Viventia Biotech initiates patient treatment for Vicinium(TM) Phase II bladder cancer trial

    TORONTO, April 3 /CNW/ - Viventia Biotech Inc., a privately held
biopharmaceutical company advancing a portfolio of novel antibody products
focused on cancer, announced today that it has initiated patient treatment in
its open-label Phase II clinical trial for Vicinium(TM), administered using
intravesical instillation for the treatment of locally persistent non-invasive
bladder cancer. The trial, which will initially enroll patients in Canada
before expanding into the U.S., is expected to be fully enrolled by Q4 2007.
Viventia's lead product, Proxinium(TM), is being developed to treat late
stage, locally advanced head and neck cancer and is currently enrolling
patients in its TARGET trial, a pivotal Phase III global clinical trial that
is also expected to complete accrual by the end of 2007. Vicinium(TM) and
Proxinium(TM) are Armed Antibodies(TM) that target the cancer antigen EpCAM.
    "The form of cancer we are treating, Tis bladder cancer, is frequently
unresponsive following initial treatment and these patients usually require
either partial or complete removal of the bladder to avoid metastasis to other
organs," said Dr. Nick Glover, President and CEO of Viventia Biotech. "The
goal of Vicinium(TM) treatment is to substantially reduce or eliminate the
need for surgical resection or removal of the bladder. The potential of
Vicinium(TM) was demonstrated in our previous trial, where an overall 95%
response rate was observed."
    The open-label Phase II clinical trial will enroll approximately
30 patients with locally persistent non-invasive Tis bladder cancer. Tis, or
carcinoma in-situ of the urothelium, is a high-grade form of bladder cancer
that behaves more aggressively than other forms of the disease. Patients with
Tis bladder cancer frequently fail to respond to standard non-surgical
interventions, such as intravesical BCG or local chemotherapy, often leaving
persistent, untreatable tumors throughout the bladder. Surgical removal of the
bladder remains the current standard treatment for this unresponsive form of
bladder cancer. Vicinium(TM) is being tested in this challenging patient
population to establish its effectiveness in eradicating persistent Tis, and
thus potentially offering an alternative therapeutic option for patients with
this tenacious form of disease. Initially, patients will be administered
Vicinium(TM) weekly using intravesical instillation over a period of six
weeks. After this six week induction treatment phase, patients responsive to
therapy may receive up to three additional maintenance cycles of Vicinium(TM)
scheduled over a total treatment period of 51 weeks. The primary clinical
endpoint will be overall response rate assessed using histology of biopsy
samples and urinary cytology. Further details on Vicinium(TM) and this
clinical trial are available at
    Vicinium(TM) has completed a dose escalation Phase I/II clinical trial in
64 patients with high risk, non-invasive bladder cancer. Dosed on a weekly
basis for 6 weeks, Vicinium(TM) was very well tolerated at all dose levels,
demonstrating a safety profile far more favorable than those of established
therapies. Moreover, significant tumor responses were also observed in this
study: 42% of patients achieved a complete response, 13% had a partial
response, and 40% had stable disease, for an overall response rate of 95%. The
early clinical benefit observed with Vicinium(TM) strongly supported further
clinical development as a therapy for superficial transitional cell carcinoma
of the bladder.
    Viventia Biotech retains full global product rights to Proxinium(TM) and
Vicinium(TM). The Company is seeking partners for Proxinium(TM) and
Vicinium(TM) capable of complementing Viventia's development expertise with
their global sales, marketing and commercial capabilities.

    About bladder cancer
    Bladder cancer is the 5th most common cancer in North America.
Approximately 60,000 new cases are diagnosed each year, with an estimated
15,000 deaths attributed to the disease annually. The incidence rate of
bladder cancer has risen by more than 35% in the past decade and its
prevalence in the U.S. population is at least 400,000 cases. Tis is a
particularly aggressive form of the disease. In Tis, involvement of the
urothelium ranges from a small focus to extensive disease throughout the
bladder. The risk of progression to muscle invasive disease and subsequent
metastases ranges from 40 to 80% with Tis, depending on the extent of disease.
Standard treatment is cystectomy. Tis does not respond reliably to the most
common forms of local therapy, BCG or chemotherapy. For many patients, Tis
bladder cancer persists following initial treatment and they ultimately may
require complete or partial removal of the bladder. There are currently
limited therapeutic options for patients failing first line therapy for
persistent disease.

    About Armed Antibodies(TM)
    Viventia Biotech Armed Antibodies(TM) are a new class of therapeutic
anti-cancer products designed to be safer and more beneficial for cancer
patients, based on an approach that leverages the principles of Power and
Precision. The Power of these anti-cancer product candidates is derived from
the potency of certain extremely active naturally occurring proteins, which
are among the most lethal cancer killing agents known. This power is harnessed
by engineering the natural proteins so that they retain all of their intrinsic
potency, but in a form that is only activated when inside a cancer cell,
yielding an exceptionally potent drug that is also far safer than typical
chemotherapies. The Precision of Viventia's product candidates comes from the
cancer-targeting properties of monoclonal antibodies, carefully selected for
their ability to specifically and preferentially bind to cancer cells.
Viventia employs only the component of its engineered human or humanized
monoclonal antibodies that is required to recognize and bind to its target on
a cancer cell.

    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 III clinical trial -
TARGET - for the treatment of head and neck cancer. Viventia is also
developing Vicinium(TM), which is in a Phase II clinical study for the
treatment of bladder cancer, and VB6-845, beginning a Phase I/II clinical
trial for the treatment of solid tumors. 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: James Smith, Tel. (416) 815-0700 x 229, Fax.
(416) 815-0080, Email:,,

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