Finally some important news today:
Stock up from $0.80 to $.95 on 235,000 shares.
Procyon BioPharma Inc. :
Innovative Product to Reduce
Severe Scars From Surgery
and Burns, Procyon
BioPharma Inc. Announces
IND Application for Fibrostat
(R) Clinical Study
10:06 EST Thursday, December 21, 2000
MONTREAL, QUEBEC--Procyon BioPharma
Inc. ("Procyon") announced today that an IND
(investigational new drug application) to complete
clinical Phase II studies, has been filed with the
Canadian Therapeutics Products Program (TPP)
branch of Health Canada for FIBROSTAT(R), a
topical cream for the treatment of severe scars
resulting from surgery and burns. The application
was filed by Procyon's development partner,
Crystaal, the Canadian marketing division of
Biovail Corporation ("Crystaal").
"This IND application brings us one very
significant step closer to seeing this innovative
product on the market," said Hans J. Mader,
President and CEO of Procyon. "It represents the
completion of the final Phase II program before
commencement of Phase III studies in Canada. We
plan to enter Phase III clinical trials by the third
quarter of 2001. We and our partner, Crystaal, are
working very hard to accelerate the development of
this product and to assure that its potential capacity
to reduce severe scarring by more than 50% can be
placed at the disposal of the public as soon as
possible," he added.
"We are very enthusiastic about the development
of FIBROSTAT(R)," said Michel Chouinard,
President of Crystaal. "It is innovative, and as a
topical cream, easy to use, with the real potential to
provide relief to patients suffering from the effects
of scarring, pain and irritation following general
surgery, plastic surgery and burns."
This clinical trial will involve eight centers across
Canada, with an enrollment of a total of 128
patients. Study protocols for the trial have been
designed with the intention of including the results
for the filing for new drug submissions in the U.S.
and overseas jurisdictions besides Canada.
In February 2000, Procyon signed an agreement
with Biovail Corporation under which Biovail
acquired under licence the Canadian rights to
FIBROSTAT(R). Under this agreement, Biovail
committed to a financing of Cdn$1.5 million to
Procyon for the completion of the development of
FIBROSTAT(R) through Phase III trials, leading
to approval by the Canadian TPP. Upon approval,
Procyon will receive a Cdn$1.0 million milestone
payment as well as a double-digit percentage
royalty on sales. Procyon also granted Biovail a
first right of negotiations for the marketing rights of
FIBROSTAT(R) in the U.S.
FIBROSTAT(R) has already been tested and used
by over 200 patients in Canada in clinical trial and
under the Special Access Program with excellent
feedback not only in terms of its efficacy in
reducing scarring, but also in significantly
alleviating pain and itch associated with the healing
process.
FIBROSTAT(R) is patented in the U.S, Canada,
Japan and Australia, with patent pending in Europe
and is one of two late-stage products in Procyon's
development pipeline. It was invented by Dr. Ken
Dolynchuk, a plastic surgeon at the University of
Manitoba, and has been exclusively licensed to
Procyon.
Procyon is a publicly listed, biopharmaceutical
Company focused principally on advancing two
powerful platform technologies that have the
potential to diagnose and treat cancer. Procyon's
non-pathogenic Antinuclear Autoantibodies (ANAs)
bind specifically to multiple cancer cell types
strongly enhancing the immune response to cancer
cells. Prostate Secretory Protein (PSP(94)) is a
naturally occurring human protein that has the
potential to treat prostate cancer by inhibiting
abnormal prostate cell growth. In addition, the
estimation of PSP(94) levels in prostate cancer
patients may have prognostic and diagnostic
applications. Procyon also has two late-stage
products: FIBROSTAT(R) and COLOPATH(R) a
rapid, non-invasive screening test for colorectal
cancer.
Procyon's shares trade on the Toronto Stock
Exchange under the ticker symbol, PBP. |
