ProCyte Corp. has put a hold on its Phase III studies of Iamingel for treatment of diabetic foot ulcers pending FDA review ofadverse cardiovascular events that have occurred in 28patients.
As a result the company's stock (NASDAQ:PRCY) plunged 30percent, or $4.63 a share, to close at $10.88 in extremely heavytrading volume of 2.3 million shares (in comparison, ProCyte'slargest stock volume last week was 48,700 shares).
During two Phase III studies involving 339 diabetic patients,seven patients have died from cardiovascular events (CVs) and21 others have reported cardiovascular events. ProCyte'spresident and chief executive officer, Joseph Ashley, stated thatnone of the adverse events "appear at all related to use of ourdrug or placebo."
FDA requested that the studies be halted on Friday. Over theweekend ProCyte had an independent biostatistician analyzethe breakdown of the treatment groups -- placebo, 0.5 percentIamin, and 2 percent Iamin -- and found that the adverseevents occurred in all three regimens. Two patients died andnine had CV events in the placebo group, four died and sevenhad CV events in the 0.5 percent drug group, and one died andfive had CV events in the 2 percent drug group.
The deaths included five cardiac arrests, one vasculitis (anallergic reaction to the antibiotic dicloxicillin) and onecardiogenic shock. ProCyte said all of these patients had ahistory of multiple, pre-existing cardiovascular complications.CVs ranged from migraine and chest pain to peripheralvascular disease and coronary artery disease. ProCyte citedstatistics from the American Diabetes Association that eachyear more than 77,000 deaths result from heart disease relatedto diabetes and 11,000 deaths result from diabetes-relatedstroke.
ProCyte (NASDAQ:PRCY) of Kirkland, Wash., has submitted thedata analysis to FDA and is requesting permission to proceedwith the trials. The company has asked for a meeting with theagency as soon as possible. Until the issue is resolved, ProCytehas postponed its follow-on offering of 2.5 million shares ofcommon stock, which was announced Dec. 7.
Jay Silverman, an analyst with Wertheim Schroder & Co., one ofthe managers of ProCyte's offering, told BioWorld that this is a"temporary setback" for the company. He said that the drug, apeptide-copper topical compound, has nothing to do with thevascular events. FDA is being more cautious in the wake offialuridine (FIAU), Silverman said. That situation has caused a"major fallout at FDA and the National Institutes of Health," andpeople at the agency are scared, Silverman said.
-- Brenda Sandburg News Editor
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