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Mentor initiates phase I trial in spasmodic torticollis

Mentor Corporation has initiated a phase I study of its proprietary botulinum toxin type A product for the treatment of pain associated with adult onset spasmodic torticollis/cervical dystonia in the US.

Adult onset spasmodic torticollis/cervical dystonia is a syndrome that causes abnormal involuntary movements or posture of the head and neck, often followed by pain in the back portions of the neck. The relentless nature of the condition can be incapacitating for many patients and result in a deterioration in the quality of life of those afflicted.

The phase I safety and dose escalation study will be a placebo controlled, single exposure study with four months follow-up.

“The initiation of the US clinical program for torticollis is another significant milestone for Mentor and our botulinum toxin product development program,” commented Joshua Levine, President and CEO of Mentor Corporation. “We are aggressively advancing our product development pipeline and will leverage our opportunities broadly to maximize shareholder value.”

Mentor established its botulinum toxin program through a broad licensing agreement with the Wisconsin Alumni Research Foundation in December 2003.

Under terms of the agreement, Mentor obtained the exclusive rights to all strains of the botulinum toxin, including botulinum toxin type A, and has the right to manufacture, develop and commercialize the underlying technology for all applications in all markets, worldwide. The company is currently conducting a phase II study for the cosmetic indication of glabellar lines.