation. Viventia's clinical
portfolio represents one of the most significant anti-EpCAM programs in active
development.

    Proxinium(TM)

    Viventia's lead drug, Proxinium(TM), is a humanized antibody fragment
conjugated to the cytotoxic protein Pseudomonas exotoxin A. The drug is in a
global pivotal Phase 3 clinical trial (the 'TARGET' trial) in patients with
advanced head and neck cancer. Proxinium(TM) has Orphan Drug status in both
the U.S. and Europe and has been designated as a Fast Track product by the
U.S. FDA.
    North American Phase II Update: Viventia recently completed a 15 patient
North American Phase 2 clinical trial with Proxinium(TM). Consistent with the
Company's previously reported Phase 1/2 clinical trial data, preliminary
results from this study continued to demonstrate the relatively benign safety
profile of Proxinium(TM) and its potential to improve local disease control in
an advanced patient population, with the prospect to impact overall survival.
    TARGET Update: TARGET is a randomized Phase 3 trial comparing
Proxinium(TM) monotherapy against Best Supportive Care (BSC), and will include
approximately 300 patients at more than 110 centers in 18 countries. The trial
is currently 50% enrolled, with complete accrual expected in the third quarter
of 2008. The Company recently completed an interim efficacy assessment on the
study's primary endpoint of median survival based on available preliminary
data. This analysis demonstrated an apparent survival advantage in the
Proxinium(TM) arm, with approximately a 40% improvement in median survival
noted between the curves. Similarly, several Proxinium(TM) patients appear to
have achieved durable responses lasting well over 12 months; the expected
survival at this stage of disease advancement is typically 4-6 months. The
final efficacy assessment for TARGET, based on the primary endpoint of median
survival, is expected to be available in the first quarter of 2009.

    Vicinium(TM)

    Viventia's second late-stage clinical product, Vicinium(TM), is in a
Phase 2 clinical study for the treatment of locally recurrent, BCG-refractory
non-invasive bladder cancer. The trial will enroll approximately 50 patients,
and is being conducted at 19 centers in Canada and the U.S. All patients
enrolled in the trial have active, refractory carcinoma in situ, the most
aggressive form of non-invasive bladder cancer, and are unresponsive to
standard therapy with BCG. In the absence of available options, such patients
would typically be considered for radical cystectomy (full surgical removal of
the bladder). Viventia believes that Vicinium(TM) may offer a new therapeutic
alternative to cystectomy for these patients.
    Patients enrolled in the study are receiving either a 6 or 12 week
induction treatment, followed by regular maintenance therapy for patients who
show a benefit following induction. Currently 29 patients have been enrolled
in the trial. Of these, 88% of patients completing induction therapy have
qualified for maintenance dosing, with 9 of the first 18 (50%) patients
assessed for efficacy demonstrating complete responses (no evidence of
disease). None of the patients treated to date have shown disease progression.
Vicinium(TM) has demonstrated an excellent safety profile, showing little
evidence of side effects, unlike the relatively high toxicity associated with
other forms of intravesical therapy, including BCG.

    VB6-845

    VB6-845 is a humanized antibody fragment targeting EpCAM fused with the
Company's proprietary deimmunized form of the cytotoxic protein Bouganin, and
is designed for systemic use against metastatic cancers. VB6-845 is currently
in a Phase 1 dose escalation trial in patients with solid tumors, which is
designed primarily to establish the safety and tolerability of the drug. The
study is also structured to provide preliminary evidence of the efficacy of
this novel cytotoxic conjugate. Approximately 40-50 patients with an advanced
EpCAM-positive epithelial cancer will receive VB6-845 intravenously on a
weekly treatment schedule.
    The study has currently enrolled 12 patients, with the longest treatment
duration being 16 weeks. Encouraging early signs of anti-tumor activity
include demonstrable stabilization of disease in several patients, as well as
objective signs of tumor responses, and signs of improvement in
disease-related sequelae in some patients. Preliminary immunogenicity data
reveal anti-Bouganin levels that are either below or near the limit of
detection, demonstrating the highly successful deimmunization of the protein.
    VB6-845 has demonstrated effective cancer cell killing properties in
pre-clinical tests. A full array of animal efficacy studies and safety studies
of VB6-845 for the treatment of ovarian cancer and other solid tumors has been
completed. In animal xenograft studies, VB6-845 elicited 100% complete cures
of established ovarian tumors. VB6-845 has been shown to be safely tolerated
in both primate and rodent animal safety studies.

    Viventia's antibody and target discovery platform

    Viventia has built a proprietary technology platform to discover and
advance the next generation of anti-cancer monoclonal antibodies. Viventia's
technologies address the fundamental considerations in developing
antibody-based therapeutics: 1) choice of target; 2) method of generation; 3)
mechanism of action; and 4) production.

    
    -   Viventia's UnLock(TM) platform isolates and identifies novel
        membrane-associated tumor markers. To date, it has identified 14 new
        potential cancer drug targets. Preliminary proof of concept studies
        performed in animal models of cancer has demonstrated the clinical
        potential of several of these targets. Viventia is actively
        investigating the relationship of some of these targets, including
        CD44E and Glut-8, to cancer stem cells.

    -   Viventia's Fusogenics(TM) platform generates fully human monoclonal
        antibody libraries by leveraging the natural immune response of
        cancer patients and capturing the resulting antibodies in a
        proprietary soluble functional library. Combining both binding and
        functionality, Viventia's Fusogenic(TM) libraries are designed for
        rapid, high-content screening, focused on the assessment of
        therapeutic potential.

    -   Viventia's ImmunoMine(TM) platform is a high-throughput antibody
        screening process that, through increasingly more rigorous tests,
        rapidly sorts therapeutically promising, tumor-specific antibodies
        from antibodies that react with normal cells.

    -   Viventia's Armed Antibody(TM) platform creates novel therapeutics by
        combining the selective targeting properties of antibodies with the
        efficacy of highly potent, tumor-activated payloads.

    -   Viventia's product development is supported by scalable internal cGMP
        manufacturing focused on high-yield microbial production. Viventia's
        process development expertise has facilitated the establishment and
        scale-up of commercially viable manufacturing processes for
        Proxinium(TM) and Vicinium(TM).
    

    About Viventia Biotech:

    Viventia Biotech Inc. is a biopharmaceutical company developing Armed
Antibodies(TM), powerful and precise anti-cancer drugs that combine cytotoxic
protein payloads with the highly precise tumor-targeting characteristics of
monoclonal antibodies to overcome various forms of cancer. Viventia's lead
product, Proxinium(TM), is undergoing a global Phase 3 clinical trial for the
treatment of head and neck cancer. Viventia is also developing Vicinium(TM),
which is in a Phase 3 clinical study for the treatment of bladder cancer, and
VB6-845, in Phase 1. The Company has created a portfolio of follow-on
antibody-based drug candidates, and has a discovery engine to provide a rich
and sustainable long-term pipeline.





For further information:

For further information: For strategic enquiries, please contact: Eugene
Rozelman, Investment Banking, HSBC, Tel: (212) 525-4170, Fax: (917) 229-5263,
Email: eugene.rozelman@us.hsbc.com; For further information, please contact:
James Smith, Tel. (416) 815-0700 x 229, Fax. (416) 815-0080, Email:
jsmith@viventia.com, www.viventia.com, www.proxinium.com

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VIVENTIA BIOTECH INC.

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