Press release: phase 1 to commence in Canada.
Approval received to conduct SYNSORB cd clinical trials
Synsorb Biotech Inc SYB
Shares issued 15,474,220 Jan 17 close $10.10
Mon 20 Jan 97 News Release
Mr David Rafter reports
The company has received regulatory approval from the Health Protection
Branch of Health and Welfare Canada to conduct phase I and phase II
clinical trials in Canada for SYNSORB Cd, a potential treatment for
recurring or relapsing antibiotic-associated diarrhea.
C. difficile associated diarrhea (CDAD) arises as a consequence of therapy
with antibiotics and is one of the most common hospital-borne infections.
Symptoms include severe diarrhea, cramping, abdominal pain and fever. In
the majority of cases the condition can be treated with other antibiotics.
However, in an estimated 20% of the more than 3.5 million individuals in
North America who contract the infection, this treatment is ineffective,
leading to a recurring form of the infection and serious complications,
including ulceration of the colon and sometimes death.
The company will initially investigate treating the recurring patient
population, a group that includes more than 750,000 new patients in North
America every year.
A phase I clinical trial will begin on January 26 with the enrollment of 24
healthy volunteers who will be followed over a 21 day course of SYNSORB Cd.
Phase II trials will commence immediately upon successful completion of the
phase I study. SYNSORB Cd is the company's second product to enter clinical
trials.-------------------------------------
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Comment:
Previous press releases dealt with Synsorb Pk, which treats E coli gastroenteritis; this press release marks the debut of Phase I testing of Synsorb Cd, which treats Clostridium difficile infections.
To my simple mind, these treatment packages should be very similar---they both use oligosaccharides to bind the toxins and thus remove them from the gut. Differences between Pk and Cd must consist of some tailoring of the oligosaccharide to mesh with/attract/bond with the different toxins.
Phase I testing of Cd means seeing that it "does no harm" to the two dozen healthy volunteers. Gee whiz---all they'll be doing is eating sugar! Will it still take a year for phase I ?
fred bealle
toronto |
