ProCyte Corp of Seattle, USA, has been rocked by the news that its lead compound, a new product for the treatment of wounds, has proved to be ineffective in pivotal clinical trials. The company's share price reacted strongly to the news, falling 68% on the day of the announcement (Monday October 17).
Iamin Gel (PC1020; glycine-L-histidyl-L-lysine; copper complex) has completed Phase III testing in diabetic plantar wounds, but the results indicate that it is no better than placebo in treating these wounds.
The Phase III studies at 30 medical centers involved 511 people with diabetes and chronic ulcers on the plantar region of the foot. All patients in the study received aggressive wound care including debridement of the wound at study entry, pressure-relieving shoes and patient education. Patients were randomized to receive either 0.5% drug, 2% drug or placebo. The primary endpoints were the reduction in wound size and analysis of the number of patients who achieved full closure of their wound at the end of treatment. Secondary end-points included number of infections and time to healing.
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