"Mentor's product formulation has been designed to yield a more purified product than any botulinum based pharmaceuticals in current use or development," commented Gary Borodic, assistant clinical professor, Harvard Medical School and a leading botulinum toxin researcher. "This product has the potential to significantly advance the field of botulinum toxin research for a variety of medical conditions."
According to the research team the aim of the study is to improve the outcome of the treatment for patients and to get the improved treatment through the approval process.
The Phase 1 safety and dose escalation study will be a single exposure study with six months follow-up. Upon completing the study, Mentor plans to move quickly into the Phase 2 dose-finding study and then the Phase 3 product registration study, all of which are required to be completed before seeking approval to market and sell the product from the US Food and Drug Administration.
"The initiation of the US clinical program is another significant milestone for Mentor and our botulinum toxin development programme," commented Joshua Levine, CEO of Mentor Corporation. "We are aggressively advancing our facial aesthetics development pipeline and believe that the botulinum toxins as well as the dermal filler products have significant potential in this rapidly expanding market."
Botulinum toxin is in fact a poison and is extracted from the bacteria Clostridia botulinum. In contaminated food the bacteria can prove lethal, but in the 1960s US medical researchers discovered that small doses of the substance could be safely injected to treat severe cases of facial muscle spasms.
More recently the treatment has proved popular as an anti-wrinkle remedy. Commonly known as 'Botox', which is marketed by leading US pharmaceutical company Allergen, the treatment takes the form of small injections, administered by approved medical experts to treat crow's feet and wrinkled areas on the forehead. A smoother, less wrinkled skin is said to then last up to six months before further treatment is necessary.
Mentor, develops, manufactures and markets science-based products for the aesthetics and urologic specialties markets around the world, established its botulinum toxin programme through a broad licensing agreement with the Wisconsin Alumni Research Foundation in December 2003.
Under terms of the agreement, the company obtained the rights to all strains of the botulinum toxin, including botulinum toxin type A, and has the right to manufacture, develop and commercialise the underlying technology for all applications in all markets, worldwide.