More good news....
SYNSORB Biotech Inc. Announces SYNSORB Pk(R) Receives Fast Track
Product Designation from USFDA
CALGARY, ALBERTA--SYNSORB Biotech Inc. ("SYNSORB") (TSE: SYB;
Nasdaq: SYBB) today announced that SYNSORB Pk(R) has received
formal notification of Fast Track Product designation from the
United States Food and Drug Administration (FDA) for treatment of
enteric hemorraghic E. coli O157 infections (EHEC).
Fast Track Product designation is granted to products that target
a treatment for a serious or life-threatening condition, and
demonstrate the potential to address unmet medical needs for such
a condition. This designation by the FDA is intended to
facilitate development and expedite review of these products.
"SYNSORB is extremely pleased to receive formal notification of
our Fast Track Product designation from the FDA," noted Dr. David
Cox, President and CEO of SYNSORB Biotech Inc. "We will continue
to work with the regulatory authorities to advance SYNSORB Pk(R)
through clinical trials and if successful, provide clinicians with
what will be the first and only approved treatment to fight this
horrible disease."
SYNSORB is dedicated to accelerated drug development from the
acquisition of promising compounds emerging from basic research
through clinical development, and ultimately to providing channels
to market for new discoveries. Headquartered in Calgary, SYNSORB
currently has two products in late stage clinical development,
SYNSORB Pk(R) in Phase III clinical trials for the prevention of
HUS and the treatment of enteric hemorrhagic E. coli (EHEC)
infections (including O157:H7), and SYNSORB Cd(R) in Phase II
trials is designed to treat recurrent antibiotic-associated
diarrhea (CDAD). SYNSORB has additional compounds in pre-clinical
development, including REOSYN, a potential cancer treatment being
developed within its subsidiary company, Oncolytics Biotech Inc.
and novel antibiotics for various bacterial and fungal infections.
In the Company's research and development program various
indications including inflammation are currently being targeted.
Shares of SYNSORB Biotech Inc. trade on the Toronto Stock Exchange
in Canada (symbol "SYB") and on NASDAQ in the United States
(ticker "SYBB").
This release contains certain forward-looking statements which
involve known and unknown risks, delays, uncertainties and other
factors not under the Company's control which may cause actual
results, performance or achievements of the Company to be
materially different from the results, performance or other
expectations implied by these forward-looking statements. These
factors include results of current or pending clinical trials,
actions by the FDA/HPB and those factors detailed in the Company's
registration statement on Form 20 F filed with the Securities and
Exchange Commission.
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FOR FURTHER INFORMATION PLEASE CONTACT:
The Equicom Group
Jason Hogan
Investor Relations
(416) 815-0700 ex 222
(416) 815-0080 (FAX)
jhogan@equicomgroup.com
synsorb.com
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