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 KIRKLAND, Wash., Dec. 13 /PRNewswire/ -- ProCyte Corporation (NASDAQ-NMS: PRCY) announced today that it has been directed by the U.S. Food and Drug Administration ("FDA") to place its Phase III clinical studies of investigational Iamin gel, for topical treatment of foot ulcers in diabetic patients, on hold pending review by the FDA.
 According to Joseph Ashley, ProCyte's president and CEO: "The directive was generated by the FDA on Friday, Dec. 10, pending their review of information to be supplied by the company. This information concerns adverse cardiovascular events that have occurred in the course of the studies, none of which appear at all related to use of our drug or placebo."
 In the course of the company's two Phase III studies, in which 339 diabetic patients have been enrolled, seven patients have died from cardiovascular-related events and 21 other patients have reported cardiovascular events.
 The seven patients who died all had a history of multiple, pre-existing cardiovascular complications. The other cardiovascular events reported range from migraine and chest pains to peripheral vascular disease and coronary artery disease. The deaths and other cardiovascular events occurred in all of the three treatment groups of the blinded studies, which include two different drug levels and a placebo.
 Diabetics with foot ulcers are prone to an increased risk of diabetic complications, such as kidney disease and heart failure, and an increased rate of mortality. According to the American Diabetes Association ("ADA"), each year more than 77,000 deaths result from heart disease related to diabetes, and diabetes-related stroke is responsible for 11,000 deaths annually in the United States. The ADA estimates that 160,000 diabetics in the United States will die this year from diabetes and its complications.
 As part of its clinical program, ProCyte has a standing safety committee comprised of medical and scientific consultants who are versed in toxicology, internal medicine, hepatology and diabetology. It was the conclusion of the three physician consultants, upon their review of the data, that given the underlying cardiac risk factors for the seven patients, these deaths were not an unanticipated or unusual outcome, but rather a factor of normal disease progression. The consulting toxicologist concluded from his review of the acute and prolonged toxicology studies completed to date, that there appears to be no direct or indirect effect of ProCyte's drug on cardiovascular parameters.
 ProCyte has had an independent biostatistician identify the treatment assignments of the patients who died or reported cardiovascular events. As a result of this analysis, the company has learned that patients who died or reported cardiovascular events had been assigned across all three treatment groups as follows:
 No. of Patients(A) Placebo 0.5% Drug 2.0% Drug
 Enrolled in Phase III 116 108 115
 Deaths 2 4 1
 CV Events(B) 9 7 5
 (A) -- As of 12/10/93
 (B) -- Represents number of patients reporting cardiovascular
 The company has not had the data analyzed for effectiveness of the drug in healing wounds, so that the data may be preserved for final analysis upon completion of the studies.
 ProCyte is requesting that the FDA allow the company to resume the Phase III studies, and it is keeping in place the important elements of the Phase III protocols that it hopes will allow the company to resume the studies with minimal effect on the clinical relevance of the studies.
 In initiating the clinical hold, the FDA informed the company that it wants to review the cardiovascular events and deaths reported in the course of the study. The company has complied with the FDA's directive and is submitting all information requested by the agency for its review. ProCyte has requested a meeting with the FDA as soon as possible following the agency's review of the pertinent information.
 ProCyte's proposed stock offering, as previously announced, has been postponed pending resolution of this situation with the FDA.
 ProCyte is a development stage pharmaceutical company that is developing a family of copper-based compounds for wound healing and tissue repair applications. The company completed a successful Phase II study of the Iamin gel for treatment of diabetic ulcers in late 1992, and commenced the Phase III studies in early 1993.
 -0- 12/13/93
 /CONTACT: Karen L. Hedine, vice president, or Joseph Ashley, president and CEO, both of ProCyte Corporation, 206-820-4548/

CO: ProCyte Corporation ST: Washington IN: MTC SU:

TW -- NY015 -- 3003 12/13/93 08:31 EST
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Publication:PR Newswire
Date:Dec 13, 1993

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