Mycobacterial Cell Wall-DNA Complex (MCC) (Urocidin)
- From: J <analyse@invalid>
- Date: Tue, 04 Apr 2006 04:10:02 -0400
http://www.theglobeandmail.com/servlet/story/LAC.20060404.RBIONICHE04/TPStory/Business
Bioniche wins FDA approval for cancer trial
Reuters News Agency
TORONTO -- Bioniche Life Sciences Inc. said yesterday the U.S. Food and
Drug Administration had given it approval to begin the second Phase 3
trial of its treatment for bladder cancer.
The small biotech company said the trial on Mycobacterial Cell Wall-DNA
Complex (MCC) will involve approximately 630 patients in a randomized,
double-blind multicentre trial.
Bioniche said the study, to be conducted in North America and Europe, will
compare Urocidin to Bacillus Calmette-Guerin (BCG) as first-line therapy
in non-muscle invasive superficial bladder cancer at high risk of
recurrence or progression.
The company said both the first and second Phase 3 trials will be carried
out simultaneously.
Last week, company president and chief executive officer Graeme McRae said
that completion of the trials and subsequent approval to market the
product in the huge U.S. market will boost Bioniche's earnings by 270 per
cent, or $100-million (U.S.) in its first year, compared with 2005 revenue
of about $27-million.
Application to the FDA is not seen until at least 2010, Mr. McRae said,
with a more conservative date for approval set for 2012.
Bioniche closed on the Toronto Stock Exchange yesterday at 95 cents
(Canadian), up 15 cents.
- - - - -- - - - - - - -
Details of phase III trial with Urocidin revealed for treatment of bladder
cancer
December 14th, 2004
Bioniche Life Sciences, Inc., (BNC), a research-based, technology-driven
Canadian biopharmaceutical company, announced details of its upcoming
phase III clinical trial using its proprietary Mycobacterial Cell Wall-DNA
Complex (MCC) - trademarked Urocidin - for the treatment of bladder
cancer.
This will be an international trial involving approximately 60 sites in
North America and Europe.
Alvaro Morales, professor of urology and oncology at Queen's University
in Kingston, Ontario is the International Principal Investigator for the
trial. At yesterday's Annual Meeting of Shareholders, Morales introduced
the two other lead investigators:
http://www.bioniche.com/news_item.cfm?id=1566
Dr. Alvaro Morales, Principal Investigator for Bioniche?s Phase I/II
clinical trial in refractory Carcinoma in situ (CIS) of the bladder,
showed results indicating that of the 25 enrolled patients, 24% were alive
and disease free (complete response) after 18 months, and 8% showed a
partial response for a total positive response rate of 32%. MCC
(Urocidin?) was extremely well tolerated by the patients and there were no
apparent safety concerns
The Company?s Senior Vice-President, Scientific Affairs and Chief
Scientific Officer, Dr. Nigel Phillips, presented data that demonstrated
MCC is effective in causing cell cycle arrest and inducing apoptosis in a
range of bladder cancer cell lines derived from high grade bladder cancers
and where the cells possess mutations in cell cycle/apoptosis regulators.
Dr. Phillips also presented data showing that MCC (Urocidin?) stimulates
urinary apoptosis markers and cytokines following intravesical
administration to patients with Carcinoma in situ of the bladder.
?Building on the positive clinical results obtained to date for the
treatment of Carcinoma in situ of the bladder, these findings indicate MCC
may be effective in treating other types of aggressive bladder cancer,
such as high-grade transitional cell carcinoma,? said Dr. Phillips.
Dr. Mario Filion, Bioniche?s Head of Biomedical Research, presented data
demonstrating that the combination of MCC with hyaluronic acid (HA)
enhances both the apoptosis-inducing activity of MCC against prostate
cancer cell lines, and the immune stimulatory activity of MCC (stimulation
of anticancer cytokine synthesis by human immune effector cells).
?These data are confirming the therapeutic potential of MCC in different
urology-oncology indications. We will be reporting on Phase I safety
results using an MCC/HA suspension in prostate cancer patients before the
end of the year,?
.
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