Two articles detailing the results of controlled clinical studies ofCurative Technologies Inc.'s (CTI) investigational wound healingtherapy have been published in the July/August issue of thejournal Wounds, the company announced Tuesday.
CTI's compound CT102 is a homologous topical treatmentcontaining a naturally occurring mixture of several growthfactors derived from pooled human blood platelets. Thecompany (NASDAQ:CURE) is developing the product to treat thechronic non-healing wounds that are common in peoplesuffering from diabetes. These wounds, which can remain asopen sores for months or even years, often lead to gangreneand amputation.
In the Phase II clinical studies, which were randomized,double-blinded and placebo-controlled, 70 diabetic patientswith chronic non-healing foot ulcers were treated with one ofthree doses of the compound or placebo for 140 days, or untilthe wound was completely healed. Dose was defined as adilution -- 0.01, 0.033 or 0.1 -- of the original platelet lysate.Efficacy was determined by evaluating complete healing(functional maturity) and reduction in area and volume ofwounds.
According to Curative of East Setauket, N.Y., "all parametersindicative of healing were significantly improved when theCT102-treated patients were compared to the placebo group.Twenty-nine percent of the patients healed in the placebogroup as compared to 80, 62 and 52 percent in the 0.01, 0.033and 0.1 dilution groups, respectively."
In addition, healing times were significantly reduced forCT102-treated wounds, and "there were no significant sideeffects associated with CT102 compared to the placebo,"according to the study's lead author, G. Allen Holloway of theMaricopa Medical Center in Phoenix, Ariz.
The companion paper published in Wounds consists of a cost-efficacy analysis of the Phase II data performed by Arthur D.Little Inc. Judith Bentkover and Annette Champion of A.D.Little's health economics group evaluated the economic impactof treating patients with CT102 and a conventional treatment(saline solution).
Applying a direct medical cost model to the results (whichincluded everything from the initial screening exam to lower-extremity amputation for patients with ulcers that did notheal), the evaluation estimated the costs of diagnosing andtreating diabetic foot ulcer patients under routine non-clinicaltrial circumstances.
The A.D. Little team found that the cost per patient healed at awound care clinic with CT102 was 38 percent less ($22,562)than the cost per patient healed at a wound care clinic withsaline solution ($36,185).
-- Jennifer Van Brunt Senior Editor
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