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Recombinant Botulinum Neurotoxin for Treatment of Spastic Disorders

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41NS086115-01A1
Agency Tracking Number: R41NS086115
Amount: $223,940.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NINDS
Solicitation Number: PA13-234
Solicitation Year: 2014
Award Year: 2014
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
NEW YORK, NY 10023-8128
United States
DUNS: 78736623
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (212) 598-6358
Business Contact
Phone: (973) 342-4899
Research Institution
One Park Avenue 6th Floor
NEW YORK, NY 10016-5802
United States

 () -
 Nonprofit college or university

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

* Information listed above is at the time of submission. *

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