Cytodel, Inc. — Department of Health and Human Services STTR Phase I: DESCRIPTION (provided by applicant): Botulinum neurotoxin (BoNT) is the active ingre
Cytodel, Inc. — STTR Phase I award from Department of Health and Human Services.
- Amount
- $223,940
- Agency
- Department of Health and Human Services · National Institutes of Health
- Program / Phase
- STTR · Phase I
- Solicitation
- PA13-234
- NAICS
- —
- Place of performance
- NY
- Period
- —
Description
DESCRIPTION (provided by applicant): Botulinum neurotoxin (BoNT) is the active ingredient in pharmaceutical products like Botox(R) (Allergan), which FDA has approved for therapeutic and aesthetic indications. Because of its inherent toxicity,the dose of BoNT required to treat spasticity disorders in large muscle groups is uncomfortably close to the toxic dose range. Serious adverse events and death have been reported, leading the FDA to introduce a black box warning into labeling for the entire drug class. Because all current BoNT products are manufactured from Clostridium botulinum cultures, they have similar safety characteristics, and cannot be engineered for improved performance using thetools of modern molecular biology. CytoDel has licensed NYU technology developed with NIH support, which enables production of recombinant BoNT derivatives with customized properties. Recombinant BoNT derivatives have bee